Last Updated on March 30, 2025 by The Health Master
Schedule M
The Central Drugs Standard Control Organization (CDSCO) has launched an online application process on the ONDLS Portal for pharma manufacturers who are willing to have an extension to comply with the revised Schedule M.
Streamlined Online Process for Extension Applications
The Central Drugs Standard Control Organization (CDSCO), the apex drug regulatory authority in India, has issued a circular explicitly stating the commencement of the online application window.
According to the CDSCO’s circular dated 24-03-2025, pharma manufacturers who are willing to seek additional time for compliance with the revised Schedule M are now required to register and submit their applications through the Online National Drugs Licensing System (ONDLS) portal.
The circular clearly mentions that no hard copy of the applications will be considered.
Deadline Approaching
The directive, issued by the Drugs Controller General of India (DCGI), further elaborates on the timeline.
According to the Department of Health and Family Welfare’s notification No. GSR 127(E) dated February 11, 2025, small and medium-sized manufacturers who are willing to extend the timeline have to submit their applications to the CDSCO within three months from the notification date, which means the deadline is May 10, 2025.
This makes it important for the pharma manufacturers to act swiftly to grab the extension.
Upgradation Plan is Key to Extension
Crucially, manufacturers seeking this extension are also mandated to submit a comprehensive “upgradation plan” to their respective licensing authority.
This plan likely needs to fill up the Form-A having details of the steps the manufacturer intends to take to meet the requirements of the revised Schedule M requirements.
For those pharma manufacturers who successfully apply and submit a desired upgradation plan, the timeline for the revised Schedule M will be extended until December 31, 2025.
This extended period is intended to provide the necessary time for infrastructure upgrades, thorough personnel training, and the allocation of financial resources.
ONDLS: A Single Window for Pharma Licensing
The Online National Drugs Licensing System (ONDLS), a sophisticated platform developed by CDSCO in collaboration with the Centre for Development of Advanced Computing (CDAC), is playing a pivotal role in this process.
Relief for SMEs: A Conditional Extension
While the updated GMP guidelines came into force for large-scale manufacturers in June 2024, small manufacturers, particularly those with an annual turnover of less than ₹250 crore, were initially given a deadline of December 2024.
This extension gives a big relief to smaller manufacturers by means of giving additional time to implement the upgradation of necessary infrastructure, plant machinery, and technical staff to meet the requirements of revised schedule M.
FORM A
Application for grant of extension of compliance with Revised GMP under Schedule-M of the Drugs Rules, 1945
| S. No. | Item | Details |
| 1. | Name and address of the manufacturer | |
| 2 | Turnover (year Apr 2023-Mar 24 ) | |
| 3 | Details of the licence in all forms, Licence no, Validity | |
| 3 | Sections held | |
| 4 | Whether holding WHO GMP/CoPP If yes, the validity of the certificate | |
| 5 | Details of gap analysis (section wise): Plant, Equipment, Lab equipment HVAC system, Utilities, Technical staff, Documentation Others | |
| 6 | Plan/strategy for compliance with the revised GMP (item wise as per the gap analysis at sl. No.5) Starting on or before 31.03.2025 | |
| 7. | Extension of time required for compliance (not beyond 1st Jan 2026) | |
| 8 | Justification of the time required for compliance |
Undertaking
I undertake that I have carried out the gap analysis and propose to initiate upgrading within three months from the date of this application and comply with the revised Schedule-M requirements as per the plan submitted at Sl. No. 6 above.
Date:
Place:
Signature
(Director/Partner/Proprietor/Authorised Signatory)
Q. What is Schedule M?
A. Schedule M provides the Good Manufacturing Practices (GMP) that pharmaceutical manufacturers have to follow to ensure the safety and quality of their products.
Q. Who is eligible for the extension?
A. Small and medium-sized pharmaceutical manufacturers (SMEs) are eligible to apply for the extension. The specific criteria for defining an SME are based on annual turnover (less than ₹250 crore).
Q. What is the deadline to apply for the extension?
A. The deadline to submit the online application is May 10, 2025.
Q. Where do I apply for the extension?
A. Pharma manufacturers can apply online on the Online National Drugs Licensing System (ONDLS) portal.
Q. What documents are required for the application?
Pharma manufacturers need to fill out Form-A, which has details of the steps the manufacturer intends to take to meet the requirements of revised Schedule M requirements.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Key Notes on Revised Schedule M: Compilation
Important short notes for Industry and Regulators
CDSCO Guidelines on Drug Recall
Quality Assurance Vs Quality Control in the Pharma Industry
Major FDA audit findings about Equipment and Instruments
Understanding GMP, cGMP, and WHO-GMP
Quality Assurance in the Pharmaceutical Industry
Duties and responsibilities of QA person in Pharma Industry
Difference: Disintegration and Dissolution test in pharma industry
Understanding DQ, IQ, PQ, and OQ in the Pharma Industry
Gist of 31 Chapters on Schedule M
Revised Schedule M Guidelines: Drug Recall and Ensuring Pharma Quality
Pharmaceutical Quality: Key Amendments in Revised Schedule M
Revised Schedule M: The Role of Pharmaceutical Waste Management
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Key Notes on Revised Schedule M: Compilation
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