The women, most of whom are poor quarry workers, were unaware that they were being used for trials conducted by Hyderabad-based firm Axis Clinicals for a breast cancer drug.
The Andhra Pradesh government has now directed the district health officials to probe the incident. “There is no illegality about clinical trials but there has to be proper monitoring,” said Andhra Pradesh health minister DL Ravindra Reddy. The state government is also awaiting a compliance report from the Drug Controller General of India (DCGI) on this matter.
Axis Clinicals is engaged in bio-availability (BA) and non-equivalence (BE) studies and has a facility that includes a clinical pharmacology unit as well as a bio-analytical laboratory for drug analysis. When contacted, Business Development AGM Abhijit Chowdhary said the company was never involved in any trials for new drugs. “We were only conducting BE studies on healthy volunteers for a generic drug and not trials for any new drug. However, he refused to give any further details about the drug or the pharmaceutical company’s name for which the BE trials were being conducted.
“We were conducting these trials with the prior permission from DCGI and now we are cooperating with them for any kind of clarifications or reports,’’ Chowdhary said.
Andhra Pradesh Drug Control Administration head RP Meena said the state had no power to regulate clinical trial research organisations (CROs). The CROs are supposed to form an ethical committee which should meet frequently to discuss the type of clinical trials being undertaken, the side-effects if any, and keep a record of who the subjects are and what precautions have been taken to do away with any side-effects.
But the so-called ethical committee remains only on paper, and a large number of innocent patients are becoming guinea pigs for all kinds of clinical trials. “The ethical committee is not functioning properly,” said a top official from a pharmaceutical company. “The missing links in the trial registry have to be plugged through necessary rules and regulations and effective implementation,” the official said.
There are several reasons why drug companies are drawn to India. These include a technically competent workforce, patient availability and a friendly drug-control system. However, the booming clinical trial industry is raising concerns because of a lack of regulation of private trials and proper ethics review, says a WHO report. More than 650 clinical trials are currently taking place in the country and all the leading global pharmaceutical companies have started moving their key trials to India. The country has a large number of patients in areas for clinical research, such as diabetes, cardiovascular disease, HIV and oncology.
The global clinical research market is pegged at around $20 billion with India’s share being about $485 million. The latter is projected to cross the $1-billion mark by 2015, a Frost & Sullivan report says. Clinical trials are needed and new medicines are imperative, but more than the investment that would come in, the bigger task at hand is to ensure safety of volunteers and generate quality data, adds the report.
