Fixed Dose Combinations popularly known as FDCs are a cocktail of two or more active drugs formulated in a single unit dose. They are very popular among physicians for ease of prescription, among patients for lower cost and among pharma…
Indian drug regulatory system is governed by the provisions laid down under Drugs and Cosmetics Act, 1940 and Rules, 1945 made thereunder. With changing times many new rules viz. Medical Device Rules, 2017, New Drugs and Clinical Trial Rules,…
April 26, 2022 Central Drugs Standard Control Organization (CDSCO), the Drug Regulatory Agency of Government of India granted restricted emergency use authorization (EUA) to Bharat Biotech's Covaxin as a COVID-19 vaccine to vaccinate children between the age of 6-12…
May 1, 2020 Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has extended the validity of WHO GMP/ Certificate of Pharmaceutical Product (COPP) expiring from March 2020 to August 2020 by six months from…
Apr 9, 2020 The Central Drugs Standard Control Organization, Government of India, has requested all State and Union Territory Drug Controllers to expedite the licensure procedure to manufacture oxygen for medical use. This is considered as a welcome move…
Recent Post
- CDSCO Issues Public Notice on Disposal of Long-Pending SUGAM Applications
- India Bans High-Dose Nimesulide: What You Need to Know
- Compounding of Offences under the Drugs and Cosmetics Act, 1940: What Stakeholders Need to Know
- 🚨 CDSCO Directive on Immediate Inspections as per Revised Schedule M – Is Your Facility Ready?
- CDSCO Issues Regulatory Clarification on Combi-Pack Approvals: Key Insights for Injectable Manufacturers
