The Union Ministry of Health has further extended the deadline for GMP compliance under Schedule M of the Drugs and Cosmetics Act by the drug-manufacturing units, to 31 December 2004. Extending the period for complying with the cGMP requirements to one more year, the government is also expected to relax certain requirements in regard to space and equipments.

The likely dilutions in the Schedule M norms are learnt to be in the view of helping small-scale manufacturers who can comply with the standards by the extended time. However, the government has specifically mentioned that there will be no further extension to the GMP compliance as per the existing order.

According to informed sources, the Union Health Minister Sushma Swaraj has signed the circular extending the deadline, last evening in New Delhi. The decision has been officially circulated to the Health Secretary and Drug Controller General of India (DCGI) soon after the meeting convened by the Health Ministry yesterday evening in New Delhi. An official notification in this regard would be circulated among the state drug control departments shortly, said sources.

The sources informed that the government has agreed in principle to relax certain clauses in the existing Schedule M notification, including specification related to ancillary areas and air handling systems. Requirement of area related to tableting, capsuling, punching etc. might be relaxed. Implementation of air-handling facilities in production, storage etc. also could be relaxed. Relaxation was also likely to be given in the norms related to in process quality control like apparatus dissolution. However, the government may mandate elaborate documentation for SSI units as Pharmabiz reported earlier.

Sources said the Government was ready to dilute the norms considering the practical difficulties and pressure from the SSI units. However, a further extension has been strictly rules out by the officials and the minister.

Reacting to the development, TS Jaishankar, chairman of the Confederation of Indian Pharmaceutical Industries (CIPI), the SSI apex body of SSI pharmaceutical associations in the country, said the industry was happy to hear the news. “Both the government and the industry has to compromise on this issue. Now the government has played their part by extending the deadline and by relaxing the norms. Now it is up to the industry to ensure that we do not relax and implement the same within the specific period. Our units will try our best to implement Schedule M within one year” said Jaishankar.