Need For Revisiting Recommended Inclusion Of French Homoeopathic Pharmacopoeia And European Pharmacopoeia In D&C Act Proposed By Ministry Of AYUSH

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Among many concerns and pending regulatory issues pertaining to Homoeopathy to be attended by various departments and authorities of Ministry of AYUSH, I would like to draw attention to the following points that may affect very severely to all stakeholders and country:

(1) Ministry of AYUSH has recommended amendment in Drugs and Cosmetic Act 1940 to include French homoeopathic Pharmacopoeia and European Pharmacopoeia under relevant provisions in clause 4(a), (b) and (c) of the Second schedule.

(2) It is understood through consultation with major Homoeopathy Professional Associations of India,  eminent Federation and Manufacturers Association of Homoeopathy in India and Pharmacy Association of India that neither they are aware of proposed inclusion of French Homoeopathic Pharmacopoeia & European Pharmacopoeia in D&C Act 1940 and Rules 1945 nor they were informed or consulted in the process.

(3) On formal inquiry about the organisation,  individual /Association/Commercial body who proposed the inclusion of French Homoeopathic Pharmacopoeia and European Pharmacopoeia in D&C Act provisions for Homoeopathy,  there hasn’t been any answer available to the straight forward inquiry.

(4) Purpose of inclusion of said two Pharmacopoeias in D&C Act is vaguely responded that import-export of Homoeopathy Drugs may benefit. This is a vague assumption and not supported by any methodical study, reports or survey by Government or Commercial analysts of repute. On the contrary, there are all chances that Indian market may get flooded with high priced unwanted  European Homoeopathy products resulting in depletion of precious foreign currency of nation without any justifiable outcomes or reasons.

India is self-sufficient and self reliant for its need for Homoeopathy products through domestic manufacturers as well to the extent of demand of imported products (import constitutes one-twentieth of total market in India today which is not due to undersupply by domestic industry but the natural evolution of business when India was 100% importer of Homoeopathy products in past).

An analogy to represent the situation that may prevail in future due to opening the market of Homoeopathy for world giants (unnecessarily and without protecting the interests of domestic industry & stakeholders) through inclusion and approving French & EU Pharmacopoeia, can be looked through the lenses and example of import of Washington apples from USA and other varieties of imported apples from Fiji, New Zealand and other parts of the world. The Apples from Kashmir and Himachal were available to Indian consumers for less than Rs. 100/- for a dozen,  a decade ago, till the time imports of apples, specially treated and waxed, were allowed to be imported in the country.  Today we find the fruit vendors, in major cities and district places, flooded with all imported varieties of apples costing Rs. 300 and beyond for a Kg and not dozen. It is a hard time to find our own Indian variety of Kashmiri or Himachali apples which are many costs effective and incomparable in its taste and variety. Consumers have to shelve 4-5 times the price of Indian apples for imported apples in today’s time.

Protecting the interests of domestic industry and consumer is the prime responsibility of policymakers, regulators and Government. Any manipulation arising out of twisting the Act or Rule of Government of India needs to be reconsidered, by Ministry and all concerned. Any such amendment in Act or Rules thereof may only be done through wider discussions involving multiple stakeholders, including the consumer forums, Homoeopathic Pharmaceutical industry, Pharmacopoeial Commission of Indian Medicine and Homoeopathy,  Homoeopathy Pharmacopoeial Laboratory, Professional organizations, etc.

(5) Any proposed change in the act without taking the stakeholders in confidence and its reciprocal obligation by other countries (in this case acceptance of Homoeopathy Pharmacopoeia of India by French and EU Drug regulatory authorities and countries) definitely jeopardizes the interests of Indian Industry,  channel partners and consumers as consequences over a long term.

In all fairness, the expert Committee to Drug Control Cell (Homoeopathy), Ministry of AYUSH, Govt of India shall take this issue on priority in their agenda to stop the process of any inclusion of additional Homoeopathy Pharmacopoeia to the Drug and Cosmetics Act 1940 of Govt of India other than already included US Homoeopathy Pharmacopoeia,  German Homoeopathy Pharmacopoeia,  British Homoeopathy Pharmacopoeia other than Homoeopathy Pharmacopoeia of India (H.P.I.).

To upgrade and update HPI with advancing science, technology and knowledge; the adoptable/feasible advances, found in any Homoeopathy Pharmacopoeia of the world, can be incorporated within HPI through mechanisms and procedures of PCIM&H, HPL involving participation as well discussion and input from Industry representatives of India.

In the best interest of the nation, Indian Homoeopathy Industry, consumers and professionals all-important modifications in Policy, Act, Rules pertaining to Homoeopathy may formally be incorporating in the Drug and Cosmetics Act through consultative participation of stakeholders.

The Pharmaceutical Wing of The Homoeopathic Medical Association of India (HMAI), the largest and oldest Association of Homoeopathy Practitioners, along with few other eminent Associations have objected to the advocated provision of inclusion of French and European Pharmacopoeia for Homoeopathy in the country.

All Homoeopathy stakeholders may unitedly oppose this recommendation of amendment in the D&C Act 1940 through representation addressed to the Drug Control Cell of AYUSH in Ministry of AYUSH, Government of India, AYUSH BHAWAN,  GPO Complex,  INA, New DELHI-110023 by writing to the office of Advisor (Homoeopathy) Govt. Of India (ks.sethi57@nic.in)

If we can see tomorrow, we as Homoeopathy community can bring status to India as “Homeopathy pharmacy of the world” without any direct intrusion or crutches in the form of foreign regulatory standards in our Indian regulatory canvas. We have a case study of India becoming one of the top 5 in the world to produce high quality, cost-effective Pharmaceutical products in just 5 decades before which we were a net importer of Modern medicine. Our regulators and policymakers need to play the role of a catalyst by providing a conducive ecosystem for the entrepreneurs, researchers, academia and professionals.

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