Research on India_Healthcare Sector in India Monthly Update_April 2013

Healthcare Sector in India Monthly Update

April 2013

Healthcare – Monthly Update

Top Story NRA accredited for meeting WHO standards Indian vaccine industry has reached an all time high with the World Health Organization (WHO) declaring India's vaccine regulatory system meeting international standards. The comprehensive review was conducted by an expert WHO team from 8 countries in Dec 2012. The National Regulatory Authority of India (NRA) and its affiliated institutions have been adjudged for fulfillment of WHO efficacy indicators for a functional vaccine regulatory system. The latest accreditation will pave the way for easy export of vaccines produced in the country since the conformity to WHO standards guarantees Indian vaccine production lines to be efficacious and safe and easily trusted.

News Update General Glivec faces patent plea dismissal The Supreme Court declined Novartis AG's petition for patent protection of its cancer drug Glivec although it has been patented in nearly 40 countries including the United States, Russia and China. The Supreme Court dismissed the plea on the grounds of exorbitant price and it not being a new medicine but an amended version of a known compound. The legal blow has affected major pharma MNCs who target Indian market for driving sales. The ruling has on the other hand been a boost for healthcare activists who have been constantly demanding from the government to make medicines cheaper since patented drugs constitute below 10% of total drug sales in India. MSD Pharma files patent infringement litigation against Glenmark The USA based pharmaceutical company MSD Pharma has moved to the Delhi High Court to bar Mumbai‐based Glenmark from selling generic versions of its anti diabetic drugs. Glenmark Pharma launched generic versions of MSD Pharma’s anti diabetic drugs Januvia and Janumet, under the names Zita and Zita Met last week. The generic version is being marketed at 20% rebated price to that of the innovator’s version that costs approximately INR 40 per tablet. Januvia and Janumet are patent protected for 20 years that was launched in 2008. Indian jurisdiction of allowing launch of cheaper generic versions of existing patent protected drugs is resulting in stiff competition between innovators and generic drug manufacturers.


Shasun Pharmaceuticals pacts with Debiopharm S.A. Chennai based Shasun Pharmaceuticals has entered a licensing agreement with Switzerland‐ based Debiopharm S.A. for manufacture and promotion of Huperzine‐A. The drug is a treatment of Alzheimer's disease. As per the agreement Shasun would be able to use the Debiopharm technology for manufacturing synthetic Huperzine‐A. Huperzine‐A is proven to be a potent and reversible acetylcholinesterase inhibitor which can remarkably improve memory deficit and cognitive performance in patients with Alzheimer's disease. News Update Regulatory Panel formed to plug irregularities in drug marketing A 4‐member committee has been formed to look into reviewing of practices and procedures adopted by the drug controller and fix responsibilities. The committee will be led by former Director of Institute of Medical Sciences, Banaras Hindu University, Varanasi, and T.M Mahapatra along with former scientist Satyawan Singh of Central Drug Research Institute, Lucknow, former Kerala Drug Controller Venkat Krishnan and a representative of the Chief Vigilance Officer of Union Ministry of Health and Family Welfare as its members. The panel will keep an eye on the Central Drugs Standard Control Organisation (CDSCO) strict adherence to scientific requirements and regulatory compliance in granting marketing approval and clinical trials on new drugs including fixed dose combinations. The committee is also seeking the active involvement of Drug Controller General of India (DCGI) to enquire into unlawful drug practices in the country, thereby helping in controlling illegal approval of drugs in India. KMSCL sells life saving drugs at subsidized rate The Kerala government has initiated a remarkable strategy of controlling price of life saving drugs. A government‐owned enterprise The Kerala Medical Services Corporation Ltd. (KMSCL) is offering drugs at a substantially low price, even to the extent of one sixth the price at which such drugs are available in retail stores. KMSCL has taken upon this initiative by procuring medicines in bulk at a heavily discounted price from drug manufacturers directly. The medicines thus procured are sold through a chain of stores called Karunya that are located at five medical colleges in the state. 70 additional hospitals to get empanelled The Indian Health Ministry is in the process of expanding healthcare service options in the NCR for the central government employees. The Health Ministry is currently reviewing the


