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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…
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…