Jan to Mar 2016

Dear Members,

All the members are aware that Hon'ble High Court

of Nagpur Bench had passed an Interim Order in the

matter of section 7 of the Biological Diversity Act

2002 and in the matter of Guidelines on access to

Biological Resources and Associated Knowledge

and Benefit Sharing Regulation 2014 notified under section 64 of

the Biodiversity act 2002 and directed the State Biodiversity

Authority Board to abstain from taking any coercive action and

directed that members shall supply necessary data/ balance sheet

to the respective State Biodiversity Board.

Accordingly, members are requested to share details of the source

from where raw material has been procured in form I.

Further progress in the matter would be regularly updated.

I warmly welcome M/s. Jamna Pharmaceuticals, Bhopal as a Life

Member of ADMA.

I also warmly welcome M/s. Sadhana Ayurvedics Pvt. Ltd., Udaipur

enrolled as an annual member of ADMA and look forward to their

active participation in the Associations activities.

I hereby urge all members who have not yet renewed their

membership for the current financial year to renew immediately

along with outstanding membership subscription if any.

I thank all those members who have responded to my appeal for

voluntary contribution on Biodiversity matter by sending their

contribution. I request the members who have not yet sent in their

contribution to send the same at the earliest.

20

A gist of activities and updates are given below for your information.1) Smt. Shomita Bishwas, Chief Executive Officer, National Medicinal Plant Board, Ministry of AYUSH, led our Indian delegation

nd thto Bangladesh between 2 to 5 November 2015 where in myself also participated in this delegation.

st2) 1 Meeting of the 'Coordination Group' to chalk out the

issues related to development and growth of Medicinal plants

sector of the Country especially with regard to demand and thsupply was held on 27 November, 2015 at NMPB, Ministry of

AYUSH, New Delhi. th3) During the meeting held on 27 October 2015, ADMA had

informed to CEO, NMPB to conduct Seminars in as many

States as possible in order to facilitate direct interaction

between Government Officials and Industry and thus help in

reducing the existing fear amongst Industry to impart

information to several Government Departments.

ADMA had also volunteered to take up the

responsibility of ensuring participation of at least 25 to 30

Ayurvedic Industries for each Seminar. It was also informed

that the Seminar can also include participation of Traders and

Farmers to whom training can also be imparted by Experts in

the field. Approximate budget also was submitted and it was

specified that as mentioned by them the said Seminar would

be funded by the Ministry of AYUSH. However, we have not

received any response on our submission made vide our Letter thno. 1115/ADMA/NMPB/434 dated 10 November, 2015.

4) ADMA had made its submission to Shri Ashish Bahuguna,

Chief Executive Officer, Food Safety and Standards Authority

of India, New Delhi on Draft on the Food Safety Standards, thvide our Letter no. 1115/ADMA/FSSAI/435 dated 10

November, 2015 and copy was marked to Secretary AYUSH.

We have also received mail from Dr. G. C. Gaur on th28 December 2015 requesting us to send the comments on

the same draft. We have forwarded the copy of the submission

made to CEO, FSSAI, for his information.

5) We had informed to all members regarding filing of Writ rdPetition on 23 November, 2015 before the Hon'ble High Court

of Bombay at Nagpur Bench under Article 226 of Constitution

of India in the matter of Section 7 of the Biological Diversity Act

2002 and also in the matter of the Guidelines on Access to

Biological Resources and Associated knowledge and Benefit

Sharing Regulations, 2014 notified under Section 64 of the

Biological Diversity Act 2002 through Central India AYUSH

Drug Manufacturers Association (CIADMA).

6) Our Association had also made submission to Smt. Indira

Hridesh, Finance Minister, Government of Uttarakand, with

regard to the classification of Ayurvedic Medicine Oils vide our thLetter no. 1115/ADMA/441 dated 30 November, 2015 and

requested that in order to avoid confusion and to bring a clarity

of opinion of the state legislature which is very much essential

and desirable that Finance Department either delete from the

exclusion clause the words 'all kinds of Oil' are else qualify the

exclusion of Oil as 'all types of Oil not manufactured under a

Drug License'.

7) With regard to the GST, ADMA had sent its representation to

the Hon'ble Minister for Finance Shri. Arun Jatleyji with the

request to include Ayurvedic, Unani and Siddha Products

under exemption category of GST vide Letter no. th1215/ADMA/GST/455 dated 15 December, 2015 and

requested to fix an appointment to a delegation from ADMA.

