New Delhi, Nov 3 (PTI) The Union health ministry has proposed making it mandatory for drug manufacturers to formally designate

New Delhi, Nov 3 (PTI) The Union health ministry has proposed making it mandatory for drug manufacturers to formally designate

New Delhi, Nov 3 (PTI) The Union health ministry has proposed making it mandatory for drug manufacturers to formally designate

New Delhi, Nov 3 (PTI) The Union health ministry has proposed making it mandatory for drug manufacturers to formally designate a suitably qualified and experienced person for batch release and maintain prescribed records for every batch manufactured, an official statement said on Tuesday.

    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 proposal is part of amendments to the Drugs Rules, 1945, aimed at strengthening accountability and oversight in the pharmaceutical manufacturing process, the statement issued by the ministry said.

    It said the aim is to strengthen accountability in the drug manufacturing process by introducing an explicit regulatory requirement for the authorisation of personnel responsible for batch release.

    While manufacturing licenses currently require license holders to furnish details of competent technical staff responsible for manufacturing and testing, there is no specific provision for mentioning the person authorised to undertake batch release.

    "Under the proposed framework, applicants seeking manufacturing licenses 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 ministry said.

    The amendments also propose to introduce a prescribed format for the Batch Release Certificate under the Rules.

    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 proposed amendments are also 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 ministry said.

    It said objections and suggestions on the proposed amendments can be submitted to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare.

(This story has not been edited by THE WEEK and is auto-generated from PTI)