Modern Pharma - 1-15 February 2013

India is aiming to export pharmaceutical products worth $ 15.5 billion in 2012-13 fiscal, a jump of around 17 per cent compared to $ 13.22 billion in 2011-12. “The $ 25 billion target, however, for pharma exports in 2013-14 would be a challenging task in view of the global slowdown” said Mridul Jain, Ministry of Commerce and Industry Joint Secretary.

“Our industry has told us about the economic impacts on pharmaceutical orders especially from Africa and least developed countries where health campaigns have slowed down; it would be challenging to meet the $ 25 billion export target for 2013-14,” Jain told PTI after addressing an Indian pharmaceutical seminar in Singapore.

The industry is in a position to capture other emerging opportunities, especially manufacturing of ‘off patent’ products or products with expired

patent, which would offset some of the decreases in orders, Jain added.

Underlining the Indian government’s policy of ‘zero tolerance’ on quality of pharma products, she said ‘track and trace barcodes’ has been introduced on consignments exported to the global market as part of the ongoing promotions and quality assurances of ‘Made-in-India’ products.

“We continue to stress on efficiency, efficacy and quality of the pharmaceutical products,” said Jain.

The European and American markets accounted for 55 per cent of the Indian pharmaceutical product exports, reflecting that most of these products were made to the highest specification of the USFDA.

“The export volumes to the European and US markets speak volumes about the high quality of

Indian pharmaceutical products,” said Jain, adding that the products were shipped to some 220 countries.

The Indian pharmaceutical industry reported business growth of about 15 per cent on compounded aggregated growth rate between 2006-07 and 2011-12. Further, market initiatives were underway to promote exports, especially the International Exhibition for Pharma and Healthcare (IPHEX) to be held on April 24-26, 2013 in Mumbai.

“We will be hosting 300 international buyers and 100 regulators from major markets at the exhibition to showcase Indian products,” she said.

Over 600 Indian companies would participate in IPHEX, being organised by the Pharmaceuticals Export Promotion Council of India, set up by the Ministry of Commerce and Industry.

In Conversation With 16Dr Krathish Bopanna

President & CEO, Semler Research Center

Special Focus 18Inadequate IT infrastructure

Challenges faced by small startups and ways to overcome them

Tips & Tricks 28Checklist for best cleanroom

infrastructure Right steps to follow

Interface 27 Ganesh Sambasivam Co-Founder & CSO, Anthem Biosciences

GSK-WADA in anti-doping pact The World Anti-Doping Agency (WADA) has inked an agreement with GlaxoSmithKline to help detect banned substances in sports. GSK had signed an agreement with WADA to support in detection of doping compounds in the early stage. Subsequent to the new pact, GSK scientists will identify substances with a probable or high risk of abuse

in sports. Commenting on

the development, John Fahey, President, WADA, s a i d , “ O u r work with the pharmaceutical industry is critical

to staying one step ahead of the dopers, who have an ever increasing level of scientific expertise. We are delighted to be entering into this partnership with GSK as it will play a significant role in helping WADA achieve its mission of a doping-free sporting culture.” WADA also inked several such agreements with different drug companies.

Aurobindo Pharma receives final approvals for oxacillin injectionAurobindo Pharma Ltd recently announced that the company has received final approvals from the US FDA to manufacture and market oxacillin for injection USP, packaged in 1 g and 2 g vials (ANDA 201539) and oxacillin for injection USP 10 g/vial pharmacy bulk package (ANDA 201538).

The products are ready for launch. Oxacillin for injection USP is a Sterile Semisynthetic Penicillin (SSP) indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug.

Par Pharma launches lamotrigine tablets in the US marketPar Pharmaceutical Companies’ operating subsidiary, Par Pharmaceutical, Inc has recently received final approval from the US FDA for its ANDA for lamotrigine 25 mg, 50 mg, 100 mg, 200 mg, 250 mg and 300 mg Extended-Release (ER) tablets.

Lamotrigine ER is the generic version of GSK’s Lamictal XR and is indicated as adjunctive therapy for partial onset seizures with or without secondary generalisation in patients. Par has begun shipping all strengths of the product.

1 - 15 F e b r u a r y 2 013 I Vo l 1 I N o 15 I `10 0

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Ranbaxy, Daiichi Sankyo to maximise synergies in Thailand

DCGI directs manufacturers to tighten safety standards

Drug firm Ranbaxy Laboratories and its Japanese parent Daiichi Sankyo will integrate their business operations in Thailand as part of strategy to maximise synergies.

Both the companies intend to integrate their business operations in Thailand to leverage and maximise the synergies of hybrid business model, which is expected to commence business on April 1, 2013, Ranbaxy said in a statement.

“The planned integration of operations will provide a strong foundation for future Daiichi Sankyo group expansion in Thailand,” the statement added. The development would be mutually beneficial to Ranbaxy and Daiichi Sankyo as it is expected to enhance their competitiveness, the company said.

As per the plan, Daiichi Sankyo and Ranbaxy would integrate the management of Daiichi Sankyo’s subsidiary in Thailand, Daiichi Sankyo (Thailand) (DSTH) and Ranbaxy’s Thailand subsidiary, RanbaxyUnichem Co (RUCL).

“ T h e n e w representative of the proposed integrated entity will be Suthas Thongprasert, who presently heads DSTH,” the company said.

The pharmaceutical market in Thailand is the second largest among ASEAN countries, and DSTH, has built its presence mainly by targeting healthcare facilities through innovative pharmaceuticals.

The company was founded in 1994 and had sales of $ 13 million in FY2011.

On the other hand, RUCL which markets generic medicines focusing on primary healthcare and pharmacies, was

established in 1983 and had sales of $ 14 million in 2011.

Ranbaxy became a part of the Daiichi Sankyo Group in 2008 after Japan’s third largest drug-maker bought a majority stake for ` 22,000 crore.

Under the hybrid business model adopted by the two firms, Ranbaxy

primarily focusses on generic medicine research both for itself and its parent firm, while the new drug discovery programme is undertaken taken up by Daiichi Sankyo.

The authority for drug regulation in India has directed the manufacturers in the industry to take a stronger stand to tighten safety and efficacy standards. This directive comes in the context of Fixed Dose Combination (FDC) issues. In absence of sanctions in terms of safety standard, the licenses of manufactures stand the risk of being banned.

Dr G N Singh, DCGI, said, “As regards the new FDCs, if any, licence by the state licensing authorities after

October 1, 2012 without approval of DCGI, the same will be considered for being prohibited for manufacturing and marketing in the country.” The SME sector could benefit from this.

A notice from the authority revealed, “ T h e M i n i s t r y

of Health and Family Welfare (MoHFW) had issued repeated statutory directions under Section 33P to the state governments to instruct their respective drug licensing authorities to refrain from granting licence for manufacture of new drugs and FDCs covered under the definition of new drug without due approval of the DCGI.”

Fahey

Dr Singh

CONTENTSIn Conversation With 16Dr Krathish Bopanna President & CEO, Semler Research Center

Event Preview 32 Bangalore India Bio 2013 Multi-functional opportunities under one roof

Printed by Mohan Gajria and published by Lakshmi Narasimhan on behalf of Network18.Senior Editor: Manas R BastiaPrinted at Infomedia 18 Ltd, Plot no.3, Sector 7, off Sion-Panvel Road, Nerul, Navi Mumbai 400 706, and published at Network18, ‘A’ Wing, Ruby House, J K Sawant Marg, Dadar (W), Mumbai - 400 028. Modern Pharma is registered with the Registrar of Newspapers of India under No. MAHENG / 2008 / 27125. Network18 does not take any responsibility for loss or damage incurred or suffered by any subscriber of this magazine as a result of his/her accepting any invitation/offer published in this edition.

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Highlights of Next EditionSpecial Focus: Cleanrooms

REGULAR SECTIONS5 Editorial / Guest Editorial

6 News, Views & Analysis

29 Projects

30 Tenders

31 Event List

33 Book Review

34 Products

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38 List of Products & Advertisers

27

16 18

26

18Inadequate IT infrastructure Challenges faced by small startups and ways to overcome them

Special Focus IT in pharma

26Automation Trends - Case Study Benefits of automated ‘vision’: Ensuring quality in pharmaceutical production

Insight & Outlook

Facility Visit 24 Labindia Analytical Instruments Pvt Ltd Leveraging advanced technology for speedy success

Roundtable Can IT alone address the supply chain issues in pharma sector?

Interface Ganesh SambasivamCo-Founder & CSO, Anthem Biosciences

Tips & Tricks Checklist for best cleanroom infrastructure: Right steps to followP K Kulkarni, Managing Director, Technolutions Projects Pvt Ltd

2022

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IT applications in pharma SMEs Providing the right cl(k)ick!

27

28

5Editorial

E-governance for pharma!

EditorialAdvisory Board

Ajit SinghChairman,

ACG Worldwide & Head, ISPE

Dr Abraham PataniPast President, IDMA & CMD, Inga Laboratories

Dr Gopakumar G NairIPR Consultant & Advisor

Dilip G ShahChairman, IGPA &

Secretary General, IPA

Daara PatelSecretary General, IDMA

The e-age has dawned and how! Although it took some time to spread its footprint in the pharmaceutical sector, it has surely begun. There are

interplays of multiple complex factors in this arena. Given a strict regulatory mechanism for doctor–patient interactions but without adequately defined clear guidelines, the challenges before us are many, especially when the pharma marketing system in the country is evolving from traditional to new channels. In addition, as patient profiles change with time, the advent of digital technology is making sure that the pharma marketers refine their perspectives as well as their strategies to leverage the e-platform.

Against this background, the Planning Commission’s recent recommendation of introducing e-governance systems in the pharmaceutical sector is a welcome move. Part of the draft plan document for the 12th Five Year Plan, this is aimed at inter-connecting all licensing and registration offices with laboratories. Besides, the panel has recommended global positioning system-based sample collection systems and online applications for licensing.

While the draft plan document is currently in the process of being approved by the National Development Council, it has recommended for legislation to make mandatory codes to identify and penalise unethical promotion on the part of pharmaceutical companies in the marketing of drugs. As per this document, while a repository of approved formulations at both state and national levels would be developed, the drug administration system

would build capacity in training and encourage self-regulation.

In this direction, the draft plan document has suggested a mandatory disclosure by pharmaceutical companies of the expenditure incurred on drug promotion, ghostwriting in the promotion of pharma products to attract author disqualification with penalty on the company and vetting of drug-related material in continuing medical education. To have an adequate impact and avoid medical conflicts of interest, there is a need for legislation wherein pharmaceutical companies would disclose payments made to doctors for research, consulting, lectures, travel and entertainment – as rightly recommended by the Planning Commission in this matter.

Further, its recommendation for the Ministry of Health and Family Welfare to encourage public & patient education in the appropriate use of drugs, particularly antibiotics & antimicrobials, would go a long way in ensuring benefit for individual patients as well as public health.

Last but not the least, there has to be a ground-up action plan to implement it in a time-bound manner involving pharmacovigilance, post-marketing surveillance, adverse drug response monitoring, quality control and testing & re-evaluation of registered products, among others.

Expectations from Budget for pharma sector

T his is going to be an interesting year for the Indian pharma industry. On one hand, we have stricter norms coming

up for illegal drug trials and unethical marketing practices, MNC buy outs and compulsory licences to manufacture generic version; on the other hand, we have the Planning Commission determined to crack down the pharma-doctor nexus. Although it appears to be a daunting task, we see the government rising up to the challenge.

The expectations from this year’s Union Budget for the pharma sector will be around tax deduction and planned incentives for growth drivers for the sector that includes contract manufacturing, R&D for pharma drug discovery and clinical trials.

Last year, service tax increase from 10 to 12 per cent came as a blow to the sector. Also, multi-fold increase in excise duty was not a welcome news at all in 2012. This year there are expectations from the government to cut on excise duty on both chemical inputs and finished pharmaceutical products. The pharma industry demands to rationalise the inverted duty structures where formulations were taxed at 5 per cent

and API at 10 per cent which for integrated manufacturers results into a cumulative CENVAT.

Pharma industry is also looking for export-related fiscal support and merely cutting the Corporate Tax might not help; we would wish if they can reduce the Minimum Access Tax (MAT) too. Also, because India is an attractive R&D and a contract manufacturing choice, we expect specific tax benefits for units engaged in R&D or contract manufacturing and not just in-house R&D. This benefitted large players like Dr Reddy, Glenmark and Biocon but did not bring any new hope for small contract manufacturing and R&D companies. We need our companies to market their new inventions on a global scale and hence we require availability of additional benefits post R&D and pre-launch stage as well. We are expecting that the government will keep in mind the industry growth in mind and will talk about Advance Pricing Agreements (APAs) that would predominantly assist healthcare and pharma companies to considerably reduce uncertainty on taxation of such international transactions.

To incubate innovation, government may want to look at providing weighted

reduction to clinical trial expenditure done by non-manufacturing bodies in approved hospitals. The success ratio in R&D is very low, even if a company is spending a billion dollar on the development of drug, there is no certainty on the returns on initial investment, and hence, it is necessary that instead of spreading the CENVAT credit paid across 2 financial years, the government should encourage companies by providing credit in the first year itself. Also, it will be great if in this year Budget as well the government keeps its promise to keep diagnostics services out of service tax scope.

For pharma, one of the growth oriented areas is IT. For clinical trials, supply chain management, and analytics, the industry is also looking to adopt IT technologies but flood of generics, intensified competition, shrinking drug pipelines, and lowered cash flows are hindering adoption. If even 80 per cent of the aforesaid expectations are met during this Budget, then we will witness a surge in the industry’s IT spending as well.

Dr Ruchi Dass Founder & CEO,

HealthCursor Consulting Group

Guest Editorial

Manas R Bastia [email protected]


FDA issues complete response letter for Rytary™

Pfizer introduces Quillivant XR™ in the US market

Impax Pharmaceuticals, a division of Impax Laboratories, announced recently that the US FDA issued a complete response letter regarding the New Drug Application (NDA) for Rytary™ (IPX066), an extended-release capsule formulation of carbidopa-levodopa, a potential treatment for the symptomatic treatment of Parkinson’s disease currently under review in the US.

The complete response letter indicates that the FDA requires a satisfactory re-inspection of the company’s Hayward facility

before the company’s NDA may be approved due to the facility’s involvement in the development of Rytary, and supportive manufacturing and distribution activities. During the assessment of the NDA, the company withdrew the Hayward site as an alternative site of commercial production at launch.

“We will work with the FDA on the appropriate next steps for the Rytary application,” said Larry Hsu, PhD, President and CEO, Impax Laboratories, Inc. “We remain committed to resolving the warning letter and bringing this new

treatment option to patients who are suffering from Parkinson’s disease.”

A complete response letter

is issued by the FDA’s Center for Drug Evaluation and Research when the review cycle for a drug is complete and the application is not yet ready for approval.

Pfizer Inc introduced Quillivant XR™ (methylphenidate hydrochloride) CII, an extended-release oral suspension, for sale in the US market. The formulation is indicated for Attention Def ic i t Hyperact iv i ty Disorder (ADHD), which would be now available on doctors’ prescription.

Making the announcement Ann Childress, MD, President, Center for Psychiatry and Behavioral Medicine, said, “In order to effectively treat patients with chronic conditions such as ADHD, it is important to consider individual patient

needs, including options for medication administration. As the first once-daily, extended-release liquid medication for patients with ADHD, Quillivant XR represents a new alternative to other ADHD treatments.”

Quillivant XR was approved by the US FDA on September 27, 2012 for the treatment of ADHD in patients aged 6 years and above. The efficacy of Quillivant XR was evaluated in a randomised, double-blind, placebo-controlled, crossover, multicenter, laboratory classroom study of 45 children with ADHD. Quillivant XR significantly improved

ADHD symptoms compared to placebo at the primary endpoint of four hours post-dose, and in a secondary analysis, showed significant improvement at every time point measured, from 45 minutes to 12 hours after dosing.

Pfizer plans to offer Quillivant XR to patients in need through the Pfizer Helpful Answers® program. Pfizer Helpful Answers is Pfizer’s family of patient-assistance programmes that help eligible patients in the US in need get a c c e s s t o t h e i r Pfizer medicines.

In BriefLupin receives FDA approval to market generic Lutera® tablets Lupin Ltd recently announced that its subsidiary Lupin Pharmaceuticals Inc (collectively Lupin) has received final approval for its levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg / 0.02 mg from the US FDA to market a generic version of Watson Laboratories, Inc’s Lutera® 28 tablets. Lupin’s levonorgestrel and ethinyl estradiol tablets are a combined oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Lupin will be marketing its generic product shortly.

