The institutions and hospitals conducting bioequivalence (BE) and bioavailability (BA) studies of drugs are soon to come under the direct monitoring of the Drug Control General of India (DCGI). The CDSCO is seriously considering to introduce the licensing and project approval system for the BE/BA centres in the country. Currently there is no requirement for any kind of approval from either DCGI or any other authority as per Drugs and Cosmetics Act, 1940 to conduct such studies.
Since the studies were conducted on the existing drugs and also the clinical trials on new drugs were not conducted, this area was so far ignored by the government. However, recently a number of controversial cases have been reported across the country in connection with unethical drug studies on human volunteers.
In India at least 24 major institutions and another 60 small laboratories and hospitals are conducting BE/BA studies on human volunteers for pharmaceutical companies for the purpose of new formulations. As there is no official recognition for such institutions or individual approval of such studies existing now, any drug testing/analysis laboratories and hospitals can conduct bioequivalence tests of existing drugs in healthy human subjects.
The latest in the BE/BA study controversy was the GVK Biosciences case. Though the company had denied the allegations that it was undertaking illegal clinical trials, following recent reports in the media, the company stated that it was taking up only bio-equivalence (BE) studies on generic drugs, and thus does not require DCGI approval. Therefore, there were no investigations/proceedings could be possible against the company under the Drugs & Cosmetics Act.
According to officials in the AP Drug Control Department, which has been appointed to investigate the issue, GVK had conducted BE studies, BA studies and comparative tests on drugs such as Azithromycin, Clarithromycin (both are antibiotics) for Ranbaxy, New Delhi and Oxibutanin for Glenmark, Mumbai and even that of US pharma majors including Pfizer.
It may be recalled that the Hyderabad Police has filed a case against the company, which started the BE studies recently at its 60-bedded hospital/testing centre here, on Monday based on the complaints received from four unemployed youths who alleged that they were paid merely Rs 30 after taking blood samples, as part of the tests.