The copy of the said Letter also was marked to Sri S.

Selvakumar, Joint Secretary, Ministry of Finance and Dr.

Hasmukh Adhia, Revenue Secretary, Ministry of Finance. th8) 65 Meeting of SFC for Central Sector Scheme for

“Conservation development and sustainable management of

medicinal plants” of National Medicinal Plants Board was held thon 7 December 2015 at New Delhi under the chairman ship of

Secretary (AYUSH) Mr. Ranjit Puranik had represented ADMA

in this meeting.th9) We had received mail from Dr. Vipin Sharma, on 17

December 2015, seeking feedback on issues related to

AYUSH Exports to Malaysia, as the delegation from Ministry of

Health, Malaysia is visting them on 23rd December, 2015 and

they had requested ADMA representative to attend the

meeting. However, all of a sudden they had advanced meeting stto 21 December 2015. Hence, Mr. Ranjit and Mr. Amit could

not attend the Meeting. However, they had sent their input note

to them.

10) On receiving the Shelf Life draft notification, we had

circulated the same for comments of our members and after

receiving comments from members same was collated and

final submission was made to the Minister of AYUSH and copy

was marked to Secretary & Joint Secretary, AYUSH.

Jan to Mar 2016

Jan to Mar 2016 3

Other names: Bargad, Bor, Ber, Ala and Pedda mari, Nayagrodha, Ala mara, Bar, Vad, Vatnam, Bahupada, Peddamarri, Al are the other names used for the Banyan tree. Indians call it a wish fulfillin g tree. Description: Banyan tree is a huge tree with very extensive branches. It is said that at one time more than 10, 000 people can sit under its shade at one time. It is a evergreen tree. It branches spread out and send trunk like roots to the ground in order to support itself. It grows to a height of more than 21 meters and lives for many years. The leaves are 10 -20 cm long and has many aerial roots. The leaves are broad, oval and glossy. White milky fluid oozes out of leaves, if broken. It can grow in to the gaint tree covering several hectares.

Other Species: F. aurea, F. benghalensis, F.

citrifolia, F. macrophylla, F. microcarpa, F.pertusa,

F. rubiginosa are the other related species of the

Banyan tree.

Location: Found in almost all the parts of India, Banyan tree is the National tree of India. It is grown

throughout the sub- Himalayan region and in the

deciduous forests. One can Banyan Tree in the

Botanical Garden of Calcutta. They are widely

grown in the Ranthambore National Park and

Corbett National Park in In di a . Cultivation methods: Banyan tree is easily propagated by root tip cuttings or the eye cuttings. Cut apiece of the stem about ha a inch below and lfabove the leaf. Insert the stem piece and a little of

the leaf stalk into the rooting medium. To reduce evaporation from the leaf surface, you can roll the leaf and secure with a rubber band. In a couple weeks roots and a new shoot will start developing. It can grow in any type of soil.

Medicinal uses: The Banyan tree also has several

medicinal properties. Its leaf, bark, seeds and fig

are used for the variety of disorders like diarrhea,

polyuria, dental, diabetes and urine disorders. The

wood of the Banyan tree is used in making door

panels, boxes and the other items. Its bark is used

for making paper and ropes. The milky latex that

comes from its leaves and stems is used in many

Ayurvedic med ici ne s .

Other uses: In India its edible leaves are used as

the plates. It is planted for the soil conservation.

Wood is used for well curbs, door panels, boxes,

furniture etc. It is suitable for paper pulp. The wood

of the aerial roots is stronger and is used for the tent

poles and cart yokes.Cultural importance: Banyan tree is respected and is considered as sacred by the people in India. In the sacred Hindu Book 'Bhagwad Gita' Lord Krishna has sung praises on the Banyan tree. People in India grow Banyan tree closer to the Peepal tree. As Banyan tree is considered as the male plant closely related to the Peepal tree. It symbolize Trimurti with Vishnu as the barl, Shiva as the branches and Brahma as the roots. Indians considered Banyan tree as 'Kalpa Vriksha' the tree that fulfill all your wishes.The mighty Banyan Tree is considered as immortal and has always been the focal point for the village communities in India. It is probably the biggest and friendliest of all trees. Banyan tree is the tree of knowledge and tree of life.

