GMP may force drug firms to shut shop

Over 2,000 small-scale drug companies may go out of business if the Good Manufacturing Practices (GMP) norms are strictly enforced.

The GMP norms, which came into effect on July 1 this year, have already started hurting a substantial chunk of the drug industry. Maharashtra, Karnataka and Gujarat have issued notices to companies asking them to put their manufacturing conditions in order.

Specified in Schedule M of Drugs and Cosmetics Act, the GMP outlines quality benchmarks for land area, equipment, storage, master formula records and manufacturing records.

Some of the requirements like land area were diluted recently after industry associations like the Confederation of Indian Pharmaceutical Industry protested against them.

Sources in the chemicals and petrochemicals ministry said bigger companies had taken steps to become GMP-compliant. But problems lay mainly with the small and medium firms, they added.

Drug Controller General of India Ashwini Kumar confirmed that notices had been issued to many of these companies. India has about 8,000 such manufacturers and they account for 15 per cent of the the country's drug production.

There is fear that once closed, they might drift towards manufacturing of spurious drugs. However, Kumar said he had put his counterparts in states on "special watch" over units recently shut, to guard against this occurrence.