Although the final deadline for compliance of GMP for drug units is on December 31, 2004 hardly 10 per cent of the drug units in Maharashtra have complied with this regulatory requirements. According to senior officials in the state FDA, there are nearly 3,000 manufacturing units in the state.
Majority of the GMP certified units are located in the cities like Mumbai, Pune and Aurangabad. It could be understood from the available facts that neither the state FDA nor the industry is serious over the implementation and adoption of Schedule M norms under the Central Drug Standard Control Organisation (CDSCO).
Small units, who form 95 per cent of the total number of drug units in the state are the most reluctant to adapt to the GMP norms. They complain about lack of resources for the compliance. These (small) players are seeking more concessions from the Central government, which includes soft loans, as also further extension of deadline.
According to FDA officials, a major complaint of these SSIs is the 'ancillary area' requirement associated with the Schedule M. Under pressure from the industry, a revised draft has been prepared by DCGI in November. As per that, the ancillary area clause is expected to be deleted from the Schedule M requirements.
Adequate air handling and water handling infrastructure are the other important requirements of Schedule M, which has also not been met by the small manufacturers.
Meanwhile, senior officials with the Central Drugs Standard Control Organisation (CDSCO) said, there is a strong likelihood for further extension of the deadline for Schedule M compliance. "Sensing pressure from the industry, we might see an extension of the Schedule M deadline by another year or so from the current deadline of December 31, 2004," said senior CDSCO officials.