Alerts & Updates 16th Jul 2024

Strengthening of Export Regulations concerning Drugs in India

Authors

Suhail Nathani Managing Partner | Mumbai
Sanjay Notani Partner | Mumbai
Harika Bakaraju Principal Associate | Mumbai
Shweta Kushe Associate | Mumbai

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On July 3, 2024, the Central Drugs Standard Control Organisation (CDSCO) issued a guidance document outlining the new procedures for obtaining export NOCs, including stringent documentation requirements and quality control measures. This regulatory development comes in lieu of measures India has been undertaking to enhance drug safety and quality of its drug exports by centralizing the issuance of “No Objection Certificates” (NOCs) for exporting unapproved, banned, or new drugs. It aims to restore confidence in Indian pharmaceuticals by ensuring stringent regulatory oversight.

Read the detailed update here