The Department of Animal Husbandry under the Union Ministry of Agriculture is working on a bill that may find the Office of the Drugs Controller General of India (DCGI) being relieved of its duties regarding the regulation and approval of veterinary drugs and pharmaceuticals in the country.
The draft, which is known to be under preparation would form the basis for a new Act for veterinary drugs, it is learnt. The Act would call for a separate pharmacopoeia for veterinary drugs, new drugs regulatory mechanism, testing laboratories, etc. Currently, regulation and control of veterinary drugs comes under the purview of Drugs & Cosmetics Act and is being carried out by the Health Ministry.
Informing this to Pharmabiz.com, Dr PN Bhat, former director & vice chancellor, Indian Veterinary Research Institute (IVRI) said that the draft has been a long time demand of the veterinary drug industry and professionals across the country. "Today Indian Pharmacopoeia has a separate section called IP (Veterinary). This would be further developed into a totally separate IP for veterinary drugs. IVRI is taking the lead in this initiative," he informed.
As of now, the Animal Husbandry Department is the nodal agency for screening all import/export applications relating to veterinary drugs. However, the Drugs Controller General of India remains the licensing authority. While the Animal Husbandry departments both at the central and state level have the expertise to handle issues relating to drug control regulation of veterinary drugs, state drug control offices, that come under the department of health are the statutory authorities to do the job. Experts feel that this has led to lack of proper monitoring and quality control of veterinary drugs in the country. The latest move is intended to clear this anomaly and bring in all veterinary related regulatory responsibilities under the purview of Ministry of Agriculture.
According to Dr Bhat, the draft is only under preparation and would take at least two years to become an Act. "The draft has to be completed, circulated for public comments, vetted by the Law Ministry, and clear all procedural hurdles before it can be placed in the Parliament", he explained.
The Indian veterinary drug industry is estimated to be enjoying an annual turnover of Rs.700 crore. The sector has not been able to develop a distinct identity as there are very few companies who are exclusively into veterinary segment. For most of the pharmaceutical companies' veterinary drugs is part of their product portfolio, promoted by a much smaller division of the parent group.
The animal health market, especially the biotech segment is expected to grow tremendously in the coming years. With increasing demand for veterinary vaccines, diagnostics, therapeutics and protein feed, companies like Bayer, Hoechst, Pfizer, Glaxo Wellcome, American Home Products and Ranbaxy are all in the process of increasing their presence in Indian market.
Other players involved into the manufacture/marketing of veterinary biologicals include Indovax (New Delhi), Shubh (Ahmedabad), Indian Immunologicals (Hyderabad), Venkateswar Hatcheries (Pune) etc.