Drug manufacturers may need a designated expert to certify batches prior to sale | Today’s news
New Delhi: The Union Health Ministry has proposed that pharmaceutical companies formally appoint a qualified person to authorize the release of each batch of drugs in the market, tightening accountability for drug quality, the government said on Tuesday.
Under the proposed amendments to the Drugs Rules of 1945, each drug manufacturer will have to appoint an expert specifically responsible for batch release. Companies will also have to issue a ‘batch release certificate’ in a prescribed format and keep records of each batch produced.
Currently, drug manufacturers are required to declare technical personnel overseeing production and testing, but there is no specific provision to identify the individual authorized to release a batch for sale, the ministry said.
Mint first reported the government’s plan to tighten these norms in February 2025.
According to the Ministry of Health, batch release is a critical phase of the pharmaceutical manufacturing process, which involves an overall review of relevant quality parameters and documentation before the batch is released for distribution.
The Ministry of Health added that the proposed changes are expected to support manufacturers in strengthening their compliance with applicable Good Manufacturing Practices (GMP) and strengthen the regulatory framework governing the quality assurance of medicines.
“The proposed changes aim to strengthen accountability in the drug manufacturing process by introducing an explicit regulatory requirement for the authorization of personnel responsible for batch release,” the Ministry of Health said.
Responsibility for the quality of medicines
Under the revised structure, “applicants applying for manufacturing licenses under the relevant provisions of the Drugs Rules 1945 would be required to appoint a suitably qualified and experienced batch release person and to maintain batch release records in accordance with the prescribed requirements.
“The proposed requirements aim to establish clear responsibilities for this function, ensure traceability of batch release decisions and provide an additional level of product quality oversight,” the statement said.
The development takes on 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 made in India that were linked to the deaths of children in Gambia and Uzbekistan in 2022 and 2023. Contaminated drugs also led to the deaths of at least 24 children in Madhya Pradesh and Rajasthan last year.
The government invited objections and suggestions to the proposed changes within 30 days in order to finalize the regulation.
