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GCP Guidelines for ASU drugs- Issues & Solutions Dr.D.Induchoodan Convener- Centre for Integration of AYUSH Systems State Committee Member- Ayurveda Hospital Management Association [email protected] 1. Regarding scientific suitability Not considering the fundamental principles of Ayurvedic Medical System and seem to implement an entirely different drug development methodology of Allopathic Medical system over Ayurveda . Solution Scientific Quality Assurance system for Ayurvedic Medicines based on its basic principles should be derived by conducting workshops in different parts of India with experienced Ayurvedic Physicians from various sectors – Clinical practice, Drug & Clinical Researches, Medicine Manufacturing and Ayurvedic Medicine Marketing. 2.Basic difference in Research & Development of Ayurvedic & Allopathic Medicines Active part of Ayurvedic medicine is combinations of several single drugs which are contradictory to active single molecule concept of Allopathic medical system. So the R & D methodology of Allopathic Medical system is not suitable for Ayurveda. The product developed by one Ayurvedic firm for one disease will be a combination of single drugs, another firm can easily duplicate it even with the difference of marginal presence of a single raw drug and hence the investments for R & D by the first firm cannot be protected by IPR law. Because of these reasons, Ayurvedic firms will not show interest in product (Medicine) development which will ultimately prevent the development of Ayurvedic system of Medicine itself. Solution The proposed GCP Guidelines for Ayurvedic Medicines should be withdrawn and a scientific Quality Assurance System suitable for Ayurvedic product development should be derived and implemented 3.Investments required for the development of a single product Product development as per the proposed GCP Guidelines necessitates investment of huge amount of money and time which is not affordable for most of the Ayurveda manufacturers and even after that, there are chances of duplication of the products. Solution Scientific and practical Quality Assurance System for Ayurveda Product development should be derived and implemented by taking sufficient time 4.Present status of Ayurvedic Medicine Development & implementation of proposed GCP Guidelines Lack of infrastructure Non availability of Clinical Research experts from Ayurvedic Sector Huge financial investment Small market compared to Allopathic sector…etc. Proposed GCP guidelines are impractical at this stage. Solution New Quality Assurance guidelines should be prepared starting from the existing guidelines as per notification no. GSR. 377 E, Health & Family welfare dated 10th August 2010 in relation to the issue of license w.r.t ASU Drugs through workshops in different parts of India and it should be implemented step wise by giving a time period of 8-10 years with financial support/ subsidies from Government side to prevent the destruction of Ayurvedic industry 5.Incompetency regulatory Authority Existing regulatory/ licensing authority in Ayurveda is not competent to monitor the implementation of proposed GCP guidelines because of lack of infrastructure and human resources and authorizing Allopathic authority for this purpose is unscientific & unethical. Solution Competent regulatory authority for Quality Assurance of Ayurvedic Product Development with an advisory board comprising participation/ representation of Ayurvedic experts from various sectors- 1/3 rd members from Researchers and Practitioners, 1/3 rd members from Manufacturing & Marketing experts and 1/3 rd members from Administrative & Academic sectors of Govt. Departments/Colleges- should be developed with in a time period of 3-5 years 6.List of approved texts for Classical Medicines Approved list of classical Ayurvedic texts is not covering important classical texts like Vaidya Manorama, Yogamrutham, Chikitsamanjari..etc which are widely used by Ayurveda Acharyas for several generations. Hence the formulations from these texts are considered as proprietary medicines. As per the proposed GCP Guideline, Clinical trial is essential for formulas from these classical texts (including Kashaya, Arishta, Leha..etc formulations from those texts) also which even affect the traditional Ayurvedic practice itself. Solution List of AYUSH approved classical Ayurveda texts should be modified after discussions with Physicians, Manufacturers and Academicians before implementing new Quality Assurance rules for patent & proprietary medicines 7.Modification in the form of Medicine Ayurveda Acharyas traditionally used to prepare same formula in different forms- for different conditions of the disease-even though it may be mentioned in any one of the forms in classical texts (Eg- Indukantham is mentioned as Ghritha in text). The proposed guideline limits the privilege of physician (or the manufacturer who is preparing medicine for the physician) to prepare different forms of the same formula for different avastha of disease by implementing compulsory clinical trial for any change in form and dose. Solution Products with same formula and different preparation forms should be considered under classical medicine category itself 8.Pathyaharakalpanas of Ayurveda & GCP Guidelines Ayurveda has several Pathyaharakalpanas which may not be mentioned in classical texts, but are in practice for generations (time tested) in different areas and manufactured by several Ayurvedic manufactures as Ayurvedic food preparations with proprietary license. Eg. “Karkkataka Kanji” is a traditional Ayurvedic food preparation of Kerala and several firms are manufacturing and marketing it with proprietary license. Ayurveda Dahasamani- formulation containing Ayurvedic herbs to prepare drinking water also comes under proprietary license. The proposed guideline demands clinical trial for these types of pathyaharakalpanas since it is proprietary. (Renewal of License also demands Phase 3& 4 of Clinical trial) Solution Separate category for pathyaharakalpanas (Ayurvedic food preparations) should be created in the license with the requirement of only pilot safety study as mentioned in notification no. GSR. 377 E, Health & Family welfare dated 10th August 2010 in relation to the issue of license 9.Ayurvedic soaps & other complementary products Now-a-days Ayurvedic soaps ..etc (Complimentary Products) are widely manufactured only to support the skin from dust, dirt, climatic variation..etc and not for any curative or preventive purposes. They are proprietary Ayurveda products and hence demands Clinical trial reports as per the new guideline. Even for renewal Phase 3 & 4 of clinical trial is essential Solution Complementary products should be exempted from the proposed GCP Guidelines and if necessary, only a pilot safety study can be implemented 10.International entry of Ayurvedic Medicines Implementation of these GCP guidelines with investment of huge amount of money and time is not helpful for Ayurvedic products to enter the global market since most of the countries not approved Ayurveda as a system of medicine and demand fulfillment of their own quality standards for entering their pharmaceutical market. It also should be remembered that several herbs including “Bala” is banned by some countries Solution If these Guidelines are essential to export Ayurvedic medicines (even then under Herbal Medicines only; not Ayurveda), make it mandatory for export only (even now, exporters are following several rules of several countries which are not essential for Indian Market) Common questions and simple answers 1. It is applicable to patent & proprietary medicines only; classical medicines has no issue: Realise Important medicines like “Murivenna” Indukantham-SukumaramGugguluthiktham kashayams comes under proprietary category in this list Common questions and simple answers 2. Why should we formulate new products since there are several formulations in Classical texts which are exempted from clinical trials: Several classical texts are not in approved list of Classical Medicines. Even Change in form (Ghritham to Kashayam) removes their classical status Ayurveda is not a dead science- Acharyas used to develop new formulations in each period (eg- new formulas in A.Hridaya than Charaka & Susrutha Samhithas). It is essential to develop new formulations as Desa & Kala Changes Common questions and simple answers 3. It is the Issue of Manufacturers only since they cannot develop new products: Manufacturers can maintain their sales by producing fast moving (mainly contributing) classical items only Physicians will not get several common medicines including Murivenna, Indukantham kashayam..etc which will affect efficacy of their practice Physicians will not get medicines from Important classical texts like Chikitsamanjari, Yogamrutham..etc (since manufactures will not produce) Physicians will not get new formulations based on difference in Desa & Kala as Acharyas suggested