In a bid to enhance accountability in the pharmaceutical sector, the government is working on a proposal to include the name of the person responsible for releasing a batch of medicines under the Drugs Rules, 1945. This move comes amid rising concerns over counterfeit and substandard drugs in the market, according to a report by Mint citing an official familiar with the matter.
The proposal follows intensified inspections by the Central Drugs Standard Control Organization (CDSCO) after India-made cough syrups were linked to the deaths of children in Gambia and Uzbekistan in 2022 and 2023, the Mint report added.
Currently, the Drugs Rules, 1945, mandate mentioning the names of staff responsible for manufacturing and testing when a drug license is issued to a manufacturer. However, there is no provision for identifying the person releasing the batch at the time of production. If approved, the proposed changes would require an amendment to the existing rules.
“The goal is to introduce transparency in the drug regulatory system and strengthen quality checks,” an official told Mint. The proposed revision was discussed in December during a meeting of the Drugs Consultative Committee (DCC), chaired by the Drug Controller General of India, Rajeev Raghuvanshi. The minutes of the meeting, released on January 20, 2025, confirm that the DCC has agreed to the proposal and recommended referring the matter to the Drugs Technical Advisory Board (DTAB) for further deliberation.
DTAB, a statutory body that advises the Union government on drug regulations, meets twice a year to evaluate recommendations from the DCC. If the changes are approved, manufacturers will be required to explicitly mention the name of the authorized person responsible for batch release on all manufacturing licenses and batch release certificates.
The move is expected to tighten regulatory oversight and ensure better compliance with quality standards in the pharmaceutical industry. However, the final decision will depend on DTAB’s approval and subsequent amendments to the Drugs Rules, 1945.
Queries sent to the health ministry spokesperson remained unanswered at the time of publication, says Mint. Moneycontrol could not independently verify the report.
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