Source: www.ecoindia.com

Classification

Kingdom : PlantaeDivision : Magnoliophyta Class : Magnoliopsida Order : Urticales Family : Moraceae Genus : Ficus Zoological name : Ficus benghalensis Found In : Ranthambore National Park

and Corbett National Park

Jan to Mar 2016

New Delhi, the 24th November, 2015.

G.S.R. 897(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by section 33-N of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published as required by he said section, for the information of all persons likely to be affected thereby; and notice is hereby given that the objections or suggestions of the stakeholders on the said draft rules will be taken into consideration after the expiry of a period of forty five days from the date on which copies of the official Gazette in which this notification is published, are made available to the public; Any objection or suggestion, which may be received from any person with respect to the said draft rules within the period specified above, will be taken into consideration by the Central Government; Objections or suggestions, if any, may be addressed to the Secretary, Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH),AYUSHBhawan, 'B' Block, GPO Complex, INA, New Delhi-110023. DRAFT RULES1. (1) These rules may be called the Drugs and Cosmetics (Seventh Amendment) rules, 2015.

(2) They shall come into force from the date of their final publication in the Official gazette. 2. In the Drugs and Cosmetics Rules, 1945, for rule 161-B the following rule shall be substituted, namely:-

“161B. Shelf life or date of expiry of medicines.-(1) The date of expiry of Ayurveda, Siddha r nani medicines shall be conspicuously displayed on the label of container or package

of Ayurvedic, Siddha or Unani medicine, as the case may be, and after the said date of expiry, no medicine shall be marketed, sold, distributed or consumable;

Provided that this sub-rule shall apply to Ayurvedic, Siddha and Unani medicines seeking licenses or renewal of licence for manufacturing after the date of notification of the rules.

(2) Every person applying or licence or renewal of licence for the manufacturing of Ayurveda, Siddha or Unani medicines efinednder clause (h) of section 3 of the Act shall submit to the State Licensing Authority scientific data ased shelf life or date of expiry of the medicine based on the studies of medicines in accordance with he guidelines prescribed in the Ayurvedic, Siddha and Unani Pharmacopoeia. Provided that this sub-rule shall be applicable after three years from the date of notification of the rules.

(3) The State licensing Authority shall, before granting license or renewal of license for an Ayurvedic, Siddha or Unani medicine, ensure validity of the data submitted by the manufacturer in support of the claimed helf-life of that medicine.

(4) The State Licensing Authority may at any time direct the manufacturer to provide the samples of the medicine and any other related information; and may share it with the harmacopoeial Laboratory for Indian Medicine, Ghaziabad for analysis or independent validation.

(5) Where the manufacturer fails to comply with direction of the State Licensing Authority under sub-ule (4), the license for the manufacturing of the medicine shall be liable for suspension after giving aeasonableopportunity of being heard

MINISTRY OF AYURVEDA, YOGA AND NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY(AYUSH)NOTIFICATION

(b) Ayurvedic medicines:

Sr. Dosage form of Ayurvedic medicines Shelf life or date of expiry withNo. effect from the date of manufacture

(i) Arka 1 year(ii) Asava Arista 10 years(iii) Avaleha, Khanda, Paka, Guda 3 years(iv) Churna, Kwatha Churna, Lapa Churna,

Dant Manjan (Churna) 2 years(v) Dhoopan 2 years(vi) Dravaka, Lavana, Kshara 5 years(vii) Ghrita 2 years(viii) Guggulu 5 years(ix) Gutika

(I)Gutika or Vati containing Kasth Aushadhi along with Rasa/Uprasa/Bhasma/ Guggulu (including Lepa Gutika and Ghan Vati) 5 years(II)sGutika or Vati containing only Kasth Aushadhi (including Lepa\Gutika and Ghan Vati) 3 years(III)Gutika / Vati containing only Ras/Uprasa/Bhasma 10 years

(x) Karna/Nasa bindu (Ear/Nasal drop) 2 years(xi) Kupipakva Rasayana 10 years(xii) Malahar 3 years(xiii) Mandura-Lauha 10 years(xiv) Naga Bhasma, Vanga Bhasma and Tamra Bhasma 5 years(xv) Netra bindu (Eye drop) 1 year(xvi) Parpati 10 years(xvii) Pisti and Bhasma 10 years(xviii) Pravahi Kwatha (Decoction with preservative) 3 years(xix) Rasayoga

(I) Rasayoga Containing only Rasa/Uprasa/Bhasma 10 years

Jan to Mar 2016

(b) Siddha medicines:-

Sr. Dosage form of Ayurvedic medicines Shelf life or date of expiry withNo. effect from the date of manufacture