This is Lupin’s 7th Oral Contraceptive (OC) product approval and a meaningful one within its US OC pipeline. A less competed for segment; there are just three players in the market for this product; Vintage, Teva and Watson. The OC market in the US is valued at around $ 5 billion and growing at around 8 per cent annually. The US OC generics segment is dominated by a few players TEVA (through its Barr acquisition), Watson and Sandoz. Novartis receives EU approval for BexseroNovartis recently announced that the European Commission has approved Bexsero; meningococcal group B vaccine for use in individuals from 2 months of age and older. Novartis is committed to making Bexsero available as soon as possible.

“This meningitis B vaccine is the most important medical breakthrough in the 30 years since I lost my son to the disease,” said Steve Dayman, Founder, MBE Meningitis UK. “It could save thousands of lives and prevent other parents suffering the same tragedy. The vaccine must be made widely available through the immunisation schedule as soon as possible - any delay could mean lives lost.”

“Each year, thousands of parents see their children die or left with severe disabilities as a result of this devastating disease. Through the combined efforts of many people over two decades, we are closer than ever to seeing an end to this suffering,” said Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics. “Our vision is a world without meningitis, and our priority is

to work with decision makers across Europe to ensure there is broad and timely access to vaccination,” he added.

Dayman

7News, Views & Analysis

EMD Serono and Pfizer receive FDA approval for Rebif® Rebidose®

AstraZeneca reconstructs top management

EMD Serono Inc, owned by Merck KGaA, and Pfizer Inc received approval for Rebif® Rebidose® (interferon beta-1a), a single-use auto-injector for the self-administration of Rebif, a disease-modifying drug used to treat relapsing forms of Multiple Sclerosis (MS).

Commenting on the approval, James Hoyes, President, EMD Serono, Inc, said, “We are pleased to announce that the FDA has approved Rebif Rebidose which provides people living with relapsing MS another option to meet their injection needs. The introduction of Rebif Rebidose underscores our commitment to the MS community and to our investment in the

development of delivery devices to assist with ease of use and support those living with MS.”

Liz Barrett, President, North America, Pfizer Specialty Care, informed, “Over the past two

decades, treatment of relapsing MS has advanced and interferons such as Rebif have remained an established treatment options. Rebif has a well-established safety profile with 18 years of clinical trial

and patient experience. We are proud to offer another delivery option for Rebif with the approval of Rebif Rebidose in the US.”

Rebif Rebidose was evaluated in a 12-week phase IIIb multi-

centre, open-label, single-arm study for the self-administration of Rebif with respect to ease of use, patient satisfaction and acceptability, and functional reliability. In the trial, patients with relapsing MS, who were receiving Rebif 44 microgram three times weekly for more than 12 weeks, continued MS therapy using Rebif Rebidose for 12 weeks. The results of the Rebif Rebidose user trial showed that the majority of patients found the device easy to use.

Rebif Rebidose (interferon beta-1a) was designed with the objective to assist with ease of use and to offer patients an alternative delivery option. Rebif Rebidose will be available in a monthly pack in two different doses, 22 microgram and 44 microgram, and in a titration pack.

Pascal Soriot, the new CEO of ailing drugs maker AstraZeneca is restructuring his top management team. Martin Mackay, R&D chief and Tony Zook, head of commercial operations are both out of the doors. Now, the global R&D operation will be under seen by Mene Pangalos, Bahija Jallal and Briggs Morrison. Pangalos will look after discovery and early development of small

molecules, MedImmune’s Jallal to over look early-stage work on biologics and Morrison to notice on late-stage development. All of them will directly report to Soriot.

In a statement, Soriot said, “This new senior executive team structure, that draws

heavily from the leadership talent within the company, enables us to bring an even sharper management focus to key pipeline assets, key brands and key markets, and helps us

further accelerate decision making.” The appointment of Executive Vice President, Global Portfolio & Product Strategy, a role bridging

between the R&D and sales organisation will be made at a later date.

In BriefRoche’s Avastin® new use approved by US FDA The US FDA has approved the new use of Avastin (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy, for the treatment of metastatic colorectal cancer (mCRC). Avastin in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy is now indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen. The approval is based on positive results from the phase III ML18147 study, which were presented at the 2012 American Society of Clinical Oncology Annual meeting and showed that people who continued to receive an Avastin-based regimen after their cancer worsened lived longer than people who switched to chemotherapy alone. “The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment,” said Hal Barron, MD, Chief Medical Officer and Head of Global Product Development, Roche. “These people now have the option to continue with Avastin plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone.” Avastin is approved in Europe in combination with fluoropyrimidine-based chemotherapy for the treatment of adult patients with metastatic carcinoma of the colon or rectum. In 2011, worldwide sales of Avastin hit around $ 5.5 billion. Actavis UK receives Generic Manufacturer of the Year Award at the Alliance Healthcare AwardsActavis UK, one of the top 10 pharmaceutical companies in UK was named as the Generic Manufacturer of the Year at the Alliance Healthcare Awards held on January 10, 2013 at Great Room in the Grosvenor House Hotel on Park Lane, London. The Generic Manufacturer of the Year award is voted for by independent pharmacy customers and recognises generics manufacturers that are excelling in their field by providing excellent product and stock range, customer service delivery and a range of additional support and training to their pharmacy customers; all of which are helps to provide better care to customers and patients. Michael Cann, Director - Generics, Actavis, collected the award on behalf of Actavis and said “We are extremely proud to win this Award which demonstrates our commitment to providing the best advice and a first class service to our pharmacy customers.”

Hoyes


Venus Remedies announced that it is aiming to garner around $ 100 million (over ` 500 crore) in the next five years from its new drug that is used for combating spread of bacterial resistance. The company, which plans to launch the drug in various countries, is introducing ‘Elores’ first in India.

“We believe this drug will be a $ 100 million product for Venus Remedies in the next five years,” said Pawan Chaudhary, CMD, Venus Remedies. The Chandigarh-based drug firm is also looking at marketing tie-ups with multi-national pharmaceutical firms to launch the product in the US.

Chaudhary said the company has mandated consultancy firm Ernst & Young to find out a marketing partner in the US to launch the drug in the US market. “We are looking for tie-ups with US-based pharma firms for launching this product. We

are confident that in the next three years it would be launched in the US market,” he said.

The drug, branded as Elores, is a novel Antibiotic Adjuvant Entity (AAE) that targets bacterial resistance mechanisms. The company claims it not only kills resistant pathogens but also prevents the spread of resistance.

Venus Remedies, which posted revenues of around ` 405 crore in the last fiscal, has already invested $ 10 million for the development of the new product since 2001 and plans to invest another $ 10 million to launch the product in various global markets.

“After India, the product would be most likely launched in South Korea. By next year, it should be available in Europe,” Chaudhary said.

The company, which has already secured patent for the product in around 44 countries, is also looking to launch Elores in various other geographies including South Africa and Latin

America. “Our target is to launch the product in as many as 50 countries, five years down the line,” Chaudhary said.

According to industry estimates, the anti-infective market in India is pegged at around ` 850 crore per annum. Around 40 per cent of the sales come from Antimicrobial Resistance (AMR) segment.

“We are expecting to capture 10 per cent share of the total AMR market in India in the next five years, making it over a ` 200-crore product,” Chaudhary said. On revenue target in the current fiscal, Chaudhary said, “We are targeting somewhere around ` 460 crore in FY13,” adding that the Elores launch would not have a major impact on the revenues in the current fiscal.

Commenting on the product pipeline, Chaudhary said that the company has 20 products in various stages of development.

Boehringer Ingelheim (BI) announced that New Drug Application (NDA) for its investigational drug Afatinib received priority review in USA. The application is currently under review for the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with an Epidermal Growth Factor Receptor (EGFR) mutation. Afatinib has demonstrated a significant delay in tumour growth compared against currently available chemotherapeutic agent. The NDA submission is based on the comprehensive LUX-Lung clinical trial programme.

Afatinib is a EGFR tyrosine kinase inhibitor and differs from first-generation EGFR TKIs both in its ability to bind to HER2, a protein involved in normal cell growth and in the irreversible nature of its binding to EGFR. It is also being investigated in clinical trial in high mortality cancers such as breast and head & neck cancers. BI strives to make Afatinib available to patients around the world. Afatinib is currently under review by the European Medicines Agency (EMA) following submission for marketing authorisation in Europe in August 2012. Further submissions worldwide are currently under preparation. Prof Klaus Dugi, Corporate Senior Vice President - Medicine, BI said, “The acceptance of the NDA filing reinforces our ongoing commitment to oncology as we take the necessary steps to seek approval for our first cancer treatment, in an area of high unmet medical needs.”

Venus eyes $ 100 million from new drug Elores in five years

Boehringer Ingelheim’s first lung cancer drug gets priority review by

the US FDA

Prof Dugi

Gujarat Ayurvedic Aushadh Manufacturers Association (GAAMA) wil l meet pharma players across the country to discuss regulations and related issues that the Ayurveda Siddha, Unani (ASU) segment has been facing. The meeting is scheduled to take place on February 9, 2013 in Ahmedabad with representatives, officials from the department of Ayush and GAAMA. The SME sector is expected to receive a boost by this move.

The prime focus of the meet would be to address all compliance-related issues that pharma manufacturers are facing in the industry for manufacturing oral liquid pharma products. This is a first meet in this regard.

Prabodh Shah, President, GAAMA said, “After careful analysis of the current situation, we have decided to focus on deliberating different options that will help us in improving the manufacturing of these products. Especially, since most of the manufacturing-related problems such as fungus formations, gas formations, colour discharge, lack of stability etc happen during post-production processes, leading to several regulatory concerns. Through this meeting we hope to get detailed suggestions from the experts on the steps that manufacturers need to take to avoid these issues and improve the quality and the shelf life of the end product.”

GAAMA to meet pharma players to discuss regulatory

issues in February


WHO reported robust growth in drug development for 17 neglected tropical diseases, attributed to the new global strategy, continuous supply of quality-driven, low-cost medicines and support from global partners. The report titled ‘Sustaining the drive to overcome the global impact of neglected tropical diseases’ reveals new momentum has shifted the world closer to the elimination of many of these conditions that take their greatest toll among the poor.

The publication charts progress in controlling, eliminating and eradicating these diseases. Two are targeted for global eradication, dracunculiasis (guinea worm disease) in 2015 and yaws in 2020. The report outlines six targets set for the elimination of five diseases in 2015 and a further 10 targets for nine diseases for 2020, either globally or in selected geographical areas.

Dr Margaret Chan, Director-General of WHO, informed, “With this new

phase in the control of these diseases, we are moving ahead towards achieving universal health coverage with essential interventions. The challenge now is to strengthen capacity of national disease programmes in endemic countries and streamline supply chains to get the drugs to the people who need them, when they need them.”

In a move to ensure drug safety and controlled administration, Haryana state Drug Controller (DC) will issue drug selling licenses online. In addition, the department will also begin to issue drug manufacturing licenses too through online system.

Informing about the new issuance system, Dr Girdhari Lal Singhal, Director - State Drug Controlling Authority, said, “Currently, 70 per cent of new sales licences are released online in Haryana. In the near future, the agency will also issue manufacturing licenses through online application system.”

Dr Chan

BioAsia 2013 attracts regulators from across the globeIn a significant development, BioAsia 2013, for the first time, will be witnessing the participation of top officials from biopharma, biotech and health regulatory agencies from across the globe. Prominent among the confirmations are South Africa, Sri Lanka, Philippines, Czech Republic, Malaysia, Jordan, republic of Lithuania, Ghana, London, Sweden and India.

Commenting on the development, Shakthi Nagappan, CEO, BioAsia, said, “BioAsia’s growing prominence as an influential and industry shaping platform for biotechnology and biopharma has drawn the attention of the regulatory community. Participation of these regulators – a very significant section, who shape the industry, is a boost for the platform and will greatly benefit the participating companies.”

The participating regulators will provide a broader

perspective of understanding on the existing regulations pursued in their respective markets and across the globe leading to an in-depth understanding on the existing regulatory frameworks and requirements. This knowledge thereby will benefit the Indian companies interested in expanding their business operations and establishing footprints in these regions through exports, joint ventures, marketing, R&D, etc.

“We are extremely glad that the Ministry of Commerce and Industry through the Pharmaceutical Export Promotion Council of India, recognising the importance of this effort, has come forward and agreed to support this initiative of BioAsia,” he added.

Commenting further Deepak Sood, Business Director, Lonza India, said, “BioAsia as a platform has been on an evolution of steady growth each year adding

new dimensions to spur the expansion of the industry and directly benefitting the entire ecosystem. The participation of the regulators gives further momentum to the growth of the industry.”

The regulatory meet, in addition to helping the companies understand the regulations, will also offer a platform for the regulators to converge and deliberate on various aspects of harmonising the regulations globally. The organisers are confident that

the regulators meet, will re-emphasise the commitment of ‘BioAsia’ towards achieving positive changes in the biotechnology and biopharmaceutical industry.

Commenting on the event, Dr PV Appaji, Director General, Pharmexcil, said “Pharmexcil and the Ministry of Commerce are working extremely hard towards achieving the exports targets of $ 25 billion by 2014-15 from the current level of $ 13.5 billion. We strongly believe that the presence of top regulators from important export destinations and some new markets during ‘BioAsia’ 2013 will be a great step forward in achieving this goal. The response so far from the Indian industries towards this activity has been overwhelming and we are expecting more than 200 Indian companies to participate and interact with the regulators.”

WHO reports outstanding drug development rate for neglected tropical diseases

Haryana drug controller to introduce online licensing system

Dr Appaji


Evolva Holding SA has entered into a collaboration agreement with Ajinomoto Co Inc, Japan, for the joint development of novel fermentation production routes for a natural functional ingredient for application in personal care. Ajinomoto Co is a world leader in the area of amino acids. During the 3.5 year collaboration, Ajinomoto Co will fund R&D activities at Evolva, focussed initially on building a novel, valuable pathway with Evolva’s fermentation technology and subsequently on improving production yield through the scale-up and manufacturing phases. During the collaboration, seven full-time

scientists at Evolva are expected to work on the programme.

Evolva will receive an upfront exclusivity and technology access fee as well as monthly research fees. In addition, Evolva will

receive milestone payments upon achieving certain goals in terms of yield, productivity and production costs. The total

fees and milestone payments to Evolva during the collaboration will amount to more than CHF 10 million. In case of commercialisation, Evolva will receive a royalty as a percentage on product sold. Panchapagesa Murali, CEO, Evolva India, said, “We value highly the confidence in our capabilities that Ajinomoto Co is showing by entering into this collaboration. We look forward to providing Ajinomoto Co with efficient production routes for their important product. For Evolva, this project has long-term benefits as it allows us to build a pathway which can be important for other products.”

GlaxoSmithKline (GSK) submitted regulatory application to FDA for albiglutide BLA office, an investigational drug candidate to cure type 2 diabetes in adults. The drug has not received approval elsewhere, and company is also planning to file another

application with EU authorities. Albiglutide, a GLP-1 receptor

agonist, is an investigational biological product for the treatment of type 2 diabetes designed for once-weekly subcutaneous dosing. In people with type 2 diabetes, GLP-1

secretion in response to a meal is reduced or absent. GLP-1 is rapidly degraded while albiglutide has been developed to have a longer duration of action by being comprised of two copies of modified human GLP-1 fused in series to human albumin.

Evolva collaborates with Ajinomoto Co

Genedata, a leading provider of advanced software solutions for drug discovery and life science research, recently announced the release of Genedata Biologics™ 3.0, the latest version of its enterprise solution for biologics R&D. A first-in-class software solution for integrated data management, Genedata Biologics enables R&D organisations to more efficiently discover and develop novel biotherapeutics. Version 3.0 dramatically improves process efficiency with new functionality for standardisation of antibody screening, protein engineering, and protein production processes.

“Standardisation is a strategic advantage in biopharma R&D. The new version of Genedata Biologics provides a complete view on all biologics candidates and their history,” said Dr Othmar Pfannes, CEO, Genedata. “The standardisation of these views and the underlying automated data processing minimises duplication of work, eliminates error-prone manual activities, and provides extremely valuable transparency across an organisation for efficient decision making. Our insight into standard processes and best practices has driven the development of Genedata Biologics, which is becoming the data management platform of choice for innovative biologics R&D organisations.”

Emergent BioSolutions begins phase 2 clinical trial for anthrax vaccine NuThrax

Genedata Biologics 3.0 boosts

efficiency through standardisation

GSK submits albiglutide BLA application to FDA

Emergent BioSolutions Inc recently announced the initiation of a phase 2 clinical trial for NuThrax, also known as AV7909, with the dosing of the first subject.

According to a release, NuThrax, a next generation vaccine being developed as part of Emergent’s anthrax franchise, consists of anthrax vaccine adsorbed in combination with a novel immunostimulatory adjuvant, CPG 7909.

“Emergent is pleased to initiate this phase 2 clinical trial of NuThrax, which supports the near-term goal and priority of the US Department of Health and Human Services (HHS) to develop next generation anthrax vaccines with advanced characteristics such as requiring fewer doses and generating an enhanced immune response,” said Adam Havey, EVP and

President - Biodefense division, Emergent BioSolutions. “We thank HHS for their continued trust and partnership as we work together to accomplish

elements of its Emergent BioSolutions Inc. announced the initiation of a phase 2 clinical trial for NuThrax, also known as AV7909, with the dosing of the first subject.