list of private hospitals, dental clinics and diagnostic facilities empanelled with the government that would facilitate addition of at least 70 more private hospitals, eye care centers and diagnostic facilities. Around 10 new super and multispecialty hospitals, 10 mid segment general purpose hospitals, 33 eye care centers, 10 dental clinics and 10 laboratories are in the process of being empanelled. BL Kapoor Super Specialty Hospital, Max Hospitals at Patparganj and Shalimar Bagh, Batra Hospital near Okhla, Rockland Hospital in South Delhi and Saroj Hospital in Rohini are some of the hospitals to be included in the list of empanelled hospitals among others. This would raise the total number of empanelled hospitals from current 130 to 200. Pharmexcil to set up pharma storage warehouses abroad The Pharmaceuticals Export Promotion Council of India (Pharmexcil) is in plans to set up warehouse facilities in Latin America, Africa and Europe under the 'Brand India Pharma' campaign. The initiative is in view to encourage export business of small and medium Indian pharma companies. The warehouses will help the small and medium exporting pharma companies to stock their products in desired conditions and supply as according to requirement. The Nigerian facility is expected to be ready by Jun 2013. Pharmexcil has also announced that the 1st overseas warehouse will give 75%, 50% and 33% subsidies for 3 years, respectively, to the user‐companies. Rajasthan Government drives Indian healthcare industry by free distribution of Imatinib Rajasthan Medical Services Corporation (RMSC) will be distributing generic version of Novartis AG's Glivec (Imatinib) tablet for free from special counters at government hospitals. This comes as part of Rajasthan Governments’ free medicine distribution scheme that was launched in Oct 2010. The blood cancer (chronic myeloid leukemia) medication, Glivec is currently sold at INR 0.12mn for a pack of 30 tablets. Blood cancer patients have to take one tablet daily, and in order to bring relief to such patients, the state health department has decided to distribute generic Imatinib tablets for free. The government is making an addition of 14 new anti‐cancer drugs to be distributed free of cost totaling the cancer drugs provided for free to 39. The pharma companies, who have shown interest in the project include Cipla, Glenmark, Naprod Life Sciences, United Biotech India and West Coast Pharmaceuticals. Indian pharmaceutical sector soon to realize drug pricing policy In a move to bring generic medicines under price control, the government has issued letters to 4,000 Indian pharmaceutical industry manufacturers across the country to submit relevant data. However, till now it has received responses from around 400 drug


manufacturers from the states of Maharashtra, Himachal Pradesh, Rajasthan, Gujarat and Andhra Pradesh. In accordance to the new pricing policy, the National Pharmaceutical Pricing Authority (NPPA) has asked pharmaceutical companies to submit complete data related to essential medicines in order to fix their prices. The NPAA has also gone further by asking pharma associations to ask their respective members to submit relevant data so that the 348 "essential" drugs pricing under National List of Essential Medicines (NLEM) could completed in time.

News Update Expansion Plans Dr Reddy’s launches Reclast generic version Hyderabad based Dr Reddy’s Laboratories Ltd. has recently launched osteoporosis treating zoledronic acid injection in the US market. The drug is a generic version of Swiss pharmaceutical company Novartis AG’s Reclast (zoledronic acid) injection which is a treatment for women suffering from osteoporosis post menopause. The injection is being made available in a single use vial for intravenous infusion. USFDA approval for the generic version will make the injection available at a price less than at what Reclast is currently available now in the US bringing relief to its patients. Elder penetrates cosmetics segment Mumbai based Elder Pharmaceuticals has plans of penetrating the Indian cosmetics segment. The company will be investing INR 150 mn to INR 200 mn within the next 2‐3 years for manufacturing and marketing of their products. The launch of new product line comes after the company’s 40%‐60% partnership with Japan's Kose Corporation, which has been named Kose Elder (India) Pvt. Ltd. for an interim period and will be involved in manufacturing and selling Made in India cosmetics. The companies will be focusing on skincare and body‐care products which will be essentially available as OTC and cater to both mass as well as prestige segments. Ranbaxy partners with Daiichi Sankyo to expand pharmaceutical business in Latin America Gurgaon based Ranbaxy Laboratories are looking towards expanding its business in Latin America by collaborating with its Japanese parent Daiichi Sankyo in pharmaceutical market. Ranbaxy will be supporting its parent company’s Brazilian subsidiary, Daiichi Sankyo Brasil Farmaceutica Ltda to penetrate the branded pharmaceutical generics market along with establishing business of providing innovative products.