(i) CuranamKutinir Curanam/Adai Curanam/Kanchi Curanam/Utkali Curanam/Pittu Curanam/ Podithimirthal Curanam/ Podi/ Pattru Curanam/ Pottanam or Kizhi Curanam/Ottratam Curanam/ Vethu Curanam/ Pugai Curanam/Kali Curanam/Thuvalai Curanam 2 years

(ii) Mattirai/ Vatakam(I) Containing only Mooligai ingredients (including Kudineer Curanam Mattirai)(eg. Nilavembu kutinir Mattirai) 2 years(II) Containing Mooligai ingredients along with Thathu Porutkal/Jeeva Porutkal/Parpam/ Centuram /Cunnam.(including kutinir Curanam Mattirai) 5 years(III) Containing only Thathu Porutkal /Parpam/ Centuram /Cunnam/ Kattu/Kalank 10 years

(iii) Rasa-Paadana Marunthugal ( All Mercurial Preparation)(I) Containing Mooligai ingredients along with Thathu Porutkal/Parpam/ Centuram/ Cunnam /Kattu /Kalanku 3 years(II) Containing only Thathu Porutkal/Parpam/Centuram/Cunnam Kattu/Kalanku 10 years

(iv) Parpam / Centuram(I) Containing only Mooligai ingredients (eg. Kungiliya Parpam) 4 years(II) Containing Mooligai ingredients with Thathu Porutkal /Parpam/Centuram / Cunnam/ Kattu/Kalanku (eg. Aya Centuram) 10 years(III) Containing Mooligai ingredients with Jeeva Porutkal (e.g. Sangu Parpam ) 10 years

(v) Karuppu(I) Containing only Mooligai ingredients (eg. Vasambu Sutta Kari) 2 years(II) Containing Mooligai ingredients with Thathu Porutkal(e.g. Sivanar Amirtham, Thalaga Karuppu) 5 years(III) Containing Mooligai ingredients with Jeeva Porutkal(e.g. Kasthuri Karuppu, Pattu Karuppu) 5 years

(vi) Patankam(I) Mooligai based Patankam (eg. Sambirani Patankam) 5 years(II) Rasa based Patankam (eg. Rasa Centuram) 10 years

(vii) KulampuBased on process-(I) Araippu Kulampu (eg. Agathiyar Kulampu) 5 years(II) Erippu Kulampu (eg. Kumatti Kulampu) 3 years

(viii) MelukuBased on process - (I) Araippu Meluku (eg. Linga Meluku) 5 yearsBased on Process-(II) Idippu Meluku (eg. Rasa Gandhi Meluku / Idi Vallthi Meluku) 3 yearsBased on raw materials-(III) Mooligai Meluku (eg. Malaikudar 3 years

(ix) KarpamBased on raw materials-I) Mooligai Karpam (eg. Karisalai Karpam , Thiripala Karpam) 2 yearsBased on raw materials-(II) Mooligai Thathu Karpam (eg. Aya Bringaraja Karpam) 5 yearsBased on process-(III) Araippu Karpam (eg. Irunelli Karpam) 3 years

(x) Satthu(I) Satthu derived from Mooligai (eg. Seenthil Satthu) 2 years(II) Satthu derived from Thathu Porutkal (eg. Aya Satthu,Eya Satthu,Thurusu Satthu) 10 years(III) Satthu derived from Jeeva Porutkal (eg. Sembu Satthu derivedfrom Poonagam, Mayiliragu) 5 years

(b) Siddha medicines:-

Sr. Dosage form of Ayurvedic medicines Shelf life or date of expiry withNo. effect from the date of manufacture

(I) Curanam Kutinir Curanam/Adai Curanam/Kanchi Curanam/UtkaliCuranam/Pittu Curanam/ Podithimirthal Curanam/ Podi/ PattruCuranam/ Pottanam or Kizhi Curanam/ Ottratam Curanam/ VethuCuranam/ Pugai Curanam / Kali Curanam/Thuvalai Curanam 2 years

(ii) Mattirai/ Vatakam(I) Containing only Mooligai ingredients(including Kudineer Curanam Mattirai) (eg. Nilavembu kutinir Mattirai) 2 years(II) Containing Mooligai ingredients along with Thathu Porutkal/JeevaPorutkal /Parpam/ Centuram /Cunnam. (including kutinir CuranamMattirai) 5 years(III) Containing only Thathu Porutkal/Parpam/Centuram/Cunnam/Kattu/Kalank 10 years