Murali

Dr Pfannes


A discovery about the way in which bugs spread throughout the body could assist in developing stem cell treatments. Researchers at the University of Edinburgh have found that bacteria are able to change the make-up of supporting cells within the nerve system, called Schwann cells, so that they take on the properties of stem cells.

Because stem cells can develop into any of the different cell types in the body, including liver and brain cells, mimicking this process could aid research into a range of degenerative conditions.

Scientists made the discovery studying bacteria that cause leprosy, which is an infectious neurodegenerative disease. The bacteria-generated stem cells also have another unexpected characteristic. They can secrete specialised proteins called chemokines that attract immune cells, which in turn pick up the bacteria and spread the infection. Scientists believe these mechanisms,

used by leprosy bacteria, could exist in other infectious diseases.

Knowledge of this newly discovered tactic used by bacteria to spread infection could help researchers to improve treatments and earlier diagnosis of infectious diseases. The study is published in the journal Cell.

Prof Anura Rambukkana, Medical Research Council (MRC) Centre for Regenerative Medicine, University of Edinburgh, who led the research, said, “Bacterial infections can completely change a cell’s make up, which could have a wide-range of implications, including in stem cell research.

“We have found a new weapon in a bacteria’s armoury that enables them to spread effectively in the body by converting infected cells to stem cells. Greater understanding of how this occurs could help research to diagnose bacterial infectious diseases, such as leprosy, much earlier,” she added.

The study, carried out in Professor Rambukkana’s laboratories at the University of Edinburgh and the Rockefeller University, was funded by the US National Institutes of Health.

Dr Rob Buckle, Head of Regenerative Medicine, MRC, added, “This ground-breaking new research shows that bacteria are able to sneak under the radar of the immune system by hijacking a naturally occurring mechanism to ‘reprogramme’ cells to make them look and behave like stem cells. This discovery is important not just for our understanding and treatment of bacterial disease, but for the rapidly progressing field of regenerative medicine. In future, this knowledge may help scientists to improve the safety and utility of lab-produced pluripotent stem cells and help drive the development of new regenerative therapies for a range of human diseases, which are currently impossible to treat.”

Bacteria’s hidden skill could pave way for stem cell treatments

The Forum For Injection Techniques (FIT) in collaboration with Becton, Dickinson and Company (BD) launched guidelines on injection methods for insulin injection pertaining to diabetes care. These guidelines include the first Indian clinical tips for best practices within insulin injection methods. So far, no recommendations as well as consensus statements have been addressed in the developing countries like India.

A scientific advisory board of well-known endocrinologists and diabetes experts brought the FIT of India guidelines based on combining clinical evidence, the implications pertaining to patient therapy and the judgment of the number of experts. Although insulin treatment is accepted among the most effective and dependable treatments in management associated with diabetes, there usually are several barriers to its usage involving type 2 diabetes instances particularly acceptance associated with insulin therapy.

The new centre where the methods and treatment techniques with use of insulin injection has been opened in Hyderabad, India.

Insulin injection guidelines

launched in India

In BriefAlembic Pharma’s net profit at ` 482.7 million Alembic Pharmaceuticals Limited reported growth in net profit by 9.1 per cent at ` 48.27 crore for the quarter ended December 31, 2012 against ` 44.23 crore in corresponding quarter last fiscal.

The Company posted 12.2 per cent growth in profit before tax at ` 60.09 crore for the quarter ended December 31, 2012 against ` 53.54 crore posted in corresponding quarter last fiscal.

The company posted total revenue of ` 372.05 crore for the quarter ended December 31, 2012, compared to ` 382.82 crore in the corresponding quarter last year.

The domestic formulations business posted sales of ̀ 227.64 crore against ` 198.78 crore with a 15 per cent growth over the corresponding quarter of the previous year.

Alembic maintained market share of 1.76 per cent; Azithral was ranked 25th and Alembic has three other brands in the list of top 300 brands of industry, ie ‘Althrocin’, ‘Roxid’ and ‘Wikoryl’.

Chronic and acute segments grew by 23 per cent and 4 per cent, respectively, in current year. The company launched a dermatology division in current year.

For the quarter, domestic API sales were ` 24.99 crore against ` 18.73 crore, while export API sales were ` 42.00 crore against ` 89.90 crore last year.


HRS Process Systems Ltd, country’s major heat transfer solution provider that is owned by UK-based HRS Group, displayed a new line of novel heat transfer products in Chemtech 2013, which was held in Mumbai from January 15 -18, 2013. The showcased product portfol io comprised Corrugated Tube Heat Exchangers (CTHE), HRS Hot Water Generation Systems based on ECOFLUX, and Plate Heat Exchangers (PHE), which are useful for prime application in pharma and chemical industry apart from HVAC, textile, hotel, food and brewery sectors.

The company’s products are mainly used in applications such as vent condensers, condensers, reboilers, heaters, water coolers, heat recovery units and oil coolers etc. HRS PSL offers expertise in exotic materials; such as haste alloy, alloy 20, nickel and titanium alloy based on specific applications used in pharma and chemical processing.

Informing about the participation, V Gokuldas, MD, HRS Process Systems Ltd, said, “ChemTech is a good platform to reach a wider segment of our target audience. This expo allowed us to share valuable information about our cost effective heat transfer solutions. HRS is an innovative technology driven company that focusses not just on heat exchanger fabrication but on application engineering as well.”

HRS PSL displays new line of energy efficient heat transfer systems at Chemtech, 2013

GVK BIO in a research collaboration with Endo Pharmaceuticals

The Commerce and Industry Ministry is examining a proposal from its health counterpart to issue Compulsory Licences (CL) for three anti-cancer drugs as part of the government’s move to make such medicines affordable.

“The Department of Industrial Policy and Promotion (DIPP) has received the proposal from the Health Ministry. It is being examined in great details,” a source said.

The source, however, said a decision on the three patented anti-cancer drugs - trastuzumab,

ixabepilone and dasatinib - the patent for which are held by Swiss drug major Roche and US-based drug maker Bristol-Myers Squibb, respectively, are unlikely to be taken in a hurry.

“The process of issuance of CL is long. The DIPP has to collect all the relevant data including number of cancer patients in India and pricing of already existed alternative cancer drugs,” another source said. Currently, a month’s dose of each of the three drugs costs more than ` 1 lakh.

The government had issued the first such licence in March last year. India’s patent office had granted a licence to Hyderabad-based drug maker Natco Pharma to make and sell a copy of Bayer Corporation’s patented cancer drug Nexavar by invoking the compulsory licensing provision of the country’s patent law.

Under the Indian Patents Act, a CL can be issued for a drug if the medicine is deemed unaffordable. Generic drug manufacturers can then bypass the patent.

GVK Biosciences (GVK BIO) announced that it has entered into a collaboration agreement with US-based Endo Pharmaceuticals focussed on discovering novel small molecules targeting an exciting protein. Under this agreement, GVK BIO will use its discovery expertise to deliver a clinical candidate and Endo will develop and commercialise the product arising out of this collaboration. This collaboration arose out of a newly launched concept

at GVK BIO named Early Discovery Assets (EDA™).Manni Kantipudi, CEO, GVK BIO commented,

“We are delighted to partner with Endo as it continues to build its discovery pipeline through external collaborations. This collaboration also confirms the value of our differentiated EDA concept, conceived to collaborate with pharmaceutical partners on discovery projects, from target to clinical candidates.”

DIPP examining proposal to issue CL for 3 anti-cancer drugs In BriefRoche appoints US academician to foster research Swiss-based drug giant Roche announced that Dr John Reed, MD, PhD, has been appointed as Head of Roche Pharma Research and Early Development (pRED) and member of the enlarged Corporate Executive Committee. Prior to joining Roche, Dr Reed was CEO at Sanford-Burnham Medical Research Institute in La Jolla, California. John Reed will succeed Mike Burgess, the current ad interim Head of pRED. “I am honored to join the Roche organisation and continue the company’s superb legacy of developing innovative new medicines for patients in need” said Dr Reed. Commenting on this, Severin Schwan, CEO of the Roche Group said, “We are delighted to welcome Dr Reed to Roche, who has led one of the world’s top laboratory-based medical research institutes. With his broad scientific and medical background he is ideally positioned to drive Roche’s strategy of translating a better understanding of disease mechanisms into promising therapeutics.” Schwan further added: “I would like to thank Mike Burgess for his valuable contributions to Roche. Mike has been instrumental in refocusing the pRED organisation during the past few months.” Ayurvet and Novartis bag awards at RMAI Corporate Awards 2012 for Excellence in Rural Marketing & CommunicationsThe Rural Marketing Association of India (RMAI) hosted the 4th edition of RMAI Corporate Awards sponsored by SREI Sahaj E Village in New Delhi on January 18, 2013. More than 120 entries were received at this bi-annual event. Ayurvet grabbed one gold and two bronze, while Novartis India bagged one bronze award. The objective of the RMAI Awards is to recognise and reward successful case studies in rural marketing.


Torrent Pharma has become the first of the large pharmaceutical firm to withdraw a drug under a new recall and alert system kicked off by the government. The company has called back two batches of its acidity drug Ranitidine (Ranitin) that did not reportedly meet the quality standards of the Drug Controller General of India (DCGI). These were manufactured at the company’s facility at Solan in Himachal Pradesh and at Gangtok in Sikkim. The batches in question were about to expire only by 2015.

Abbott Laboratories reported a 35 per cent drop in fourth-quarter profit because of costs related to its spinoff of its AbbVie pharmaceutical business. The Illinois-based company, which completed the separation of AbbVie on January 1, posted $ 1.05 billion in profit, or 66 cents a share, for the quarter ending December 31, 2012 compared to the $ 1. 69 billion of the previous year.

“In 2012, we achieved a significant milestone in Abbott’s 125-year history with the creation of AbbVie while delivering another year of strong results,” said Miles White, Chairman & CEO, Abbott, in a statement.

Dr Reddy’s Laboratories announced that it has launched desloratadine ODT (2.5 mg & 5 mg), a bioequivalent generic version of Clarinex® Reditabs® (desloratadine) in the US market on January 24, 2013. Dr Reddy’s ANDA for desloratadine ODT is approved by the USFDA.The Clarinex® Reditabs® brand had US sales of approximately $ 5.3 million for the most recent twelve months ending November 2012 according to IMS Health.

Watson acquires Uteron Pharma SAWatson Pharmaceuticals, Inc recently announced that it has completed the acquisition of Belgium-based Uteron Pharma SA for $ 150 million in cash up front, and up to $ 155 million in potential future milestone payments. The acquisition of Uteron expands Watson’s Global Brands pipeline of women’s health products including two potential near term global commercial opportunities in contraception and infertility, and one novel oral contraceptive, projected to launch globally in 2018. Several additional products in earlier stages of development are also included in the acquisition. According to the company the transaction is expected to be minimally dilutive to non-GAAP earnings in 2013 and 2014, and accretive in 2015.

“This is a strategic acquisition of a solid pipeline, sound development expertise, and sufficient manufacturing capacity to generate value for shareholders within the next two years, and

provide the potential of multiple global product introductions through the latter half of the decade,” said Fred Wilkinson, President, Watson Global Brands and Biosimilars. “We have structured the financials of the acquisition to reflect the immediate value of the late stage pipeline, with approximately $ 45 million in near-term milestones and appropriately balancing the development risks and investments required to commercialise these assets, when compared to the longer-term opportunities.

He added, “The acquisition capitalises on the growing potential of the expanded global commercial footprint for our women’s health brand franchise following the Actavis acquisition. As a result of the Uteron acquisition, Watson welcomes the opportunity to access resources within the Walloon Region of Belgium, and acquires a valuable source of research and innovation. We also look forward to expanding our R & D team

with the inclusion of the research and clinical professionals in Liege, Belgium as well as continuing their ongoing collaborations with the University of Liege. This transaction is a first step in fulfilling our promise to enhance our branded opportunities globally, while creating near term revenue for Global Brands and further expanding our women’s health development portfolio.”

Uteron’s executive team including Stijn Van Rompay, Co-CEO and Co-Founder, and Professor Jean-Michel Foidart, CSO and Co-Founder, will continue to manage Uteron, which will become a key part of research and development activities of an enlarged and growing women’s health business for Watson.

“We believe this transaction provides excellent value for our shareholders and validates the potential of Uteron Pharma’s strong product pipeline, which is a result of great dedication and hard work of our extremely talented

employee partners. We are pleased that Watson has committed to long term development of our product portfolio in the Walloon region and the continued collaboration with the University of Liege,” said Francois Fornieri, Co-CEO, Uteron Pharma.

“Uteron Pharma has developed a strong pipeline of innovative products in different stages of development in the area of women’s health, based on strong in-house research capabilities combined with deep partnerships with other scientific-led groups, such as Pantarhei Bioscience, which initiated and co-developed Estelle, one of our pipeline products. Joining forces with Watson provides an excellent opportunity to advance our product portfolio further and leverage the global commercial platform of Watson. We look forward to working together with Watson to bring products to market which will have a significant impact on women’s lives,” said Van Rompay.

Torrent Pharma recalls acidity drug after

failing quality

Abbott reports a net earning decline of 35

per cent in Q4

Dr Reddy’s announces the launch of

desloratadine ODT


The pharmaceutical industry forms an integral part of the overall healthcare segment. In the current scenario, great emphasis is given on formulating, manufacturing high quality, effective and safe drugs. Keeping this in mind, an initiative has been taken to form the Society for Pharmaceutical Dissolution Science (SPDS) by a team of experienced senior professionals from the Indian pharma industry and

academia. This initiative has been supported by Sotax India, a fully owned subsidiary of Sotax AG Switzerland, a global organisation that has pioneered dissolution science.

SPDS will impart knowledge and training by organising a number of high-quality, value-added workshops and seminars that will help pharmaceutical industry professionals and academia to improve their knowledge and skill set. This will result in much better on-job performance and efficiency.

The seed of SPDS was sown by Founder & President

Vijay Kshirsagar and Dr L Ramaswamy, General Secretary, SPDS and MD, Sotax India Pvt Ltd.

SPDS will work in close tandem with colleges, universities other professional and regulatory bodies related to the pharmaceutical industry in an effort to update PhD scholars, post-graduates and pharmacy students through training and workshops to provide a better understanding

of the sophisticated modern dissolution systems, equipment and software.

Plans are also underway at SPDS to make a web portal. This interactive website acts as a source of knowledge. One can post queries or issues in the arena of dissolution, methods, developments and more. A panel of experts will address all inquiries and offer solutions to the same. The society is also planning a comprehensive e-journal that will feature articles from society members as well as industry professionals from around the world.

Besides, SPDS will also organise workshops, seminars, events both nationally and regionally. Disso India 2013 will be an Annual International Convention to be first held in Mumbai in May 2013. This event will be organised under the Chairmanship of renowned Dr Vinay G Nayak, President-Technical, Alembic Pharmaceuticals Ltd and the Organising Secretary; Dr Ramaswamy.

The scientific programmes shall be designed and executed by the Dr Mangal Nagarsenkar , Sc ient i f ic Committee Chairman, and Head of the department & Professor – Pharmaceutics, Bombay College of Pharmacy, with the support of other committee members as well as international scientific advisors such as Dr Vinod P Shah, Pharmaceutical Consultant from USA, Dr Umesh Banakar from Banakar Consul tancy and others.

Aurobindo Pharma recently announced that it has received US health regulator’s approval to market generic version of blood pressure lowering medicine plendil extended-release tablets in the American market.

The company has received final approval from the US FDA to manufacture and market felodipine extended-release tablets USP in strengths of 2.5 mg, 5 mg, and 10 mg, Aurobindo Pharma said in a statement. Felodipine extended-

release tablets are the generic equivalent of AstraZeneca’s plendil extended-release tablets, and are indicated for the treatment of hypertension, to lower blood pressure, it added.

“The annual sale of the product is nearly $ 64 million for the twelve months ending March 2012 according to IMS,” the company said. It added that the product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad.

SPDS launched at 64th Indian Pharmaceutical Congress

Aurobindo gets USFDA approval for hypertension drug

Ami Polymer receives DMF certification from FDA

Ami Polymer Pvt Ltd, a major provider of silicone rubber products for the pharma, food and medical grade, received DMF certification from US FDA. The agency has granted the number 26201 compliance to the company for producing silicone tubings and braided hoses. Recently, the company has developed bi-colour tube/strip tubes for use in colour coding apart from flame retardant silicone rubber gasket complying with V-0 class of UL 94 standards.

Ami Polymer also deals in FEP (PTFE) encapsulated O-rings of silicone, viton and EPDM through its well equipped in-house testing laboratory, rheometer and competitive workforce.

