India's Drug Regulator and Revised Schedule M Compliance

India's drug regulator has enforced strict compliance with the revised Schedule M to ensure the quality of pharmaceutical products by mandating Good Manufacturing Practices (GMP). The revised guidelines were notified in January 2022, with implementation deadlines varying based on company size.

Key Actions and Requirements

• State drug regulators are required to inspect pharmaceutical manufacturing units applying for an extension of Schedule M compliance.
• Inspections aim to verify adherence to the revised GMP requirements. Non-compliance will lead to strict action under the Drugs and Cosmetics Act and rules.
• Monthly reports on inspections, observations, and actions taken must be submitted to the Central Drugs Standard Control Organisation.

Timeline and Extensions

• Units with an annual turnover of more than Rs 250 crore were required to comply by July 1, 2023.
• Micro, Small, and Medium Enterprises (MSMEs) had an initial deadline of January 1, 2023, but they requested more time to modify their manufacturing processes.
• The government granted an extension, allowing small drug companies until December 31, 2023, to comply with the revised Schedule M.

The regulator's notice, dated November 7, emphasizes the importance of this compliance, stating it as a top priority.