Hyderabad: Fixed dose combinations of vitamins, minerals, probiotics and topical medicines might be banned as the Drug Controller General of India is considering the Kokate Committee report on these drugs.
The committee reviewed 6,214 drugs and according to its members, about 1,083 were found to be irrational. The committee has classified the drugs under four categories — irrational, requires further deliberations, rational and requires additional data.
A senior drug controller said, “These combinations are largely of supplementary medicines like vitamins, probiotics and other supplements which are required to boost the immunity of a patient undergoing treatment. The flaws found by the committee were that the companies were supposed to register and submit documentary evidence in a specified format to prove the efficacy of the drugs. But that has not been done.”
While the production of these supplements continues, the actual market report in terms of health benefits or abuse has not been documented by these companies. Independent pharmacologist and hospitals have recorded the adverse drug reactions, which have been studied by the committee.
A senior drug control officer said, “These reports have been compiled and studied and the irrationalities identified.” With the Indian Drug Manufacturers Association insisting on removing food supplements as medicines so that they can be sold without prescription, the drug controller is not convinced.
A senior officer said, “This will lead to misuse as anyone can order them and there will be no control. Presently, the doctor’s prescription is a valid document to understand the need for supplements. But if it is removed than one is not aware what the patients are consuming.”