Clinical trials would be more popular in India if they had safer,clearer protocols.
On October 21,after an undue delay of almost 10 months,the ministry of health,appearing before the Supreme Court,offered to get 157 concurrent global clinical trials of new chemical entities (NCEs) reviewed and approved by the technical and apex committees. These GCTs had been scrutinised only by the new drugs advisory committee (NDAC) and approved by the Central Drugs Standard Control Organisation (CDSCO) a few days before the Supreme Court order of January 3,2013. The court had,at that time,directed that there be three-tier scrutiny of all clinical trials. Why did the drug regulator and the ministry of health wait for 10 months? Perhaps they expected the PIL on which the Supreme Court is monitoring the regulation of clinical trials to fade away.
As reported in this paper,pharmaceutical companies and contract research organisations involved in clinical trials in India are indeed threatening to move trials out of the country. How far are such threats justified in light of the apex courts demand for strict monitoring of the clinical trials?
In medical science,experimental drug research or clinical trials with human subjects are indispensable. They must be conducted before new drugs are introduced and used in the treatment of diseases. Till 2005,our laws allowed clinical trials of NCEs after a phase lag,that is,after a phase of trial had been completed in the country where the NCE originated and reports of its safety and efficacy had been made available. Such a regime provided better safety for Indian patients participating in the clinical trials. With amendments made to the law in 2005,the condition of a phase lag was removed for phase II and III clinical trials. It made way for concurrent global clinical trials of the NCEs. The October 21 Supreme Court order affects only such concurrent clinical trials,not others.
From the data provided by the government and cited in the court order,the NDAC had received a total of 1,122 applications for clinical trials and only 331,or 30 per cent,of them were for concurrent global clinical trials of NCEs. As of now,for 70 per cent of the clinical trials approved by the drug regulators,no serious dispute in regulation has been reported. So to argue that the uncertainties in related regulations are killing scientific activities is only partially true,at best.
The discovery of new molecules and the conceptualising and designing of human clinical trials may constitute an advance in science. But all global clinical trials of NCEs are conceptualised and designed in other countries. The NCEs are patented abroad. The doctors-investigators involved in India learn,at the most,how to implement protocols to test such drugs on Indian patients. In fact,our scientists might have contributed more in some of the other 791 trials scrutinised by NDAC.
The Supreme Courts stipulation that committees scrutinise not only ethics and patient safety but also issues related to the relevance of testing such molecules in India,and in the event of a successful trial,the availability of the newly discovered drugs to Indian patients,is absolutely valid. The data presented to the Supreme Court in January 2013 showed that of the 475 global clinical trials of NCEs,conducted from January 2005 to June 2012,only 17,or 3.6 per cent,were introduced in the Indian market. And despite using Indian patients for such discoveries,these 17 patented drugs were neither freely available for participants,post-trial,nor marketed to them at concessional prices.
Thus,this is a crisis of the clinical research business and not of the science of clinical research. And this crisis was brought about by the business people themselves as they exploited the laxity in regulations from 2005 to 2012.
The industry would receive more popular support if it made public the protocols and the standards used to assess injuries and deaths in trials,if it were more efficient in providing compensation for those who suffer and ensured that,irrespective of the cause,all patients suffering from serious adverse events are freely cared for with the best available medical care.
Jesani is editor,Indian Journal of Medical Ethics