Speaking on the development, Alpesh Gandhi, Technical Director, Ami Polymer Pvt Ltd, said, “Being a quality manufacturer of hi-tech silicone transparent tubes, it was our aim to provide our customers with a value-

added service. Our 80 per cent supply goes to pharmaceutical segments where quality and continuous improvements is a prime concern. Keeping this trend, all pharmaceutical giants who manufacture life saving vaccines, syrups etc insist for DMF certification from US FDA where the entire process, physical parameters and the quality of the products are evaluated and documented. We have now been assigned DMF number 26201 for manufacturing ‘Platinum cured silicone transparent tubes & braided hoses’ at our most modern cleanroom certified environment of class 10000.”

With the added quality certification to its product range of silicone tubings and braided hoses, the company would be able to approach the right vendor and make their purchasing system more user-friendly where 100 per cent pure quality is a matter of concern.

Inauguration of SPDS by dignitaries at the 64th IPC

16 In Conversation With

What kind of background you come from?I come from pharma background; essentially I got trained as a pharmacologist. The journey started with a B Pharm degree from JSS College of Pharmacy where Dr G Parthasarathi inspired me to take up pharmacology as a specialisation. Later on, I went on to pursue M Pharm in Pharmacology under the guidance of Dr R Balaraman at Maharaja Sayajirao University of Baroda where my interest in research was stimulated. I also have the distinction of having two doctorates, a rare feat, which includes a PhD in psychopharmacology from NIMHANS, Bengaluru and DSc in Biochemical Pharmacology from International University of Washington, Washington DC. Pharmacy education provided a tremendous boost and self confidence to do something different. Subsequently, I served at AstraZeneca, TCS and Manipal Acunova learning various intricacies of pharma, IT and healthcare industries. Now, I head Semler Research Center (SRC), a pharmaceutical services company.

Did you always know that you wanted to be in corporate business?I had a good career in R&D but I never wanted to stay confined to benches. There was always something more that I wanted to do. I firmly believed that wide opportunity to learn exists in the corporate world rather than by being a bench scientist and learning a few things. As the saying goes, ‘transition is to transcend someone’s expectation.’

Is generic industry a threat to research industry?Not really. Generic industry will always stay across various geographies as it is a way to reduce the healthcare cost on patients and government. A lot of innovation can be done within generics too. However, pharmaceutical R&D is the lifeblood of this industry but it is a high-risk investment.

What is the rate limiting step that prevents the nurturing of research industry in India?Not one but there are many factors such as ability to spend, under leveraged cost arbitrage and risk-taking ability of the investors. Abroad, we frequently see heavy investment by the government bodies in bench work. There will be hardly an investor willing to invest during the initial phase of any product unlike the growth phase. Investors’ appetite is merely 3 to 4 years long and one needs to see what returns are offered. In addition to this, interest rates in our country are phenomenally high. One cannot easily survive in such situations.

What chiefly prevents India from becoming a clinical research hub?India has a great potential to grow in research. It is the lack of transparency to deal with things at all levels that brings down the entire clinical research industry in India. People have started losing their jobs. Lack of focus by regulatory body has slowed down growth of this vibrant

industry in India. It is not the regulatory individuals but the entire system and practices who are the key reasons for a disaster of this nature. We need to put systems and processes in place so that we do not become targets for wrong reasons. We need to learn from the West, and all we need to follow is one established system and practice. As the President of Indian Society for Clinical Research, I am trying my best to set the right mindset and employ best ethical practices.

What gives SRC an edge over its peers?At SRC, we work altogether on an entirely different model due to which we are a one-stop solution for many of our clients. We are different from conventional CROs. We work on many aspects of drug discovery process. We provide a wide range of services, primarily in the areas of pharmaceutical development, bioavailability and bioequivalence studies, early and late phase clinical development, regulatory services & medical and scientific writing. Our range of services helps global pharmaceutical,

biotech and device companies to significantly enhance their R&D success from quality, cost and timeline perspectives. We also offer innovative capital solutions to emerging pharma, biotech and virtual companies - from risk sharing to making fixed costs variable to sharing human capital.

In the last two years SRC has reached newer heights. How does it feel heading a best-in-class bioservice organisation?On a personal front, I do feel like a successful entrepreneur but I believe that there is always more to learn and achieve. All thanks to the people of the company who worked hard and share a common vision to make the company propser.

Tell us about new projects in the pipeline.With an expertise in drug development in areas such as dermatology and ophthalmology, we are now expanding our operations into oncology and injectables. It gives us some advantage of getting faster into the market space.

What keeps your team motivated?At SRC, encouragement goes a long way within a team and individually. When someone does well over here, they are sure to get recognised. In addition to that, we let our teams to be creative and offer them a sense of ownership. At the end, tough time never lasts but tough people do.

What are the most important personal skills someone must possess to be successful in business?Apart from core skill set, one must be good at attitude and communicate effectively. Many a times, it is very unfortunate to see people at very senior level with poor set of behavioural and communication skills.

What do you do to rejuvenate yourself?I love to spend time with my family and socialise with friends. Apart from that I spend some quality time thinking about the challenges of life and take up some reading.

…says Dr Krathish Bopanna, President & CEO, Semler Research Center. A humble man with an impressive academic background and professional accomplishments, he shares details about his transition from being a research scientist to a successful entrepreneur and about the research trends in India.

Hardik [email protected]

The lack of transparency to deal with things at all levels brings down the entire clinical research industry in India

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18 Special Focus

Globa l ly , Ind ia accounts for about 8 per cent of the total pharma

production, with its standing as third major manufacturer of pharmaceuticals by volume. Small startups constitute about 40 per cent by value and 87 per cent by manufacturing of the entire Indian pharma sector. These entities are referred as the hub of employment, skill and knowledge of pharma industry in India. As the Indian pharam sector is experiencing strong consumption and is exposed to robust export market, it puts the sector into high adherence to quality and other time delivery constraints. The increased pressure components enhanced the reliance of the sector on IT tools significantly.

Dr Neesha Desai, Co-Founder & Lab Manager, Arasan Chemicals Pvt Ltd, says, “The Indian pharmaceutical industry has come a long way since independence and today is the third largest in the world and is one of the most developed industries in the country. Technologically strong and self-reliant, the pharmaceutical industry in India has low costs of production, low R&D costs and innovative scientific manpower. These factors have helped India emerge as one of the most globally preferred outsourcing destination for pharmaceuticals, which in turn has propelled the emergence of startups operating in the entire spectrum of the pharmaceutical industry.”

Challenges and drawbacks One of the main challenges faced by pharma Small and Medium Enterprises (SMEs) is the implementation of IT tools at an affordable cost. Soft technology can help small industries manage and understand licensing and Intellectual Property Rights (IPR) issues as well as Computer Aided Design (CAD)-based drug developments. But the majority of players are still not investing adequately in advance IT solutions.

“While understandably they tend to focus more on their core competence involving their technical expertise, it is also necessary that they build good IT infrastructure and systems that would help build strong foundations for a growing company. Not doing so severely hampers the startups in several areas, such as customer service, data handling and analysis, inventory management, statutory compliances and even a proper understanding of the business cash flow. Hence, the importance of an adequate IT infrastructure even for a small startup cannot be

underestimated,” comments Dr Desai.

Small and Medium Business (SMB) sector of India possess only about 30 per cent GMP-certified plants with restricted capability to retain and attract skilled workforce. In addition, small businesses are more vulnerable to economic ups and downs than major companies due to their limited ability to adapt to market variations. Generally, IT is regarded as a single functional area; however, the term has broad specifications knitted around different skill

sets and factors that continue to affect the pharma SMBs such as inadequate IT literacy, lack of IT support, improper procedural standards, varied proportion of IT management skills and awareness.

For implementation of cost-effective IT solutions industry needs to change the traditional mindset and look for new-age measures to stay ahead of time. Currently, small manufacturing units face several drawbacks such as:

Low IT literacy among senior personnel working in SMEs for long tenures, who possess the authority to bring infrastructural changes and responsible for financial nodes, may not be supportive to the modern age measures.

Inability of SMBs to hire or retain dedicated skilled IT employees due to high salary demand and poor infrastructure with respect to IT systems and support solutions. In addition, IT personnel also prefer to work with MNCs and major players, as workflow is more streamlined in these organisations.

Informal procedure follow-up and lack of discipline in SMEs lead to improper documentation with regular policy changes. This seems to be difficult for outside solution providers to understand present business practices and synchronising them with advanced IT solutions.

Resistance to consulting solutions by SMEs to save cost is another grey area, as an efficient consultant may save effort and time in choosing need-based IT solutions. In the process of resolving the complex issues by using in-houses expertise, SMEs often tend to invests more and end up in getting incompetent solution. In context to the

consu l t ing scenar io , Dr Ruchi Dass, Founder & CEO, HealthCursor Consulting Group, informs, “Apparently, wireless technologies are

transforming the ways supply chains are managed today. At HealthCursor, we have consulted companies to handle such problems using technology-based interventions. In the pharma industry, counterfeit is considered as the biggest threat and today there are solutions like Sproxil, Mpedigree, Pharmasecure and Original1 addressing these. Episurveyor is handling drug stockouts; RapidSMS and SMSforlife track distribution. There is a lot to learn from these models.”

Measures and opportunities The robust growth rate of 14 per cent registered by the Indian pharmaceutical industry in the past five years and to maintain this growth rate the sector needs a strong IT infrastructure that may help in achieving the ambitious target set by planning commission of India for pharma industry in 12th Plan both for manufacturing and export domains.

“While investment in this area may be limited initially, it would be a good idea to invest in low cost systems and infrastructure which could take care of functions such as communications, data storage and retrieval, accounting and even something as basic as a well designed website. It is important for the entrepreneur to understand that apart from their areas of core competence, investing in reasonable IT systems and infrastructure would fuel and support their further growth,” insists Dr Desai.

Ministry of Small Scale Industries focus on the development and promotion of SMBs in India by introducing various policies, support and regulatory measures to help these industries meet the demands. Ministry of Science and Technology designed various programmes to offer technological support as well as assisting in development of SMEs.

The SME sector plays a significant role to serve for outsourcing through contract manufacturing at domestic and global scales. As these small businesses are now getting extensive exposure to global markets by trouncing the challenges, they can cash on the opportunities lying ahead in the field of contract manufacturing and drug export.

“The solution could lie in identifying the areas that require investment, budgeting smartly and gaining a thorough understanding of the systems and infrastructure installed. This would help considerably when the small startup is ready to take on bigger challenges ahead” avers Dr Desai.

Wireless technologies are

transforming the ways supply

chains are managed today.

Dr Neesha DesaiCo-Founder & Lab Manager,

Arasan Chemicals Pvt Ltd

Dr Ruchi DassFounder & CEO, HealthCursor

Consulting Group

Challenges faced by small startups and ways to overcome themSmall and Medium Enterprises (SMEs) constitute a large portion of each industry in India and pharma is no exception. This segment faces several challenges due to various factors, and one of them is related to inadequate IT infrastructure in place as new age industries cannot work without the modern tools of business delivery due to several regulatory and service constraints.

Inadequate IT infrastructure

The solution could lie in identifying the areas that require

investment, budgeting smartly and gaining a

thorough understanding of the systems and

infrastructure installed.

Nikunj [email protected]

20 Special Focus

T he near future of pharma will see pharma manufacturers, regulators, prescribers

and patients taking advantage of all the technological advances throughout the pharma value chain. Pharma industry has evolved considerably and IT is one of the key factors contributing to this growth. Discussing the IT developments in pharma, Somenath Nag, Director – Business Development and Marketing, ALTEN Calsoft Labs, avers, “The Indian pharma industry has experienced a phenomenal growth over the last few decades. Its turnover has grown from a mere $ 0.3 billion in 1980 to about $ 21.73 billion in 2009-10. At present, the Indian pharma industry ranks third in terms of volume of production (10 per cent of global share) and is the 14th largest by value (1.5 per cent); growth has been driven by not only big companies but also the small and medium pharma companies. IT has contributed a lot in this phenomenal growth.” He continues, “Various software systems such as Enterprise Resource Planning (ERP), Laboratory Information Management Sys tem (LIMS) have enabled small pharmaceutical companies to increase productivity, efficiency and achieve regulatory compliance.”

Relying on IT applications Pharma companies are using IT rampantly. Elaborating on abundant IT usage, Nag comments, “Pharma companies are using IT across various functional areas such as R&D, QC, QA, clinical development, manufacturing and supply chain, sales, marketing and corporate management.” Today, a number of software solutions are commonly used in the pharmaceutical industry.

Elaborating on the transition that has taken place during the years, Subir Bhatnagar, Vice President and Global Head – Solutions, AGC Networks, says, “About a decade ago, Small and Medium Business (SMB) players in pharma were conservative in their IT spending. They focussed on R&D and IT was considered a communication technology, but today the situation has changed to a great extent. SMB pharma firms have realised that IT can play a considerable role in better product development as well as business management, giving them an edge over the increasing competition.” He explains that today they use the whole gamut of IT services be it network solutions such as SSL VPN for secured connectivity across plant with warehouses

and offices, to cost-effective storage solutions such as cloud applications, which help them transport and track their stocks; one of them typically being On-Demand ERP solutions. Some of them also look for cloud-based collaboration solutions to interact with their vendors and customers. He highlights, “Most IT companies now provide solutions in an opex mode that means they hardly have to invest on technology and are at liberty to let go of the one which does not deliver value.” He says, “From applications perspective, today many pharma companies deploy accounting applications developed for pharma vertical and transport solutions for better material management. Though we have few applications which help them in R&D, the main support from IT is of business infrastructure management.” Expressing his thoughts on how India is placed, Bhatnagar says that in developed countries the technology adoption in SMEs is at a better stage across verticals and not just pharma. But this gap is soon closing with Indian SMEs adopting technology at a fast pace. He

says, “A key reason for this gap is the fact that till some time back technology companies were focussing on the needs of large enterprises. Now, there is a lot of focus in tailor sizing the solutions developed for SMEs and leveraging large Indian SME base, which is growing at a faster pace than enterprises. So the situation is different today, but will not be for long.”

However, it is all about understanding that IT today is a strategic tool, hence, should be adopted keeping the corporate strategy in mind. Companies need to treat IT as a strategic function and use it as a distinctive competence to build competitive advantage. Few essential factors that need to be considered while deploying an IT system are:

Criticality of the business process and necessity of IT enablement of that business process

Return on investment Business value derived

from adoption of IT in any business process

Statutory-/compliance-related needsImprovement initiatives

in pharma companies have yielded maximum benefits in terms of improved quality, increased profitability and improvement in service levels.

Cost intensive but is it effective?Any IT system implementation is a cost-intensive affair. In traditional model, any IT system implementation required both fixed cost as hardware, software licenses and storage and variable costs such as annual maintenance fee, consulting fees, support cost. Talking about the cost factor, Nag says, “These costs, especially the fixed cost, were a challenge for small companies in adopting IT systems. The new SaaS or ‘On Demand’ software and cloud computing have made a paradigm shift in how smaller companies adopt and use IT applications.” He elaborates that SaaS- or cloud-based solutions eliminate the need of fixed costs in the

form of IT infrastructure and converts the complete IT application cost to a variable cost. Due to this, SaaS and cloud computing are enabling smaller companies to adopt IT faster than earlier and to become more competitive in the market place. Commenting on the cost factor, Bhatnagar says, “It is a myth that technology adoption is a costly affair. With existing technologies such as VoIP, speaking has become cheaper. With platforms such as Facebook giving one the opportunity to build enterprise’s group staying connected comes at virtually zero cost; emerging technologies on cloud model are further being explored to deliver efficiency at lower costs. Optimistically, we do not see any next gen technology built which will be more expensive than the predecessors. Finally, there is no hardware or services process of which have gone up and tech companies now have opex model for most of technology deployments. All these facilitate SMEs to take the maximum advantage of technological advancements.”

Overcoming the hurdlesWhile adopting IT companies often face following challenges:

Identifying right business process that needs automation

Identifying right product/solution that fulfil the need correctly and optimally

Identifying a right partner Resistance to change

Discussing about the challenges, Nag avers, “Among all the above factors, the resistance to change is the most severe challenge that companies face. To overcome these challenges, companies need to manage the IT adoption initiative as a change management initiative and follow all the processes required to implement as successful change management processes; they should create an IT strategy and IT adoption road map. Further, evaluating these strategy and road map from time to time is also required. Also, it is important to calculate the total cost of ownership for 3 years for any solution.” Talking about his company, Bhatnagar avers, “At AGC we create solutions that help SMEs operate efficiently and effectively. Adopting Information and Communication Technology (ICT) is an adaptive challenge, not a technical challenge. AGC Networks plays a critical role in this process by breaking the myth that ‘technology is for large enterprises’ by first understanding their business needs and then helping them in choosing the appropriate technology. Most of these SMEs are mostly owner driven. Making them aware of technology and its benefits is doable but convincing them to adopt over their existing system is challenging as at times this adoption can disrupt their way of operating, though momentarily.” Thus, building a strong channel network across the country becomes imperative in order to stay close to the target customers.

