Drug cos will have to submit bio-equivalence report

While the definition of healthcare is rapidly progressing from illness care to wellness care, to improve the quality of generic drugs, the government had asked all drug manufactures to submit their bio-equivalence report of new drugs in one year. And, if they do not furnish the report within the stipulated time, their drug manufacturing licenses would be cancelled. However, for the generic drugs already in circulation, the government had asked the drug makers to submit the efficacy test report within four years.

According to market experts, no drug manufacturer ever submits the bioequivalence report of any drug after getting the manufacturing license, which is a must to keep a track of potency of any drug.

According to sources, the Central Drugs Standard Control Organization (CDSCO) had directed the states to submit the bioequivalence report of every generic drug being manufactured in their respective states.

Bioequivalence test is done to check the efficacy of a drug on human body. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.

To check the potency of drug, both generic and branded drugs would be administered to 10 people each and after examining their blood report in every half an hour, the drug would be validated by the drug controller. The drug manufacturers have been told to submit their bioequivalence report from any certified lab.

In total, there are 60,000 formulations of generic drugs in the country and out of which about 40,000 formulations are generic, while rest 20,000 formulations are branded ones.

Reacting to the non-responsive attitude of drug manufacturers towards bioequivalence reports, a senior official said, "It is to be taken as the last chance as the government will not accept any excuses on the quality front. As the government has made it mandatory for all doctors to prescribe only generic drugs, its quality has to be at par with branded drugs."

Commenting on the development, Indian Pharmaceutical Alliance's Secretary General DG Shah said, "This is the move that we were demanding for long as drug makers were never worried about maintaining the quality of drugs, which is most important. When a drug has no effect on human body, what's the use of administering it to patients?"