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The central government has now given an option to drugmakers to seek the extension via a separate request form explaining their plan for upgrade
Earlier, MSME companies were asked to execute Schedule M starting January 1. (Representational image/Shutterstock)
Micro, small and medium drug companies in India have now received an extension to meet the standard specified in the revised Schedule M, the notification released by the union ministry of health and family welfare announced on Saturday.
Earlier, MSME companies were asked to execute Schedule M starting January 1.
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However, these companies had sought an extension in the implementation of new standards, and now they have to upgrade their facilities by December 31, 2025.
The central government now allows drugmakers to request an extension by submitting a form along with their unit upgrade plan. This extension will save thousands of small units from failing the upcoming audits and closing their businesses, as they have cited financial constraints in upgrading their manufacturing sites to meet global standards, in a short period.
According to government data, there are around 10,500 manufacturing units in the country, of which at least 8,500 are in the category of micro, small, and medium enterprises (MSME). Of these, 2,000 are approved by the World Health Organization and certified as WHO-GMP (Good Manufacturing Practices).
Schedule M deals with good manufacturing practices for premises, materials, and requirements for plants and equipment. It also contains details about quality control systems, quality control laboratories, cleaning of equipment, housekeeping, and cross-contamination, among other issues.
What does the latest notification say?
As per the earlier order, a timeline of twelve months was provided for the implementation of the provisions with respect to small and medium manufacturers having a turnover of Rs 250 crore or less.
“…several representations have been received from various associations to extend this timeline to enable small and medium scale manufacturers to comply with the provisions of revised Schedule M,” the notification said.
Based on the request, the government announced that it intends to amend the previous notification. The government has now given an option to drugmakers to seek the extension via a separate request form explaining their plan of upgrading.
“Provided that the small and medium manufacturers with a turnover of or less than two hundred and fifty crores may seek an extension of this timeline for implementation and for that purpose shall make an application to the Central Licence Approving Authority in Form ‘A’ annexed to this notification within three months from the date of publication of this notification along with the plan of degradation,” the notification said. “For such manufacturers, the timeline for implementation shall be extended till 31 December 2025.”
What are the big changes?
Major changes that will take place after the implementation of the new schedule include an audit of suppliers, validation of equipment, specific requirements for manufacturing hazardous products and biological products, self-inspection, and a quality audit team.
In 2018, Schedule M was revised in sync with the Centre’s plan to implement uniform standards for the drug manufacturing industry before joining the Pharmaceutical Inspection Cooperation Scheme (PICS), a global mechanism to improve cooperation in GMPs between regulators. The PICS compliance helps promote drug exports as it offers greater market access and makes it easier for global regulators to trust the quality of medicinal products.
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January 05, 2025, 01:20 IST
News india Govt Gives Small, Medium Drugmakers Until End Of 2025 To Upgrade Manufacturing Sites, Asks For Plan