Centre proposes mandatory qualified personnel for drug batch release

The proposed amendments seek to strengthen accountability in drug manufacturing by requiring qualified personnel for batch release and maintaining prescribed records

The Centre has proposed to mandate all drug manufacturers to formally authorise a person with appropriate qualifications and experience for the batch release of drugs and maintain prescribed records for every batch manufactured.

 

As part of the proposal, the Union Health Ministry will amend Rule 68 of the Drugs Rules, 1945, which deals with manufacturing licences for the sale or distribution of drugs other than homoeopathic medicines.

 

“The applicant for the grant of a licence under this part shall authorise a person, for batch release in compliance with Schedule M (good manufacturing practices or GMP), with appropriate qualifications and experience,” the Union Health Ministry stated in a draft notification.

  

Till now, such licences were only approved by the Central Licensing Approving Authority (CLAA) or any person designated by it.

 

This designated person is mandated to be a graduate in pharmacy, pharmaceutical chemistry or medicine with a specialisation in clinical pharmacology or microbiology from a university established in India by law.

 

The proposed amendment will now also allow drug manufacturing companies to appoint anyone deemed qualified as an authorised person for batch release and maintain batch-release records in accordance with the prescribed requirements.

 

Objections and suggestions from stakeholders have been sought within 30 days of the draft notification’s publication.

 

Officials in the Union Health Ministry aware of the matter told Business Standard that the proposed amendment aims 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 licences currently require manufacturers 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,” they added.

 

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

 

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 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 ministry said in a statement.

 

It added that the amendments are also expected to support manufacturers in strengthening their compliance with applicable GMP and reinforce the regulatory framework governing the quality assurance of drugs.