New Delhi: Drug manufacturers may soon be required to formally appoint qualified and experienced personnel to authorise the release of each drug batch, under amendments proposed by the Union health ministry to the Drugs Rules, 1945.
The proposed changes seek to make manufacturers accountable for batch-release decisions and ensure that prescribed records are maintained for every batch produced. The ministry has also proposed a standard format for the Batch Release Certificate.
At present, manufacturers applying for licences are required to provide details of competent technical staff responsible for manufacturing and testing. However, the rules do not specifically require them to identify the person authorised to approve the release of a batch.
Under the proposed framework, applicants seeking manufacturing licences will have to designate a suitably qualified and experienced person for the task and maintain batch-release records in the prescribed format.
Batch release is a key quality-control step in pharmaceutical production. It involves reviewing quality parameters and relevant documentation before a batch is cleared for distribution. The proposed provision is intended to establish clear responsibility for such decisions and improve their traceability.
The ministry said the amendments would also help manufacturers strengthen compliance with Good Manufacturing Practices (GMP) and reinforce the regulatory framework for drug quality assurance.
