Last Updated on May 21, 2025 by The Health Master
Antimicrobials
India’s Drug Technical Advisory Board (DTAB) has recommended all antimicrobials be classified as “new drugs” according to New Drugs and Clinical Trials (NDCT) Rules, 2019, as they will become new drugs in the future.
This is a collective decision by the DTAB in the interest of public health and safety, as classifying drugs as new opens opportunities for additional regulatory oversight efforts.
DTAB Recommendations
Recently the DTAB suggested such classification and seeks to align with the Drugs Consultative Committee (DCC) associated assessment of all antibiotics under the classification of “new drug.”
Such assessments are part of efforts to reduce the licensing and usage of antimicrobials to reduce antimicrobial resistance (AMR) concerns.
The 92nd meeting of the DTAB took place April 24, 2025, where such decisions were noted in the minutes.
Addressing the Silent Pandemic
Both the DCC and the DTAB have been actively exploring robust measures to curb AMR in India.
This growing resistance to antibiotics, antivirals, antifungals, and antiparasitics is recognized globally as a serious public health crisis.
The decision to classify all antibiotics as “new drugs” under the NDCT Rules, 2019, is a direct response to this urgent need for stronger regulation.
Past Recommendations
The DTAB has been consistently working towards addressing AMR.
In the 91st DTAB meeting held on August 14, 2024, the board recommended amending the labeling requirements for antimicrobial products under the Drugs Rules, 1945.
This included the addition of a distinctive blue strip or box to easily identify these medications, aiming to promote more responsible usage.
Curbing Misuse
Furthermore, the DTAB has concurred with the DCC’s recommendation to prevent the sale of antimicrobials by traders to non-pharmaceutical industries lacking the necessary licenses
This recommendation arose from concerns that the use of antimicrobials in sectors like food and beverages could inadvertently contribute to the development of AMR.
As earlier DTAB minutes highlighted, the misuse of antibiotics, antivirals, and antifungals is a significant driver of this resistance.
Uniform Implementation and Labeling
The 64th DCC, in its meeting on June 19, 2024, had considered various proposals to combat AMR.
These included the uniform implementation of Schedule H and H1 drugs by State Drug Controllers and the introduction of a new rule mandating blue color strips for antimicrobial packaging.
The DCC also supported amending existing drug rules to include the phrase “except antimicrobials” in conditions related to drug sales.
Closing Loopholes
Until recently, there existed forms in the Drugs Rules, 1945 whereby antimicrobial non-inclusion meant that certain businesses did not have to obtain pharmaceutical licensing.
For example, in Form 20B—Drugs other than specified in the Schedule I or H—conditionality line, it states that licensed sellers’ conditionality does not apply to licensed sales to governmental authorities/hospitals/registered medical professionals and then, thereafter, beverage/confectionery/biscuit/non-durable products.
The same applies for Forms 20BB, 21B, and 21BB.
Therefore, as per the latest DCC suggestion, such exemption forms are to be revised to ensure that antimicrobial drugs are no longer part of these exemptions.
Thus, far more businesses outside the pharma realm that manufacture drugs will now need special licensing—if they don’t already—to acquire and store such drugs for their purposes.
Final Amendment
During the most recent DCC meeting, it was discussed that all activities under Form 20B, Form 20BB, Form 21B, and Form 21BB will be amended to say “except antimicrobials.”
This is important to prevent physical transfer for illegitimate purposes or to position compounds in fields/institutions that would taint antimicrobials‘ use for any infectious disease purposes for both humans and animals.
Q. Why are all antimicrobials considered “new drugs”?
A. It is considered as new drugs allow better regulation to fight the war on antimicrobial resistance (AMR) problems.
Q. What are “new drugs” as per the NDCT Rules, 2019?
A. “New drugs” are those that are typically more stringently reviewed and required in the field than others; for example, more clinical trials and safety requirements. By deeming all antimicrobials as “new drugs,” this more stringent review process will be facilitated.
Q. What other steps have been taken for AMR in India?
A. Other steps include proposing a blue strip label for antimicrobials and that they cannot be sold in non-pharma units unless there is a license.
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.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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