Regulatory Blog

Last week, two pivotal updates were introduced: the Union Health Ministry proposed major amendments to the New Drugs and Clinical Trials...

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, has released a notice a...

The Central Drugs Standard Control Organization (CDSCO)  under India’s Ministry of Health & Family Welfare has released a detailed...

The Central Drugs Standard Control Organisation (CDSCO) has published a fresh guidance document titled “ Guidance Document for Issuance...

Clinical trials are a cornerstone of medical advancement, requiring meticulous planning and adherence to regulatory guidelines. In India,...

India's CDSCO Pharmacovigilance released an updated guidance " Pharmacovigilance Guidance Document for Marketing Authorization Holders of...

The Central Drugs Standard Control Organisation (CDSCO) in India has issued a draft guideline on Good Distribution Practices (GDP) for...

India's Central Drugs Standard Control Organization (CDSCO) has published draft guidance "Post Approval Changes in Biological Products:...

To address the challenges in the management of medical devices, India's Central Drugs Standard Control Organization (CDSCO) has...

Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro...

India’s Central Drugs Standard Control Organization (CDSCO) has published the steps that need to be followed by the manufacturers and...