The business agreement will aid the Daiichi Sankyo Group to expand its presence in Brazil through hybrid business model. Both Daiichi Sankyo and Ranbaxy are having considerable pharmaceuticals business through innovative pharmaceuticals and generic products that are being marketed by Daiichi Sankyo Brazil and Ranbaxy Farmaceutica respectively in Brazil.

Industry Expert Speak Glivec faces patent plea dismissal – Ameet Hariani, Managing Partner Hariani & Co. Law Firm “Henceforth, multinational pharma companies are likely to want that their patents are first recognised in India before launch of a patented product.” MSD Pharma files patent infringement litigation against Glenmark – Ali Asghar Dholkawala, advocate and IP expert Wadia Ghandy and Co. Law Frm “Any data submitted to the government is not considered patent infringement under the patent act. Also, grant of marketing approval doesn't amount to patent infringement under the Drugs and Cosmetics Act of India.” Pharmexcil to set up pharma storage warehouses abroad – Bhavin Mehta, Member – Pharmexcil "We have invited a large number of drug regulators from overseas market, which will immensely help local pharma companies to promote the quality and affordability aspect as envisaged in 'Brand India Pharma' campaign. The campaign has been initiated by Ministry of Commerce and executed by Pharmexcil.

Transactions (Feb 2013 – Apr 2013)

Date Buyer Target Deal Size (INR mn)

% stake Deal Status Type of

Transaction

25th Apr 2013

International Finance

Corporation

Fortis Healthcare Ltd.

542 6 Planned Private Equity


23rd Apr 2013

Somerset Indus Capital Partners

Cygnus Medicare Pvt.

Ltd. N.A. N.A. Completed Private Equity

16th Apr 2013

Fulcrum Venture India

Shield Healthcare Pvt.

Ltd. 218.2 N.A. Completed Private Equity

15th Apr 2013

Seedfund &

Asian Healthcare Fund

Total Dental Care Pvt. Ltd. 500 N.A. Completed Private Equity

12th Apr 2013

Singapore based investor

Amrish Oncology

Services Pvt. Ltd.

330 N.A. Completed Private Equity

12th Apr 2013

OrbiMed Advisors

Claris Lifesciences

Ltd. 2013.04 N.A. Completed Private Equity

2nd Apr 2013

India Venture Advisors

Global Baroda Hospital

N.A. N.A. Completed Private Equity

1st Apr 2013

Mortara Instruments

Inc Cardiac Science 1140 N.A. Planned M&A


25th Mar 2013 ChrysCapital

Ipca Laboratories

Ltd. 2174 4 Completed Private Equity

22nd Mar 2013

Jacob Ballas Capital India Pvt. Ltd.

Vivimed Labs Ltd.

670 13.1 Completed Private Equity

22nd Mar 2013

Quadria Capital

Milestone Religare

Investment Advisors Pvt.

Ltd.

N.A. 100 Completed Private Equity

20th Mar 2013

Intel and Sequoia Capital

Healthkart 760 N.A. Completed Private Equity

15th Mar 2013

Fresenius Kabi India Pvt. Ltd.

