MAKING TRIALS FAIR

Regulating clinical research continues to be an area of serious concern for the health authorities in India with increasing number of violations taking place in various parts of the country. The most recent one is reported from the state of Andhra Pradesh last week. In this case, 20 persons were subjected to clinical trials in Warangal district of the state by an unknown contract research company. The matter came to light after the death of one of the subjects due to serious adverse effects of the drug. It seems that the district health officials were unaware of any such trials in the area. In another instance,7 girls died during a trial of HPV vaccine conducted during 2010 by an NGO in the states of Gujarat and Andhra Pradesh. Nearly 25000 girls were subjected to the trials in which both the state governments were collaborating partners. The trial got suspended later in April 2010 and a committee was appointed to inquire into the irregularities of the trial. Now even after several months of submission of the inquiry report, the health authorities do not seem to be acting on the findings. Several other cases of violations of clinical trial guidelines were reported in the country for the last 10 years.

India has detailed guidelines under Schedule Y of the Drugs & Cosmetics Act to streamline the clinical research in the country. But, many of these guidelines are weak, need to be modified, notified and made into a part of the Act. It is the absence of the stringent provisions of the Act that emboldens the pharmaceutical companies and CROs to break the rules during clinical research. Take the case of formation of ethics committees. Although D&C Act stipulates establishment of an ethics committee at the trial site before conducting the research, many trials are being conducted either without them or with ineffective committees. Because of this, most of the protocol violations, negligence of researchers, failure of investigational products, adverse events due to concomitant medication, etc. go unreported. The health ministry needs to develop a suitable mechanism to regularly inspect operations of ethics committees  to curb deaths and serious injuries. The compensation to the victims of trials is another critical area that is being neglected by the pharma companies and the CROs. It is important that the government should stipulate adequate compensation to relatives of  subjects who die during a trial or get seriously injured.

by

Akshaya Srikanth

Pharm.D Internee

Hyderabad, India