There is a lot of focus in tailor

sizing the solutions developed for

SMEs and leveraging large

Indian SME base.

Somenath NagDirector – Business Develop-ment and Marketing, ALTEN

Calsoft Labs

Subir BhatnagarPresident and Global Head –

Solutions, AGC Networks

Chandreyee [email protected]

Providing the right cl(k)ick!Technology in its complete avatar as communication, network, storage and applications provides enterprises ways to operate seamlessly and cost effectively with optimal use of resources. Let us analyse the advantages of IT applications along with the conjoined challenges.

IT applications in pharma SMEs

Companies should create an IT strategy and IT adoption road

map. It is important to calculate the total cost

of ownership for 3 years for any solution.

22 Special Focus: Roundtable

Can IT alone address the supply chain issues in pharma sector?

A field that is governed by so many stakeholders and involves various stages of operation cycle cannot rely on one absolute solution. Definitely, IT enables quick checkpoints and easier implementation of technology tools, but it cannot single handedly address all the issues, especially where human ethics and accountability come in the picture.

Editorial take

Dr Ruchi DassFounder & CEO, HealthCursor Consulting Group

Bejon MisraFounder, Partnership for Safe Medicines India

Firoz KhanHead - Department of Hospital Admin, Teerthanker Mahaveer University, Moradabad, UP

The existence of unsafe and poor quality medicines in the supply chain is a global phenomenon. It is not restricted to a few countries or a particular region. There are several factors working in the supply chain starting from the manufacturers of Active Pharmaceutical Ingredients (APIs) and dealers of the raw materials to the manufacturers of pharmaceutical products, dealers, transporters, retailers, medical practitioners, healthcare providers and the patients/consumers. There has to be a strong linkage that is trustworthy and accessible to all the players in the supply chain and IT alone can not address the issue. There has to be a focus on consumer education and awareness to authenticate and report the outcomes promptly to the regulators to ensure recall of all such pharma products which are found unsafe and not of particular standards to ensure health and safety to the consumers. Laws already exist to protect the consumers from such criminals working at the cost of public health to enrich themselves by profiteering and undermining global trade. The answer is prompt convictions against such criminals to send a strong signal by even awarding death penalties to the culprits. It has to be a war against spurious and not of standards medicines by all the countries in a unified manner, irrespective of our boundaries or economic profile. In my view, it is similar to terrorism and counterfeit smuggling. We have to bring all the countries on a common platform to build credibility and comfort similar to the World Health Assembly (WHA) to tackle this menace and ensure prompt justice to the consumers. IT has a limited role, which is confined to authentication and verification based on serialisation and standards. The technology has to provide a human face to the issue by engaging with all the stakeholders and make it friendly and accessible. Partnership for Safe Medicines (PSM) is working towards this goal and countries such as USA, India, China and others coming together on the issue will definitely provide the protection to the consumers globally.

In a pharmaceutical company, there is exhaustive data with respect to drug formulations, chemical

compounds for drugs, details of clinical trials etc, which can be stored using IT. Pharmaceutical companies are using

IT across various functional areas such as R&D, QC, QA, clinical development, manufacturing and supply chain, sales, marketing and corporate management. Not only the industries, but also hospital, clinical and community pharmacies are acknowledging the importance of IT solutions. IT is used to assist the delivery of pharmaceutical care, medication regimen adherence, patient safety, measurement of therapeutic outcomes and patients’ self-care management today, a number of software solutions are commonly used in the pharmaceutical industry such as Enterprise Resource Planning (ERP) Laboratory Information Management System (LIMS), Sales Force Automation (SFA), Customer Relationship Management (CRM).

It is impossible to develop a ‘world-class SCM excellent company’ that will be successful in tough, competitive international markets over a sustained period of time in pharmaceutical industry but with the emergence and aid of IT, which appears to be of critical importance for most companies in pharma sectors, it seems possible.

So we can say that the strategic use of IT combined with operational excellence — integrated, and streamlined processes in an electronic work environment – becomes critical to a pharmaceutical company’s success as well as the way to get the industry to an entirely new business model. But at the same time, it is also true that IT alone cannot address the pharma sectors’ issues, whether it is related to supply chain or any other segment.

IT is the way to go. As the Internet, email and other technologies have become ubiquitous, the expectations of consumers have grown correspondingly. They are less patient and more demanding now. Also, companies would not want to pull people from important jobs to focus their attention on supply chain problems. In this scenario, I see technology addressing some of the perennial problems in supply chain management. Recently, students from MIT Zaragoza – Master of Engineering in Logistics and Supply Chain Management (SCM), USA did internship with HealthCursor Consulting Group on ‘Impact of mHealth solutions on the pharmaceutical supply chain’ and the findings stated technology-based measures for handling stock-outs for a medium to long term contraceptive for women in Kenya and tackle absence of reliable end-customer data visibility in the UAE. Stock-outs and absence of end customer data has left SCM challenged. Technologies have become ubiquitous and are addressing some of the pressing issues in SCM today. With growing customer expectations - the smartest way today to handle SCM-based challenges is to invest in new tracking technologies. The Indian pharma industry is governed by low-cost generic manufacturers, and most of them are either hesitant to adopt the advanced IT solutions or finding it an out-of-pocket expenditure. The providers of IT security solutions must keep these factors in mind while offering such a solution to them. In addition, the sector also lacks in dedicated in-house IT teams to repair the breakdown instantly apart from a gap between consulting groups and pharma companies. However, things are falling in line with stringent regulatory and growing opportunities in the export market.

While there are certain dynamics such as short life cycles, Internet purchasing behaviours and intense price competition that has caused less of an impact on pharma as compared to an

unparalleled volatility in the high tech industry. But, there are some unique aspects which needs

to be appropriately addressed with regards to the pharma sector. Planning for raw materials, dealing with manufacturing constraints, establishing and monitoring distribution inventory levels, dealing with significant market demand volatility etc are some of the supply chain management issues, which are common across diverse industries. To ensure a full-fledged supply chain system for the pharma sector, subtle key issues need to be taken care of.

While focussing on supply chains, pharma space needs to focus on various issues viz, cost and yield

of manufacturing process, the quality control requirements of regulatory agencies etc. Regulatory control not only over the manufacturing process but the associated regulatory issues of different market regions such as packaging, labelling and shelf life requirements needs to be taken care of as well. Thus, IT alone cannot address the supply chain issues in pharma sector. For survival of pharma industries in

a good economic shape, decreasing demand volatility has become very essential; in a scenario where there

is increased global competition, downslide of economic conditions, changes in regulatory factors and insurance coverage. Product expiry and scrap due to expiry are the two key issues while planning supply in pharmaceutical industry. For conscious, value-driven business decisions, an adept Multitier Sales and operations planning (S & OP) is required to ensure rapid demand and supply of products. Optimising capacity, inventory and product shelf life are the keys for bettering the supply plans in pharma space. It needs to be understood that from the planning perspective both (ie expiry mitigation and obsolescence planning) have similarities albeit they appear to be two different attributes from a superficial level.

Dr Dhanalakshmi IyerDirector, Lateral-i

Soft technology has come a long way from

being merely a supportive tool to providing core solution across the operation dynamics. Product

security in pharma industry remains a major issue, and IT proves to be an efficient tool, but can IT alone

address issues in pharma supply chain?

Nikunj [email protected]

24

Established in 1981 Labindia Analytical Instruments Pvt Ltd, and promoted by a group of committed and

visionary technocrats, engineers and professionals today Labindia is one of the largest manufacturers, exporters and distributors of analytical instruments in India. In 1995, Labindia started manufacturing dissolution apparatus, pH metres, conductivity metre, titrators, etc that find application in almost all the industries such as pharma, chemical, food, petrochemical, lubricant, beverage, effluent, paint etc, in both quality control and R&D departments. Headquartered in Thane, the company has manufacturing and demonstration plants at Mahape and Rabale. While the Rabale plant houses all instruments, Mahape plant houses instruments manufactured by Labindia. Further, the company has its regional branch offices in Bengaluru, Gurgaon, Pune, Chennai, Lucknow, Thiruvananthapuram, Chandigarh, Kolkata, Vadodara and Hyderabad.

Setting the benchmarkThe manufacturing unit is located at New Mumbai (MIDC), which is well connected and easily accessible from several locations in the city. The factory is well equipped with a tool room and sophisticated production facilities for manufacturing the indigenous products. Moreover, Labindia pioneered the application and training centre, equipped with ultra modern research facilities and professional application support. The technical expertise in the field of analytical laboratory instrumentation for the past three decades has resulted in launching new instruments complying with international standards in terms of quality, performance, reliability,

regulatory and GLP/GMP. With 14 branches and 500 professionals all over India, the group has achieved rapid success in the past few years and evolved into a highly successful sales, marketing, service and support

organisation, recognised all over India as a key supplier of state-of-the-art instrumentation and reagents.

Talking about the strength of the company, Shrikant B a p a t , C M D , Labindia Analytical Instruments Pvt Ltd, says, “We have established a base of more than 7,000 customers. We have qualified, skilled, trained and committed sales, service team and excellent service/application support. Further, value-added

service is provided to the customers in case of emergency breakdown by well equipped tool room and manufacturing facilities.” Elaborating on the journey so far, Bapat says, “After working with Murphy, the radio company, I really wanted my talent to grow. I was an electronic engineer and this was helpful for my entry into the field of instrumentation. After working with Perkin Elmer for the last 25 years our name is synonymous with Applied Biosystems, Leica and many other known international brands.”

Significant yearsDiscussing the milestone years for Labindia Analytical, Bapat says, “The journey of Labindia started with servicing of the existing instruments by Perkin Elmer. There was a time when Perkin Elmer was looking for an agent and four of us, Shriram Bhalerao, Vijay Bibikar, Virendra Upadhye and self came together and decided to form a company that will represent Perkin Elmer. We performed with expertise. We have progressed through passing times and today are manufacturing our own products and even exporting products such as gas chromatography systems, spectrometers, etc. This is the tale of the establishment of Labindia Analytical Instruments Pvt Ltd.” He added, “With time, we have started appointing people and have established several offices throughout the country.

In 1981, there was an exclusive representation of Perkin Elmer in India for chromatography products. In 1986, Perkin Elmer was awarded exclusive agency for its entire range of products, which included spectroscopy, chromatography and thermal products. And in 2007, Labindia and Perkin Elmer went independent. In 2008, in-house physical testing instruments for tablet, UV & AA spectrometers was launched, and in 2009, it became the channel partner for FTIR from Bruker Optik, Germany; microwave digestion; muffle furnace, peptide synthesiser, moisture & fat analyser and protein analyser from CEM, USA. Further, in 2010, it became

channel partner for ICP and mercury analyser from Teledyne Leeman Labs, USA. In 2011, the company became channel partner for GC, GCMS & ICPMS from Bruker CAM, USA, and in 2012, the company became the channel partner for handheld EDXRF from Elvatech, Ukraine.

Expanding with vigourThe company has several overseas business partners. Discussing the export of the company, Bapat says, “Most of the countries are our business partners. For example, the US, the UK, Brazil, Egypt, Mexico, Malaysia, Ghana, Kenya, Vietnam, Russia, Uganda, Jordan and Bangladesh. The company has benefitted few of the leading pharma companies. Discussing in this regard, Bapat remarks, “Most of the important pharma companies such as Cipla, Dr Reddy’s, Ranbaxy, Pfizer, Unichem Laboratories, Watson, Sanofi-aventis, Lupin, Aurobindo, Torrent, Novartis, Johnson and Johnson, Bristol Laboratories Ltd, Apotex, Sun Pharma, Glenmark, Alkem, GlaxoSmithKline, Abbott, Zydus, Cadilla, Famy Care, Sandoz are our clients.” According to Subhash Agarwal, President - Sales and Marketing, Labindia Analytical Instruments Pvt Ltd, the company renders complete assistance to laboratories. He emphasises, “Manufacturing innovative products is the benchmark of our company. We are the first company to manufacture such innovative products, which vary in their applications. We have specialised dissolution products that determine the rate of dissolution of tablets in our body, required by any tablet manufacturer.” He says, “We are an ISO certified company and all our products are USFDA and USP compliant. We can easily say that our products are used in pharma companies, pharmaceutical colleges, laboratories, research institutes and many others.” Thus, from marketing the existing analytical instruments to manufacturing new instruments, the company has come a long way.

Facility Visit

We have progressed through passing times and today are manufacturing

our own products and even exporting products such as gas

chromatography systems, spectrometers, etc.

Shrikant Bapat CMD

Chandreyee [email protected]

Labindia Analytical Instruments Pvt Ltd Leveraging advanced technology for speedy successOver the past few years, globally, there has been a huge demand for analytical instruments and automation products. And in this regard, Labindia is doing its best to keep up with the pace of the growth in revenue and technology.

Analytical instruments at the lab

26 Insight & Outlook: Automation Trends - Case Study

Benefits of automated ‘vision’

Ensuring quality in pharmaceutical production

Center for Medicine in the Public Interest (CMPI) estimates that more than 25,000 pharmaceutical packaging

lines globally require modification to implement effective track and trace technologies. This presents challenges to manufacturers and machine builders.

Track and trace solution requires implementing three levels of functionality:

Print and verify marking numbers on all products

Mark each product with a unique serial number and create a central database

Track, store the location and status of each product as it travels through the supply chain until it is sold to the customer.Serialisation data is obtained

from four layers of supply chain operations, from individual medicine to manufacturing to final delivery. Any hierarchy-level information appearing on packaging such as blisters, folder cartons, bundles, cartons, packages or container also is recorded on production floor. Information is collected at internal supply chain level where product data on shipments between manufacturing facilities is recorded for further distribution. Product delivery is recorded at external supply chain level, allowing for an end-to-end product verification process.

CounterfeitingWHO estimates that about 15 per cent of medicinal products in the world are counterfeit. CMPI estimates that activities related to counterfeit drugs generate $ 75 billion annually and expects to grow by 20 per cent annually in coming years.

Defect detection and quality control

21 CFR Part 11Complying with USFDA regulations on electronic records/electronic signatures and pharmaceutical inspection co-operation schemes has created challenges for pharmaceutical manufacturers. It includes fortifying access control measures while providing an electronic trail for all transactions.

FDA suggests that procedures and controls shall include: (A) Validation of systems to ensure accuracy, reliability, consistent intended performance and ability to discern invalid or altered records. Generate, accurate and complete copies of records in both human readable and electronic form.

(B) Protection of records to enable their accurate and ready retrieval throughout the records retention period. Limiting system access to authorised individuals. Use of secure, computer-generated, time-stamped audit trails to independently record operator entries and actions that create, modify or delete electronic records. Use of

operational system checks to enforce permitted sequencing of steps and events, as appropriate.

(C) Use of authority checks to ensure that only authorised individual scan use the system. Determine that person who develops, maintains or use electronic record/electronic signature systems have education, training and experience to perform their assigned tasks. Establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.

Machine vision meeting the challenges of the pharma industry

Serialisation and trackingAdvanco, serialisation and tracking solutions deployed a traceability solution using Cognex In-Sight® ID readers for manufacturer that produces and distributes 60 million medicine boxes annually. In 1.4 seconds, it decodes all 2-D code sprinted with inkjet onto surface of each medicine package. An alarm trigger removes defective products ensuring that all shipment packages are traceable and improves production processes.

Defect detectionProduct testing company EISAI

Machinery GmbH, used two Cognex In-Sight vision systems to inspect delicate glass vials in fraction of a second. It determines cake height of freeze-dried contents and detects presence of any foreign objects on their surface and for ‘splashings’ caused by unwanted boiling during freeze-drying process. In-Sight system inspects underside of glass vials for cracks. In-Sight colour vision system checks both vial cap and flip-offseal, inspecting for parts presence, cover colour and for aluminum caps, correct crimp processing. It ensures that only glass vials with 100 per cent product quality are distributed to clinics, pharmacies and medical practices.

Process automationAutomated Systems of Tacoma, Inc (AST) used Cognex vision system to develop single-platform machine to fill vials, syringes and other containers. It eliminates need to purchase multiple filling machines and can handle all liquid packaging needs.

Code verificationPharmaceutical products manufacturer Sanofi-Aventis used Cognex vision systems to implement a print and code verification solution to comply with GS1 codes readability regulations. Designed as mobile system, it can be adapted for packing lines and installed along production process. It reads printed data and verifies against selected information camera at a speed of 300 parts per minute.

Machine vision tools for the pharmaceutical industry

PatMax® uses a set of boundary curves, not tied to a pixel grid and looks for similar shapes in image without relying on specific gray levels. Result is in ability to find objects despite changes in angle, size and shading.

Test Run delivers quality improvement. If it fails to inspect properly, quality manager can add to Test Run database and make required modifications.

OCRMax™ prevents misreads, handles process variations and provides easy font management. It is easy to set up and simple to use across all platforms.

