The regulatory changes governing clinical research or drug trials in the country may have been done keeping the safety of patients and drug trial participants in mind. But, if industry experts are to be believed, the biggest loss, too, will be faced by the patient community.
The stringent norms for clinical trials in India, which were notified by the Ministry of Health and Family Welfare in January following directives by the Supreme Court, have already had an impact in the form of fewer drug trials. While, on the one hand, approvals have slowed down, on the other side, pharmaceutical companies are waiting for the uncertainty surrounding regulatory changes to be clarified.
Early this month, US agency National Institutes of Health suspended about 40 ongoing clinical trials in the country due to the regulatory uncertainty.
The ultimate impact, however, is likely to be on patients, since Government rules require new drugs to go through successful clinical trials in the country before they can be marketed in India.
About 321 clinical trials had been conducted in 2011, which dipped to 262 last year and till now only 56 trials have received approval from the Government.
Dhananjay Bakhle, Executive Vice-President, Lupin Ltd, said: “The current regulatory environment has discouraged Lupin to conduct clinical trials in India. We are now looking at destinations outside India for conducting our clinical trials.”
He added that besides the financial implication, the slow approval process for drug trials is another challenge and pharma companies are shying away from conducting trials.
“If Indian companies have to go outside for their clinical trials for developing new products, it will make an adverse impact on the number of new drugs introduced in India. Similarly, if global companies are discouraged in doing trials in India, their interest in bringing new drugs to India will also reduce. Net result is reduced treatment options for patients in India,” Bakhle said.
Compensation
There are certain contentious clauses, one of which is that compensation has to be given to a patient in case of any injury or ailment or death during the trial period. A senior executive from a pharma company, who wished to remain anonymous, said that while pharma companies are on board to foot the bills of participants in case of trial-related complications, the vague clause can mean that if the participant suffers from an injury or death in an unrelated event, such as an accident, the company will still have to compensate the patient or a relative. This, he said, was an unreasonable demand.
Suresh Menon, executive member of the Indian Society for Clinical Research, added that there are some illegal and unethical practices going on in the industry, but the Government regulations will penalise even those entities which have been conducting research in the most ethical manner, and, as a consequence, deter them from conducting research.
Amit Sengupta, Associate Co-ordinator, People’s Health Movement, however, refutes such claims. He said the issue is that a lot of vulnerable patients were being put through illegal drug trials since the regulatory mechanism was unable to handle the sudden rise in trials after 2005, when the Drugs and Cosmetics Act was amended.
“The Act has a provision to surpass the (drug) trial (for new medicines) where public interest is concerned,” he said.
Menon said that while India does need defined compensation rules (which were not there till the Government introduced the dialogue on this in 2011), these rules need to be balanced for all stakeholders and a few clauses (notified in January) go against scientific studies.
One such clause is that the investigator or sponsor of the drug trial will have to compensate the participant if the intended effects of the drug are not achieved or even if the patient is given a placebo.
Both of these, experts argue, go against the grain of research since one can only have a theory on the possible effects of the drug but cannot determine the same before the research itself.