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The Revised Schedule M, notified by the Union Health Ministry on January 5, 2024, has come into force for the large pharmaceutical companies in the country as the six months time allowed by the ministry for the large companies to upgrade their units as per the new Schedule M has come to an end on July 5. After more than five years since the release of its draft Rules, the Union Health Ministry had notified the Revised Schedule M norms for the Indian pharmaceutical industry to bring the pharmaceutical quality standards in the country on par with the international standards. The final notification dated December 28, 2023 has been published and the notification was released by the Gazette of India on January 5, 2024. While introducing the Revised version of the GMP, the Ministry stated that the companies must introduce the new GMP on the basis of annual turnover where the small and medium manufacturers with less than Rs. 250 crore should implement the Rules within 12 months from the date of notification and large companies with more than Rs. 250 crore turnover should carry out the changes in six months time. Thus, the last date for the large companies ended on July 5. As per the new norms, the manufacturers must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the license and do not place patients at risk due to inadequate safety, quality or efficacy. Of course, it is a right and timely move by the Health Ministry towards achieving global quality standards in the pharmaceutical industry. The revised standards also aim to enhance quality control measures, proper documentation, and IT support, thus ensuring the production of high-quality medicines in India and for the global market.
Certainly, for the Indian pharmaceutical industry, which has drawn up an ambitious target of making it a US$ 600 billion industry in the next 25 years, a quality boost was the need of the hour, especially in the backdrop of the fact that, for that last couple of years, the Indian pharmaceutical industry’s image has taken a severe beating following the WHO holding Indian pharma companies accountable for exporting contaminated medicines in the aftermath of deaths of several children in Gambia and Uzbekistan. No doubt, the Indian pharmaceutical industry has seen an envious growth, exporting affordable quality medicines to around 200 countries in the world, including the developed countries like the US and Europe. By any standard, it is a great feat for a sector which was dominated by the multinational pharmaceutical companies until the 1970's. Even though it has come a long way to adorn the epithet of 'the pharmacy of the world', the ‘Gambian tragedy’, and other subsequent similar incidents in some other countries, was a rude reminder to the Indian drug authorities to maintain the quality of pharmaceutical products produced in the country. By implementing the Revised Schedule M, the government wanted to plug all the loopholes in the regulatory system to prevent the repeat of such unpleasant incidents, which were a blot in the image of the Indian pharmaceutical industry. The Indian pharmaceutical industry should take a leaf out of the recent announcement of the DoP secretary Dr Arunish Chawla who had reminded the industry about the Prime Minister’s vision that all Made in India products should be ‘zero defect, zero effect on the environment’. Now, the inspection time will start soon. The Tamil Nadu drug control department has already announced its plan to start inspections from next week. The industry should cooperate with the regulatory authorities and should pull out all the stops to maintain the quality of Indian pharmaceutical products.
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