DCGI Mandates Inspections of Pharmaceutical Manufacturing Units for Schedule M Compliance

The DCGI has instructed states and Union Territories to inspect pharmaceutical units for compliance with revised Schedule M norms. Non-compliance will result in strict actions. Inspections are crucial for ensuring adherence to good manufacturing practices ahead of the January 1, 2026, implementation date.

The Drugs Controller General of India (DCGI) has directed all states and Union Territories to conduct inspections at pharmaceutical manufacturing facilities. This move aims to ensure adherence to the revised Schedule M norms, which outline good manufacturing practices (GMP). The DCGI's communication emphasises the importance of compliance with these updated standards.

In a letter dated November 7, the DCGI informed state and UT drug controllers about the revised Schedule M, which was published on December 28, 2023. This schedule details the GMP requirements for premises, plants, and equipment used in pharmaceutical production. An extension for implementation has been granted until December 31, 2025, for MSMEs with a turnover of Rs 250 crores.

Compliance Inspections and Actions

The DCGI's letter stressed that immediate inspections should be conducted for units that have not applied for an extension. For those units, the revised Schedule M is already in effect. "In case any manufacturing unit is found non-complying with the requirements of revised Schedule M during inspections, strict action shall be initiated," stated the letter.

For units seeking an extension, inspections are planned to verify compliance before their new implementation date of January 1, 2026. The DCGI has requested that relevant inspections be organised for these units to ensure they meet the updated standards.

Significance and Reporting

This directive comes in light of recent incidents in Madhya Pradesh where children's deaths were allegedly linked to cough syrups contaminated with diethylene glycol (DEG). The DCGI has underscored the urgency of this matter by asking states to prioritise these inspections.

The DCGI also instructed states to submit monthly reports detailing observations made during inspections and actions taken. This requirement aims to maintain transparency and accountability in ensuring GMP compliance across pharmaceutical manufacturing units.

The focus on stringent inspection and compliance highlights the government's commitment to safeguarding public health by ensuring pharmaceutical products meet high-quality standards. The DCGI's directive serves as a reminder of the critical role regulatory bodies play in monitoring and enforcing industry standards.

With inputs from PTI