Drugs regulator moves import approvals fully online with new rulebook
New Delhi, Aug. 7 -- India's apex drugs regulator is planning a new rulebook for importing bulk drugs and finished medicines by migrating all approval processes online, according to a document reviewed by Mint.
The proposed changes have been outlined in the Central Drugs Standard Control Organisation's (CDSCO) "Guidance Document on Common Submission Format for Import & Registration of Drug(s) (Bulk & Finished Formulations) in India", which will impact the country's $60 billion pharmaceutical market, according to the department of pharmaceuticals.
With bulk drug import dependence limited to around $5.2 billion, the country remains significantly reliant on foreign active pharmaceutical ingredients for critical bulk drugs and finished form...
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