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DTAB recommends all antimicrobials to be considered as new drug under NDCT Rules
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Gireesh Babu, New Delhi
May 06 , 2025
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The Drugs Technical Advisory Board (DTAB) has recommended that all the antimicrobials shall always be deemed to be considered as new drug, under the definition in the New Drugs and Clinical Trials (NDCT) Rules, 2019 in public interest.
The Board has earlier requested the Drugs Consultative Committee (DCC) to consider the proposal for inclusion of all antibiotics in the definition of new drugs in the New Drugs and Clinical Trial (NDCT) Rules, 2019, to address the issue of antimicrobial resistance (AMR). The latest recommendation comes after considering the DCC recommendations.
"After detailed deliberation, DTAB recommended that all the antimicrobials shall always be deemed to be considered as New Drug under the definition of 'New Drug' under New Drugs and Clinical Trials Rules, 2019 in public interest. Accordingly, consequential changes may be made in the Rules," said the minutes of the 92nd meeting of the DTAB held on April 24, 2025.
It may be noted that the DCC, in its meeting held in 2024, made recommendations including amendment of the rules so that the Central Drugs Standard Control Organisation (CDSCO) can have a regulatory oversight on approval of antimicrobials across the country.
Both the DCC and the DTAB have been deliberating improving measures to curb the menace of AMR in the country. The AMR has been recognised as a serious and growing threat to public health globally. It has also been highlighted as a global health priority in multiple high-level flora ranging from the UNGA, G7 to G20. In this context, it was proposed to include all antibiotics in the definition of new drug in the NDCT Rules, 2019.
The Board, in its meeting held on August 14, 2024, recommended to amend the labelling requirements under the Drugs Rules, 1945 to add a blue strip or box for antimicrobial products to address the issue of AMR.
Besides, the Board agreed with the DCC's recommendation to amend the rules to the effect that no antimicrobials should be sold by the traders to the non-pharmaceutical industries who are not holding requisite licenses. The recommendation came after the Committee was informed that the antimicrobials may also be used in other industries such as food, beverages and other non-medicinal, where the sale and use of antimicrobials in non-pharma industries lead to AMR.
"Antimicrobial resistance can be caused due to misuse of antibiotic, antiviral, antifungal, etc. and accordingly recommended that the matter may be deliberated in the DCC initially," according to the DTAB minutes of an earlier meeting.
The DCC, in its meeting held on June 19, 2024, considered various proposals including uniform implementation of Schedule H and H1 drugs by State Drug Controllers through enforcement activities and insertion of new Rule under Drugs and Cosmetics Act and Rules, for manufacturing blue colour strips for antimicrobials.
It also considered a proposal to amend the Drugs Rules to conditions in various forms to include the word "except antimicrobials," and agreed with the recommendation.
At present, the Drugs Rules, 1945, in certain forms, has provisions to exempt selling of drugs to manufacturers of beverages, confectionery biscuits and other non-medicinal products, where such drugs are required for processing these products.
For instance, the Form 20B of the Drugs Rules, which is to apply for licence to sell, stock or exhibit or offer for sale or distribute drugs other than those specified in Schedule C, C(I) and X by wholesale, has conditions that no drug shall be made to a person not holding the requisite license to sell, stock or exhibit for sale or distribute the drug.
However, the condition shall not apply to the sale of any drug to an officer or authority purchasing on behalf of government, or a hospital, medical, educational or research institution or a registered medical practitioner for the purpose of supply to his patients, or "a manufacturer of beverages, confectionery biscuits and other non-medicinal products, where such drugs are required for processing these products."
Similar provisions are also there in Form 20BB, Form 21B and Form 21BB of the Drugs Rules, related to wholesale of drugs. The latest recommendation from the DCC is to exempt antimicrobials for the use of non-pharmaceutical purposes from this provision.
The recent meeting held by the DCC, which considered various proposals on curbing the menace of antimicrobial resistance (AMR), opined, "to amend the conditions at serial no - 3(ii)(c) under Form 20 B, Form 20BB and condition at serial no. 4(ii)(c) under Form 21B, Form 21BB of Drug Rules 1945, to include the word 'except Antimicrobials'".
The DCC's recommendation came after it was informed that the antimicrobials may also be used in other industries such as food, beverages and other non-medicinal, where the sale and use of antimicrobials in non-pharma industries lead to AMR.
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