New Indpress
 
Bangalore, Nov 13: Karnataka, among many other states across the country has become an exclusive market for clinical trials, with no law to control and regulate the procedure followed and the drug induced for the trials. Over 10 percent of the adverse drug reactions (ADR) reported are due to the clinical trials, claim doctors.

There is no authority and government body to record the number of trials being conducted in the state. The Drug Control Department grants permission for conducting clinical trials, but it is not monitored. According to the Drugs and Cosmetic Act, a monitoring committee had been set up, which apparently does not apply stringent methods to regulate clinical trials.

Pharmaceutical companies, medical practitioners and multinational firms tie up to conduct clinical trials in various parts of the state. People are being used as guinea pigs and though a drug may show reliable clinical outcomes in other countries, the efficacy might not prove beneficial in India.

Chairman of Krupanidhi College of Pharmacy Dr Suresh Nagpal said that clinical trials are being conducted without acknowledgement from any administration. Last year the clinical trial market had a turn-over of about Rs 2,250 crore.

Over 40 per cent of students who pass out from medical colleges are under qualified and have no experience in the field, he said. These students work in primary health centres and government hospitals which conduct these trials, he said.

“Karnataka has a huge patient population, especially in districts like Bellary and Shimoga, where vector diseases are most prevalent. About seven pharmacological industries are involved in clinical trials in Karnataka,” added Dr Nagpal.

President of the Society for Pharmacovigilance of India (SOPI) Dr D D Santani said that it will approach the central government and suggest to form a law and a licensing system for hospitals to conduct clinical trials.

Member of SOPI Prof Dr R S Thakur said that cost savings on trials outsourced to India was between 30 per cent and 50 per cent. Trials are going on in areas such as psychiatry, neurology, cardiology, gastroenterology, endocrinology, dermatology and ophthalmology.

The clinical research services market in the state was valued to be over a hundred crore last year. The market is expected to grow further in the next 10 years. Thakur said that the government has to address this issue. Though awareness of improved clinical-trial training is slowly increasing, the issue of ethical standards continue to be an area of concern.