(iii) Rasa-Paadana Marunthugal ( All Mercurial Preparation)(I) Containing Mooligai ingredients along with Thathu Porutkal/Parpam/ Centuram/ Cunnam /Kattu /Kalanku 3 years(II) Containing only Thathu Porutkal/Parpam/Centuram/CunnamKattu/Kalanku 10 years

(iv) Parpam / Centuram(I) Containing only Mooligai ingredients (eg. Kungiliya Parpam) 4 years(II) Containing Mooligai ingredients with Thathu Porutkal /Parpam/Centuram/Cunnam/ Kattu/Kalanku (eg. Aya Centuram) 10 years(III) Containing Mooligai ingredients with Jeeva Porutkal (e.g.Sangu Parpam) 10 years

(v) Karuppu(I) Containing only Mooligai ingredients (eg. Vasambu Sutta Kari) 2 years(II) Containing Mooligai ingredients with Thathu Porutkal(e.g. Sivanar Amirtham, Thalaga Karuppu) 5 years(III) Containing Mooligai ingredients with Jeeva Porutkal(e.g. Kasthuri Karuppu, Pattu Karuppu) 5 years

(vi) Patankam(I) Mooligai based Patankam (eg. Sambirani Patankam) 5 years(II) Rasa based Patankam (eg. Rasa Centuram) 10 years

(vii) KulampuBased on process - (I) Araippu Kulampu (eg. Agathiyar Kulampu) 5 years(II) Erippu Kulampu (eg. Kumatti Kulampu) 3 years

(viii) MelukuBased on process - (I) Araippu Meluku (eg. Linga Meluku) 5 yearsBased on Process - (II) Idippu Meluku (eg. Rasa Gandhi Meluku/Idi Vallthi Meluku) 3 yearsBased on raw materials-(III) Mooligai Meluku (eg. Malaikudara Meluku) 3 years

(ix) KarpamBased on raw materials-(I) Mooligai Karpam (eg. Karisalai Karpam , Thiripala Karpam) 2 yearsBased on raw materials-(II) Mooligai Thathu Karpam (eg. Aya Bringaraja Karpam) 5 yearsBased on process-(III) Araippu Karpam (eg. Irunelli Karpam) 3 years

(x) Satthu(I) Satthu derived from Mooligai (eg. Seenthil Satthu) 2 years(II) Satthu derived from Thathu Porutkal (eg. Aya Satthu, EyaSatthu,Thurusu Satthu) 10 years(III) Satthu derived from Jeeva Porutkal (eg. Sembu Satthu derived fromPoonagam, Mayiliragu) 5 years

(c ) Unani medicines

Sr. Dosage form of Ayurvedic medicines Shelf life or date of expiry withNo. effect from the date of manufacture

(i) Arq (except Arq-e-Ajeeb) 1 year(ii) Arq -e-Ajeeb 5 years(iii) Ayarij / Sunoon/ Zuroor/Ghazah 2 years(iv) Burood / Surma / Kohal/shiyaf 5 years(v) Habb (Pills) 3 years(vi) Halwa 3 years(vii) Itrifal 3 years(viii) Jauhar/ Jawahir 5 years(ix) Jawarish 4 years(x) Khamira 3 years(xi) Kushta 10 years(xii) Laboob 3 years(xiii) Laooq 3 years(xiv) Majoon / Dawa 3 years(xv) Marham / Zimad / Qairooti 2 years(xvi Mufarreh 3 years(xvii) Murabba 1 year(xviii) Nabeez 10 years(xix) Qurs (Tablets) 3 years(xx) Qutoor 1 year(xxi) Raughaniyat/ Tila 3 years(xxii) Sharbat/ Sikajabeen 3 years(xxiii) (I) Sufoof (Without Salt) 2 years

2 Sufoof (Containing salt) 1 year(xxiv) Tiryaq 3 years” :

[F. No. K.11024/5/2013-DCC (AYUSH)] JITENDRA SHARMA, Jt. Secy.Note.—The principal rules were published in the Gazette of India vide notification No. F.28-10/45H(I), dated 21st December, 1945 and were last amended vide notification G.S.R.826 (E), dated 30.10.2015.

Jan to Mar 2016

Jan to Mar 2016

At the outset, we thank you for giving us the opportunity to offer our suggestions/comments on the proposed amendment. We also thank you for the provision under proposed rule 5(a) for extended shelf life for 3(a) drugs on the basis of scientific data submitted by the manufacturers.

