The Ayurvedic drug manufacturing industry in Kerala, which mainly manufactures patented and proprietary drugs, will have to withdraw a large number of the existing drugs, if the proposed move to mandate clinical trials for patent and proprietary drugs in the ASU (Ayurveda, Sidha, Unani) sector becomes a reality.

Informed sources told Pharmabiz that at present about 10,000 varieties of proprietary drugs are being manufactured in Kerala by 800 odd players, most of them are traditional small-scale units. Out of this, only around 440 drugs are manufactured in accordance with the 58 classical texts suggested by the Central Government. The Kerala manufacturers mainly follow about 40 classical texts like Chilkitsamanjari, unique to the state.

If the government goes ahead with the move, while the 440 drugs are likely to be cleared for the tag of being time-tested for centuries, rest of the 9500 odd popular innovated drugs will have to be withdrawn, and subject to the process of the norms for clinical trials for approval and manufacturing license. These include fast moving drugs like Aswagandha Rasayanam, Ajamamsa Rasayanam etc., for which most of the leading manufacturers have about five to ten varieties in the market. The move would ultimately wipe out the Ayurvedic industry in the state, now in the process of growing at a rapid pace to tap the global markets, fear industry sources.

Sources aver the move is impractical and will ultimately cause the closure of majority of the units.

"The expenses for the phased clinical, toxicological and animal studies are to the tune of at least Rs 25 crore for each drug similar to the allopathic drug parameters. The industry cannot afford it. The medicines of Ayurveda are based on Thridosha. The government should think of a mechanism based on the fundamentals instead of insisting the clinical-animal trial method of the allopathic system or just copying Schedule Y to bring in some norms for standardization and quality. The move would have relevance if the Ayurvedic drugs caused side effects or deaths. "Not a single new drug was developed by the Indian allopathic companies in the last fifty years. These rules are being framed to protect the interest of multinationals, who are trying to hijack Ayurveda," opined Dr D Ramanathan, general secretary of the Ayurvedic Medicine Manufacturers Organization of India (AMMOI).

He noted that the DTAB committee for ASU sector lacked industry representation, and the move stems mainly from ignorance on the manufacturing systems and style followed by various states. While there was an earlier move to implement the mandatory clinical trials, the industry had vehemently opposed it, noted Dr.Ramanathan.