The Health Ministry announced the proposal on Tuesday. The changes are being considered through amendments to the Drugs Rules, 1945. The primary objective is to make the manufacturing, testing and market-release processes more transparent, accountable and safe.
What Is the Batch Release Process?
Batch release is an important stage in pharmaceutical manufacturing. It involves examining a medicine’s quality, testing reports and relevant documentation.
A batch can be released into the market only after confirming that it meets all prescribed quality standards and regulatory requirements.
Under the existing system, pharmaceutical manufacturers are required to provide details of technical personnel responsible for manufacturing and testing. However, there is no clearly defined provision requiring the disclosure of the person specifically authorised to approve the release of each batch.
Qualified Professional to Be Held Responsible
Under the proposed amendments, pharmaceutical companies will have to designate a qualified and experienced individual responsible for authorising the release of every medicine batch.
Manufacturers will also be required to maintain proper records related to the batch-release process to ensure accountability and traceability.
Standardised Batch Release Certificate Proposed
The Ministry has also proposed introducing a prescribed format for the batch-release certificate.
This standardised documentation is expected to improve quality verification, establish clear responsibility and strengthen regulatory oversight of pharmaceutical products.
Government Invites Suggestions and Objections
The Ministry of Health has invited objections and suggestions from relevant stakeholders regarding the proposed amendments.
Interested parties can submit their feedback to the Under Secretary (Drug Regulation), Ministry of Health and Family Welfare.
The proposed changes are expected to strengthen quality control in India’s pharmaceutical industry and improve public confidence in the safety and reliability of medicines.
