Last Updated on May 30, 2025 by The Health Master
DTAB
The Drugs Technical Advisory Board (DTAB) has approved a recommendation for better accountability and quality control of pharmaceuticals manufactured in the country.
The recommendation came from the Drugs Consultative Committee (DCC) following an earlier meeting that sought to have the name of the authorised person who will print the batch number of the manufactured drugs on the drug manufacturing license.
DTAB Recommendation
According to the minutes of the 92nd DTAB meeting held on April 24, 2025, this matter was considered for providing the name of the authorized person releasing the batch on all manufacturing licenses to be issued under Drugs Rules, 1945.
This was brought to light based on the DCC meeting held on December 20, 2024.
The amendment came about because of a High Court of Himachal Pradesh order that required all manufacturers in that state to identify the name and signature of approved testing and analysis technical persons on the certificate of analysis.
The court’s observation required more clarity with such persons at such an important point of drug manufacturing.
Fulfilling the Gap
The DCC discussed this after and found that there is a necessity for an identification of competent technical persons for manufacturing and testing as provided in the manufacturing license under Drugs Rules on the following Forms, but there is NO necessity as of now to identify the authorized person who can give batch-release permission on a finished form.
- Form 25,
- Form 25A,
- Form 25F,
- Form 28,
- Form 28A,
- Form 28B,
- Form 28D,
- Form 28DA,
- Form 28E &
- Form 28F.
Realizing batch release to be a critical operation with implications on the quality and safety of the drug in question, the decision to print the name of the authorised person on all manufacturing licenses was met with much appreciation.
Regulatory Relaxation for Loan Licensees and for Biologicals
Besides the crucial decision about the authorised person for batch release, the DTAB also gave its approval to DCC’s recommendation to amend Rule 89 of the Drugs Rules, 1945.
To allow for the following Forms of loan licensees to be added who are seeking various permission’s for biologics, vaccines and antibiotics.
- Form 25A,
- Form 25F,
- Form 28A,
- Form 28B,
- Form 28DA,
- Form 28E &
- Form 28F.
Form 29
Also, during the DCC meeting, there was a discussion regarding the need for clarifying provisions relating to Form 29, which is a license required for the manufacture of drugs in the matter of examination, test, or analysis. Currently, Rule 89 prescribes that only those who do not have Form 25 or Form 28 licenses require Form 29.
However, no such clarifying provisions exist to include these persons who intend to manufacture drugs that have Form 25A or 28A licenses for the same purpose.
Q. Why is it important to add the name of the person authorized for batch release on the drug license?
A. This information adds credibility and accountability as it binds a person to be charged with quality before any batch of manufactured drugs is released in the Indian market.
Q. Will this apply to all drug manufacturing licenses in India?
A. Yes, DTAB agreed for this to be added in all manufacturing licenses under Drugs Rules, 1945.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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