Small & Medium Pharma Manufacturers Association state their objections to the Ministry of Health and Family Welfare’s notification published in the Gazette of India dated January 5, 2025, regarding the Revised Schedule M implementation timeline for MSME manufacturers.
The letter, signed by Nipun Jain, Chairman, Small & Medium Pharma Manufacturers Association, stated several reasons objecting to this decision. They are as follows:
- The notification mentioned that ‘Gap Analysis’ is not defined in the Drugs and Cosmetics Act, and therefore should be dropped.
- As per the notification, to avail of the extension, companies must submit an application to the Central Licensing Authority. However, as manufacturing licenses are given by the State Licensing Authority, this compliance was deemed contrary to the law and prevented ease of doing business.
- Lastly, the letter reiterated that pharma MSMEs are not against the upgradation or quality, however, hasty implementation of the new guidelines may force companies to shut down and subsequently lead to unemployment and price rise.
Therefore, the letter urges the government for financial and technical assistance as well as a condition-free time frame of two-three years. After which, if pharma MSME manufacturers have still not adhered to the quality standards then the government should take action against those manufacturers.