(I) of the Drugs & Cosmetics Act, 1940
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For Private & Restricted Circulation Only October-DecemberVol.1 No. 4 January 2011 - March 20121 A QUARTERLY NEWSLETTER FOR AYURVEDIC & HERBAL INDUSTRY From the President’s Desk Dear Members, We have been informed by the Department of AYUSH vide their Order dated 19th June 2012 with regard to constitution of following Subcommittees of ASUDTAB, co-opting therewith representative of 4 Associations. (i) Sub-Committee to examine Schedule ‘Z’ and other relevant Notification - ADMA (ii) Sub-Committee to evaluate the proposed Retail Sale License for ASU Drugs - AMMOI (iii) Sub-Committee to review the Model Laboratory Practices for testing of ASU Drugs - KIMMA (iv) Sub-Committee to amend First Schedule of Drugs and Cosmetics Act 1940 for the list of Authoritative ASU books - ADMA (v) Sub-Committee to examine Shelf life of ASU Medicines. – AMAM Meeting of the Sub-Committee to amend First Schedule of Drugs and Cosmetics Act 1940 for the list of Authoritative ASU books was held on 17th July 2012 wherein our Hon. General Secretary Shri Chandrakant Bhanushali represented ADMA in the said meeting. Subsequently another meeting also was called on 8th September 2012 by Dr. Ramesh Babu Devalla, Director, CCIM and Director General, CCRAS to finalise the list of books for recommendation to ASUDTAB for amendment in First Schedule of Drugs and Cosmetics Act 1940 and this meeting also was represented by our Hon. General Secretary Shri Chandrakant Bhanushali. The gist of the discussions are reported in the Secretary Report. Meeting of Sub-Committee of ASUDTAB to examine Schedule ‘Z, was held on 4th September 2012. Our representation made to the ASUDTAB Committee by Dr. Nagesh Sandu is given on Page No 5 of this issue. The Department of AYUSH issued a Notification GSR 597(E) dated 30th July 2012 with regard to Prefix and Suffix. The recent notifications and meetings of the ASUDTAB is becoming the burning issue to the industry. Your Association is striving to resolve these issues by making proper representations and seeking appointment with the Ministry. From June to September 2012, 20 new members have enrolled as a member of the National Association. I warmly welcome them and look forward to their active participation in the association’s activities. The names of the members are as follows: 1. M/s Shashi Nutraceuticals, Rajasthan 2. M/s Jolly Pharma (India), Ludhiana 3. M/s Sava Provate Ltd., Pune 4. M/s K. Patel Phyto Extractions Pvt. Ltd., Mumbai 5. M/s. Navnath Herbals, Nashik 6. M/s. Chirayu Pharmaceuticals, M.P. 7. M/s. Robo Remedies, Bangalore 8. M/s. Grace Drugs & Pharmaceuticals, A.P. 9. M/s. Kamson Healthcare Pvt Ltd, A.P. 2 October-December 2011 From the Secretary’s Desk Dear Members, v) Nodal points for Ayurveda, Siddha and Unani and Sowa rigpa appointed by the Sub-committee A gist of activities and updates are will coordinate and consolidate the information / given below for your information. list of books 1. A Meeting of the Sub-Committee vi) The Nodal points will report directly to Director to amend First Schedule of Drugs PCIM Dr. Ramesh Babu and Dr. D.C.Katoch, and Cosmetics Act 1940 for the list Joint Advisor (Ay.) & Convener Sub-Committee. of Authoritative ASU books was vii) Letters to the concerned Institutes/ Universities attended by me on 17th July 2012. Consequent upon will be sent by Dept. of AYUSH. elaborate discussions on the prons and cons and various aspect of proposed revision of Schedule I viii) The list of the books will be vetted by the books, the Sub-Committee unanimously agreed to respective Pharmacopoeial Committees. determine and adopt the following criteria for short ix) Next meeting of the PCIM will be held on listing classical books. 8th November 2012 at CCRAS Hq., New Delhi for making final selection of books for a. The intended books should have been authored recommendation to the ASUDTAB. before 1947 except the ones already listed in First Schedule of Drugs and Cosmetics Act 3. Even though 19 members of ADMA interested to 1940. participate in Global Ayurveda Congress held in Toronto, Canada, majority of the members could b. The book with the original text in original not participate due to non-receipt of Visa. While language be considered, commentary and regretting for the same, we request all the members translated version of the text may not be taken to come forward to take part in the international up. events where the department of AYUSH has the c. The books should have predominance of provision of reimbursement of expenditure incurred medicinal formulations. on participation in the event. d. The book should have been published in India. 