New Delhi, Nov 10 (PTI) The Drugs Controller General of India (DCGI) has asked all states and Union Territories to initiate inspection at pharmaceutical manufacturing units to ensure strict compliance with the good manufacturing practices (GMP) as per the revised Schedule M norms.
In a communication to all state and UT drug controllers on November 7, the DCGI said, "In case any manufacturing unit is found non-complying with the requirements of revised Schedule M during inspections, strict action shall be initiated."
The letter was in connection with the revised Schedule M published by the central government, on good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products, on December 28, 2023, and a subsequent extension granted for implementation till December 31, 2025, for MSMEs having a turnover of Rs 250 crores.
"In this regard, you are requested to initiate planning for carrying out relevant inspections of manufacturing units who have applied for extension of revised Schedule M and effective date for revised Schedule M implementation for them is January 1, 2026, to verify their compliance with the requirements," the letter said.
However, immediate inspection and action shall be initiated right now for those units that have not applied for the extension, as the revised Schedule M is already applicable for such units.
"In case any manufacturing unit is found non-complying to the requirements of revised schedule M during inspections, strict action shall be initiated against such units as per the provisions of Drugs and Cosmetics Act and rules thereunder," the letter said.
The direction holds significance in the backdrop of recent deaths of children in Madhya Pradesh, allegedly due to cough syrups contaminated with diethylene glycol (DEG).
The DCGI highlighted that the communication be treated as a "top priority," and asked the states to submit monthly reports providing details of the observations made, and the actions taken following the inspections.