Parenteral Drugs India

Ltd. 2000 N.A. Completed M&A

13th Mar 2013

Route One Strides Arcolab 558.1 N.A. Completed Private Equity

11th Mar 2013

Temasek Holdings

Healthcare Global

Enterprises (HCG)



2nd Mar 2013 IFC Hikal Ltd. 435 N.A. Planned Private Equity

28th Feb 2013

Cipla Ltd. Cipla Medpro South Africa

Ltd. 391.32 N.A. Completed M&A

28th Feb 2013 Mylan Inc.

Agila Specialties Pvt.

Ltd. 86,000 100 Completed M&A

25th Feb 2013

WestBridge Capital Partners

& TA Associates

Dr. Lal PathLabs

2,434 N.A. Completed Private Equity

25th Feb 2013

Lighthouse Funds

Suraksha Diagnostic Pvt.

Ltd. 500 N.A. Completed Private Equity

21st Feb 2013

Helion Venture Partners

LifeCell International


19th Feb 2013

IMCD Group B.V

Indchem International N.A. N.A. Completed M&A


14th Feb 2013 Vivimed Labs

Finoso Pharma Pvt. Ltd. 150 N.A. Completed M&A

8th Feb 2013

Ma Foi Strategic

Consultants

Oviya MedSafe Pvt. Ltd.

N.A. 17.5 Completed M&A

Annual Financial Results – Revenue (INR mn)

Companies FY ‘09 FY ‘10 FY ‘11 FY ‘12

Biocon Ltd. 16,492.50 23,932.70 27,947.70 21,483.0

Blue Star Ltd. 25,026.2 25,249.7 29,536.8 27,888.5

Cadila Healthcare Ltd. 29,066.00 35,780.00 44,671.00 50,899.7

Cipla Ltd. 52,876.20 56,704.00 63,850.70 68,477.0

Dabur India Ltd. 28,122.40 33,958.00 40,817.40 52,832.0

Dr. Reddy’s Laboratories (DRL)

69,441.00 70,277.00 74,693.00 96,737.4

GlaxosmithKline Consumer Healthcare Ltd. 19,757.6 23,693.3 27,688.6 28,857.3

Glenmark Pharmaceuticals Ltd.

21,241.20 25,291.30 29,490.70 40,206.4

Jubilant life Sciences Ltd. 35,491.00 38,047.80 34,484.40 42,539.5

Lupin Ltd. 38,508.30 48,318.10 57,851.90 70,829.1

Nestle India Ltd. 51,395.5 62,609.4 74,994.6 77,409.0


Opto Circuits (India) Ltd. 8,185.197 10,775.826 15,855.631 23,568.543

Piramal Healthcare Ltd. 32,478.20 36,276.30 25,157.70 20,838.3

Ranbaxy Laboratories Ltd. 75,970.40 89,607.70 101,614.1 117,153.2

Siemens India Ltd. 93,070.2 96,272.4 119,718.1 124,657.9

Strides Arcolab Ltd. 13,101.6 16,958.4 25,245.2 25,645.1

Sun Pharmaceuticals Industries Ltd.

42,723.00 38,086.30 57,214.30 80,056.6

Torrent Pharmaceuticals Ltd. 16,306.60 19,160.40 22,264.80 26,959.2

Wockhardt Ltd. 3,6294.4* 36,477.60 37,633.50 46,138.0

* Change in Financial Year Ending

Annual Financial Results – Income (INR mn)

Companies FY ‘09 FY ‘10 FY ‘11 FY ‘12

Biocon Ltd. 931.2 2,932.40 3,675.20 3,384.0

Blue Star Ltd. 1,802.9 2,114.9 1,609.6 ‐1,051.0


Cipla Ltd. 7,710.20 10,825.90 9,895.70 11,442.4

Dabur India Ltd. 3,905.00 5,010.80 5,685.70 6,449.0


‐5,168.00 1,068.00 11,040.00 14,262.1

GlaxoSmithKline Consumer Healthcare Ltd.

