DCGI Orders Nationwide GMP Inspection Drive to Enforce Revised Schedule M
New Delhi: The Drugs Controller General of India (DCGI) has directed all states and Union Territories to immediately launch a nationwide inspection drive across pharmaceutical manufacturing units to ensure strict adherence to the revised Good Manufacturing Practices (GMP) norms under Schedule M.
The move comes amid rising concerns over drug quality and safety, following recent incidents such as the deaths of children in Madhya Pradesh allegedly linked to diethylene glycol (DEG)-contaminated cough syrups.
Schedule M, part of the Drugs and Cosmetics Act 1940 deals with 'Good Manufacturing Practices' to be followed by pharmaceutical manufacturing units in the country. Earlier, the Medical Dialogues Team had reported that the new guidelines issued on December 28 had stated the manufacturer must be responsible for the quality of the products so that "they are fit for their intended use, comply with the requirements of the license, and do not place patients at risk due to inadequate safety, quality or efficacy."
Now, 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 that have applied for an extension of revised Schedule M and the effective date for revised Schedule M implementation for them is January 1, 2026, to verify their compliance with the requirements," the letter was quoted by PTI.
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 with the requirements of revised schedule M during inspections, strict action shall be initiated against such units as per the provisions of the 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, PTI reported.
