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DTAB backs inclusion of name of authorised person of batch release on the license
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Gireesh Babu, New Delhi
May 15 , 2025
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The Drugs Technical Advisory Board (DTAB) has agreed with recent recommendations of the Drugs Consultative Committee (DCC) regarding inclusion of name of authorised person responsible for release of batch of product on the license, among others.
The Board, in its 92nd meeting held on April 24, 2025, was considering the proposal to include the name of authorized person responsible for release of the batch of product under all the manufacturing licenses under the Drugs Rules, 1945.
It has considered the recommendations by the DCC in its meeting held on December 20, 2024, where it recommended to include the name of authorized person responsible for release of the batch of product, on the licence. It also recommended to prescribe the format of the batch release certificate. The Committee also recommended that the matter be referred to the DTAB.
The DTAB, in its latest meeting, agreed with the recommendation of the DCC, after detailed deliberation.
It also noted that the Drugs Controller, Himachal Pradesh also apprised the Board stating that there is an order from the High Court of Himachal Pradesh wherein the Court has directed that all the drug manufacturers in the State of Himachal Pradesh to incorporate name of the approved competent technical person for testing/analysis, etc. with signature on the certificate of
analysis.
The DCC during the meeting in December, was apprised that the manufacturing licenses under Drugs Rules such as (Form 25,25A, 25F, 28, 28A, 28B, 28D, 28DA, 28E & 28F) issued under Drugs Rules have the provision for mentioning the name of competent technical staff for manufacture and testing.
However, the manufacturing license does not bear the name of the authorised person responsible for release of the batch product.
As batch release is also one of the critical processes in manufacturing and testing, it was proposed to include the name of authorized person responsible for release of a batch of product under all the manufacturing licenses, it observed.
The DTAB, in its latest meeting, also recommended that the Rule 89 of the Drugs Rules, 1945 should be amended to the extent by incorporating various forms related to the loan licensees applying for various approvals related to biologics, vaccines and antibiotics. This is also in tune with the recommendation of the DCC in its meeting in December, 2024.
"DTAB recommended that Rule 89 should be amended to the extent by incorporating 'Form 25A, 25F, 28A, 28B, 28D, 28DA, 28E & 28F'," said the minutes of the latest meeting.
The DCC recommended amending the drugs Rules, 1945 to add provisions related to loan licensees applying for manufacturing of a drug for examination, test or analysis of biologics, vaccines and antibiotics among others, to bring in better clarity.
According to Rule 89 of the Drugs Rules, 1945, if the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, obtain a licence in Form 29. Form 29 issues a license to manufacture drugs for purposes of examination, test or analysis.
However, the Rule 89 does not have specific provision for obtaining a license in Form 29, in case a person proposes to manufacture a drug for the purpose of examination, test or analysis which is falling under licenses on Form 25A, 28A, among others.
DCC after detailed deliberation agreed with the proposal to appropriately amend the Drugs Rules, 1945 related to Form 29 for better clarity and also opined that the license issued in Form 29 of Drugs Rules is site specific.
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