In view of several representations to extend the timeline to enable small and medium scale manufacturers to comply with the provisions of revised Schedule M, the Ministry of Health and Family Welfare (“MoHFW”) has issued a draft Notification proposing to extend the compliance timeline for eligible manufacturers till 31st December, 2025. Comments are invited on draft amendments to Schedule M till 11th January, 2025.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No.414 A, D Wing, Nirman Bhawan, New Delhi – 110011 or e-mailed at drugsdiv-mohfw@nic.in.
The initial timeline of 12 months for compliance, set to expire shortly, was deemed insufficient for small and medium-scale manufacturers to implement the required provisions. Therefore, for small and medium-sized manufacturers with an annual turnover of Rs. 250 crores or less, it is proposed that a request for an extension of the implementation timeline may be submitted. To obtain an extension until 31st December, 2025, an application must be made to the Central Licence Approving Authority in Form ‘A’ within three months from the date of publication of notification with a plan outlining the necessary upgrades.
Source: Ministry of Health and Family Welfare
