Quality hiccups for small pharma firms

Government says no change in December 31 deadline to meet schedule M guidelines

Several small and medium pharmaceutical units in Gujarat are facing closure owing to their failure to meet the quality norms set by the government.

According to the revised schedule M guidelines of the Drugs and Cosmetics Act, all pharmaceutical manufacturing units are required to ensure that their air and water handling systems meet the standards on control systems by December 31, 2004.

The upgradation process under the new norms is expected to cost a small pharmaceutical firm around Rs 40-50 lakh, which could be a big challenge for small firms.

A number of other regulatory guidelines of organisations like the International Conference on Harmonisation and World Health Organisation are also available for pharma companies to implement good manufacturing practices.

The implementation of upgraded quality norms are also critical for any company to meet competition in the exports market. There are around 800 small scale industry (SSI) pharmaceutical units in the state.

"I hope that most small and medium pharmaceutical companies adhere to these guidelines, because we will be left with no other option than sealing them down from January 1," said S P Adeshara, commissioner, Food and Drugs Control Administration (FDCA), Gujarat.

He added that while many firms have invited the FDCA for inspection after upgrading their facilities, there are others which do not have the funds for upgradation. Neeraj Kumar Singh, co-ordinator of Quality Circle, a move by the Gujarat State Branch of the Indian Drug Manufacturer's Association, said about 30 per cent of the small and medium pharmaceutical companies have already begun or completed the upgradation process.

"We have been trying our level best to use the Quality Circle to ensure that most pharmaceutical companies adhere to the schedule M guidelines by December 31," he said.

Quality Circle is a co-operative movement in the pharmaceutical industry, where small pharmaceutical companies come together to increase their bargaining power.

The Schedule M story so far

Originally scheduled to come into force from January 1, 2003, the implementation of Schedule M guidelines of the Drugs and Cosmetics Act, were postponed by a year to January 1, 2004, and again by a year to December 2004, after a series of representations made by several associations of pharmaceutical industries and even state governments.

The government has made it clear that it will not extend the deadline any further which means beginning next year, all pharmaceutical companies that do not adhere to the new guidelines will be sealed by the state food and drugs commissionerate.