Pharma units face heat for skipping mfg norms

Pharmaceutical companies that have failed to meet the deadline""which expired on July 1""to comply with Schedule M of the Drugs & Cosmetics Act will find the going tough in the days ahead.

Throwing the book at erring units, the Drug Controller General of India (DGCI) has alerted the state drug authorities to put units that have shut down recently under special watch, fearing these units may continue production on the sly.

The original deadline for the implementation of Schedule M""targeted at improving the manufacturing practices on the parameters of land area, equipment, storage, master formula records, manufacturing records etc""was set for 2002.

Thereafter, the government extended the deadline thrice, in the face of resistance by a many units represented by Indian Drug Manufacturers Association and Confederation of Indian Pharmaceutical Industry.

This has given rise to fears that as many as 2,000 units may be left with no option but to shut shop. However, this is being looked upon as just the cost of transition to better practices.

Council for Scientific and Industrial Research director general RA Mashelkar, who headed the committee on spurious drugs, calls it "inevitable and essential rationalisation," which has to come about as the country adopts standardised modes of manufacturing.

Citing the example of China, he said: "There are going to be costs which will be borne by small and medium enterprises."

Ashwini Kumar, the DGCI, calls this the "normal course of economic flux in a transitory period".

According to DG Shah, secretary general of Indian Pharmaceutical Alliance, those who can't comply with Schedule M have no business to be in the market as quality standards cannot be compromised when lives are at stake.

Both Mashelkar and Kumar acknowledge that some units may simply go underground.

Mashelkar however believes that the government should help these small companies in their rehabilitation process. There is talk of a fund being constituted to bail out these out.