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…
December 16, 2024 In a significant move to support patients battling rare diseases, the Central Drugs Standard Control Organization (CDSCO), India’s apex drug regulatory body, has directed drug regulators across the country to fast-track the approval process for medications and…
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- GMP Guidelines
Loan Licensing in Pharmaceutical Manufacturing: Key Principles, Guidelines, and Regulatory Framework
Loan licensing in pharmaceutical manufacturing plays a crucial role by allowing companies to outsource manufacturing or testing operations to third-party facilities. This setup, governed by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, helps pharmaceutical…
The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health & Family Welfare, is India's principal regulatory authority for the registration and regulation of medical devices. The CDSCO ensures that medical devices available in the market are safe…
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…
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