|
The Laghu Udyog Bharati (LUB), an association of small and micro enterprises headquartered in New Delhi, has recently urged the Union Health Minister to consider a further extension of the deadline, till 2026 end, for implementing the Revised Schedule M in pharmaceutical companies with a turnover below Rs. 50 crore. Even though the MSME pharma units in the country have been demanding at least two more years to implement the Revised Schedule M, the Union Health Ministry in February this year rejected it and issued the final notification extending the deadline for implementation of the Revised Schedule M by just one more year for the MSMEs. Now, all the units below Rs. 250 crore turnover have to implement the Revised Schedule M by December 2025. 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 some 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 the Indian drug authorities to maintain the quality of pharmaceutical products produced in the country. It was under this background, the ministry on December 28, 2023 notified the Revised Schedule M for which the ministry had released the draft guidance more than five years back.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 mandated that the drug manufacturers with annual turnover above Rs. 250 crore have to comply with the Revised Schedule M within six months and for the MSMEs with less than Rs. 250 crore annual turnover, the timeline has been fixed as 12 months. By implementing the Revised Schedule M, the government wanted to plug all the loopholes in the regulatory system to prevent the repeat of unpleasant incidents such as Gambian tragedy, 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 was a right and timely move by the Health Ministry to implement the Revised Schedule M in the county to achieve global quality standards in the Indian pharmaceutical industry. However, though the Indian pharmaceutical industry as a whole had welcomed the move, small and micro pharma units below Rs. 50 crore turnover are now demanding more time to implement the new GMP norms. It is true that around 4000 of the total 10,500 pharma units spread across the country are micro and small units which 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 these units. As per the new rules, all these units also have to do the upgrading changes by December 2025. Financial requirements, technology upgradation and absorption of skilled personnel are part of the revision which will be a huge burden for these micro and small units. They argue that upgradation of infrastructure in line with the revised standards may take several months of construction activities in the factories and these 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 micro and small 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. All said and done, the government had given these units enough time as the draft of the Revised Schedule M was first published way back in 2018. Still the government should positively consider the demands of the micro and small units given the crucial role these units play to provide cheaper and quality to medicines to the needy people.
|