4. A meeting of Sub-Committee under ASUDTAB to e. The latest addition of book may be considered if examine Schedule Z was held on 4th September 2012 it published in multiple editions at CCRUM, New Delhi. Dr. Nagesh represented f. The books should be physically available for ADMA in this meeting and the representation made examination. by him has been published in page no. 4 and 5 of 2. Meeting of PCIM experts and Sub-Committee this issue. th of ASUDTAB was held on 8 September 2012 at 5. ADMA representatives had been invited to the CCRAS at New Delhi to firm up the list of books for first meeting of Ayurveda Sectional Committee recommendations to ASUDTAB for incorporation in FAD 26 held on 7th September 2012. Dr. Amit has Schedule 1 of Drugs & Cosmetics Act 1940 wherein represented ADMA in this meeting. Minutes of the I have represented ADMA in the said meeting. meeting received is circulated to all the members for Minutes of the meeting received was circulated to all their information. the members for their information. The conclusion of the meeting are as follows: 6. ADMA representatives were invited for the State Level Steering Committee meeting of Maharashtra i) All the titles should have the information State Horticulture and Medicinal Plant Board contained in the agreed format. which was held under the Chairmanship of Chief ii) The content pages of books published in regional Secretary, Agriculture and Forest at Mantralaya on languages will be translated and information 11th September 2012. Since the Chief Secretary compiled about Chapter, No. of formulations was held up in some other meeting and there was in each chapter and total no. of formulations in inordinate delay, my self and Mr. Ranjit Puranik each book. could not wait for this meeting. iii) The information should be put on the websites 7. Expert Committee Meeting on Access and Benefit of the respective Councils and Department of sharing for processing of applications was held AYUSH within 7 days to invite stakeholders on 13th September 2012 at National Biodiversity comments / list of Books. Authority, Chennai. Dr. Amit Agarwal represented iv) The time period for obtaining comments will be ADMA in this meeting. We are awaiting to receive 30 days. the minutes of the meeting. October-December 2011 3 Page 2 Matter continued 8. 5th World Ayurveda Congress & Arogya Expo 2012 11. We are seeking for interactive meeting with the with the support of ADMA and local Associations Secretary, Department of AYUSH to discuss on had already organized Road Shows at the following latest notification GSR 597(E) dated 30th July 2012 places:- received in regard to Prefix and Suffix , GSR 249(E) dated 22nd March 2012 in regard to mention of the Ahmedabad on 18th August 2012 additional information on label, the true list of all Nashik on 2nd September 2012 ingredients with their official and botanical names Nagpur on 12th September 2012 along with part used and form of ingredient, and proposed amendment in Rule 153 and 158B and Indore on 15th September 2012 introduction of Schedule Z (related to requirement Amritsar on 22nd September 2012 and guidelines for permission to manufacture of Patna on 29th September 2012 ASU drugs for sale or to undertake clinical trials) in relation to amendment in these Rules in Drugs It is also finalized for the Road Show at Kerala on 6th & Cosmetics Rule 1945. There are so many other October 2012. There was a good response from all the unsolved matters which are to be resolved. We have members of the said cities. Moreover, there was a good already circulated the agenda points to all members interaction with the local associations with regard to the and other Industry Associations and requested for common problems faced by the industries. their feed back for the collective representation. 9. We are planning further Road shows of 5th World 12. We wish to inform all members that WAC authorities Ayurveda Congress & Arogya Expo in Chennai, have given an opportunity to conduct Industry Kolkata, Guwahati, Delhi, Bangalore, and Hyderabad related Workshop/Seminars on the following during the month of October 2012 and the exact Topics in parallel with 5th World Ayurveda Congress dates would be communicated in due course. All and Arogya Expo 2012 being organized from 7th members are requested to support this Event. Along – 10th December 2012 at Lal Parade Ground at with the Road Shows a Seminar also was Organized Bhopal. ADMA planned to conduct industry related by ADMA with the Support of the Local Association workshops / seminars on the following topics for the and we are happy to inform that ADMA up dated on benefit of ASU industry manufacturers. various recent amendments in Drugs & Cosmetics Act, 1940 & Rules 1945 and its impact on Industry i) Workshops on GLP and GMP on Technology to all the ASU Industry members. In addition to and Upgradation this members were made awareness on Quality ii) Seminar on GCP (Good Clinical Practices) Control and Technology in Ayurvedic Medicines etc.