India CDSCO Updates
The latest guidances, approvals, and safety alerts from India CDSCO, curated by automated regulatory intelligence.
Indiscriminate use of NSAIDs and antibiotics is being highlighted as a safety concern linked to increased risk of Chronic Kidney Disease (CKD), implying the…
Maintains/announces an official list of registered BA-BE study centres and bio-analytical laboratories for conducting bioavailability/bioequivalence work under…
Alerts regulated entities and the public to avoid use of cosmetics products that are not authorized by CDSCO, signaling enhanced compliance and potential…
Mandates amendments to India’s Drugs Rules, 1945 to require the mandatory installation of CCTV surveillance systems at drug sales premises.
Focuses on coordinated enforcement by drug regulatory and law enforcement agencies to deter illegal manufacturing and distribution of misbranded drugs.
Extends the use of a prior intimation mechanism for specified bioavailability (BA) and bioequivalence (BE) studies submitted to CDSCO as part of approval of…
Amends India’s Drugs Rules, 1945 Schedule K to incorporate levonorgestrel emergency contraceptive tablets (0.75 mg and 1.5 mg) into the specified regulatory…
Prohibits the manufacture, import, sale, and distribution of carboxypenicillins and phosphonic acid derivatives intended for animal use, signaling a…
Cancels an earlier CDSCO cancellation order dated 24.08.2026 involving Skintle Enterprises Pvt Ltd, indicating a regulatory action that may affect the status…
Draft notification proposes adding four additional drugs to India’s Schedule H1, which typically triggers tighter regulatory controls on their manufacture…
Prohibits all fixed-dose combination (FDC) formulations containing chlorpheniramine maleate and phenylephrine HCl from being used in children below four years…
Amends India’s Drugs and Cosmetics Rules, 2017 to incorporate EU countries within the scope of Rule 63 and extends/aligns Quality Management System (QMS)…
Introduces amendments to the Drugs and Cosmetics (i.e., MDR) Rules, 2017 by adding a Ninth Schedule and adding specific labelling requirements tied to…
Addresses CDSCO expectations for the manufacturing and marketing of drug products containing enclomiphene and its combinations, specifically highlighting…
Clarifies the regulatory submission pathway under India’s New Drugs and Clinical Trials Rules, 2019 for granting Permission to Import and Market new drugs that…
Clarifies the regulatory submission pathway for seeking Permission to Import and Market new drugs that are not approved anywhere globally when Phase III global…
Inviting comments on standard IVD evaluation protocols drafted by ICMR and CDSCO, indicating a move toward more harmonized and predictable assessment…
Amends the Drugs Rules, 1945 (via Rule 89) to enable licence applications under Form 29 for multiple licence categories that fall under Forms 25A, 25F, 28A…
Initiates stakeholder consultation on operational guidance to enable a single Ethics Committee review for multi-centre clinical research in India, potentially…
Common Submission Format guidance for importing and registering drugs (bulk and finished formulations) in India is intended to standardize how dossiers are…