This document outlines significant revisions to Schedule M of the Drugs Rules, 1945, updating the Good Manufacturing Practices (GMP) and requirements for pharmaceutical manufacturing facilities […]
Provision for auto-generated Market Standing Certificate and Non-Conviction Certificate for licenced medical device.
In order to promote ease of doing business and to simplify the regulatory procedure, CDSCO vide its notice File No.: MED/52/2024-eoffice dated 09.04.2025 amended the […]
“New Drugs” in India
In India, New Drugs are defined under New Drugs and Clinical Trials Rules, 2019 made under Drugs & Cosmetics Act, 1940. Definition: New Drugs (i) […]
Submission of online application for extension of time to comply with revised Sch M on ONDLS portal – www.statedrugs.gov.in
Department of Health and Family Welfare has published a notification vide G.S.R. 127(E) dated 11th February 2025 regarding seeking extension of the timeline for implementation […]
National Regulatory Authority (NRA): CDSCO
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics […]
Application for grant of extension of compliance with Revised GMP under Schedule-M of the Drugs Rules, 1945.
Central Government has extended the timeline as: “Provided that the small and medium manufacturers with turnover of or less than two hundred and fifty crores […]
Reconstitution of Drugs Technical Advisory Board (DTAB) {S.O. 1159(E) dated 12.03.2025}
In exercise to the powers conferred by sub-sections (1) and (2) of section 5 of the Drugs and Cosmetics Act, 1940 (23 of 1940) hereinafter […]
New Online Export NOC System on SUGAM Portal
To further enhance the ease of doing business in India, CDSCO has made online application system for submitting online application for obtaining Export NOC on […]