“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 (Central Drugs Standard Control Organisation) from time to time on priority,” the drug regulator said in a letter to state drug regulators and port officers.
ET has seen a copy of the letter dated May 16.
The move comes following recommendations from a sub-committee of experts that was constituted on the behest of India’s top technical body on drugs, the Drugs Technical Authority Board (DTAB).
The meeting of the sub-committee was held on May 1.
Last year, the expert committee had held a meeting in the Indian Council of Medical Research (ICMR) on a 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 ban inappropriate combinations being sold in the country immediately and to ensure that such combinations do not find their way to India markets in the future.Subsequently, a meeting was held under the chairmanship of Directorate General of Health Services (DGHS) Atul Goel to discuss how to regulate antibiotics overuse and irrational use.
The committee in October last year decided that the drug regulatory authority will be responsible for six-monthly reviews of various fixed drug combinations of antibiotics marketed in various states.
The proposal was placed in the 90th DTAB meeting held in January this year and a sub-committee was constituted under the chairmanship of D S Arya to examine the matter in detail and give their recommendation. The DGHS letter to state authorities is based on the recommendations of this sub-committee.
