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 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. including Schedule Z. Members also had an opportunity to interact with iii) Interactive meet of Stakeholders in medicinal Licensing authorities. . 10. While thanking WAC authorities for the opportunity iv) An Interactive session to discuss issues of the provided to interact with all the Associations of the Industry with department of AYUSH th State, we request all the members to Support 5 We request all the ASU Industry members to participate World Ayurveda Congress & Expo scheduled to be in the above Workshop / Seminar and make the event th th held at Bhopal from 7 to 10 December 2012 by grand success. booking the stalls in great numbers so as to avail

maximum discount for ADMA members. Chandrakant Bhanushali Hon. Gen. Secretary 4 October-December 2011

long pieces. Stems of the seedlings and coppice shoots Eucalyptus Tree - Classification are quadrangular. Flowers are in cymose panicles. The fruit is a . Kingdom : Plantae Division Magnoliophyta Other Species Class: Magnoliopsida Eucalyptus abdita, Eucalyptus acies, Eucalyptus api- Order : culata, Eucalyptus albopurpurea, Eucalyptus alligatrix, Eucalyptus ammophila, Eucalyptus amplifolia, Eucalyp- Family : tus andrewsii are the other related species of Eucalyp- Genus : Eucalyptus tus. There are 700 species of Eucalyptus. Zoological name : Eucalyptus globulus, Eucalyptus polybrachtea Location

Found In : Nagarhole National Park and It is widely grown in Tamil Nadu, Andhra Pradesh, Bandipur National Park Gujrat, Haryana, Mysore, Kerala and in the Nilgiri Hill. It grows well in deep, fertile, well drained loamy soil with adequate moisture. It is also found in Nagarhole National Park and Bandipur National Park in India. .

Cultivation methods

Eucalyptus grown in well drained sandy soil. It is propagated through seeds, soft wood cuttings and semi hard wood cuttings. At the time planting it must be taken into account that ts roots are not broken. It needs water before and after planting. It requires full sunlight.

Medicinal uses

Eucalyptus is known for its use either as an essential oil or tea for its ability to relieve congestion and ease breathing in colds. It oil is also used as the pain reliever foe sore and overextended muscles. The essential oil of Eucalyptus contains cineole, a potent antiseptic that helps in killing the bacteria and fungi. It helps in increasing cardiac action. It is taken in all types of fever. Other names It helps in purifying the blood. It lowers the blood sugar. It brings relief to the patients of Asthma and bronchitis. Tailapatra, Sugandhapatra, Tailaprana, and Nilgiri Taila It is the excellent topical remedy for aching joints and are the other names used for the Eucalyptus. rheumatism. It helps in improving the blood circulation.

Description Other uses

Eucalyptus is a tall evergreen tree. It attains the height Eucalyptus is used as the pulpwood in the manufacture of more than 300 feet. of the tree on juvenile of the paper as well as raw material. It is used as the shoots are opposite, sessile, cordate-ovate and covered poles for the construction of huts and houses. It is used with a bluish white bloom. The adult leaves are alternate, in making plywood, doors and windows lanceolate and are 6-12 inches long and 1-2 inches broad. It flowers are cream in colour. The appearance of its bark varies with the age of the tree. Its bark Source: http://www.ecoindia.com/flora/trees/neem- tree.html consists of long fibers and can be can be pulled off in October-December 2011 5

SCHEDULE- Z: Representation from ADMA to ASUDTAB Sub-Committee Meeting on 4/9/2012.

Current scenario of Clinical Trials with respect of effectiveness by way of Clinical Trials-Phase I, II & III to the ASU Industry: Presently the ASU Industry seem to not have taken the Ayurvedic paradigm in mind. conducts Clinical Trials based on their Marketing Dept In the (Proposed Rule 158 B) the words “Experience or needs or requirements specified for Export and today, Evidence of effectiveness” (158 B in effect) has been Clinical Trials are not mandatory for approval of ASU revised to “Evidence of effectiveness”: This is quite medicines. unfair to Indigenious Medicine /ASU Systems of India which have a proven history of usage- both empirical Schedule Z & GCP: Overall Industry & treatise based and their resultant knowledge based Opinion: practices which have been handed down from generation Pros: There is a definite need for harmonization of to generation. It is further observed that the existing currently conducted Clinical Trials on ASU drugs by Rule 158 B has the statement ” The standard protocol way of bare minimum Guidelines for Clinical Trials. GCP will also include concept of Anupan, Prakriti & Tridosh Guidelines are the need of the day as & in this context etc published by CCRAS & other Government/Research efforts made by Dept of AYUSH are commendable. bodies”. But this has been inexplicably removed in the Certain aspects such as “The Principle Investigator proposed 158 B. ADMA had in its letter dated 28th / Chief Investigator should be from respective ASU December 2011 to the Dept of AYUSH) provided system (3.3.1)” do take the ASU perspective into specific comments on Schedule Z (then Appendix III of account. Further, the specific technicality of the ASU GCP Guidelines) separately as Annexure IV. However, System has been well taken into account in existing review of 9th July 2012 version of Schedule Z Rule 158 B (10th August 2010) which stipulates shows that these comments have not been taken additional data for safety & clinical efficacy in case there into consideration at all. is a new indication or new solvent used. ADMA opines RULE 153: New Reg fee under 24-D from Rs. 1000 to that ASU Products (Old or New) contain known herbs/ Rs. 10,000 too high especially considering small scale drugs with proven efficacy. Usage is based on empiric manufacturers and ADMA suggested to the Dept to or historic use & it is well known that if the given ASU consider reduction of the same. system is followed there is no scope of any uncertainty or toxicity as is what happens when we talk of a new RULE 158 (B): molecule or NCE (New Chemical Entity). All possible situations of toxicity, complications etc have been well Issue No. 1. Direct application of described in the ASU Texts & this is what differentiates Allopathic Concepts: ASU from other traditional systems or herbal medicine t is evident that the designing of these Guidelines has or folk medicines or ethno-medicines etc and gives it been heavily influenced by the Allopathic requirements the status of a Codified System of Medicine which is to the extent that certain requirements in the proposed well equipped with Authoritative Treatises (Granthas). GCP Guidelines appear to be directly applied without However ADMA also proposes that Ayurvedic considering the ASU aspects involved. Parameters like Tridosha, Pancha Mahabhuta, Agni, Rasa, Guna, Virya, Vipak, Prabhava etc. have to be Example 1: Impurity profile: [Mentioned in Appendix I take into account along with modern Biochemical (of Proposed Schedule Z) para 2.4 and 2.5] Example parameters. Inclusion and exclusion criteria, end points 2: Pharmaco-kinetic studies [Mentioned in Sec 1.11.13 and methodology should be based on ASU philosophy. sub point (iii); Appendix III, Proposed (Schedule Z) Introduction of New Categories such as Balya/Poshak/ Point II 8 (iii)]. Example 3: Chemical name: [Mentioned Muqawi/Unavuporutkal/Positive Health Promoter; in Appendix I-A (of Proposed Schedule Z) para Saundarya Prasadak (Husane afzal)/ Azhagh sadan; 2.1]. Example 4: Manufacture of active ingredients Aushadh Ghana (Medicinal plant extracts-dry/wet) is a [Mentioned in Appendix I-A (of Proposed Schedule welcome development. Z) para 2.5]. Example 5: Intravenous infusions and injectables [Mentioned in Appendix I-A (of Proposed It is observed that certain irrelevant elements Cons: Schedule Z) para 4.2] from the Allopathic System have directly incorporated & hence must be suitably amended to meet the ASU Note: All the above examples clearly show that concepts requirements. Clarity & guidance for compliance on & systems applicable in the System of Allopathy issues like active ingredients, chemical names, impurity or Modern drugs have been directly used as such profile, excipients etc also needs to be provided. while drafting the proposed GCP Guidelines, without Further the proposed changes for demonstrating Proof considering their relevance to ASU drugs. 6 October-December 2011