Packaging quality controlBoehringerIngelheim uses Cognex vision to achieve printing quality inspection on a production line churning out around 300,000 blister packs and 100,000 folding packs every day. Challenge was high speed at which blister packs move on the production line, variable accuracy of inkjet printing on foils with irregular surfaces and dirt, pressure and sharp edges. Depending on product type, examination is made of varying details, including lot number, expiry date and pre-printed information. It recognises relevant symbols and letters and on previous parameters and tolerance limits, assesses product quality.

Label verificationArturTheis GmbH has a machine that inspects labels with different identification and information carriers including 1-D codes, genuine lettering and holograms and bollinos. If not aligned, then information such as use-by date, product and lot numbers cannot be applied correctly.

PatMax technology in In-Sight micro system helps to inspect product variety with different label shapes and colours by orienting itself to geometric features of the cartons. It determines position values without errors—even under variable lighting and position conditions and despite changing angles, sizes and shading.

Product safety and packaging integrity are stringent aspects in pharmaceutical industry. These are ‘early adopters’ in deployment and use of machine vision technology. Technology is implemented to stay compliant with regulations and mitigate risks.

CMPI estimates that activities related to counterfeit drugs

generate $ 75 billion annually and expects to grow by 20 per cent annually in coming years.

Didier LacroixGlobal Senior VP (Sales & Marketing), Cognex Inc

[email protected]

27Insight & Outlook: Interface

What was the reason behind setting up Anthem Biosciences?In our previous assignment we (the founders of Anthem) were in the top positions and had reached a point where there was no vertical growth. So, we wanted to see if we could do something more challenging and creative. That led us to setting up Anthem.

What got your interest in contract research?Contract research is an area that we know best as we have years of experience in this field. Due to the experience we have, we realised that there are a few things that we could do in certain areas which could be good differentiators in the industry. Thus, at Anthem we set up platform technology in the area of biology. Today, many of our clients have conveyed that the platform we offer to our clients for discovery services is unique. This definitely is a great achievement for us. When we set up this company our sole purpose was to come up with unique offerings

for our clients, which no one can provide besides us. Also, unfortunately contract research has a negative connotation attached to it as clients give you the protocol and you do exactly what has been asked. But we have started creating Intellectual Property (IP) in areas that do not conflict our client, and there are IP solutions that we have created which would serve as tool for drug discovery.

Where do you see Anthem going with this new concept?The market is not doing very well at the moment; a lot of people are losing their jobs as a result of which the outsourcing opportunities have faced a downfall from the West to India. Many experts

also feel that there is a huge contract research outsourcing incline towards China rather than India. Thus, companies that can be creative and innovate are the ones that would stand through time. With this concept, we have an upper hand and are sustaining this downfall.

What is the reason behind the tilt to China?Today, China has many positives; its infrastructure is a big plus and there are many incentives that the Chinese government is offering to the pharma and biotech companies to come to China. This clearly is a big deciding point for the companies of the West to go to China. More importantly, most of the big pharma and biotech companies have been working with China for the past decade or so and have invested a lot of capital.

What changes need to be made to strengthen the contract research segment in India?We have to make changes within ourselves, and one of the ways is by creating IP; important and novel aspects we need to bring in. The moment we do that, we will be noticed in the global scenario and there will be companies knocking at our doors.

There is a huge contract research outsourcing incline towards China rather than India

…observes Ganesh Sambasivam, Co-Founder & CSO, Anthem Biosciences. Here, he sheds light on the current scenario of Contract Research Organisations (CROs) globally and the urgent need to innovate in this sector.

Jasleen Kaur [email protected]

Companies that can be creative and innovate

are the ones that would stand through time

28 Insight & Outlook: Tips & Tricks

Cleanrooms are meant to serve clearly defined functional requirements and are not just structural elements such as walls and ceilings. Various issues must be considered with respect to design, engineering, installation, operations and maintenance of cleanrooms. Expertise

in these areas more than length of experience is critical in meeting these objectives. It must be noted that cleanrooms mean an integrated solution that comprise multiple engineering disciplines. Here’s a checklist for things to keep in mind while developing cleanroom infrastructure.

Operation and maintenanceThis is the most critical phase of using the cleanrooms. All efforts taken at the previous stages simply go waste if

the operating team is not trained in using the cleanrooms. Scratches on epoxy floors, stains on wall panels due to overuse of coloured disinfectants, peeling off of the silicone sealants, gaps in wall panels due to multiple removals, creaking door closers, cracks along joints between walls and ceilings are common observations.

The operation and maintenance teams must be fully educated about the need for clean rooms and implications of non conformance from both statutory and commercial aspects.

Execution plan: Once the basic design is agreed upon, the detailed execution plan must be made where each of the activities that linked are clearly spelt

out. It is typically done using a Microsoft Project or any other similar software. This is essential since a number of activities are interrelated. For example, some big equipment may have to be taken in by removing a certain number of panels of the cleanrooms. The detailed engineering, execution, site acceptance and commissioning activities for Heating, Ventilation and Air Conditioning (HVAC), utilities and instrumentation are to be dovetailed to the cleanroom construction plans. Civil finishes such as covings, cleanroom drains also need careful attention.

Detailed engineering: Once the design engineering is done, the detailed engineering must take into consideration the available execution

capability. A rigorous exercise is necessary to integrate process equipment including its cleaning, operation and maintenance, provision of utilities, needs for cleanroom drains, multi-floor construction if required, equipment cut-outs as may be required for installation of heavy process equipment such as big fermentors or fluidised bed dryers etc. The detailed engineering must be done in conjunction with all auxiliary areas and should include plans, sections and elevations. 3D modelling is increasingly used to sort out possible hiccups during execution and to eliminate crossovers with other disciplines of engineering.

The sampling points and procedures for monitoring of air, personnel and equipment must also be reviewed as part of the detailed engineering reviews. A very detailed safety review is essential of the detailed engineering done especially if the facility is using solvents (mainly APIs), has live areas (as in case of BSL 2 or 3 biotech facilities), highly potent product operations (as in case of oncology products) etc. It is equally essential to avoid too much of overdesign. For example, use of bag in bag out HEPA filters for general oral solids is a case of overdesign. Not only does it increase cost of installation, it also increases cost of spares and maintenance for no apparent benefit.

Execution and commissioning: The actual execution must follow the scheduling as done earlier. This must be controlled by a senior project functionary. Detailed

procedures must be available for monitoring progress and resolving conflicts, if any, without compromising on the URS requirements. In an event of unforeseen changes due to factors outside the control of the project team, all changes must be once again reviewed by the same team that undertook the design review. Change control procedures must be in place well before the execution starts.

Testing and qualification protocols must be discussed well before the commissioning starts. Properly experienced and trained functional heads is a pre requisite for successful commissioning. Test methods must have been discussed with the vendors and approved by QA. Test equipment must be known as also the acceptance criteria. Such equipment must have been calibrated and traced to proper national or international standards.

In case of an unfulfilled test, QA approval must be sought before the next set of tests are performed and reviews must include risk analysis.

The actual execution must be undertaken by highly qualified team to ensure that there are no rough edges in execution. The cleanrooms must provide uniform, monolithic, smooth and easy to clean surfaces and contours. The integration of the multiple components like wall panels, doors, view panels, risers, floor, ceiling and multiple covings apart from utility chases is the job of specialists. Such expertise must have been vetted before the design was approved. No activity shall be allowed till a full review of commissioning data is done to ensure compliance to URS elements.

Multi-functional basic design: Once the URS is made and approved by a multi-functional team of users, the design team must evolve a proposal that takes into

consideration not only the URS but goes further in making sure that operational and maintenance issues are taken care of. For example, if there is no adequate space for locating the ducts and filters, maintenance is not possible. Similarly, sampling points for validation must be included as part of the basic design. Each of the elements in the URS will need to be verified through a design qualification exercise once again by a multi-functional team.

Checklist for best cleanroom infrastructure

Right steps to follow

Well-defined User Requirement Specification (URS): The URS must be very well defined. It must clearly specify

what the application of the cleanroom is. Typically, cleanrooms are used in cell cultures (biotech), sterile products (both API and formulations), vaccines, electronics (wafers) as well as secondary operations. The requirements do change based on the applications. For example, the need for viable particulate control is stringent in aseptic processing, whereas particulate control is much more critical for assembly of satellite components. The regulatory requirements are explicit in many cases. For example, for aseptic areas the standards are clearly defined. However, several parameters are to be user defined based on products, process sizing, number of personnel working, the product stability requirements such as temperature, humidity, photo and solvent protection also must be clearly specified.Beyond this, the need for expansion must be known before the design is started.

1Tips&Tricks

6Tips&Tricks

3Tips&Tricks

4Tips&Tricks

5Tips&Tricks

2Tips&Tricks

P K KulkarniManaging Director, Technolutions Projects Pvt [email protected]

29Projects

API facilities Project type: New facilityProject news:Pharma major Cipla plans to invest ` 500 crore for setting up API facilities at Patalganga, Bengaluru and Kurkumbh.

Project location:Patalganga, Bengaluru and Kurkumbh Project cost: ` 500 crore Implementation stage:Planning

Contact details:CIPLA LtdMumbai Central, Mumbai – 400 008Tel : +91 22 23082891, +91 22 23095521Fax : +91 22 23070013, +91 22 23070393Email: [email protected], [email protected] Website: www.cipla.com

Develop vaccines for chikungunya and Japanese Project type:New facilityProject news: Hyderabad-based Indian Immunologicals Ltd (IIL), a wholly owned subsidiary of National Dairy Development Board, has joined the league of few companies in the world to develop world’s first vaccine for chikungunya. IIL is also developing a live vaccine for Japanese Encephalitis virus (JEV) for the first time in the country. Right now both the vaccines are undergoing pre-clinical toxicology studies.

Project location:Karakapatla, Hyderabad, Andhra Pradesh Project cost:NA Implementation stage:Planning

Contact details:Indian Immunologicals Ltd (IIL) Road # 44, Jubilee HillsHyderabad - 500033, Andhra Pradesh Tel : +91 40 23544585, 23544593Fax : +91 40 23544007Email: [email protected] Website: www.indimmune.com

Industrial enzymes and biopharmaceuticals Project type: New facilityProject news:Anthem Cellutions (I) Ltd is planning to set up an industrial enzymes and biopharmaceutical plant at Harohalli Industrial Area, Ramangara District, Kanakapura, Ramanagara of Karnataka.

Project location:Ramanagara, Karnataka Project cost: ` 97 croreImplementation stage:Planning

Contact details:Anthem Cellutions (I) Ltd

F1&F2, Canara Bank RoadBommasandra Industrial area Phase IHosur Road, Bengaluru -560099Tel : +91-80-40444000/66724000Fax : +91-80-40444020/66724020Email: [email protected],[email protected] Website: www.anthemcell.net

Manufacturing speciality chemicals and APIs Project type:New facilityProject news:Vivimed Labs Ltd (Vivimed) has set up its own sector-specific Special Economic

Zone (SEZ) in Srikakulam District, AP, which will help the company to support its growing demand from the export markets and also from upcoming industries for the manufacturing of speciality chemicals as well as APIs. Project location:Srikakulam, Andhra Pradesh Project cost:` 1,200 million Implementation stage:Planning

Contact details:Vivimed Labs Ltd (Vivimed) Veernag Towers, Habsiguda, Hyderabad, AP 500 007, Tel : +91(0)40 2717 6005/6Fax : +91(0)40 2715 0599Email: [email protected]: www.vivimedlabs.com Manufacturing tablets and capsules Project type: New facility

Project news:Vivimed Labs Ltd (Vivimed) is setting up a pharmaceutical formulation plant in Chouttuppal, Andhra Pradesh, to be utilised for manufacturing of tablets and capsules in accordance with USFDA and cGMP standards.

Project location:Chouttuppal, Andhra Pradesh Project cost: ` 400 million Implementation stage: Planning

Contact details:Vivimed Labs Ltd (Vivimed)Veernag Towers, HabsigudaHyderabad, AP 500 007, Tel : +91(0)40 2717 6005/6Fax : +91(0)40 2715 0599Email: [email protected] Website: www.vivimedlabs.com

ProjectsNew projects and expansion activities are the barometers of industrial growth. These also present business opportunities to service providers like consultants, contractors, plant & equipment suppliers and others down the value chain. This feature will keep you updated with vital information regarding new projects and capacity expansions being planned by companies in the pharma/lifesceinces industry.

Information courtesy: www.tendersinfo.com1, Arch Gold, Next to MTNL Exchange, Poisar, S V Road, Kandivali (W), Mumbai - 400 067, Maharashtra, India

30 Tenders

Org: Organisation’s name; TRN: Tendersinfo Ref No; Desc: Description; DSLD: Doc Sale Last Date; BOD: Bid Opening Date; Loc: Location; BT: Bidding Type

Information courtesy: www.tendersinfo.com1, Arch Gold, Next to MTNL Exchange, Poisar, S.V. Road, Kandivali (W), Mumbai - 400067 Maharashtra, India

Tel: Fax: Email: [email protected]

Drugs Org : Directorate Of Health And Family Welfare Services TRN : 14320048Desc : Supply of drugs for day care chemotherapy unit of district hospital, tumkur 2012-13 BOD : February 11, 2013Loc : Tumkur, Karnataka BT : Domestic (NCB)

Inductively coupled plasma mass spectrometry Org : Japan Atomic Energy Agency TRN : 14053384Desc : Supply of inductively coupled plasma mass spectrometry BOD : February 12, 2013Loc : Japan BT : Global (ICB)

Medicine Org : Department Of Posts TRN : 14328191Desc : Supply of medicine to postal dispensary, JalpaiguriBOD : February 12, 2013Loc : Jalpaiguri, West Bengal BT : Domestic (NCB)

Liquid chromatography tandem high resolution mass spectrometer (LC/HRMS) Org : Public Works And Government Services Canada TRN : 14230155

Desc : Provision of liquid chromatography tandem high resolution mass spectrometer (LC/HRMS).BOD : February 13, 2013Loc : Canada BT : Global (ICB)

KHD screen bowl centrifugal Org : Petrochemical Kala Company

TRN : 14292647

Desc : Provision and fixing of KHD screen

bowl centrifugal

BOD : February 13, 2013

Loc : Tehran

BT : Global (ICB)

Natural gamma ray spectroscopy system Org : Oil And Natural Gas Corporation

Limited (ONGC)

TRN : 13895526

Desc : Supply, installation, commissioning,

testing, calibration & training of natural

gamma ray spectroscopy system


Loc : Dehradun, Uttarakhand

BT : Domestic (NCB)

Engine emission particulate analyser spectrometer Org : Research Designs And Standards

Organization (RDSO)

TRN : 13416818

Desc : Supply, installation and commissioning

of engine emission particulate analyser

spectrometer for exhaust emission from

diesel/bio-diesel and dual fuel

locomotives of Indian Railways


Loc : Lucknow, Uttar Pradesh

BT : Domestic (NCB)

Spectrometer Org : Department Of Atomic Energy

TRN : 14290673

Desc : Supply of tera hertz spectrometer


Loc : Mumbai, Maharashtra

BT : Domestic (NCB)

Atomic absorption spectrophotometer Org : Uttar Pradesh Pollution Control Board

TRN : 14328626

Desc : Supply of atomic absorption

spectrophotometer, gas chromatograph,

UV-visible spectrophotometer, 3-stage

water purification system, sound

level metre.


Loc : Lucknow, Uttar Pradesh

BT : Domestic (NCB)

Latest Popular Tenders Brought to you by www.tendersinfo.com

31Event List

N A T I O N A L E V E N T S

I N T E R N A T I O N A L E V E N T S

The information published in this section is as per the details furnished

by the respective organiser. In any case, it does not represent the views of

Modern Pharma.

