The Department of Ayush has mandated that all homoeopathy manufacturers in the country should be ready to comply with good manufacturing practices (GMP) norms by 2008. The government move to enforce GMP has already started pushing homoeopathy companies to gear up for the certification process. The sector has been demanding to introduce GMP a few years ago after the allopathy and ayurveda sectors started adopting GMP norms.
The main objective of the move is to ensure homoeopathy drugs a smooth entry into the global market and see a consolidation of the sector in the domestic market. Presently, the homoeopathy drugs are either carried by doctors abroad or companies have been making efforts on their own to enter the overseas market through OTC route.
In India, the homoeopathy sector has 150 companies with a total market size of Rs. 400 crore and registering an annual growth rate of 25 per cent. Some of the leading companies are New Delhi-based SBL Pvt Limited, Indian arm of the Germany based homoeopathy giant Dr Wilmar Schwabe Pvt. Ltd, New Delhi-based Baksons Drugs & Pharmaceuticals Pvt. Ltd and Chennai-based Bahola Healthcare. Apart from these large players, the sector has only small units and most of them are located in Kolkatta Delhi, Uttar Pradesh followed by Tamil Nadu (six units), Maharashtra, Gujarat and Karnataka (two each).
None of the homoeopathy manufacturers in India are currently GMP compliant. The compliance calls for proper space allocation and an investments ranging between Rs 50 lakh to Rs 1.5 crore for units producing tablets, ointments, liquid orals, ophthalmic (sterile) and coatings. The GMP guidelines have called for a minimum space allocation of 500 sq.ft to 700 sq.ft and that requires an investment of Rs 5 lakh for generics.
There are reports that the government is working out modalities to offer soft loans to speed up compliance because of the nature of the industry structure. There are quite a few big homoeopathy manufacturers and then there are a number of small players with no medium sized units. "If the required financial support is not provided then the announcement from the government will force many small players to shut down operations," informed sources from the Karnataka Directorate of Ayush.
The key advantage of the GMP standard is the acceptance of homoeopathy drugs in the international market. It will also allow homoeopathy drugs to be recognized on par with the allopathy preparations, Kartik Raghava Murty, managing director, Bahola Healthcare (P) Ltd. told Pharmabiz.
Homoeopathy, according to Murty, is the first choice in alternative medicines because these medicines are easy to consume and they cure a wide range of disorders from simple colds to anxiety to diabetes and cancer. None of the medicines are poisonous or have side effective and are harmful in extra dosage. "Therefore an official regulatory clearance of the production practices undertaken by companies will provide the much-needed boost to the sector," he added.
Sources from Baksons, Schwabe and homoeopathy doctors said that the GMP norms would provide a face lift to the image of the sector as quality standards and production practices were suspect among small players.