The Union Ministry of Health and Family Welfare revised the date of the implementation of the revised Schedule M of the Drugs and Cosmetics Act allowing pharma MSMEs an additional 12 months to comply, extending the date to December 31, 2025. To avail of this extension, pharma companies with a turnover of less than 250 crores must file an application with the Central Licensing Authority with details of their upgradation plan.
The notification by the ministry reads, “Provided that the small and medium manufacturers with turnover of or less than two hundred and fifty crores may seek extension of the timeline for implementation and for that purpose shall make an application to the Central Licence Approving Authority in Form ‘A’ annexed to this notification within a period of three months from the date of publication of this notification along with the plan of upgradation. For such manufacturers, the timeline of implementation shall be extended till 31st December, 2025.”
The Ministry stated that the reason for allowing this extension is to enable pharma MSMEs to arrange the finances for upgradation and time for implementation of the required changes. It also informed that it is as per request by several associations that represent the pharma MSMEs.
Reacting to this announcement, Dr Viranchi Shah, National President, IDMA said, “IDMA welcomes the Government’s move to allow an extended timeline for compliance to Schedule M revisions by a year. This helps those SMEs who have initiated the upgradation, but couldn’t reach the finish line in the stipulated time frame. The goal of this exercise is to upgrade the players and not to close them, but to handhold them. This extension is the right step in the right direction. We also appreciate CDSCO and SLAs for joining hands with IDMA and the industry in running nationwide training sessions for technical upgradation of the industry.”
Kaushik Desai, Pharma Consultant said, “MSMEs will get an extension subject to providing gap analysis and plan to achieve in one year. There is also a small window open for submission of comments within seven days by stakeholders including all associations who have been advocating for extension.
These comments are very important to submit. Once an extension is given then companies are bound to follow. There should be at least periodic reports of upgradation for monitoring and compliance which is not explicitly specified.
One of the reasons given is delayed delivery of required machines/equipment but I do not see this as an issue. The pharma machinery industry is ready to deliver if ordered in time. This notification is a positive step by Govt in enduring compliance to schedule M.”
Reacting on LinkedIn to the draft, Saranjit Singh, ex-professor at NIPER and an independent industry consultant/trainer, commented, “It is good to provide an extended window. But it has to be on a case-to-case basis, looking into the positive intention of the firm owner. Also, the inspectorate has to be all in all tilted towards protecting the interest of patients, keeping aside all lures put before them.”