Clinical trials must be allowed but with strict vigil

India has over 16% of the world’s population and a huge chunk of the global disease burden. But less than 2% of global clinical trials take place in the country. Is this good or bad? What is the shape of things to come?

The questions are triggering a polarizing discourse in the country. Much of the discussion pits ‘growth’ of the fledgling industry against what some perceive as the dangers of getting ‘mired in the quicksand of evolving regulation’. Is this a gross over-simplification of complex issues?

Union health minister Ghulam Nabi Azad’s candid admission last week that 436 lives were lost in the country last year during clinical trials of drugs has strengthened the case for  better regulation of such  trials in the country. In a written reply to a question in the Lok Sabha, Azad said the cases of 2012 are ‘under examination’. Only the final enquiry report will tell how many of those deaths were causally linked to the clinical trials. But concerns and criticism persist.

Stung by a hail of criticism, including from the Supreme Court, the government  has introduced new rules for clinical trials. But both health activists and the industry are calling for greater clarity in the new regulatory architecture.
So where do we go from here?

We all know that without clinical research, it is not possible to find newer and better medicines. We also know some of the reasons why big pharmaceutical companies are drawn to India: a technically competent workforce, patient availability and relatively low costs of conducting such research.

But India also has vast pools of illiteracy and poverty. Many of those volunteering for a clinical trial are not aware of their rights and ill-equipped to ascertain if the trial is following ethical guidelines.

Till date, a section of the clinical trials industry has been reluctant to acknowledge this basic fact and introspect on why and how risky practices have taken place in the past. Clinical trials need to continue. But there is no point pretending that there are no black sheep in the game, and that supervision has been lax.

The Supreme Court’s stinging rebuke of the Central government for its failure to stop dodgy clinical trials appears to have had its intended effect. Hence, the new rules for clinical trials in the country. These rules, notified by the health ministry, say that “in case of an injury or death during the clinical trial to the subject of the clinical trial, the applicant shall provide complete medical management and compensation in the case of  trial related injury or death” in accordance with the rules that have been instituted. Now, all ethics committees which review clinical trials are also required to register with the licensing authority within a stipulated time period.

But on both counts, much more needs to be done to ensure that clinical trials undertaken in the country meet the highest ethical standards. This is key to India’s ambitions of being a medical research hub.

“Neither the Drug Controller General of India nor the Ethics/Expert Committees have the competence to decide on the quantum of compensation. There should be an independent compensation tribunal just like Road Accident Tribunal manned by accountants, medical and legal experts and actuaries,” argues Dr Chandra Mohan Gulati, a Delhi-based public health expert and editor of Monthly Index of Medical Specialities.

“Registration of ethics committees is a step in the right direction as it has been a demand that health activists have been making for a while, but more needs to be done. There needs to be further mechanisms of accreditation and quality certification of ethics committees, and also more information in the public domain about ethics committees reviewing clinical trials, their composition and so on,” says Dr. Anant Bhan, a Pune-based researcher on bioethics and global health.
Pragmatism, profits and welfare of patients are not as implacably opposed to each other as they are sometimes made out to be. Effective regulation, which takes on board public concerns about safety of clinical trials, is actually a driver of growth, rather than a hindrance. In this globalised and interconnected world, nothing escapes scrutiny for too long. And it is in everyone’s interest to ensure that mechanisms are put in place and regularly monitored to ensure the safety of those taking part in a clinical trial. Facts matter. Perceptions matter equally. So more information in the public domain is a must.

Patralekha Chatterjee is a Delhi-based writer

@ patralekha2011