Issue No 2: Requirements are Elaborate, various categories given in tabular format. ADMA held Exhaustive & Unrealistic the viewpoint that Pilot Study is an acceptable solution at this stage for ASU Medicines instead of the proposed Example 1: Requirements/concepts like analysis by Phases I, II, III. GLP labs [Appendix-I (Of Proposed Schedule ‘Z’), para 2.2 & 2.3, Geno-toxicity [Appendix-III (Of Proposed Some Ground realities: Schedule ‘Z’] point 3, Animal Toxicology (non- clinical toxicity study), Reproductive toxicity, animal a) Current level of Expertise & need for Training & pharmacology Appendix-IV (Of Proposed Schedule Capacity Building: ADMA indicated that neither majority ‘Z’) excipient compatibility, Multicentre studies, (Sec of ASU practitioners have adequate expertise to conduct 3.1.15) etc. A major part of the Ayurvedic Industry Clinical Trials following such Guidelines nor do most being small scale in nature would be significantly the Allopathic doctors have adequate exposure to the impacted. Meetings were held by ADMA at Ahmedabad ASU philosophy to be able to build these principles in on 18th August 2012 & 2nd September 2012 at Nashik to a trial design. Thus there is a great void which can attended by State Licensing Authorities. Overall small be filled only by proper training and capacity building. scale & medium scale manufacturers are very much Since it took more than 10-15 years for Schedule Y to disturbed & affected with these proposed changes. come to its present level a similar approach should be adopted for ASU Industry. b) Nature of ASU Industry: Example 2: Reference Standard Characterization (Ref. Appendix I to Sch Z para 2.6): Problems concerning Further, it was pointed out that the status of compliance lack of standard agencies to provide for such reference to Schedule T is still wanting and how slow the process compounds at reasonable costs are well known to of upgradation really is in context of the ASU Industry those involved in such work & there is an urgent need (especially the SSI & MSME component) which is not to resolve the same. organized to expected levels & which is lacking in financial capacity. Issue no.3: Disharmony 158 B, 170 and Sch Z: Guidelines for ensuring Rationalization of P&P There is considerable overlap & disharmony amongst Category of Ayurvedic Medicines: There was a various rules & Schedules which are in vogue & 2 Day Seminar on “Herbal Products: Regulatory some which are proposed when compared with the Aspects” held by Dept of Clinical Pharmacology, proposed GCP Guidelines such as Rule 158(B):[10th TNMC & BYL Nair Ch. Hospital, Mumbai on 29th August 2010] Guidelines for issue of license with & 30th June 2012. It was therein proposed that the respect to Ayurveda, Siddha or Unani Drugs; Rule formation of an Expert Group to formulate Guidelines 170: Guidelines for evaluation of Ayurveda, Siddha, for Recipe Formulation of P&P Products could work Unani Drugs and Traditional Herbal Medicines and on generation of such Guidelines to resolve issues proposed [vide communication dated 9th July 2012] such as Irrational Combinations, etc Schedule Z: Requirements & Guidelines for Permission to Manufacture of ASU Drugs for Sale or to Undertake Conclusions: Clinical trials. This has already caused undue confusion GCP Guidelines: ADMA recommends that the GCP on in Industry as well as at level of State Licensing ASU drugs should come out in a phased manner where Authorities (SLA’s). There is a need to harmonize the initially there would be a preliminary document on same & remove the overlaps. Rule 170: Guidelines Introduction on ASU drugs / brief operational guidance for evaluation of Ayurveda, Siddha, Unani Drugs document in the simplest version along with a brief and Traditional Herbal Medicines) ADMA proposes regulatory law on Clinical Trial on ASU drug. scrapping of Rule 170. Capacity Building: Currently adequate capacity is Issue no.4: Contradiction of prevailing not available in ASU industry. It is essential to build Statutory Provisions: this capacity. Manpower needs to be trained on the Schedule Z specifies requirements & guidelines for guidelines for proper compliance. Once the capacity Permission to manufacture of ASU Drugs for Sale or is built in, it would only be fair for the regulatory to undertake Clinical Trials. This is contradicting the bodies to be gradually stringent and aim for higher existing statutory provisions as currently according to standards. the Sec 33 EEC of the The Drugs & Cosmetics Act- 1940- no permission is required to manufacture an ASU Schedule Z: Pilot studies/Proof of Effectiveness instead drug for Clinical Trial. There would thus be a need to of Phase I, II & III of Clinical Trials. ammend Sec 33 EEC also. Proposed changes have a direct bearing on Cost of New In the ASUDTAB Sub-committee meeting there was a Product Development. Further, the Product Approval specific category based discussion with respect to the process would become very lengthy. October-December 2011 7

ADMA representation on Prefix and Suffix to AYUSH medicines licensed under 3(a) and 3(h)(i) of the Drugs & Cosmetics Act, 1940.

