CDSCO asks SLAs to Provide list of antibiotic combinations licensed for manufacturing and marketing
New Delhi: With an aim to reduce the excessive and irrational use of antibiotics, the Directorate General of Health Services, the Central Drugs Standard Control Organization, has written to all states and UT drug controllers, requesting to provide the list of antibiotic combinations licensed by them for manufacturing and marketing in their respective states till date within 2 weeks.
Furthermore, the Directorate General of Health Services has urged all the state licensing authorities (SLAs) to monitor the availability of unapproved antibiotic combinations, if any, moving into the market under their jurisdiction and inform the CDSCO on priority.
This came with reference to the meeting of the expert group held on April 25, 2023, at ICMR HQ, New Delhi, on the pathway for strategic access to new antibiotics and regulation against excessive and irrational use of antibiotics in India.
One of the recommendations of the expert group was to take steps to ensure that inappropriate combinations being sold currently should be banned immediately, and steps should be taken so that the inappropriate combinations do not find their way to Indian markets in the future.
Previously, a meeting was held under the chairmanship of Dr. Atul Goel, DGHS, on October 16, 2023, to discuss how to regulate antibiotic overuse and irrational use. The committee has decided that CDSCO will be responsible for 6 monthly review of various fixed drug combinations of antibiotics marketed in various states.
Further, the proposal was placed in the 90th DTAB meeting held on January 25, 2024, wherein the committee deliberated the matter and a sub-committee was constituted under the chairmanship of Dr. D.S. Arya to examine the matter in detail and give their recommendation via O.M. no F.No. 15-05/2024-DC dated 08.04.2024.
In this regard, the first meeting of the subcommittee was held on May 1, 2024, through Webex, wherein the following actions were recommended:
1) Request SLAs to provide the list of antibiotic combinations licensed by them for manufacturing and marketing in their respective states.2) Request SLAs to monitor the availability of unapproved antibiotic combinations if any, moving in the market under their jurisdiction and intimate CDSCO on priority.
In view of above, the committee further recommended to all states and UT drug controllers,
"You are requested to provide the list of antibiotic combinations licensed by you till date within 2 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."
To view the official notice, click the link below:
