- The Indian government has granted a one-year extension for pharmaceutical SMEs with an annual turnover under INR 2.5 billion (US$28.77 million) to comply with revised Schedule M standards.
- The revised Schedule M outlines Good Manufacturing Practices (GMP) and quality benchmarks for the pharmaceutical sector.
- The extension follows requests from small and medium manufacturers needing more time to upgrade infrastructure, train personnel, and secure funding.
- The Union Health Ministry announced the new deadline in response to industry concerns.
- Affected manufacturers must submit an upgrade plan via Form A to the Central License Approving Authority (CLAA).
- The original deadline to submit Form A was March 31, 2025; it has now been extended to May 11, 2025.
- Form A serves as a declaration of intent, detailing how manufacturers will meet the updated GMP and equipment standards within the extended timeframe.
-
Initial Deadline & Classification:
-
In January 2025, the government set December 31, 2025 as the deadline for ~8,500 MSME pharma units to comply with revised Schedule M standards.
-
Large manufacturers (turnover > INR 2.5 billion / US$28.77M): Given 6 months to comply (deadline: June 28, 2024).
-
Small and medium manufacturers (turnover ≤ INR 2.5 billion): Granted 12 months to comply (initial deadline: December 28, 2024).
-
-
Extended Timeline for SMEs:
-
Compliance deadline for SMEs extended by 1 year; now effective until December 31, 2025.
-
To qualify, SMEs must submit an upgrade plan (Form A) to the Central License Approving Authority (CLAA) by May 11, 2025.
-
- Enforcement and Penalties:
-
-
-
Audits to begin 3 months after Form A submission to assess compliance progress.
-
Non-compliance may result in penalties, including potential factory closures.
-
-
- Strategic Objective:
-
-
The revision aligns Indian pharma regulations with global GMP standards, improving drug quality, safety, and efficacy.
-
Aims to enhance India’s global reputation as a reliable pharmaceutical exporter.
-
-
-
Koul, S. (2025, February 25) Over 8.5K MSME pharma units get 1-yr breather to adopt Schedule M standards, Business Standard, website
-
Conditional extension of timeline to small and medium pharmaceutical manufacturers for compliance with revised Schedule ‘M’ notification, (2025, February 12); Press Information Bureau, website
About The Author
