The Drugs Technical Advisory Board (DTAB) has directed the Central drug regulator to take up the matter related to withdrawal of product license for antibiotic fixed dose combinations (FDCs), which are being used irrationally, with the State Licensing Authorities (SLAs) following non-submission of response by the state drug regulators.
The Board, in its 92nd meeting held on April 24, 2025, analysed the status report with regard to examination of a proposal to regulate the FDC antibiotics and its irrational use. It noted that the Drugs Controller General (India) (DCGI) has given several reminders to SLAs for obtaining the requisite information.
“The non submission of the desired information by the SLAs is not justified. DTAB opined that the DCG(I) may take up the matter with SLAs for withdrawal of the product license of such FDCs for appropriate action as per the provisions,” said the minutes of the meeting.
The DCGI has earlier asked the state drug regulators to provide the list of antibiotic combinations licensed by them and monitor the presence of unapproved antibiotic combinations, if any, in the market as part of efforts to curb the irrational use of antibiotics. The request from the national drug regulator was in the backdrop of recommendations from the sub-committee formed by the DTAB.
The sub-committee, after its first meeting held on May 1, 2024, recommended that the drug regulator should request the State Licensing Authorities (SLAs) to provide the list of antibiotic combinations licensed by them for manufacturing and marketing in their respective states and to monitor the availability of unapproved antibiotic combinations if any, moving in the market under their jurisdiction and intimate the Central Drugs Standard Control Organisation (CDSCO) on priority.
The DCGI, Dr Rajeev Singh Raghuvanshi, in a communication to the SLAs on May 16, 2024, said, “…you are requested to provide the list of antibiotic combinations licensed by you till date within two weeks. You are also requested to monitor the availability of unapproved antibiotic combinations if any, moving in the market under your jurisdiction and take necessary action under the provisions of Drugs and Cosmetics Act & Rules and intimate to CDSCO from time to time on priority”.
The move started when a meeting of experts held at the Indian Council of Medical Research (ICMR) on April 25, 2023 on pathway for strategic access to new antibiotics and regulation against excessive and irrational use of antibiotics in India, recommended to take steps that inappropriate combinations being sold currently should be banned immediately and steps should be taken that such combinations do not find their way to India markets in future.
A meeting held under the chairmanship of Dr Atul Goel, Director General of Health Services (DGHS) on October 16, 2023, subsequently discussed how to regulate antibiotics overuse and irrational use. The meeting decided that the CDSCO will be responsible for six monthly reviews of various fixed drug combinations of antibiotics marketed in various states.
The proposal was also placed in the DTAB’s 90th meeting held on January 25, 2024, where it has formed a subcommittee under the chairmanship of, headed by Dr D S Arya, Professor, Department of Pharmacology, All India Institute of Medical Sciences, to examine the matter in detail and give their recommendation for necessary action. The DTAB also recommended that a pharmacologist, medicine specialist and microbiologist should also be part of the committee.
It may be noted that the DCGI, in March this year, directed the State drug regulators in the country to cancel the product permission granted by them for manufacturing and marketing of certain antibiotic drug combination meropenem and disodium EDTA for injection since it is a new drug and needs approval from the Centre also.
Raghuvanshi, during the time, said that it has come to the notice of the Central Drugs Standard Control Organisation (CDSCO) that some manufacturers are involved in manufacturing and marketing of unapproved drugs which is not yet approved by his office for manufacturing or marketing in the country and falls under the category of new drug.
