INDUSTRY
Deadline for implementing Schedule M for small pharma units extended by a year
- IBJ Bureau
- Jan 05, 2025
In relief to thousands of micro, small and medium pharmaceutical units in the country, the Union Ministry of Health has taken steps to extend the deadline for implementation of the revised Schedule M manufacturing standards to one more year for those units which apply for an extension.
A draft notification has been issued by the ministry to bring in changes to the notification issued in December 2023, which mandated compliance by units above Rs 250 crore turnover in six months and units below Rs. 250 crore turnover in one year from the date of notification.
The draft amendment provides for small and medium manufacturers with turnover of below Rs 250 crore to seek extension of the timeline for implementation. These units shall make an application to the Central Licence Approving Authority in a form provided with the notification within a period of three months from the notification, along with the plan of upgrade.
“For such manufacturers, the deadline for implementation shall be extended till December 31, 2015,” the draft amendment has said.
It has also provided Form A, the application for grant of extension of compliance with revised Good Manufacturing Standards, under Schedule M of the Drugs Rules, 1945.
The revised Schedule M, for which the draft was issued in 2018, has major additional features compared to the previous Schedule M standards, including standards for Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), qualification and validation, establishment of system to recall the defective products, self-inspection team and quality audit, supplier audit and approval and stability studies, among others.
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