The Association has made the following representation to Shri It is important here to also add that there exist prefix and Anil Kumar, Secretary, Ministry of Health & Family Welfare, Suffix to names of medicines stated in the pharmacopoeia Department of AYUSH on 12th September 2012. which are in consonance with ‘traditional’ reference and We are in receipt of the above named Notification with thereby the deletion of such extensions to names of regards Prefix and Suffix to AYUSH medicines licensed products even when licensed under 3(a) of the D&C Act under 3(a) and 3(h)(i) of the Drugs & Cosmetics Act, is detrimental to a traditional practice within the sector. 1940. We have shared the said Notification with our b. With regards to your restriction in the use of membership and the feedback received has been names that ‘resemble’ or ‘mimic’ formulations summarized below for your consideration: mentioned in the FIRST SCHEDULE, you may 1. Dept of AYUSH in the past has issued Notifications please note that whilst such core intention is on the same subject. You are request to clarify if understandable, we are afraid its operational the same stand withdrawn or otherwise. As this new latitude due to inefficient drafting is too vast and Notification can only confuse if cogently read with prone to disharmonious implementation and the earlier Notifications. abuse at hands of state licensing authorities. We foresee that discretional interpretation will provide 2. Like always we would take this opportunity to bring to for unfair competition between AYUSH Industry your notice the flagrant misuse of the power for rule in India. The notification in manner drafted needs making bestowed on the Central Government under to be changed to something objective, clear and Sec 33-N of the Drugs & Cosmetics Act, 1940. You capable of singular interpretation. will agree that rule making envisaged in the scope of the current notification does not justify the disregard c. All in all, the Notification should be made the scheme provided in the Drugs & Cosmetics prospective and not retrospective. We have Act, 1940, whereby such and other notifications strong objections to this violation of a principle need to come through the process of AYUSH of ‘promise’ that gets set aside by overnight Pharmacopoeia Committee’s, ASU-DCC and ASU- de-licensing formulations which have been DTAB, which mean stakeholder participation and a previously licensed. You will agree such an ad- consultative process. One cannot justify why this hoc action can be termed illegal and against the scheme which has all the democratic principles principle of justice. within needs to be bi-passed time and again with the d. The Notification deals with Rule making on the abuse of Sec 33-N at the hands of Dept of AYUSH subject of naming of medicines as defined in in arbitrary and high handed manner. May good Drugs & Cosmetics Act, 1940, under Section counsel prevail in such matter in times to come and 3(a) and 3(h)(i). You will agree that ‘naming’ as the strength in stakeholder consultation dawn on such is beyond the scope of the definitions stated your good judgment for the better demonstration of in the Act and as such your Rule making may democratic values in everyday policy frame. exceed the provisions of the Drugs & Cosmetics 3. Assuming the past Notifications have been withdrawn Act, 1940, and as a whole be illegal. You will or stand cancelled we share the suggestions for agree that specifying ‘licensing conditions’ to be your consideration : extended to something as important as ‘naming’ of the medicines would be too stretched and we a. With regards the use of prefix or suffix for say that such Rule making is beyond the scope medicines licensed under section 3(a) of of the Act and thereby the Rules therein are the Drugs & Cosmetics Act, 1940, you may illegal. please note that such products maybe in the market from a time period in excess of 20 You will agree that Rule 161 which deals with years and as such to suddenly and overnight aspects as specific as labeling of medicines is extinguish their identity is downright illegal also silent on the aspect of ‘naming’ and as such and detrimental to a smooth flow of commerce. the Drugs & Cosmetics Act, 1940 can be said You are requested to clarify the compelling not to cover this subject at all. reasons as to why such action is justified May we request you to seek and share legal which may also tantamount to affecting opinion on this fine point and prevent downstream revenues for the AYUSH Industry. hardship to AYUSH industry who would have to 8 October-December 2011

