Drugmakers may need designated expert to certify batches before sale

New Delhi: The Union health ministry has proposed making pharmaceutical companies formally designate a qualified person to authorise the release of every batch of drugs into the market, tightening accountability for drug quality, the government said on Tuesday.

Under the draft amendments to the Drugs Rules, 1945, every drugmaker will have to appoint an expert specifically responsible for batch release. Companies will also be required to issue a “Batch Release Certificate” in a prescribed format and keep records for every lot produced.

At present, drugmakers are required to declare the technical personnel overseeing manufacturing and testing, but there is no specific provision for identifying the individual authorised to release a batch for sale, the ministry said.

Mint first reported on the government’s plan to tighten these norms in February 2025.

According to the health ministry, batch release is a critical stage in the pharmaceutical manufacturing process, involving an overall review of the relevant quality parameters and documentation before a batch is released for distribution.

The health ministry added that the proposed amendments are expected to support manufacturers in strengthening their compliance with applicable good manufacturing practices (GMP) and reinforce the regulatory framework governing the quality assurance of drugs.

“The proposed amendments aim to strengthen accountability in the drug manufacturing process by introducing an explicit regulatory requirement for the authorisation of personnel responsible for batch release,” the health ministry stated.

Accountability for drug quality

Under the revised structure, “applicants seeking manufacturing licences under the relevant provisions of the Drugs Rules, 1945, would be required to designate a suitably qualified and experienced person for batch release and maintain batch-release records in accordance with the prescribed requirements.”

“The proposed requirements are intended to establish clear responsibility for this function, ensure traceability of batch-release decisions and provide an additional level of oversight of product quality,” the statement said.

The development assumes significance for India’s $60-billion pharmaceutical industry amid concerns over the quality of drugs manufactured in the country.

The drug regulator has stepped up risk-based inspections of domestic pharmaceutical units following cases involving contaminated cough syrups manufactured in India that were linked to the deaths of children in Gambia and Uzbekistan in 2022 and 2023. Last year, contaminated medicines also led to the deaths of at least 24 children in Madhya Pradesh and Rajasthan, respectively.

The government has invited objections and suggestions on the draft amendments within 30 days to finalize the regulations.