Govt plans audit of 81 years of drug approvals amid safety concerns
New Delhi, July 3 -- India is preparing to launch a massive trace-and-track exercise to identify missing drug approvals from its central repository, amid concerns that decades-old formulations not meeting current safety and efficacy standards may still be in circulation.
The initiative aims to resolve discrepancies in the Central Drugs Standard Control Organisation's (CDSCO) database and create a comprehensive repository of missing drug approvals over the past 81 years, including legacy licences dating back to 1945 when the country's drug laws were first enacted, according to three government officials and documents reviewed by Mint.
"It has been observed that certain drugs and fixed dose combinations (FDCs) approved by CDSCO are not re...
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