| GMP norms lay down the ground rules for pharmaceutical manufacturers to achieve a zero-defect product of WHO-defined (World Health Organisation) standards and the deadline for conforming to these is December 31, 2004. The Indian pharmaceutical industry needs to upgrade itself in GMP to have a presence in the global market. | |
| The CEO of a medium-sized pharma company, however, says, "Out of 30,000 pharma companies in India, only 1,000 are GMP compliant. Unless the government gives some incentive or funding in this regard, it is not possible for the remaining 29,000 to get GMP compliant in ten days." | |
| The government though has a different take on the whole issue. The deputy drugs controller of the Central Drugs Standard Control Organisation, M Venkateswaralu, says, "The industry had been given about two years' time to become GMP compliant. Moreover, we cannot compromise on the health of a billion people by deferring the implementation of the Schedule M again." | |
| Schedule M of the Drugs and Cosmetics Rules, 1945, deals with GMP of pharma companies. Venkateswaralu, however, adds that closure of non-compliant pharmaceutical companies is not the objective of the government. | |
| The industry association that represents the interests of the pharmaceutical companies, Pharmexcil, though thinks that there is a way out of this predicament. | |
| Says, P V Appaji, executive director, Pharmexcil: "The government should set up a separate cell to deal with GMP. They should be assisted by two or three consultants from the pharma industry. This cell should assist the pharma companies to comply with GMP standards and should provide necessary advice in this regard." | |
| The cell, according to Appaji, should check whether companies can afford to comply with the standards and provide funding to those that cannot. | |
| "The cell can ask erring companies to close down, if non-compliance becomes a regular feature," he points out.
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