December 30, 2024 In a bid to streamline the process of clinical trial approvals in India, the Central Drugs Standard Control Organization (CDSCO) has enhanced the functionalities of the Sugam Portal, allowing sponsors and researchers to efficiently submit clinical trial…
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,…
Business Continuity is an issue that affects all organizations whether small or large, domestic or multinational. The extent of impact however may vary from organization to organization. Recently, we have witnessed a global pandemic which has disrupt almost all type…
Central Drugs Standard Control Organization (CDSCO) under the aegis of Ministry of Health and Family Welfare, Government of India has been taking many steps to control the menace of unapproved and irrational Fixed Dose Combinations (FDCs). In this process, government…
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
