New Delhi: Drugmakers that want to extend the timeline for implementation of Schedule M must carry out a gap analysis and file an application with the drug regulator, detailing their strategy to comply with the revised manufacturing standards.
Small and medium manufacturers with turnover of less than ₹250 crore may seek extension of the timeline by submitting a plan of upgradation within three months from now, the drug regulatory authority said in a notification issued on Tuesday.
“These companies will have to comply with the revised Schedule M requirements as per the plan submitted by them,” a senior official told ET.
As per the notification, a company’s director, proprietor or partner will have to submit a gap analysis and give an undertaking to initiate upgradation within three months from the date of the application. The submission should also justify the time period they seek to comply with the requirements.
As reported by ET, Tuesday’s notification gave small drug companies time until December 31 this year to adhere to the revised Schedule M. The application should be submitted to the Central Licence Approving Authority online, it said.
The drug rules will be amended to provide the extension of time for another year.
The revised Schedule M-which outlines tighter quality norms for manufacturing-was notified in January last year. While units with annual turnover of more than ₹250 crore had to comply from July 1, 2023, the implementation date for MSMEs was January 1 this year.
However, MSMEs sought more time to make the necessary changes in their manufacturing processes.
The ministry then issued a draft notification, proposing to extend the deadline for the MSMEs. In this regard, it had invited public comments by January 11.
“The feedback was compiled, and the final draft was sent to the legal affairs department for vetting,” a person cited above told ET.
The country’s pharma lobby groups had been seeking a two-year extension to the deadline, saying much time is needed for improving infrastructure, increasing manpower and training.
Federation of Pharma Entrepreneurs (FOPE) wrote to the drug controller, seeking an extension of the notification implementation.
