A supportive eco-system is developing to ensure safety but since the system is by and large self-regulatory, it will be a while before it is fully secure.
N K Ganguly,
Former Director General,
Indian Council of Medical Research
These trials are not easy ... They need a surveillance infrastructure and a supporting eco-system. Both are developing. In another five years, our clinical trials environment will be very good
In any clinical trial, tests are done on sick patients and on healthy ones and you check for adverse reactions. So, it is just possible the children who died at AIIMS did not die due to the drugs, I cannot say for sure at this moment. The thing I can say though, is that the system of checks is well-designed — if the results show an adverse reaction, it will be brought to the AIIMS Ethics Committee. In PGI Chandigarh, where a drug was being tested, one such adverse reaction occurred and the trials were stopped.
The major reason for why we need to do clinical trials, of course, is that India is now developing new molecules on its own — previously, we did just limited trials since we were copying drugs developed abroad. Right now, new molecules have been developed for diabetes, TB, cancer, and so on. So we have to do all stages of tests, from I to IV. India has also become a very large hub for producing vaccines and this again makes clinical trials essential.
These trials are not easy — most vaccine trials, for instance, can’t be done in a controlled hospital environment but need to be done in field settings. They need a surveillance infrastructure and a supporting eco-system. Both are developing, both will take some time, and in the meanwhile, there will be some unethical practices. But it is a vast country and we are trying to limit this. We’re planning for a new drug regulation authority, there are guidelines for clinical research, a good clinical practices guide, accreditation services for hospitals, Schedule Y (a compendium for clinical trials) has also been updated, and a biotech regulatory authority is in the offing — all told, we’re creating a good regulatory environment for trials.
As for the eco-system, now that around 100 Clinical Research Organisations (CROs) are here, including several top-class global ones, there are training units coming up; masters degrees in clinical research and data management are being offered; Pune University is starting one. The Indian Council of Medical Research has opened five toxicology centres to do the pre-clinical trial part of studies; there are two companies in Mumbai that help find the various pathways through which a drug works; companies are doing pharmacodynamics and pharmacokinetics; several primate centres are coming up; all existing animal facilities have been upgraded… None of this was there earlier and as more such systems develop, the process will get better.
The way the actual testing works is that the sponsor clears every project with the Drug Controller General of India (DCGI) and, as part of the process, has to have a Management Committee, an Ethics Committee and a Data Safety Management Board; there are then various monitoring committees and the DCGI is training people to ensure these guidelines are being followed. The structures are all there and the larger trials, by the Bill and Melinda Gates Foundation for instance, are being done under these rules. But much of this is self-regulatory and there will be lapses. The rules and their implementation are being strengthened and as the support eco-system gets better, the chances of regulatory failure also decline. In another five years, India will have a very strong clinical trials environment in place.
(As told to Sunil Jain)
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Harinder S Sikka,
Director, Corporate Affairs,
Piramal Healthcare Limited
Given the callous attitude of an over-stressed medical fraternity, a blanket permission to conduct clinical trials was always expected to leave serious consequences in its wake
On January 1, 2005, India became TRIPS (trade-related aspects of intellectual property rights) compliant. In one stroke, India’s hitherto reliance on drugs manufactured and patented by MNCs became out of the reach for thousands of small and big Indian companies who had been copying them with impunity. But this also meant that cure for diseases prevailing in the Indian subcontinent now had to be researched by our own scientists, a challenge that was expected to be mired in controversies and ethics.
Having become a recognised global player for manufacturing the highest-quality drugs at lowest costs, Indian companies were overzealous in catapulting themselves to lap up the new opportunity. But one question that hung like a Damoclean sword was whether this new-found freedom would actually reduce our citizens to guinea pigs.
Our legal framework provides more laws than actually needed. Yet, there has always been a question mark on its effective implementation on the ground. Given the callous attitude of an over-stressed medical fraternity in the government and private hospitals across the country, a blanket permission to all and sundry for conducting clinical trials was always expected to leave serious consequences in its wake. An overburdened judiciary, an ‘anything goes’ attitude and non-adherence to professional guidelines further facilitated in the mushrooming of clinical trials as a business.
The harsh reality is that had there been a strong pharmaco-vigilance mechanism in place, incidents like the one in AIIMS would not have occurred. Compounding the problem further is the fact that the Drugs Controller General of India (DCGI) has not been allowed to function as an autonomous body. On the contrary, it suffers from bureaucratic and political interference, which in turn hinders its independent decision-making. At the US Food and Drug Administration, there are hundreds of scientists and researchers on its permanent role, ensuing razor-sharp scrutiny, total compliance of regulations and speedy decision-making. In contrast, even as India has the required legal framework in place, the overall system still remains woefully inadequate in addressing the all-important and crucial safety and efficacy norms and regulatory and pharmaco-vigilance issues.
Healthcare is a global issue. Rapidly rising research costs are putting a huge premium on new drug discovery. All avenues therefore, must be discovered to help save mankind from healthcare disasters. But while executing noble intentions, we need a strong, independent body that can ensure discipline, strict compliance, zero tolerance and utmost professionalism to counter any abuse in clinical trials. Just because AIIMS is a government-controlled institution, there’s no guarantee that all guidelines and regulations would have been strictly followed. The only way to check this imbalance is to follow established models that have been in practice in the developed world for many decades. And to achieve that, an autonomous DCGI with world-class infrastructure is an absolute must.