The Kerala drug control department and the Kerala Pharmaceutical Manufacturers' Association (KPMA) have initiated a joint effort to help the SSI units in the state to comply with the norms of revised Schedule M.

With the final deadline less than nine months away, the move comes in the wake of poor response and complacency on the part of the 90 odd unorganized SSI drug manufacturers in the state to set up facilities complying with the norms and escape from permanent closure for ever. As of now, just five or six units have GMP manufacturing facilities, and a few other units have started complying with the GMP norms, it is learnt.

As part of this, the Kerala drug control department, in association with KPMA, is organizing a two day work shop on GMP and complying with Revised Schedule M' at Kochi on May 29 and 30. The workshop is likely to act as a platform for the manufacturers to air their grievances and discuss the impediments in complying with the norms, and share information on ways to comply with the deadline.

The workshop was mainly aimed to sensitize the unorganized and small manufacturing units mainly supplying to hospitals and depending solely on Government orders, on the need for complying with the government stipulation and its consequences, sources told Pharmabiz.

"Though it is said that there are about 90 formulation manufacturers in the state, I think the number will be much less than that and we are not sure how many of the units will survive after the deadline. Major problem is that the majority is not serious about modernization and the revised deadline. To our knowledge, only a few units have either started or are in the process of trying to modernize and comply with the Schedule M norms," said Dr. Dr A M D Namboodiri, vice-president of the Federation of South Indian Pharmaceutical Manufacturers Association (FSPMA) and President of the Kerala Pharmaceutical Manufacturers Association (KPMA).

According to Purushothaman, General Secretary of KPMA- which has only 40 odd manufacturers in its active membership list, the workshop aims to sensitize the members on need to comply with the Schedule M and options to mobilize the required funds. " A high level meeting of FSPMA is scheduled at Hubli in Karnataka this week, and we are planning to discuss the possible options and work out a detailed strategy with our apex body, the Confederation of Indian Pharmaceutical Industry (CIPI), which is appointing various consultants to guide the units in implementing the norms." said Dr.Namboodiri.