cope with this confusion and flip flop in regulatory this Notification proposed and oblige. environment. May we as always request the Dept of AYUSH to call 4. We draw your specific attention to the past a meeting of stakeholders and their Associations for a Notifications, clarifications and communication discussion on this subject matter and to explore solutions issued by the Department of AYUSH on this same which meet the expectations of transparency and yet subject scope of Prefix and Suffix : do not create hardships to AYUSH industry almost instantly. We look forward to a considered opinion from i. No.K.11024/7/2002-DCC (AYUSH) dated 4th your good office and indication of an early date for our February 2008 discussions on the matter. ii. D.O.No.K-11024/7/2002-DCC (AYUSH) dated 15th Any delay in submission of this communication may April 2008 kindly be condoned and we may also lodge as always th iii. F.No.K.11020/1/2008-DCC (AYUSH) dated 18 a note of protest with your good office of not receiving July 2008 the said Notification directly from the Dept of AYUSH iv. F.No.K.11020/1/2008-DCC (AYUSH) dated 14th but from our agency who keeps us abreast of such August 2008 Notifications. We receive and re-circulate for the Dept of v. F.No.K.11024/7/2002-DCC (AYUSH) dated 26th AYUSH communications to the AYUSH Industry almost August 2008 on daily basis and are surprised that almost every time such important communication is received only from You will notice that the subject and scope of the third party agencies and not directly. We have followed Notification and further clarifications and communications your advise and attempted registering on your website were considerable in coverage and sensitive to the for updates and even written to your official with regards nuances and ‘tradition’ that governs the AYUSH Industry the hopeless attempts to find the registration space to and market acceptance. Your latest Notification under no avail. Kindly rectify this anomaly and habit of not discussion is mute to such considerations and such keeping stakeholders abreast of developments, Rules drafting can at best be termed incomplete and thereby and regulations that affect their existence. irresponsible. You are requested to withdraw as a whole

Light on Ayurveda, Journal of Health. Light On Ayurveda is a journal published from USA, and has 4 issue per year. LOA is a peer-reviewed journal edited by Balram Singh, and has an Advisory and Editorial Boards with eminent experts from different parts of Globe. It has interesting “Features” and regular columns like-“Guidelines for Practitioners, Light on Science Discovery, Healthy through summer with Ayurveda, book reviews’. In the “Summer issue of 2012”, I find a very interesting “Glossary of Sanskrit Terms” with their meaning in English. It also has a very informative article on “Impact of Nutritionally Engineered, processed, packaged Food regimen on Type 2 diabetes’ based on patient data. One finds articles written by Vasant Lad, Devesh Rastogi, Diana Luire, Thomas Mueller, and the like authors of repute. I recommend your readers and members to Subscribe to this Journal apart from contributing articles/papers to the same. For Details Visit www.loaj.com and contact in India Mr R P Jain at [email protected] D B A Narayana, Bangalore, 14th August, 2012. October-December 2011 9 10 October-December 2011 October-December 2011 11

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10. M/s. Sai Pharmaceuticals, Pune who have joined as a Life Member of this National Association. 11. M/s. Abeers Pharmaceticals Pvt Ltd, New Delhi I urge them to actively participate in the association’s activities. 12. M/s. Dr. Anil Patil’s Vedicure Pvt Ltd, Mumbai, I request all Members who have not yet renewed their 13. M/s. Kuligai Chemicals & Pharmaceuticals Pvt. Ltd., membership for the current year to renew their membership Chennai immediately along with the arrears of the previous years, if 14. M/s. Kudos Laboratories India, New Delhi any, so as to enable us to serve you better. 15. M/s. Everest Pharma, Pune Subharthee Dey 16. M/s. Reve Pharma, Nashik President-ADMA 17. Mr. Ashok Gaikwad, Mumbai 18. M/s. Paladin Health Care, Ludhiana 19. M/s August Bio Pharma, Nashik 20. M/s. Shri Swami Samarth Ayuvedic Pharmaceuticals, Trimbakeshwar. I warmly welcome M/s Kashmir Herbal Remedies, Amritsar 12 October-December 2011

With Best Compliments From LVG Healthcare Pvt. Ltd. Manufacturer of Authentic Shastrokta and Patent Ayurvedic Medicines l Powder l Tablet l Capsule l Tail l Bhasma l Syrup l Avleh Plot No-9 to 11, Ratnamani Industrial Estate, Sarkhej-Bavala, N.H. 8-A, Changodar, Ahmedabad-382213. Telephone no. 079-22149710 Email Address: - [email protected] Website: - www.lvg.co.in