The Indian clinical trials industry is estimated to be worth $400 million and trends suggest it will only grow. Considering these factors, the government had ample time and reason to fashion a strong regulatory mechanism to protect its citizens who are the subject patients and ensure that all norms were followed stringently by the CROs and the pharma industry.
As usual, the government has been found wanting and in its absence the Supreme Court, in response to a PIL filed by the Swasthya Adhikar Manch, has banned all clinical trials for new drugs on humans until a monitoring mechanism is set up. The court cannot be faulted for adopting a tough stance. Its intervention has come in the wake of charges that the medical companies do not adhere to the norms for such trials. Between 2005 and 2012, the government has said that 2,644 people died during clinical trials of 475 new drugs out of which 80 deaths were found to be attributable to the trials. The Swasthya Adhikar Manch has said these figures were merely passed on by the government from the private conductors of the trials and were not accurate.
The controversies over the numbers and how many deaths were due to trials and how many due to the natural progression of the disease in terminally ill patients are inconclusive. While the Central Drugs Standard Control Organisation (CDSCO) has come out with draft compensation rules, health activists have pointed out a number of loopholes which have been well documented.
Besides, the CDSCO has come in for severe criticism from the Parliamentary Standing Committee on Health and Family Welfare in 2011 over its tardy functioning. As if this were not enough, the Ranjit Roy Chaudhury expert committee, appointed to recommend reforms in drugs regulation and clinical trials, has said the myriad remedial steps already suggested have been largely ignored. The CDSCO suffers from severe personnel and infrastructure shortages. Worse, its lack of autonomy combines with these leading to delays in decisions. It also lacks in-house expertise in relation to regulatory issues, the committee has reported. All this goes to show the obvious: piecemeal remedies in an area as crucial as healthcare cannot be the answer.
Over the years, India has emerged as a major centre for clinical trial of new medicines. Pharmas in the West have been finding it difficult to conduct clinical trial of drugs as the laws have become strict there. Besides, they have to pay huge compensation in case those on whom the drugs are tested suffer even mildly. In India, there is little awareness among the public about the norms that govern clinical trials. Since a majority of the poor in India cannot afford medicines, they are considered better guinea pigs than those who have been dependent on drugs. Also, the companies have to spend only a pittance as compensation.
If the government fails to convince the apex court about the steps it has taken to enforce the norms for clinical trials, the danger of it extending the ban on clinical trial cannot be ruled out. Needless to say, that will not be in the interest of medical science and the Indian pharmaceutical industry. During the last few decades, India has emerged as one of the largest producers of drugs, which are cheaper than those produced by their Western counterparts. Clinical trials of new medicines are a must before they can be marketed. If there is a blanket ban, the Indian pharmaceutical industry will lose its ability to develop new drugs.
yogesh@newindianexpress.com