For the pharmaceutical companies with a turnover of less than Rs. 250 crore, time is ticking away fast to implement the Revised Schedule M. According to reports, a large number of MSME units, especially small and micro units with less than Rs. 50 crore turnover, is literally struggling to find the wherewithal to implement the Revised Schedule M which was brought by the Union Health Ministry to give the badly needed quality boost to the Indian pharmaceutical products. But the fact remains that the stringent and costly requirements for upgrading to the Revised Schedule M are proving to be an insurmountable challenge for many of the small and micro pharmaceutical units in the country. 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. Under this background, it is certain that many of the small and micro units might not be able to meet the deadline. 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.
It is a fact that the pharmaceutical industry received enough time of more than seven years to implement the Revised Schedule M as the Ministry had released the draft guidance way back in 2018. Then after five years, the ministry on December 28, 2023 notified the Revised Schedule M. Though the MSME pharma units in the country have been demanding at least two more years to implement the Revised Schedule M, the 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, till December 2025, for the MSMEs. 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 the 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. More importantly, the recent Coldrif cough syrup tragedy which claimed 26 innocent children in Madhya Pradesh due to contamination of drugs proved to be the proverbial last nail in the government’s decision not to extend the deadline any further. Obviously, the industry is hoist with its own petard as it should have been more careful on quality issues, especially after the Gambian tragedy. So, the Ministry has its own reasons to insist on implementing the Revised Schedule M at the earliest. Be that as it may, the government should not lend a totally blind eye towards the genuine problems of small and micro units which are now staring at closure of their units. For the units with a turnover of less than Rs. 50 crore, the government should think of allowing some more time to implement the Revised Schedule M. If the government gives them one last chance, certainly heavens will not fall. |