Central Drugs Standard Control Organization (CDSCO), Government of India has a mandate for approval of drugs to be manufactured and...
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BLOGS
Mosquiorix becomes first malaria vaccine to receive WHO prequalification
22 September, 2022 In a historic development, World Health Organization (WHO) has granted prequalification to malaria vaccine developed by...
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India publishes Drugs Medical Devices and Cosmetics Bill
9 July, 2022 The Ministry of Health and Family Welfare, Government of India has published a draft of New Drugs,...
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CDSCO has published draft guidelines for IVDMD
9 July, 2022 Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has published...
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Potential problems during Audit
In our series regarding various auditing techniques, we have touched upon many topics namely qualities of an Auditor, time management...
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Solubility of Active Pharmaceutical Ingredients
Solubility is the capacity of the solvent to dissolve a solute. Solutes may differ in both the extent and the...
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CDSCO publishes list of approved COVID-19 vaccines in India
18 June, 2022 Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has...
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CDSCO issues draft notification for Schedule H2 drugs
17 June, 2022 Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has...
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CDSCO waives off requirement of TSE BSE certification
17 June, 2022 Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has issued...
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Test License for drugs in India
Indian drug regulatory system is governed by the provisions laid down under Drugs and Cosmetics Act, 1940 and Rules,...
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API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.