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Ramesh Shankar
Wednesday, May 8, 2024, 08:00 Hrs  [IST]

To bring the Indian pharmaceutical quality standards on par with the international quality standards, the Union Health Ministry on December 28, 2023 notified the Revised Schedule M for which the Ministry had released the draft guidance more than five years back. The notification mandates that the drug manufacturers with annual turnover of more than Rs. 250 crore have to comply with the Revised Schedule M within six months from the date of publication of the rules and for the micro, small and medium enterprises (MSMEs) with less than Rs. 250 crore annual turnover, the timeline has been fixed as 12 months from the date of publication of notification. With the amendment, the words 'Good Manufacturing Practices' (GMP) have been replaced with 'Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products' with provisions for annual Product Quality Review (PQR), Quality Risk Management (QRM), Pharmaceutical Quality System (PQM) and others in order to bring the pharmaceutical and biopharmaceutical quality standards in the country on par with the international standards. No doubt, a quality boost was the need of the hour for the Indian pharmaceutical industry, 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. Even though the country 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 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.

Of course, there can be no two opinions about the fact that it is a right and timely move by the Health Ministry to achieve global quality standards in the Indian pharmaceutical industry. However, though the Indian pharmaceutical industry as a whole has welcomed the move, there are demands from the MSMEs to extend the timeline from one year to at least two years, if not more, and some financial assistance from the government to implement the new GMP norms. It is true that a large number of the total of 10,500 units spread across the country is MSME units which are the backbone of the pharma sector in India. MSMEs are crucial for a country like India where a large number of the total 140 crores of people need cheaper medicines which could be possible only through MSME units. As per the new rules, all the units have to do the upgrading changes within one year. Financial requirements, technology upgradation and absorption of skilled personnel are part of the revision which will be a huge burden for these MSME units. The MSMEs have demanded to the government that a minimum of three years may be needed for the MSMEs to comply with the new requirements, considering that they have to implement it along with running the operations. The MSMEs argue that upgradation of infrastructure in line with the revised standards may take several months of construction activities in the factories and the MSME units, which rely on their day-to-day operations for sustenance, may not be in a position to stop operations for months for renovation. The entrepreneurs argue that they need to run the facilities in order to service their existing loans, pay its employees and workers and meet the orders which are already in place. This would mean that the manufacturers may have to carry out the works parallel to their day-to-day operations. Also, they may need time to arrange the financials - a minimum of Rs. 2 to 5 crore or more - subject to the size of the units, to carry out the upgradation. Even though the government had given these units enough time as the draft of the Revised Schedule M was first published way back in 2018, the government should consider the demands of the MSMEs for extension of timeline and some financial incentives. Given the crucial role it plays to provide cheaper and quality medicines to the needy people, the government should consider its demand positively.

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