Document Date: March 24, 2025
Applicable Act/Rule: Drugs and Cosmetics Rules, 1945
Applicable Section/Rule: Schedule M (Revised)
The Directorate General of Health Services under the Central Drugs Standard Control Organization (CDSCO) has issued a circular regarding the online application process for seeking an extension of time to comply with the revised Schedule M of the Drugs and Cosmetics Rules, 1945. This update is directed towards small and medium manufacturers with an annual turnover of less than ₹250 crores.
As per Notification G.S.R. 127(E) dated February 11, 2025, manufacturers seeking additional time for implementation must submit an application in Form ‘A’ through the Online National Drugs Licensing System (ONDLS) Portal (www.statedrugs.gov.in). The deadline for implementation was three months from the notification date which is now extended until December 31, 2025.
Key Points:
This move aims to streamline the extension process and ensure that manufacturers have adequate time to meet the updated regulatory requirements.
Disclaimer: The information contained in this Article is intended solely for personal non-commercial use of the user who accepts full responsibility of its use. The information in the article is general in nature and should not be considered to be legal, tax, accounting, consulting or any other professional advice. We make no representation or warranty of any kind, express or implied regarding the accuracy, adequacy, reliability or completeness of any information on our page/article.