Relief for Drugmakers: Health Ministry Extends Schedule M Deadline, Sets Compliance Terms
New Delhi: Through a recent Gazette notification, the Health Ministry has informed drug manufacturers that those seeking an extension for implementing the revised Schedule M must conduct a gap analysis and submit an application to the drug regulator, detailing their compliance strategy. Small and medium manufacturers with a turnover of less than Rs 250 crore are required to submit an upgradation plan within three months.
This extension offers relief, but also underscores the urgency for manufacturers to meet the revised Good Manufacturing Practices (GMP) standards.
In exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), with the consideration that consultation with Drugs Technical Advisory Board will be held as per the provisions of the said Act, the Central Government has made the following rules, further to amend the Drugs (Amendment) Rules, 2023, namely:-
1. Short title and Commencement:-
(1) These rules may be called the Drugs Amendment Rules, 2025.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs (Amendment) Rules, 2023, in rule 6, in the Table, in the entry against ‘Small and Medium manufacturers’, under column (2) after the words “Twelve months from the date of publication of these rules”, the following proviso shall be inserted, namely :-
“Provided that the small and medium manufacturers with turnover less than two hundred and fifty crores may seek extension of the 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 a period of three months from the date of publication of this notification, along with a plan of upgradation and for such manufacturers, the timeline for implementation shall be extended till 31st day of December, 2025”.
Under the new rules, manufacturers must conduct a thorough gap analysis of key areas, such as plant, equipment, HVAC systems, utilities, technical staff, and documentation. The analysis will serve as the foundation for a compliance strategy, which must be submitted to the Central Licence Approving Authority (CLAA) in Form A. This form requires manufacturers to justify the time needed for compliance and present a detailed plan for upgradation, starting by March 2025.
From a drug manufacturer’s perspective, the upgradation process is both an opportunity and a challenge. While the extension provides some breathing room, it also requires significant investment in modernizing facilities and upgrading equipment. The gap analysis must be detailed, with a clear plan to address deficiencies identified across various sections. Manufacturers must not only focus on infrastructure but also ensure that their staff is trained and documentation is updated to meet the new GMP requirements.
This deadline isn’t just about compliance, it's about positioning for growth and ensuring the future of the business. By embracing these changes, manufacturers can avoid penalties and enhance the quality of their production. The updated Schedule M is an essential step toward improving industry standards, and companies that act swiftly will be better positioned to thrive in both domestic and global markets.
To view the original notification, click on the link below:
