As per the latest data collected by the Mashelkar Committee, only 400 out of the 18, 000 odd small scale sector pharmaceutical companies in India have complied with the revised Schedule M norms. The committee, which is in the process of submitting its final report on suggestions to revamp the drug industry and trade practices in India, gives the indication that according to this data, only these 400 units in the SSI sector would be able to survive if the government sticks to the December, 31, 2003 deadline for the GMP compliance.

Informed sources told Pharmabiz that the Mashelkar Committee reached this figure by consulting the respective Drug Control Administration (DCA)s in all the states, and compiling the data furnished by them. Out of the 400 units, more than half are from the states of Maharashtra and Gujarat.

Only 20 units in Tamil Nadu, which has a large concentration of SSI units, have adhered to the Revised Schedule M norms. Apart from these 400 units, another 100 to 150 units have incorporated modernization in their manufacturing lines, though not fully adhering to the prescribed revised norms.

In the case of most of these units, urgency in modernization was to meet their own interests like undertaking export orders or other immediate future prospects, than trying to oblige with the government decision, said sources.

When contacted, T.S.Jaishankar, chairman of the Confederation of Indian Pharmaceutical Industry (CIPI), which represents the SSI's with membership of over 18000 licensed manufacturers in the country, said it was impractical on the part of the SSIs to fully comply with the norms, unless the government extends the deadline.

"I agree with the fact that a bit of lethargy and relief has crept into the minds of entrepreneurs of many units, following reports that appeared in Pharmabiz and some other newspapers that the Schedule M deadline will get an extension of two years. Nevertheless, the news of just 400 units complying with the norms should not be interpreted as our unwillingness to comply with the policy of the government. It shows our helplessness," said Jaishankar.

Meanwhile, the SSI sector expects the much-awaited decision to extend Schedule M deadline within a week's time. Sources said the extension could be for two years, though there were reports that the extension would be limited to one year.