Bangalore INDIA BIO Bangalore INDIA BIO is an event which will prove to be beneficial for the industry leaders, policy makers, opinion leaders and professional experts related to biotechnology industry. By attending this event they will get a scope to improve and enhance their knowledge. This expo will also give them an opportunity to get familiar with the latest techniques which are required for bringing some useful and modern changes in the technical institutions and companies. This event will bring forward the significance of biopharmaceuticals, bio industrial services and bio informatics and agri biotechnology; There will be a CEO Conclave that will aim at unique and niche gathering of CEO of biotechnology, lifesciences, rearch heads where they in an panel will discuss on the industry trends and the growth ahead; February 4-6, 2013, The Lalit Ashok, Bengaluru

For details contact:M M ActivTel: +91-80-41131912

Fax: +91-80-41131914Email: [email protected]: www.bangaloreindiabio.in

Nutra India SummitNutra India Submit enjoys its 8th successful year in showcasing healthcare and wellness products, nutritional food supplements and natural products. These products are manufactured under the brand name of the trusted companies and each of them is clinically tested before launching them in the consumer market. There will be conferences, forums, award ceremonies and several other programmes that will be running simultaneously with the exhibition and the summits will be visited by 500 delegates from across 12 countries of the world such as Canada, Japan, USA and others. The show will be hosted by over 60 exhibitors coming from different departments in the nutritional sector; March 13-16, 2013, Vivanta by Taj President, Mumbai

For details contact:M M Activ, Bengaluru

Tel: +91-80-41131912Fax: +91-80-41131914Email: [email protected]: www.mmactiv.in

IphexiPhex plays a major role in introducing the Indian market to the advanced medicinal products. This show covers up the entire medical industry, starting from hospital services, medicines, pharmaceuticals and surgical sectors. Professionals are informed about every recent happening that took place and are also updated about the added policies

so that the attendees are kept up to date with the pharmaceutical sector. 250 companies have already registered to participate in this event as they think that this podium is the best way to reach out to the customers; April 24-26, 2013, Bombay Exhibit ion Center (BEC), Mumbai

For details contact:Pharmaceuticals Export Promotion CouncilTel: +91-40-23735462/23735466Fax: +91-40-23735454Email: [email protected]: www.iphex-india.com

India’s premier industrial trade fair on products and technologies related to Machine Tools, Hydraulics & Pneumatics, Process Machinery & Equipment, Automation Instrumentation, Packaging & Auxiliaries, IT Products,

Electrical & Electronics, Material Handling and Safety Equipment.

HYDERABADAndhra Pradesh,

May 31- June 3, 2013

AURANGABADMaharashtra,

Feb 22-25, 2013

For detailsNetwork18 Media & Investments Ltd

Ruby House, 1st Floor, J K Sawant Marg, Dadar (W), Mumbai 400 028.

BIOSIGNALS 2013The purpose of the international conference on Bio-inspired Systems and Signal Processing is to bring together researchers and practitioners from multiple areas of knowledge, including biology, medicine, engineering and other physical sciences, interested in studying and using models and techniques inspired from or applied to biological systems. A diversity of signal types can be found in this area, including image, audio and other biological sources of information.; February 11-14, 2013, Barcelo Sants Hotel, Barcelona, Spain

For details contact:Biosignals SecretariatTel.: +351 265 100 033Fax: +44 203 014 5436Email: [email protected]: www.biosignals.biostec.org

Bioinformatics 2013The purpose of the international conference on bioinformatics models, methods and algorithms is to bring together researchers and practitioners interested in the application of computational systems and information technologies to the field of molecular biology, including for example the use of statistics and algorithms to understanding biological processes and systems, with a focus on new developments in genome bioinformatics and computational biology; February 13, 2013, Barcelona, Spain

For details contact:Bioinformatics SecretariatTel.: +351 265 100 033Fax: +44 203 014 5436Email: [email protected] :www.bioinformatics.biostec.org

32 Event Preview

Bangalore INDIA BIO 2013

Multi-functional opportunities under one roof

With an annual growth of over 15 per cent per year, biotechnology is one of the rapidly growing industries

in India. With Bengaluru being a major biotechnology hub, Bangalore INDIA BIO 2013 intends to provide a platform for industry experts, regulatory bodies and academicians to discuss recent advances and challenges in areas of biotechnology, fostering the development of this sector across the borders.

Bangalore INDIA BIO 2013, the flagship event of the Government of Karnataka is organised in association with Vision Group on Biotechnology and MM Activ Sci-Tech Communications during February 4-6, 2013 at The Lalit Ashok, Bengaluru. This will be the India’s biggest biotech conference opening doors to scientific discussion and business opportunities across vibrant areas of biotechnology such as bioinformatics, biosimilars & Intellectual Property (IP) regulations, clinical research, contract research, regenerative medicine & vaccines, molecular biotechnology, partnering & deal making, biofuel & agri-biotechnology and bio-services & equipment. Event will be graced by regulatory authorities, industry veterans and academic stalwarts from more than 20 countries. Theme of this year’s conference is ‘Biotech for a better tomorrow’. Exhibitors include professionals from bio-pharmaceutical industry, diagnosis

& instrumentation sector, engineering & equipment suppliers, IP consultants, law firms, CROs etc among others while the visitor profile include professionals from biotech and allied industry, international business delegates, regulators & policy makers, scientific & academic professionals and the conference delegates. The annual trade show will emphasise to promote outsourcing, collaborations and tie-ups. Around 3,000 business visitors and 175 exhibitors are expected to attend this exhibition.

Special eventsCEO conclave is an exclusive gathering of leaders from biotech community. Panel discussion on key issues concerning the biotech industries, both nationally and globally, will be the time for industry experts to mingle and gain insight into various challenges and opportunities. Scheduled on February 4, 2013, the conclave has an interesting panel discussion which will start with a talk by Karen Bernstein, Founder, Biocentury, the globally read biotechnology publication. She will talk about global trends in this sector and how India can convert many of these challenges into the opportunities. In the words of biotech veteran, Dr Kiran Mazumdar-Shaw, “CEO conclave provides opportunity to both startups and mature companies to interact.

Many collaborations are catalysed at such platform. These interactions also allow young CEOs to seek advice from business leaders.” Teleplenary talks will consist of high impact keynote lectures shared using a video call facility. Poster session – ‘Walkway of Discovery’ – will provide young researchers to showcase their innovation in this field. An exciting event, bio-excellence awards will recognise achievers in the field of life sciences and biotechnology. Tutorials and workshops will provide a platform for exchange of information among sharply focussed groups. India’s largest state level ‘Bio-quiz 2013’ will aid to increase awareness in the field of biotechnology. This year the

bio-quiz is expected to have 600 teams encompassing 1,200 students.

Year gone by…Last year, Bangalore INDIA BIO 2012 witnessed 500 delegates from more than 18 countries in 22 conference sessions, participation of over 450 organisations and over 4,000 business visitors in 3 days. Bioexcellence Awards were presented in the categories of bio-pharma, agri-biotech, bio-services, industrial-biotechnology and bioinformatics. There were 80 national and international organisations who showcased their innovations.

Similar to last year, this year an equally high participation and success is anticipated.

India’s biggest biotech show is back with its thirteenth edition covering a comprehensive range of topics in vivid areas of biotechnology. A slew of events are lined up right from multi-track conferences, international trade show, vision leadership series & plenary talks, workshops, CEO conclave, poster session, bio-quiz to bio-excellence awards. Here’s a review of things to look out for…

Snapshot of the previous edition

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Abbott has completed the separation of its research-based pharmaceuticals business, which became AbbVie, a new independent biopharma company. AbbVie is a research-based special i ty biopharmaceuticals company with a broad portfolio of medicines, including leadership in immunology and virology, and a pipeline of breakthrough therapies.

Abbott is one of the largest science-based, diversified healthcare companies, with market-leading offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals.“We wish our colleagues

at AbbVie continued success as they become part of a new, independent company

that is a lready making a significant difference, focussing on highly specialised, market-leading therapies for some of the world’s most difficult-to-treat diseases,” said Miles D White, Chairman and CEO, Abbott.

Marck Biosciences has opened a new chapter in Africa with the award of the South African Medicines Control Council approval for six products manufactured at its Small Volume Parenterals (SVP) facility at Kheda, Gujarat. The MCC approval

will also enable Marck Biosciences to achieve immediate access to key markets including Namibia, Botswana, Zimbabwe, Swazi land, Lesotho, Zambia, Malawi and Madagascar. MCC approval is expected to result in waiver of inspection by the authorities of these countries and an easier registration of certified products. For

Marck Biosciences, the approval carries the opportunity of accessing some of

Africa’s most stable growth economies. MCC-South Africa’s

certification is also recognised by 43 participating authorities of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This may

facilitate export by Marck Biosciences of certified SVP

to PIC/S participating authorities as well as non-PIC/S authorities who accept GMP certificates from PIC/S participating authorities.Speaking on the MCC-South Africa

approval, Bhavesh Patel, MD, Marck Biosciences, said, “The MCC-South Africa approval for our Kheda facility will provide further impetus to our current expansion efforts in the African region and PIC/S countries. We would also augment our efforts by our own filing and licensing with new partners in SA. I see strong revenue potential in these under-served markets and we believe that we can make a quantum contribution to healthcare products in these countries.”Six products have obtained approvals

from MCC-South Africa, including sterile water for injections BP 5/10 ml; ciprofloxacin eye drops 5/10 ml; timolol (0.25 and 0.5 %) eye drops 5/10 ml; lidocaine injection BP (1%) 5/10 ml and lidocaine injection BP)2%) 5/10 ml.

Médecins Sans Frontières (MSF) welcomed the approval by the US FDA of bedaquiline, the first new drug active against Tuberculosis (TB) to be registered since 1963. “The first new drug to treat TB in 50 years is an immense milestone,” said Dr Manica Balasegaram, Executive Director, MSF Access Campaign. “The fact that the drug is active against drug-resistant forms of the disease makes it a potential game changer.”Today’s treatment for multidrug-

resistant TB (MDR-TB) is a two-year course of up to 20 different pills per day and around eight months of daily injections. Patients are subjected to excruciating side effects, ranging from permanent deafness and persistent nausea to psychosis. Globally, only 48 per cent of people who start treatment for DR-TB are cured. In MSF programmes, the cure rate is slightly better – 53 per cent – but still unacceptably low.

“Ministries of health and drug regulators need to work together to make sure people with MDR-TB benefit from

this important medical advance as soon as possible. The onus is on all of us to use bedaquiline to devise new treatment regimens for drug-resistant TB that are shorter, more tolerable for patients and are more effective,” said Dr Balasegaram. “With better treatment on the way, there should be all the more incentive to scale up our efforts to treat MDR-TB today.” The scale of the DR-TB epidemic is huge, with 310,000 new cases notified in 2011. But globally, only 19 per cent of people thought to be infected are receiving treatment.“Scale-up of global DR-TB

treatment has remained shockingly low, to a large degree because the current treatment regimen is so complex and costly for health programmes and difficult to tolerate for patients,” said Dr Francis Varaine, Leader - TB Working Group, MSF. “With simpler, shorter and more effective treatment regimens, we will be able to scale-up treatment and cure more people with DR-TB.”

In addition to bedaquiline, developed by Janssen, a second new drug that is active against MDR-TB called delamanid, developed by Otsuka, is undergoing registration by the European Medicines Agency and is expected to be approved for use in 2013. Together, the two new drugs represent an unprecedented opportunity to improve treatment for MDR-TB, and ensuring the drugs are combined and introduced in the most effective manner is extremely urgent.Access to new drugs will depend to a

large degree on the manufacturers. MSF calls on the manufacturers to make the drugs available for research in order to develop shorter, more effective regimens, to register them in high-burden countries as quickly as possible once they have been approved, and to ensure they are affordable in countries where they are needed most. MSF treated 26,600 TB patients in 36 countries in 2011 – 1,300 of whom had drug-resistant forms of the disease.

In Conversation With 13Manish Gupta CEO, Indegene Lifesystems Pvt Ltd

Special Focus 14Nanotech in pharma Aiming for sizeable benefi ts in India

Policies & Regulations 16Pharmaceutical trademarks: Scanning the changing trends

Interface 19Pulin Shroff Managing Director, Charak Pharma

Abbott completes separation of research-based pharma business

MCC-South Africa approval opens up key African markets for Marck Biosciences

16 - 31 J a n u a r y 2 013 I Vo l 1 I N o 14 I `10 0

Scan this code onyour smart phoneto visit www.modernpharma.in

MSF calls for rapid registration in countries with high DR-TB

Patel

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Earnings momentum to be sustained by most large-cap genericsAccording to Kotak Institutional Equities earnings growth is expected to stay over 20 per cent y-o-y for large-cap generics except Ranbaxy. The strong performance will be driven by launches/market share gains in the US, stable growth in domestic formulations and a favourable currency. Cadila and Lupin will also benefit from acquisitions on a y-o-y basis. The EBITDA margin too is expected to expand y-o-y for Cadila (350 bps, weak base/currency), Cipla (150 bps, product mix/currency), Lupin (260 bps, Tricor) and Glenmark (244 bps, product mix). Dr. Reddy’s margin is expected to remain flat y-o-y. Domestic growth to remain stable

A growth in domestic formulations is expected to be the highest for Sun Pharma (20 percent y-o-y). Cadila reported a 24 per cent growth, higher than Biochem, which is expecting an underlying growth of 18 per cent. Lupin, Glenmark and Cipla are also likely to post healthy growth (17-18 per cent y-o-y). Dr. Reddy’s is expected to grow in line with industry growth of 15 per cent and Ranbaxy’s growth may stay muted (11 per cent y-o-y).

US approvals, competition may hold the key to stock performanceFor Lupin, the launch of generic

Tricor has been an expected event with focus shifting to entry of further competition. The launch of more OC products and ramp up will be key factors. Dr. Reddy’s execution of US launches has gained momentum. Additional limited competition launches (in 4QFY13) and US pipeline visibility for FY2014 are likely triggers. A stable performance for the quarter and execution on the US pipeline will be the key for Cadila. The quarter will provide the base business performance for Cipla after the benefit from escitalopram over the past two quarters. Glenmark will be required to sustain its strong earnings performance given the heightened expectations.

3QFY13 Preview

33Book Review

Reviewer: Dr Mandar Kubal, Director, Infectious Diseases & Pulmonary Care Pvt Ltd

Many a blockbuster drugs had found its origin in natural sources such as plants and animals. It has been the extraction of active chemical entities that has propelled a natural product from its habitat into the pharma industry. The editors have put together a good collection of 20 chapters in the revised third edition book to better explain the basics of isolation techniques, newer methods of isolation techniques and troubleshooting tips related to these isolation techniques.

The first two chapters deal with the basics of natural products isolation. The third to fifth chapters introduce the reader to the state-of-the-art super critical fluid extraction, accelerated extraction and microwave extraction techniques used today. The book devotes six chapters to extraction based on chromatography and its latest variations, including HPLC and gas chromatography. There are dedicated chapters for isolation of marine-based active principles and secondary active metabolites. Towards conclusion, the book discusses in detail on scaling up of technology for mass extraction for commercial purposes and future prospects. Every chapter follows an introduction, basic concept explanation, step by step guide in laboratory and a troubleshooting guide format.

Handbook of Ayurvedic Medicinal Plants

Natural Products Isolation: Methods and Protocols

Editor: L D Kapoor

Price: ` 3995

Publisher: Pharmaceutical PressDistributor: Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: [email protected]

Editors: Satyajit D Sarker & Lutfun Nahar

Price: ` 9500

Publisher: Informa HealthcareDistributor:Wisdom Book Distributors, Hornby Building, 1st Floor, 174, D N Road, Mumbai 400 001, Tel: 022 2207 4484/6631 8958, Telefax: 022-2203 4058 Email: [email protected]

Ayurveda, the traditional Indian system of medicine, is the oldest form of medicine from which many other traditional systems have emerged. The system draws heavily from the natural flora of the continent and ancient texts describe in great detail the importance of the same. The author has put together an excellent collection of 251 plants of medicinal value in Ayurveda and described them in detail.

Each plant is described in formats of traditional name, foreign names and taxonomical classification, and habitat, parts of significance, characteristics, actions, Ayurvedic uses, active chemical constituents, pharmacological doses and actions. The author describes every plant from an ancient Ayurveda perspective and from a modern scientific/ pharma perspective. Very simple language and illustrations make this book an excellent reference guide on plants of Ayurvedic significance.

34 Products

Looking For A Specific Product?Searching and sourcing products were never so easy.

Just type MPH (space) Product Name and send it to 51818eg, MPH Laboratory software and send it to 51818

Temperature and process controller

Fuji Electric’s s e l f - t u n i n g temperature and process controller has low-cost options that include RS485 communications,

digital input, timer function, heater burnout alarm, dual outputs and programmable alarms. The faceplate is watertight and corrosion-resistant. The three-button keypad allows programming and the screw-terminal on the back eliminates the need for sockets. In addition to auto-tuning and fuzzy control, it has self-tuning control, which automatically retunes the controller under certain conditions, without the need to revert to auto-tuning. It accepts temperature and process inputs and offers two control outputs and two programmable alarms.

Procon Technologies Pvt LtdAhmedabad- GujaratTel: 079-27492566, Mob: 09824310188Email: [email protected]: www.procon.co.in

Digital test gaugeThe digital test gauge Accu-Cal Plus is ideal for pressure m e a s u re m e n t and for c a l i b r a t i n g p r e s s u r e t r a n s m i t t e r s , switches and

gauges. Accu-Cal Plus digital test gauge offers outstanding accuracy, resolution and stability for pressure measurement and calibration requirements. It is used extensively in process monitoring and control industry. It is housed in waterproof casing of polished stainless steel and rated IP65/NEMA4. Accurate stainless steel pressure sensors offer models to cover from vacuum up to 10,000 psig with accuracy up to 0.05%

AODD PUMPThe pump sizes range from 1/4” size to 3”size. P u m p housings are available in polypropylene,

PVDF, nylon, aluminium and stainless steel. Internals are available in teflon, EPDM, nitrile rubber or viton. The Pumps run on dry, non-lubricated, clean air. The pumps are in bolted construction and are designed for a variety of industrial applications. They are self-priming and can carry solid particles/slurries without any damage. It is useful in industries like pharma, glass and fiberglass, oil & gas, marine/shipbuilding, metal and steel, effluent treatment, paint, aircraft, electroplating/surface treatment, food and beverage, automotive, chemical,

Pipetting systemIt enables users to deliver consistent, reproducible pipetting with higher-quality results. Its revolutionary ClipTip interlocking technology locks tips securely into place to deliver an airtight seal on every channel.

