THE DEBATE ON CRITICAL TRIALS: RIVAL VIEWS

On one hand are the protagonists of the rapidly growing clinical-trial industry who argue that the pronouncements will make clinical trials costly and time-consuming, will reduce India’s competitiveness as a clinical trial destination, will impede the growth of this industry and therefore will be a loss-making proposition for the nation. On the other hand, there are the likes of the petitioners before the Supreme Court, who claim that the Indian citizen deserves more respect than being made guinea pigs primarily at the hands of foreign pharmaceutical industry.

Before assessing the respective positions let us examine the broad canvas of the clinical trial of new drugs. Clinical trial is an essential part of the process of discovery of new drugs and its commercialisation. Once a new drug has been discovered, it must be tried on a sample of the target population for ascertaining the right dosage and potential side-effects. Without this trial, a new drug is not allowed be marketed in a country. This trial is done in three phases.

Phase 1 trials are not allowed in India for new drugs discovered abroad. Prior to 2005, phase 2 and Phase 3 trials were allowed only after a phase lag, which ensured that before any clinical trials were conducted in India, the potential ill-effects of the drugs were known from trials abroad. However, in order to openup the sector, India allowed concurrent phase 2 and phase 3 trials. In practical terms, this enables the pharmaceutical companies to conduct the said phase trials in India without waiting for the results of the trials conducted in the drug-discovering country. Post-opening up, there were certain trial calamities, which some say, could have been avoided if there was a phase lag, or if the trial population had access to better emergency care facilities. The Supreme Court seems to be hedging these very risks by securing a multi-layered approval process, which is expected to filter out risky trial proposals.

‘The Independent’ newspaper of UK has recently reported that the Indian clinical trial industry was currently estimated at £310 million (over Rs. 3,100 crores) and projected to grow to £600 million (over Rs. 6,000 crores) in the next three years. Instead, the industry has actually shrunk by £100 million (over Rs. 1,000 crores), adds ‘The Independent’. This loss of business is being attributed, inter alia, to (a) the new compensation rules; (b) oversight of public ethics committee — which is expected to be tougher on proposals; (c) provisions of inspection of clinics by CDSCO; (d) multilayered approval process within the office of the Controller General of Drugs. These new variables in the approval process of clinical trials in India, it is argued, will make the trial costlier and lengthier.

Government statistics suggest that in a span of 7 years (2005-2012) around 2,644 people died during clinical trials. Some 80 of these deaths were attributable to the clinical trial itself. Assuming that these figures are robust and not under-reported, the opening up of the clinical market has led to revenue of Rs 3,100 crores annually for a loss of 10 lives at the minimum and 378 lives at the maximum. This puts the value of life of the citizen to Rs 310 crores at the most and about 8 crores at the least. The question that will face the protagonists of ban on clinical trials is whether as a nation we put higher value to the lives of our citizen? Do we have the moral standing as a nation to disregard this economic benefit when starvation deaths still make headlines, bonded labour is still not a memory and where governments announce ex-gratia payments to the tune of Re 1 to Rs 10 lakhs for death attributable to its agencies? The risks of clinical trials may well seem worth taking even if the death figures were 10 times higher than the highest reported. Added to this is the fact stated in a note prepared by the Indian Society of Clinical Researchers that clinical research ensures better and more effective treatment for several thousand patients in India.

On the other hand, the protagonists of the current policy face an equally difficult question. In a country where life is held so precious that we make an example out of a disillusioned persons attempting suicide and put him behind bars for years and where law proscribes euthanasia, can the executive quasi-legislate to allow individuals to take equal risks? And our failure as a nation to provide blanket of security to our entire citizenry cannot mean that we allow them to be used as a guinea pig. If the spiral is set off, it is difficult to fathom where this will stop. Organs can be traded with impunity, human trafficking could assume legitimacy beyond a threshold value, and the list can go on.