NEW DELHI: In a bid to enforce Good Manufacturing Practices (GMP) at drug manufacturing companies, India’s drug regulator has asked all states and Union Territories (UTs) to start inspections to confirm strict compliance with the revised Schedule M norms.
In a notice to all state and UT drug controllers, the Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, said, “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.”
The notice, dated November 7, said, “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 the Drugs and Cosmetics Act and rules thereunder.”
The direction has come in the light of deaths of over 20 children in Madhya Pradesh and Rajasthan due to cough syrups contaminated with diethylene glycol (DEG), a toxic industrial solvent.
Highlighting that the direction be treated as a “top priority,” the DCGI has also asked the states to submit monthly reports detailing inspections, observations made, and the actions taken following these inspections.
It also directed states to initiate planning for conducting relevant inspections of manufacturing units that have applied for an extension of the revised Schedule M.
It said that the effective date for revised Schedule M implementation for them is January 1, 2026, for verifying their compliance with the requirements.
Speaking with the TNIE, Ravi Udaya Bhaskar, honorary director general, All India Drugs Control Officers' Confederation (AIDCOC), the apex body of drug control officers in the country, said, “It’s good that government has not extended the implementation of amended schedule M uniformly for large scale and micro, small, and medium enterprises (MSME) despite demands from the industry.
“It’s going to build a quality culture in the country,” he added.
Experts said the latest direction indicates that the drug regulator could end the current extension of timelines, valid till December 31, 2025, granted to thousands of MSMEs for complying with the revised Schedule M.
There are an estimated 10,000 pharma units, of which over 8,000 are MSMEs.
The centre had notified the implementation of the revised Schedule M standards, which are in line with the World Health Organisation's (WHO) Good Manufacturing Practices (GMP) and other international standards, in December 2023.
However, it gave MSMEs more time to comply with the standards. The centre initially gave the MSME six months to comply with the manufacturing standards, then extended the timeline to December 2025 in January this year.