Available for both single and multichannel pipettes, the F1-ClipTip pipetting system is simple but powerful. With minimal force, each tip is clipped securely on the F1-ClipTip pipette using a patented three-interlocking clip design. The pipette and tip form a complete seal to secure the sample volume in each tip for enhanced accuracy and precision. Features include: Ergonomic design, lightweight, adjustable 120° finger rest for both right- and left-handed operator comfort, 150 percent increase in air boost to ensure efficient delivery of microvolumes and prevent capillary action for low volume pipetting and volume lock adjustment.

Thermo Fisher Scientific Mumbai - Maharashtra Tel: 022 - 6680 3000Fax: 022 - 6680 3001/02Email: [email protected]: www.thermoscientific.com

of full scale. It provides numerous user-configurable features including adjustable sample rates, dampening, tare, custom engineering units, minimum/maximum and password-protected field calibration. A five digit rotating backlit display with oversized digits, 20 segment bar graph and high contrast provides superior resolution and excellent readability in poor light conditions or bad viewing angles. Temperature compensation circuitry and multi-temperature calibration provides outstanding accuracy over a temperature range of 0 to 50° C.

Cole-Parmer India Pvt LtdMumbai - Maharashtra Tel: 022-67162209 / 2222Fax: 022-67162211Email: [email protected] Website: www.coleparmer.in

clay and ceramics. Major advantages are that it is lube-free, non-stalling operation, corrosion-free, weight reduction, air valve body available in corrosion-free engineered plastics, commonality of spares across models and sizes.

Shanbhag & AssociatesMumbai - Maharashtra Tel: 022-28346604, 28340071, 28218008Fax: 022-28388334Email: [email protected]: www.shanbhags.com

35Products

The information published in this section is as per the details furnished by

the respective manufacturer/distributor. In any case, it does not represent the views of

Modern Pharma

One must look after ease of operation. He/she

should know how to operate the product so as to

avoid technical errors and incorrect output.

J. Noelraj (Team Leader - Marketing)Trident Pneumatics Pvt Ltd

Particle counterIt is the only particle counter in the world that measures down 0.3 micron at 100 lpm flow rate with a t h e o re t i c a l l y perfect counter. Counting efficiency is an expression of the probability that a particle counter will sense and count a particle passing through its sample volume. This probability is a function of size up to a certain critical size above which all particles are normally sensed and counted. The model’s most sensitive threshold for 100 lpm flow rate is 0.3 microns. The counting efficiency for 0.3 microns is 50% and for 0.5 microns it is 100%.

MeasureTest InstrumentsMumbai- MaharashtraPhone: 022-2202 7982 Email: [email protected]: www.measuretest.com

Pharmaceutical medicines

A wide assortment of pharmaceutical medicines that are known for their effective results are offered. Made in proper hygienic conditions, these medicines are categorised into topical, oro-dental, gynaec & haemostats, intravenous fluids, anti-allergic, cold & cough medicines, antibiotics and quinolones & cephalosporins, antacids, anti-ulcerants & laxatives and appetite stimulants enzymes.

Schwitz BiotechAhmedabad – GujaratTel: 079-27493057Mob: 09825374233Email: [email protected]: www.schwitzbiotech.com

Work benchThe work bench features steel frames, panels and shutters made from prime quality CRCA steel.

This steel is coated with epoxy paint and a special encapsulated powder that has a film thickness of 40-60 microns. This imparts a high scratch-resistance and

Gas flow adsorption analyserThe model SGA-100 is a continuous gas flow adsorption analyser which is specially designed for the study of water or organic vapour isotherms at temperatures ranging from 0°C

to 80°C (standard version), 250°C (high-temperature version), at an ambient pressures. The term symmetrical refers to a design feature where by both the sample side and the reference side of the microbalance is subjected to identical temperature, relative humidity and flow rate. This provides significant stability and accuracy and allowing the possibility of performing absolute or differential adsorption experiments. The instrument is used in industries such as catalyst, chemicals, pharmaceuticals, foods, electronics, etc.

Smart Instruments CompanyThane - MaharashtraTel: 0251-2801123, Mob: 09323509969Email: [email protected]: www.smartinsrument.com

Pallet shrinking toolThe pallet shrinking tool is used for shrink wrapping. Shrink wrapping of export pallets, giant pallets, giant articles, big

articles/machinery are used to avoid damage during transportation. Boxes on pallets and other products can be shrink-packed within minutes. It provides five-sided protection for any size or shape load from small uneven pallets to large machinery and more strength than stretch wrapping. The tool is compact, portable and handy weighing 950 g.

Dharmesh EnterprisesMumbai - MaharashtraTel: 022-55233591Email: [email protected]: hotairguns.com

Liquid process filter cartridgeLiquid process filter cartridge is available in depth, pleated, membrane and speciality types, ranging from 0.01 to 100 micron. It can

be made available in 4 distinguishing sizes with variety of end connectors. These US grade filters are manufactured in ISO class 7 environment using FDA listed materials. It can be used in typical applications like pre filtration, pre RO, final filtration, clarification, particulate removal from non sterile formulations, filtration for pharmaceutical fermentations, filtration of water for injection, tank vent filtration, sterile filtration of active pharmaceutical ingredients and also for large and small volume parentals. They specialise in microbial removal, catalyst and steam recovery, particle and haze removal, solid contaminants removal, etc.

Thermax LtdPune - Maharashtra Tel: 020-66476356Email: [email protected]: www.thermaxindia.com

the encapsulated powder ensures that no oil or chemical marks are formed on the surface. Every shelf on the cabinet is equipped with a load carrying capacity of 40 kg UDL to ensure maximum efficiency in the cabinet drawer.

Godrej & Boyce Mfg Co LtdMumbai - MaharashtraTel: 022-67964363, Mob: 09920113138Email: [email protected]: www.godrej.com

36 Marketplace

PLUS: Energy smart hospitals: Guiding a ‘green’ healthcare

Vol 9 I No 2 I January 2013 I www.modernmedicare.co.in I ` 100

Scan this code

on your smart phone

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Facility and

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Learning to

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37Marketplace

38 List of Products & Advertisers

Looking For A Specific Product?Searching and sourcing products were never so easy.

Just type MPH (space) Product Name and send it to 51818eg, MPH Laboratory software and send it to 51818

Acoustic enclosure ....................................................... 7,27Air circuit breaker .................................................BICAir sterilisation .......................................................BCAnalytical instrumentation.................................... 17AODD PUMP ......................................................... 34Ball check valve ............................................................... 31Ball valve ............................................................. 14,31Bearing ..................................................................... 12Bend ......................................................................... 14Blower ........................................................................ 6Blow-fill seal machine .............................................. 9Bush .......................................................................... 31Butterfly valve .................................................... 14,31Cable carrier .................................................................... 12Cable connector ...................................................... 12Car washing hose .................................................... 21Chain ........................................................................ 12Chain pulley block ................................................. 36Chiller ....................................................................... 33Clean room clock ................................................... 37Clean room door ..................................................FICClean room monitor .............................................. 37Cleanroom equipment and accessories ............... 23Cold room ............................................................... 33Column and chemistries ....................................... 17Compact pneumatic cylinder ............................... 15Condensing unit ..................................................... 33Connector ................................................................ 12Contactor and motor starter ...............................BICContainer sterilisation ...........................................BCControl panel .......................................................... 33Crab .......................................................................... 36Crane ........................................................................ 36Data logger ....................................................................... 37Dehumidifier ........................................................... 29Diaphragm valve ................................................ 14,31Digital differential pressure transmitter and indicator ................................................................... 37Digital GPS clock .................................................... 37Digital magnahelic gauge ...................................... 37Digital temperature controller .............................. 36Digital test gauge .................................................... 34Drive ......................................................................... 36

Drive / invertor .....................................................BICDry vacuum pump ................................................. 37Dry van pump ..................................................... 7,27Dual channel with modbus ................................... 36Dynamic controller ................................................ 36Dynamic pass box ................................................FICEcoflux corrugated tube heat exchanger ......................8Electric actuator and gripper ................................ 15Empower.................................................................. 17End cap .................................................................... 14EOT/HOT crane ..................................................... 36Evaporating unit ..................................................... 33Exhauster ................................................................... 6FEP/PFA/PVDFmaterial ................................................ 31Filter cock ................................................................ 14Fire resistant door .................................................FICFitting ....................................................................... 31Flame proof hoist ................................................... 36Flameproof clock .................................................... 37Flow indicator ......................................................... 14Foot valve ................................................................. 14Garden hose / power spray ........................................... 21Gas flow adsorption analyser ................................ 35Gasket ....................................................................... 31Gear box .................................................................. 36Gear pump .............................................................. 10Goliath crane ........................................................... 36Goods lift ................................................................. 36Guided compact pneumatic cylinder .................. 15Heart valve frame ........................................................... 13HPLC........................................................................ 17Human-machine interface ..................................BICHumidity ................................................................. 37Humidity and temperature transmitter .............. 37HVAC and MEP ....................................................BCHydraulic accessories ............................................. 21Impeller ............................................................................ 14Industrial chilling equipment ............................... 33Infomedia Yellow Pages.......................................... 35Informatics .............................................................. 17Inspection system ................................................... 11JIB crane ........................................................................... 36Laminar air flow unit................................................... FIC

Liquid process filter cartridge ............................... 35Long neck pipe end ................................................ 14Lonizer ..................................................................... 15LVS .........................................................................BICMachines and plants for dry and wet preparation .. 25Mechanical vacuum booster ................................... 6Metal doorset ........................................................FICModular clean room ............................................FICMonoblock high vacuum pump .......................... 37Monorail trolley ...................................................... 36Motorised chain pulley block ............................... 36Non return valve ............................................................. 14Oil seal high vacuum pump ......................................... 37Pallet shrinking tool ...................................................... 35Particle counter ....................................................... 35Peristaltic pump ...................................................... 37Pharmaceutical medicine ...................................... 35PID controller ......................................................... 36Pipe ........................................................................... 31Pipetting system ...................................................... 34Plastic masterbatch ................................................. 37Plate heat exchanger ................................................. 8PLC ................................................................... 36,BICPlug valve ................................................................. 31Pneumatic tool and accessories ............................ 21Pole ring ................................................................... 14Profile controller ..................................................... 36PTFE ......................................................................... 31Pump ......................................................7,10,27,36,37Rapid endotoxin detection system .............................. 37Reducer .................................................................... 14Refrigrated compressed air dryer ......................... 15Regular HSE / pesticide spray hose ...................... 21Reverse laminar air flow ......................................FICRod ........................................................................... 31Roots blower ...................................................7,27,36Roots vacuum pump ............................................. 37Rotary gear pump .................................................. 10Rotary pump ........................................................... 37Scoop ................................................................................. 14Servos .....................................................................BICSheet ......................................................................... 31Showel ...................................................................... 14

Silicone FBD gasket ................................................ 37Silicone rubber braided hose ................................ 37Silicone rubber compound ................................... 37Silicone rubber cord/square/strip ......................... 37Silicone rubber corona teater sleeve ..................... 37Silicone rubber extruded gasket and profile ....... 37Silicone rubber moulding ...................................... 37Silicone rubber sheet .............................................. 37Silicone rubber sponge .......................................... 37Silicone rubber tubing ........................................... 37Single stage monoblock vacuum pump .............. 37Single stage vacuum pump ................................... 37Slipon flange ............................................................ 14Spade ........................................................................ 14Special TPU gas hose ............................................. 21Swing check valve ................................................... 31Synchronised digital clock ..................................... 37Tee ..................................................................................... 14Temperature and differential pressure indicator 37Temperature and process controller .................... 34Temperature controller .......................................... 36Transfer trolley ........................................................ 36TRI lobe roots blower .............................................. 6Tubes ........................................................................ 31Turnkey solution for biotech and pharma industry ...BCTwin - screw co-rotating extruder ........................ 13Twin - screw element ............................................. 13Twin - screw extruder ............................................ 13Twin lobe roots blower ....................................... 6,36Two stage vacuum pump ................................. 36,37Universal controller ........................................................ 36UPLC ........................................................................ 17Vacuum booster pump ............................................... 7,27Vacuum pump ........................................................ 37Vacuum system .................................................... 7,27Valve .................................................................... 14,31Washer ............................................................................... 14Water ring vacuum pump ..................................... 36We know water ......................................................... 3Wire rope hoist ....................................................... 36Wireless clock .......................................................... 37Work bench ............................................................. 35‘y’ type strainer ............................................................... 14Zero liquid discharge effluent treatment................... 19

BC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Product Pg No Product Pg No Product Pg No Product Pg No

Our consistent advertisersBC-Back cover, BIC-Back inside cover, FIC-Front inside cover

Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No Advertiser’s Name & Contact Details Pg No

ACE Instruments 37T: +91-40-23078848 E: [email protected]: www.alwaysace.com

Acme Air Equipment Co Pvt Ltd 6T: +91-79-25831985E: [email protected]: www.acmeairequipments.com

Aeron Composite Pvt Ltd 36T: +91-79-65258500E: [email protected]: www.aeroncomposite.com

Airtech Systems (I) Pvt Ltd 23T: + 91 22 28592275E: [email protected]: www.airtechsys.in

Ani Engineers 10T: +91-2752-241479E: [email protected]: www.anivaryapumps.com

Bhavya Polymers 37T: +91-2762-224114E: [email protected]: www.bhavyapolymers.com

Bry Air (Asia) Pvt Ltd 29T: +91-11-23906777E: [email protected]: www.bryair.com

Charles River 37T: +91-80 - 25588175E: [email protected]: www.criver.com

Everest Blower Systems 27T: +91-11-45457777E: [email protected]: www.everestblowers.com

Everest Blowers 7T: +91-11-45457777E: [email protected]: www.everestblowers.com

Fabtech Technologies Intl Pvt Ltd BCT: +91 22 61592900E: [email protected]: www.fabtecheng.com

GMP Technical Solutions Pvt Ltd FICT: +91 -22 66083790E: [email protected]: www.gmptech.net

HRS Process Systems Ltd 8T: +91-20-6604-7894/95E: [email protected]: www.hrsasia.co.in

IC ICE Make Refrigeration Pvt Ltd 33T: +91-79-65426394E: [email protected]: www.icemakeindia.com

Igus India Pvt Ltd 12T: +91-80-39127800E: [email protected]: www.igus.in

Joyam Engineers & Consultants Pvt Ltd 37T: +91-79-26569533E: [email protected]: www.joyamvactech.com

Mifa Systems 36T: +91-79-26870825E: [email protected]: www.mifasystems.com

Mitsubishi Electrical India Pvt Ltd BICT: +91-020-27102000E: [email protected]: www.MitsubishiElectric.in

Network18 31T: +91+022-303242518

E: [email protected]

W: [email protected]

Netzsch Technologies India Pvt Ltd 25T: +91-044-42965121


W: www.netzsch-grinding.com

P P I Pumps Pvt Ltd 36T: +91-79-25832273


W: www.ppipumps.com

Parth Poly Valves Pvt Ltd 14T: +91-79-22200198


W: www.parthvalves.com

Prayag Polytech Pvt Ltd 37T: +91-011-47262000


W: www.prayagmb.com

Ravel Hiteks Pvt Ltd 37T: +91-044-24961004


W: www.ravelhiteks.com

Reynders Label Printing India Pvt Ltd 15T: +91 149 3305400


W: www.reynders.com

Salesworth Synergies Pvt Ltd (Rommelag) 9T: +91-80-25274495


W: www.rommelag.com

Salesworth Synergies Pvt Ltd (Seidenader) 11T: +91-80-25274495


W: www.seidenader.de

Samson Extrusion Ind Pvt Ltd 21T: +91-022-23422238


W: www.samson-grp.com

Sanosil Biotech Pvt Ltd 3T: +91 22 22872295


W: www.sanosilbiotech.com

SSP Pvt Limited 19T: +91-129-4183700


W: www.sspindia.com

Steer Engineering Pvt Ltd 13T: +91-80-23723309


W: www.steerworld.com

Supremo Line & Control 35T: +91-79-22205282


W: www.supremoproduct.com

Techno Industries 36T: +91-79-25830742


W: www.technoind.com

Waters (India) Pvt Ltd 17T: +91-80-28371900


W: www.waters.com

RNI No: MAHENG / 2008 / 27125,

40

Documents

Modern Pharma - 1-15 February 2013