In medical science, bioavailability is considered to be a critical factor while administering a standard drug dosage form on patients. Treating a disease or a symptom depends largely on how efficient is the bioavailability of the drug in a patient's body. The drug licensing authorities, therefore, have a responsibility to ensure that every dosage form, allowed for manufacturing in the country, should have certain definite standards of bioequivalance of the drug originally approved by the DCGI. But, in India while granting manufacturing licenses by state drug authorities, there is no practice of demanding quality test of the product from the intending manufacturers. What they verify is only whether the drug from which formulations are sought to be made, is approved by the DCGI or not. No state drug officials insist on a stability test and bioequivalance studies of the product before issuing the manufacturing license. In short, the state licensing officers do not care to know whether the dosage form, they allow for manufacture, will work or actually fit for patient consumption. By granting manufacturing permission for formulations without bioequivlance study, the licensing officers are, thus, exposing millions of patients in the country to the grave risk of deficient drugs. The state drug authorities, however, have a safety clause. They are not granting any marketing permission but are issuing only a manufacturing license. A question remains to be answered here is whether a manufacturing license issued at state level automatically entitles manufacturers to market the product throughout the country. The Drugs & Cosmetics Act is silent on this matter.
Be that as it may, the fact remains that a large number of the single ingredient brands and generics of any drug, currently marketed in the country, are without submitting a bioequivalance report. In the case of fixed dose combinations, not even one bioavailability study is being insisted upon as the manufacturing licenses are usually issued by the state drug authorities. This is despite the fact that a combination is considered to be a new drug and permission for marketing combinations is expected to be granted by only DCGI. And the number of combinations is running into several thousands in the country and almost all of them are irrational and harmful. Some of these combinations are nimesulide with paracetamol, ampicillin with cloxacillin, amoxicillin with cloxacillin and theophylline with ephedrine and phenobarbitone. These products have no scientific rationale and in some cases not even their toxicity acceptance has been established. To a large extent, these inadequacies in drug administration have to be tackled at the state level itself. Currently, most state drug authorities have no adequate number of technically qualified people and administrative freedom. Establishment of a technical advisory board on the lines of DTAB in each state can be of great help to streamline the system of drug licensing.