India’s apex drug regulator plans to ensure medicine labels carry name of authorized person responsible for the batch

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Subscribe to enjoy similar stories. To fix accountability, the government is working on a plan to include the name of the person responsible for releasing a batch of medicines under the Drugs Rules, 1945, according to an official familiar with the matter. This comes against the backdrop of growing complaints about counterfeit and substandard drugs circulating in the market.

The Central Drugs Standard Control Organization (CDSCO) increased inspections in the domestic pharmaceutical market after India-made cough syrups were linked to the deaths of children in Gambia and Uzbekistan in 2022 and 2023. Currently, under the Drugs Rules, 1945, there is a provision of mentioning the names of staff responsible for manufacturing and testing when the drug license is issued to the manufacturer. If the proposal to add the names of the personnel releasing the batch is approved, the Drugs Rules, 1945, will need to be amended.

The changes, if any, will have to be cleared in the Drugs Technical Advisory Board (DTAB) meeting, a statutory body which advises the Union government on framing policies and rules related to the Drugs and Cosmetic Act, 1940. DTAB holds meetings twice a year where it deliberates on the recommendations of the Drugs Consultative Committee (DCC). At present, the process for manufacturing medicines entails the manufacturer opening two units—one for production and another for testing.

Once the medicine is produced, it is sent for quality control and safety testing. The same person cannot head both units, so the data from the two units is compiled and approved by the person responsible for releasing the batch of medicines. “Currently, there is no provision in the legal document for including the name of the person