Pharma Companies Must File Compliance Strategy: ET HealthWorld

Drugmakers Must Conduct Gap Analysis and File Application for Schedule M Extension

New Delhi: Drugmakers looking to extend the timeline for implementing Schedule M must conduct 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 turnovers under ₹250 crore can seek an extension by submitting a plan of upgradation within three months, according to the drug regulatory authority.

The drug regulatory authority said in a notification issued on February 13 that companies will have to comply with the revised Schedule M requirements as per the plan submitted. The submission should also justify the time period they seek to comply with the requirements.

The revised Schedule M, which outlines tighter quality norms for manufacturing, was notified in January last year. Units with annual turnovers over ₹250 crore had to comply from July 1, 2023, while MSMEs had to comply from January 1 this year. MSMEs sought more time to make necessary changes in their manufacturing processes.

The ministry then issued a draft notification, proposing to extend the deadline for 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.

The country’s pharma lobby groups had been seeking a two-year extension to the deadline, citing the need for time to improve infrastructure, increase manpower, and train employees. The Federation of Pharma Entrepreneurs (FOPE) wrote to the drug controller, seeking an extension of the notification implementation.

The revised Schedule M will be amended to provide the extension of time for another year.

Reference : https://health.economictimes.indiatimes.com/news/pharma/pharma-industry/pharma-companies-must-file-compliance-strategy/118196588