The West Bengal Small Scale Pharmaceutical Manufacturers Association (WBSSPMA) has accused the Central Government of yielding to the pressure from multinational drug majors while framing its Good Manufacturing Practices norms under the revised Schedule M of the Drugs and Cosmetics Rules. The association felt that the revised norms are not meant for upgrading the standards of drug manufacturing but are aimed at killing the SSI sector thereby monopolizing drug manufacturing business in the country.

"The existing infrastructure was sufficient for SSI drug companies of the country to produce quality medicines at affordable prices all these years. Even the bigger companies have been outsourcing part of their requirements from SSIs. There have been no instances of sub-standard drug production due to lack of proper facility. The only reason why the government wants to enforce revised standards is to kill the competition," the association argues.

Speaking to pharmabiz on the sidelines of the recently concluded Indian Pharmaceutical Congress at Kolkatta, Satyajyoti Ghoshal, secretary WBSSPMA said that there was no rationale behind asking a multinational company and an SSI unit to maintain same infrastructure facilities. "The infrastructure requirement of a company should be based upon the production output. Sterility norms should be stringent for companies that work in shifts, and manufacture different products using the same infrastructure. For smaller companies, surviving on single product, or limited production of a few products, the rules should not be so stringent," he maintained.

The WBSSPMA, a constituent body of the Confederation of Indian Pharmaceutical Industries (SSI), wanted the government to approve a unit, based on the quality of the product and not on the infrastructure. "No where in the developed world, license is given based on the infrastructure facilities. Everywhere, it's the product that is tested and if it is found to be of constituent quality, the facility is approved," Ghoshal says. He cautioned Indian Government against the "multinational ploy" to destroy the low cost manufacturing base of the country.

Meanwhile, the CIPI has reiterated its demand for keeping revised Schedule M in abeyance. In a representation to the union health minister, CIPI wanted revised Schedule M to be scanned in the light of standard attained and to be made need based for the SSI. "The SSI in general has been manufacturing quality products passing all quality tests as per the prescribed pharmacopoeias. They complied with the provisions of seven amendments of the Drugs & Cosmetics Act 1940 &Rules 1945 and reached a standard not to be wished away. The 8th amendment in the form of revised Schedule M deserve to be scanned in the light of standard attained and to be made need based for SSI," the plea said.

It wanted a review committee including representatives of the SSIs to be appointed for ascertaining the need-based requirement, keeping in mind the Indian economic condition. "The Gazatte notification no GSR.738 (E) dated 8.11.04 allowing only 30 days for suggestion virtually deprived the entire small scale industry to take cognizance of the same," the representation said.