2,327.8 2,998.5 3,552.1 3,765.6


1,916.60 3,244.70 4,532.10 4,603.5


Jubilant life Sciences Ltd. 2,831.80 4,214.60 2,297.20 145.6

Lupin Ltd. 5,015.40 6,816.30 8,625.50 8,676.5

Nestle India Ltd. 6,550.0 8,186.6 9,615.5 9,815.7


Piramal Healthcare Ltd. 3,162.50 4,819.00 128,833.60 1,115.0

Ranbaxy Laboratories Ltd. 2,964.90 14,967.50 ‐28,997.3 ‐19,573.5

Siemens India Ltd. 7,046.0 7,577.7 8,677.5 7,300.6

Strides Arcolab Ltd. 1,096.80 1,224.50 2,244.8 8,258.4


18,177.30 13,510.80 18,160.60 25,872.5


Wockhardt Ltd. ‐4,355.4* ‐9,804.20 905.2 3,427.1

* Change in Financial Year Ending

Quarterly Financial Results – Revenue (INR mn)

Companies JanMar 2012

AprJun 2012

JulSep 2012

OctDec 2012

Biocon Ltd. 5,892.2 5,770.0 5,924.0 6,342.2

Blue Star Ltd. N.A. N.A. N.A. N.A.


Cipla Ltd. N.A N.A. N.A. N.A.

Dabur India Ltd. 13,858.3 14,620.0 15,372.2 16,307.2



26,584.0 25,406.0 28,809.0 28,651.6


8,608.7 7,869.6 8,275.4 7,090.7


10,751.2 10,404.1 12,551.9 13,812.6

Jubilant life Sciences Ltd. 12,235.9 12,358.9 12,197.3 13,018.1

Lupin Ltd. 20,063.7 22,191.5 22,392.6 24,658.7

Nestle India Ltd. 20,558.7 19,865.8 21,155.9 21,526.4


Piramal Enterprises Ltd. 7,055.3 7,472.4 8,630.3 9,935.7

Ranbaxy Laboratories Ltd. 36,954.0 31,740.6 26,513.9 (68,096.4)

Siemens India Ltd. 37601.432 34,141.3 34,141.3 24,508.6

Strides Arcolab Ltd. 5,274.7 5,082.9 5,773.4 N.A.


23,299.3 26,581.4 26,638.6 28,520.1


Wockhardt Ltd. 12,413.90 14,258.2 13,474.4 14,350.4

Quarterly Financial Results – Income (INR mn)

Companies JanMar 2012

AprJun 2012

JulSep 2012

OctDec 2012

Biocon Ltd. 978.0 790.0 896.5 917.6

Blue Star Ltd. N.A. N.A. N.A. N.A.

Cadila Healthcare Ltd. 1,708.8 1,947.9 951.4 1,029.1


Cipla Ltd. N.A. N.A. N.A. N.A.

Dabur India Ltd. 1,705.1 1,494.0 2,023.7 2,111.1


3,427.0 3,360.0 3,925.0 3,633.1


1,319.7 1,066.0 1,285.5 696.5


1,482.7 782.8 1,567.5 2,129.2

Jubilant life Sciences Ltd. ‐635.3 50.1 1,520.0 266.9

Lupin Ltd. 1,556.4 2,803.9 2,904.6 3,352.3

Nestle India 2,757.3 2,459.7 2,673.1 2,789.3


Piramal Enterprises Ltd. (386.8) 40.8 (920.2) 610.7

Ranbaxy Laboratories Ltd. 12,467.6 ‐5,857.3 7,541.7 (19,076.6)

Siemens India Ltd. 3,040.0 (157.6) (157.6) 730.7

Strides Arcolab Ltd. 6,420.7 904.8 524.9 N.A.

Sun Pharmaceuticals Industries Ltd. 8202.1 7,955.5 3,196.4 8,813.0

Torrent Pharmaceuticals Ltd. ‐16.5 1,018.5 1,072.5 1,123.3

Wockhardt Ltd. ‐1,916.4 3,779.7 4,535.5 4,278.4


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Research on India_Healthcare Sector in India Monthly Update_April 2013