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cGMP regulations in India to be diluted?

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Friday, March 13, 2009, 19:26 This news item was posted in Legal category and has 1 Comment so far.

The question doing rounds now is whether India would water down cGMP norms any further, succumbing to the demands of a clutch small-time drug makers.

Current good manufacturing practices or cGMP is a set of norms to be followed by pharmaceutical manufacturers to ensure quality and safety of the drug products. Read more about cGMP regulations.

More reading:

What is GMP?

Current Good Manufacturing Practices 9cGMP) on FDA site

India and cGMP

India started enforcing cGMP standards for drug manufacturing in the later half of the year 2005 – after much dithering. The implementation of cGMP regulations – which was originally planned for the year 2001 — had been postponed, at least thrice, as India’s pharmaceutical industry demanded more time to comply with the new set of  manufacturing standards. 

Amendment to Schedule M, Drug and Cosmetics Act

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

However, even after 3 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. These pharma manufacturers, which number in thousands in India’s rather unorganised SSI/SME sector, have been demanding more relaxations—if not a total waiver – of the requirements listed in the cGMP document. 

Indian pharma manufacturers’ intense lobbying 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 probe after over two years.  

And the final report was tabled this month, 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 sympathised with the concerns raised by the small scale manufacturers in India over the possibility that the proposed amendments were likely to favour the big manufacturers and the MNCs and deny 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 apprehensions 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. 

Obviously, 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 / counterfeit pharma products made in the country. Moreover, India is also widely suspected to be the possible hub of substandard and fake medicines circulated across the world.

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One Response to “cGMP regulations in India to be diluted?”

  1. hema said on Wednesday, June 24, 2009, 6:45

    how does drugs and cosmetics act supports the pharmaceutical company in India? and how important the act is when it comes to applicability by such company? whats the scope of application of this act to such companies?

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