Clinical Trials India is in Danger?
The government must ensure ethical clinical trials, a critical part of the pharma sector, without imposing draconian regulations that drive away companies.
The current problems affecting clinical trials in the country — a critical component of the $18 billion pharma sector and essential for developing affordable medication — are following a familiar pattern. There are certain commonalities in the manner in which regulatory oversight functions in various sectors in the Indian economy. The guidelines that seem adequate on paper turn out to be lacking in practice — not because there is something fundamentally wrong with them but because of flawed implementation. This could be due to corruption, inefficiency or a lack of resources. In an effort to plug the gaps, harsher guidelines are instituted. This does not address the real problem of implementation, of course; it merely creates counterproductive red tape.
As far as the first part of the problem goes — inadequate implementation — a parliamentary committee on health report tabled late last week offers ample evidence. The report castigates the government for irregularities in the clinical trials of a cervical cancer prevention vaccine carried by US non-governmental organization Programme for Appropriate Technology in Health (PATH). The results of those trials — the deaths of seven girls in 2009-10. Three years on, no accountability has been fixed; various regulatory bodies like the Indian Council of Medical research have allegedly been more active in protecting the HPV manufacturers’ interests than observing ethical guidelines.
This is not a rare occurrence. Clinical trials have become a lucrative proposition in India; various ethics committees have struggled to cope with the increased burden. As a result, they are often seen as compromised, little more than a rubber stamp. Given the vulnerability of those who take part in these trials, that is alarming. Many of the patients are from rural areas, unable to parse all the clauses and conditions of the consent forms they sign before undergoing these trials. Compelled by a lack of effective, affordable treatment in the normal course of things, they have few options in any case.
The government’s primary responsibility is towards them; regulatory bodies must ensure they are not exploited by pharmaceutical companies. But the new regulations introduced at the beginning of this year via the Drugs and Cosmetics (First Amendment Rules), 2013 are the wrong way to go about it.
Many of the clauses are both unfeasible and far too draconian. For instance, they do not make any distinction between side effects caused by the drug being tested and unrelated adverse impact; the company testing the drug is liable for both. No company is likely to take on such a risk. The regulations also state that the company must compensate the patient if the drug does not have the positive impact it is intended to — a fundamental misreading of the very nature of clinical trials. As a result, the number of clinical trials in India this year has plummeted.
This is potentially every bit as harmful as regulatory bodies’ failure to safeguard the interests of patients. Just as it is not in the latter’s interests to have pharmaceutical companies operating unhindered with the bottom line as their only consideration, it is also not in their interests to have the pharmaceutical sector that has made India a global hub of affordable generic medicine take a severe hit. The government must strike the correct balance.
