Last Updated on March 13, 2026 by The Health Master
DTAB 93rd Meeting
Download minutes of meeting of 93rd DTAB held on 16-02-2026, the link is given below: The 93rd meeting of the Drugs Technical Advisory Board (DTAB 93rd meeting) introduced several crucial amendments and recommendations that will significantly transform the regulatory control of pharmaceutical manufacturing and distribution in India.
These developments are vital for all those involved in the pharmaceutical industry to ensure compliance with the Drugs and Cosmetics Act and the CDSCO.
Download minutes of meeting of 93rd DTAB held on 16-02-2026
Antimicrobials to be included under “New Drugs”
One of the most significant recommendations of the DTAB is the inclusion of all antimicrobials under the definition of “New Drugs” as defined in the New Drugs and Clinical Trial (NDCT) Rules, 2019. These drugs will be under enhanced regulatory control to ensure better oversight on the growing issue of antimicrobial resistance.
The decision to include antimicrobials under the “New Drugs” category will only be applied prospectively. Hence, all existing licensees will be allowed to continue operating without any additional requirements.
Good Distribution Practices to be given legal sanctity
The DTAB has also recommended giving legal sanctity to Good Distribution Practices (GDP). The Drugs Rules, 1945, will be amended to make GDP mandatory for all firms involved in manufacturing, selling, stocking, or distributing drugs. This will help ensure that all drugs maintain their quality from manufacturer to consumer.
Microbial limits in Schedule M to be revised as per WHO guidelines
The DTAB recommendations will align the microbial limits within Schedule M with the world health organization (WHO) guidelines. The microbial limits for Grade A areas will now be as specified in the WHO Technical Report Series (TRS) 1044.
However, the strict requirements within the revised Schedule M will not be applicable to all drug categories.
The following will be exempt:
- Medical gases
- Empty gelatin capsules
- Disinfectant fluids
Licenses for marketers and wholesalers of drugs to be issued
The Drugs and Cosmetics Rules will be amended to allow for the issuance of licenses for “marketers” of drugs. This will allow increased control over the marketing of drugs.
A separate license “form” will be created for the wholesale distribution of bulk drugs. This will specifically focus on the wholesale distribution of drugs categorized as Schedule NDPS (Narcotic Drugs and Psychotropic Substances).
Wholesale License Qualification Requirements
| Role | Recommended Qualification |
| Competent Person (Bulk Drugs) | Degree in Science with 2 years of experience OR Registered Pharmacist |
| Competent Person (Rule 64) | Registered Pharmacist OR Degree in Science with 2 years experience AND a 6-month online certificate course |
Strict restrictions on the advertising of drugs
The DTAB recommendations will prohibit the advertising of drugs listed in Schedule H, H1, and X of the Drugs and Cosmetics Rules, 1945, without the prior sanction of the Central Government of India.
All drugs categorized under Schedule G will now be moved to Schedule H. By placing these drugs into Schedule H, the regulation of the advertisement of these drugs will be automatically addressed.
Additional recommendations
The following additional recommendations were made during the 93rd DTAB meeting:
- Animal health products will no longer be manufactured or sold in the country by any company. This applies to products containing Carboxypenicillins and Phosphonic acid derivatives used to promote the growth of animals used for food production.
- Nicotine replacement products will only be available in the country in flavored Nicotine gums (2mg). Furthermore, the sale of these products will be banned from being sold to minors.
- The importation of drugs for the sole purpose of conducting analytical tests will no longer require the permission of the CDSCO. However, this permission will be required for the importation of narcotics.
- The manufacture and sale of Fixed-Dose Combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride will be prohibited from being sold to children of four years of age and under.
- For all those involved in the pharmaceutical industry, it is vital to be aware of the prospective amendments recommended by the DTAB to ensure that the operations of their companies are in compliance with the Drugs and Cosmetics Act, 1940, as amended.
