⚠ Regulatory Alert Drug residues in shrimp exports have triggered a sweeping directive from CDSCO, putting state drug controllers on notice to act — or face more international trade fallout. India's Central Drugs Standard Control Organization (CDSCO) has…
January 6, 2023 Government of India vide gazette notification no. GSR 922 (E) dated 28.12.2023 has notified new set of rules and regulations for implementation of Good Manufacturing Practices for manufacturing of pharmaceutical products. The new rules are covered under…
Central Drugs Standard Control Organization (CDSCO), Government of India has a mandate for approval of drugs to be manufactured and imported for sale in India. The drugs approved by CDSCO can only be further licensed by State Licensing Authorities to…
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,…
Ethics Committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international laws. Central Drugs Standard Control Organization, the national drug regulatory authority has…
Recent Post
- CDSCO Notifies Final Guidance Document on Medical Device Software (MDSW)
- When a “+” Sign Isn’t Just a Plus
- DCC intends to tighten control on manufacturing and supply of printed packaging materials used for drugs
- High-Alcohol Oral Formulations Move Into Schedule H1
- DCC Recommends Comprehensive Regulatory Mechanism to Curb Unapproved Drugs and FDCs
