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As the deadline nears, the state drug regulators have been asked to start with the inspections of companies that never registered for the extension. (Source: Pixabay)
The country’s apex drug regulator has asked states to enforce good manufacturing practices (GMP) in line with global standards, even in smaller companies, and initiate planning to carry out inspections of manufacturing units to confirm strict compliance with revised Schedule M.
However, no extension was granted on the December 2025 deadline, which many companies had sought.
In 2023, the Centre had notified revised Schedule M requirements wherein “good manufacturing practices” was upgraded to “good manufacturing practices and requirements of plan and equipment for pharmaceutical products”.
In his letter, Drugs Controller General of India (DCGI) Dr Rajiv Singh Raghuvanshi said, “…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 1st January, 2026, to verify their compliance with the requirements. However, immediate inspection and action shall be initiated right now for those units who have not applied for the extension, as the revised Schedule M is already applicable for such units.”
Earlier this year, smaller pharmaceutical manufacturers were given a year extension to implement stricter norms. The companies, however, had to apply with the DCGI for extension, providing a plan for upgradation.
This comes following the death of 22 children after consuming contaminated cough syrup in Madhya Pradesh’s Chhindwara district. Probe revealed that at least three brands of cough syrups consumed by the children contained higher than permissible limits of the contaminant diethylene glycol, with the highest 48.6% found in the syrup manufactured by the Tamil Nadu-based company Sresan pharmaceuticals.
While the stricter norms have been in the works for some time, it was notified early last year after a string of incidents in 2022 and 2023 when cough syrups exported from India were found to contain higher than permissible limits of contaminants diethylene glycol and ethylene glycol.
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The big pharma companies, with a turnover of more than Rs 250 crore, were asked to implement the stricter norms within six months; smaller companies were given a year.
The country has around 2,000 big pharmaceutical manufacturing units, most of which had already complied with the new norms since they followed the similar WHO norms required for exports. The 8,500 smaller manufacturing units had asked for more time to implement the norms, which would involve several infrastructure modifications as well.
As the deadline nears, the state drug regulators have been asked to start with the inspections of companies that never registered for the extension.
This would be followed by inspections from January onwards of units that applied for an extension. “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,” the letter said. DCGI has also asked state regulators to submit monthly reports on inspections, observations and action taken.
Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government’s management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country’s space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University’s Dart Centre. Dutt has a Bachelor’s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More
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