Most of the dosage forms of approved drugs in the market are with serious functional inadequacies as the samples are not tested for bioequivalence before the drug authorities grant the manufacturing licenses in India. As a result, the therapeutic effect of drug formulations of same drug with same strength by different companies varies. As there is no provision to ensure the required bio-availability of the drugs from the dosage forms individually in the absence of bioequivalence test before approval, it is always left to the fate of the patient as well as the assumption of the doctor to choose the right pill.

Although there were deliberations in the Drug Technical Advisory Board (DTAB) by several drug experts in the past on the need to make bioequivalence test mandatory, no serious attempt was ever made in this direction by the government as there is stiff resistance from the industry. The industry is not in favour of the same as conducting bioequivalence test of each dosage forms while seeking the manufacturing and marketing license would increase the cost.

At the same time, the drug companies which export the formulations to regulated markets and also to other foreign markets invariably do the bioeqivalance tests irrespective of the costs incurred as it is mandatory in the regulated as well as unregulated markets. The defective products are often go unnoticed in India as there is not strict ADR monitoring in the country.

According to Dr C J Shishoo, a pharmaceutical expert and a consumer activist, since there is no effective system for ADR monitoring unlike the other pharmaceutically developed countries, the defective products make a success in marketing despite many dosage forms sold in the country show wide variations in bioequivalance. "As there is no mandatory bioequivalance test requirement adopted in the country for approving drug products, the licensing authorities can not even ask the manufacturers to produce certificates to prove the efficacy of his formulation," he added.

There are several new launches even from major pharmaceutical companies, which were duly approved by the state and central drug control offices for manufacturing and marketing in the country show poor efficacy as the dosage form does not have the therapeutic effect as it is expected.

A senior drug control official in the country admits that since the analytical chemistry often differs from therapeutical chemistry, a bioequivalence test is always required to evaluate the actual efficacy of the product. All dosage forms should always be bioequivalent and identical and if it varies, obviously the same therapeutic effect cannot be expected from all the products. "Though ensuring the bioavailability and identical nature of the dosage forms is essential, it is unfortunate that in India it is still not mandatory," he said.