We observe that although the proposed rule (1) of 161B has a proviso that the sub-rule shall be applicable to new license or renewal after the date of Notification, already the present rule 161(B) provides for declaration of Date of Expiry for ASU medicines both 3(a) & 3(h). Hence as per the existing rule 161(B) currently the labels of all ASU medicines are supposed to declare the Date of Expiry. Kindly find our following suggestions on the Draft Notification:

1. Sub rule (2) of the proposed rule deals with 3(h) medicines. The proviso allows for a period of 3 years after date of notification for submission of stability data at the time of renewal of license. Many of these products are in the market for several decades. In view of this we request you to exempt products which are already in the market for 5 years. It should be noted here that most manufacturers have innumerable products and it may be impossible to generate and furnish stability data as required in a period of 3 yrs. We request that a period of 7 yrs may be more appropriate and may be allowed.

2. The shelf life of the following product categories has been reduced to '10 yrs' from 'no expiry'. This needs to be reconsidered as these categories have factually 'no expiry':

- R a s a u s h a d h i e s w i t h o u t a n y kashtaaushadhies (in powder form)

- Asava-Arishta- KupipakvaRasayanas

Association made the following suggestions on draft notification on Shelf Life vide letter th

dated 11 January 2016, to Shri Shripad Rao Yasso Naik, Hon'ble Minister for AYUSH, Government of India, New Delhi.

thADMA Submission on Shelf life draft Notification dated 24 Nov 2015

- Parpati- Bhasma other than Naga Vanga &

Tamra bhasmas- Pishti

3. Shelf life of Pravahi Kwatha (Decoction with preservatives) has been mentioned as 3 years in the said Notification. However, Pravahi Kwath formulations- manufactured through fermentative method (Reference Method of Manufacture using sandhana kriya as per Ayurved Sar Sangraha) should be included in the list of Shelf life mentioned for 3(a) category (ii) to avoid confusion. The shelf life for this ca tegory shou ld be same as tha t recommended for Asava Arista products.

4. The new notification does not provide for shelf life of the following categories of ASU medicines, which was provided in rule 161(B). This needs to be provided for classical drugs as defined in sec 3(a).

- Capsules made of hard/soft gelatin (depending upon the content material) for Kashtha aushadhi

- Capsules of hard/soft gelatin (depending upon the content material) – containing K a s h t h a a u s h d h i w i t h R a s a , Bhasma

- Syrups/Liquid Orals- Gel- Lotion- Liniment- Cream - Dantamanjan paste - Granules

5. We understand that word Guti translates into Tablet and Vati translates into Pill, however for clarity it should be mentioned expressly and shelf life be prescribed for uncoated, sugar coated and film coated tablets and pills separately. Similarly word Malhar translates

Jan to Mar 2016

into ointment however this should be expressly stated.

6. In the following categories after the word “Bhasma” the following words need to be added “except Naga, Vanga & Tamra Bhasma”

ix Gutika III xvii Pishti Bhasmaxix Rasa yoga I

7. More clarity is required on two subsections of Gutika [ix-(III)] and Rasa yoga [xix-(I)] included in proposed table with respect to bhavana of herbal liquid done during the processing.

8. Reference be made to the particular Ayurvedic Pharmacopoeia of India, Volume 8 containing the Shelf Life Guidelines which can be used to decide the expiry date, in case a manufacturer wishes to assign a shelf life longer than one specified by the notification. The Guideline can be used for all Patented and Proprietary Ayurvedic medicines, both new and existing products. However, ADMA submits that more details of Stability Protocol

with guidelines for parameters as appropriate for different dosage forms as per API will be required otherwise it is possible the Licensing Authority may refuse granting or renewal of license or suspend license quoting for any specific parameter or condition not included in Stability Study. Further, it is suggested that data of Accelerated Stability Study should be considered sufficient for the grant of new license i.e. 3 & 6 month for 1 year & 2 year shelf life respectively.

9. ADMA bel ieves th is endeavor to scientifically determine shelf life will go a long way in enhancing the creditworthiness of ASU medicines, however there is a need for capacity building & upgradation at the level of micro & small scale ASU Industries. Hence it is proposed that Dept of AYUSH should provide relevant progressive & promotive Schemes for the same.

We hope you will consider our suggestions as above and amend the draft notification suitably.