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DCC recommends change in rules for regulatory oversight by CDSCO for approving antimicrobials
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Gireesh Babu, New Delhi
February 19 , 2025
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The Drugs Consultative Committee (DCC), the advisory committee that advises the Central and state governments on matters that require uniform implementation of laws across the country, has recommended 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.
The Committee, in its latest meeting, was considering a proposal regarding inclusion of all antimicrobials in the definition of New Drug under the New Drugs and Clinical Trial Rules (NDCTR), 2019.
After detailed deliberation, the DCC recommended that, "suitable provisions may be made in the rules for regulatory oversight by CDSCO for approving antimicrobials in the country to ensure uniformity of implementation and compliance with the rules."
The decision follows a recommendation from the Drugs Technical Advisory Board (DTAB) in its meeting in August, 2024, where it has recommended the DCC to consider the proposal for inclusion of all antibiotics in the definition of new drugs in the NDCTR, 2019, to address the issue of antimicrobial resistance (AMR).
It may be noted that both the DCC and the DTAB have been deliberating improving measures to curb the menace of AMR in the country.
The National Programme on AMR Containment, under the National Centre for Disease Control, in a report in July, 2023, said that in 2019, 4.95 million deaths were estimated to be associated with bacterial AMR of which 1.27 million deaths were directly attributable to bacterial AMR.
"It is estimated that AMR will cause 10 million every year by 2050, becoming the number one cause of deaths globally (2). A major contributing factor to antibiotic resistance is overuse of antibiotics by humans, with approximately half or more of hospitals using antibiotics inappropriately," it added. Amoxicillin and clavulanic acid 625 mg, azithromycin 500 mg, cefixime 200 mg and ceftriaxone 1g, all in the watch group, were the most commonly used antibiotics over the years.
The DCC, in its previous meeting held last year, recommended amendment of Drugs Rules to the effect that no antimicrobials should be sold by the traders to the non-pharmaceutical industries who are not holding requisite license.
The meeting 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 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.
Some of the other proposals which came up for the consideration of the Committee include 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.
The DTAB meeting held later during 2024, also 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. The DCC also in its previous meeting considered this proposal.
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 meeting observed that 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 NDCG Rules, 2019.
The Board deliberated the matter and observed that the G20 declaration stated for tackling the issue of antimicrobial resistance.
"Antimicrobial resistance can be caused by due to misuse of antibiotic, antiviral, antifungal, etc. and accordingly recommended that the matter may be deliberated in the DCC initially," according to the minutes of the meeting.
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