The Central Drugs Standard Control Organization (CDSCO) and the Directorate General of Health Services (DGHS) have requested lists of antibiotic combinations that have been granted manufacturing and marketing licenses by state and UT drug controllers in an effort to reduce the overuse and irrational use of antibiotics. They have been given until the end of the week to turn in this data.
In addition, the DGHS has asked state licensing authorities (SLAs) to keep an eye out for unapproved antibiotic combinations in their markets. If they find any, they must inform the CDSCO immediately. This initiative follows the recommendations of an expert group meeting held on April 25, 2023, at ICMR headquarters in New Delhi. The group focused on improving access to new antibiotics while controlling the misuse and overuse of existing ones.
The expert group suggested immediate action to ban inappropriate antibiotic combinations currently being sold and to prevent such combinations from entering the Indian market in the future.
On October 16, 2023, a meeting led by Dr. Atul Goel, DGHS, discussed strategies to regulate the overuse and irrational use of antibiotics. The committee decided that the CDSCO would review various fixed drug combinations of antibiotics marketed across states every six months.
This proposal was presented at the 90th Drugs Technical Advisory Board (DTAB) meeting on January 25, 2024. During this meeting, a sub-committee was formed, led by Dr. D.S. Arya, to delve deeper into the issue and make recommendations. The sub-committee's formation was documented in an official memorandum dated April 8, 2024.
The sub-committee's first meeting took place on May 1, 2024, via Webex. They made the following key recommendations:
1. SLAs should provide a list of antibiotic combinations they have licensed for manufacturing and marketing in their states.
2. SLAs should monitor their markets for unapproved antibiotic combinations and report any findings to the CDSCO immediately.
Based on these recommendations, the committee sent out a formal request to all state and UT drug controllers. They have asked for the lists of licensed antibiotic combinations to be submitted within two weeks. They also asked SLAs to actively monitor for unapproved combinations and take necessary actions under the Drugs and Cosmetics Act and Rules. SLAs are to report to the CDSCO regularly and with high priority.
(Input from various sources)
(Rehash/ Susmita Bhandary/MSM)
