Amendment to Schedule M, Drug and Cosmetics Act

The amendment of the Schedule M of India’s Drug & Cosmetics Act that came into effect in accordance with the WHO terms was more relaxed and far less stringent than the ones insisted by US or European drug regulators. Interestingly, many of the Indian pharm companies who export to regulated markets follow US FDA or MHRA of UK standards.

However, even after five years of implementation of cGMP regulations in India, the small scale industries (SSIs) or small and medium enterprises (SMEs) are yet to come to terms with the concept. Indian pharma manufacturers’ intense politicization ultimately succeeded in forcing the Indian government to set up a parliamentary committee to see if the Schedule M regulations were detrimental to the small scale drug units. The committee headed by the former chairperson of the Upper House Dr Najma Heptulla completed the investigation after over two years. And the final report was tabled, though the Parliament did not take up the report for discussion due to lack of time. According to sources, the Committee has recommended that the Indian government should “proactively reach out to the SSIs to support them” as they graduate to become Schedule M compliant. Taking a serious view of the instances of closing down of small scale units in certain states, the Committee sympathized with the concerns raised by the small scale manufacturers in India over the possibility that the proposed amendments were likely to favor the big manufacturers and the MNCs and reject the smaller units the level-playing field even in the domestic market.’’ India’s Health Ministry, however, took strong objection to these views. It pointed out that a large number of SSIs have already complied the revised cGMP regulations and the rest are in the process. Also, on the anxieties that Schedule M compliance would require costs unbearable to small industries the Ministry replied that 80 per cent norms do not require investment and certain provisions have already been relaxed.  The Indian government is more concerned with spread of substandard drugs in the country. As of now there is no clear estimate of the fake and forged pharma products made in the country. India is also widely alleged to be the possible hub of substandard and fake medicines across the world.

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