In Tamil Nadu’s first wave of inspections under the Revised Schedule M of the Drugs and Cosmetics Act, 1940, only 4 out of 46 pharmaceutical manufacturing companies achieved 100% compliance. Conducted by state drug inspectors on November 8 and 9, the inspections revealed a mixed picture of adherence to the newly updated Good Manufacturing Practices (GMP).Key Findings from the Inspections

1. Compliance Levels:

   • 4 companies fully complied with the revised norms.

   • 50% of companies met at least 80% of the standards.

   • A minority complied with less than 70% of the guidelines.

2. Scope of Inspections:

   • Focused exclusively on state-level checks, unlike risk-based inspections involving the CDSCO.

   • Covered 46 out of Tamil Nadu’s 352 pharmaceutical manufacturers in the first phase.

   • Inspections spanned two days per company, with teams comprising two drug inspectors and a senior inspector.

3. Training and Preparation:

   • Prior to the inspections, 132 drug inspectors underwent specialized training in September to familiarize themselves with the updated Schedule M norms.

4. Support for Industry:

   • The department is actively guiding companies to achieve compliance, with formal enforcement set to begin after January 4, 2025, the deadline for smaller manufacturers.

   • Companies with turnovers above ₹250 crore were inspected after missing their earlier compliance deadline of July 5, 2024.

Authorities’ Perspectives
M. Sridhar, the Tamil Nadu Drug Controller, emphasized a balanced approach:

“We are supporting the industry to comply with the Revised Schedule M while ensuring robust regulation. Our goal is full adherence to the norms by all manufacturers in Tamil Nadu.”

Industry Challenges:
The Tamil Nadu Pharmaceutical Manufacturers Association (TN PMA), led by M. Varadarajan, expressed concerns about the timeline.

“While upgrades are underway, we’ve requested an extension from the Central government, as more time is needed to implement the required changes.”

Broader Implications
The inspections mark the first major step in enforcing GMP-focused compliance across Tamil Nadu under the revised rules, notified earlier this year. With over 300 manufacturers still awaiting inspections, the findings highlight both progress and significant challenges ahead.
The Revised Schedule M aims to elevate manufacturing standards across the country, ensuring higher-quality pharmaceuticals. However, this inspection cycle reveals that achieving full compliance will require sustained effort, industry cooperation, and potentially extended timelines.