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).
Two-unit process
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 responsible for batch release while granting license to the drug maker. There was no accountability and the staff available at the time of the release of the batches of medicines would be the one whose name was put on the label as the person clearing the batch,” the official said.
With the new plan in the works, “we will be able to know the name of the person responsible,” the official said. The goal is transparency in the drug regulatory system and strengthening the quality checks. The official added that this is a step towards ensuring the quality and safety of pharmaceutical products manufactured in India.
Queries sent to the health ministry spokesperson remained unanswered till press time.
Discussed in December
The proposal for including the name of the person issuing batch clearance was discussed in December at the Drugs Consultative Committee meeting headed by the CDSCO chief and Drug Controller General of India Rajeev Raghuvanshi, according to the minutes of the meeting released on 20 January 2025, seen by Mint.
“As batch release is one of the critical processes in manufacturing and testing, it is therefore proposed to include the name of the authorized person responsible for release of batch of product under all the manufacturing licenses. The DCC after detailed deliberation agreed with the proposal to include the name of authorized person responsible for release of batch of product, on the license and the format of batch release certificate and further recommended to refer the matter to Drugs Technical Advisory Board,” the minutes said.
During 2023-24, around 2,988 drug samples were declared ‘not of standard quality’, while 282 were found to be spurious or adulterated, according to government data.
India’s FY 2023-24 pharmaceutical market is valued at $50 billion, with domestic consumption valued at $23.5 billion and exports at $26.5 billion. The country’s pharma industry is considered the third largest in the world by volume and fourteenth in terms of production value, as per the pharmaceuticals department.
