REGULATING CLINICAL TRIALS
1. Clinical trials in India: new statistics, new regulations
Ever since the clinical trials have come under the scanner of the Supreme Court of India ("SC") following its order on January 3, 2013, the regulatory agencies, the Drug Controller General of India ("DCGI") and the CDSCO have intensified the monitoring of the clinical trials and the government had also set up Apex Committee and Technical Committee to supervise the clinical trials. In the last few years, they have issued notices in 235 cases and inspected 577 clinical trial sites. Increased proactive steps and new guidelines have resulted in a sharp decline in the number of clinical trial approvals. Till the end of August this year, the DCGI has given permission to only 162 clinical trial applications.
The government had also constituted 12 New Drugs Advisory Committees ("NDACs"). The NDACs met 78 times and evaluated 1,122 applications for approval of clinical trials, new drugs and fixed dose combinations. Among these applications, 331 were related to approval of Global Clinical Trial ("GCT"), which included clinical trials of new chemical entities and NDACs have recommended for approval of 285 applications. For 46 applications, no recommendation have been made. Out of the above 285 applications, DCGI has given approval to conduct clinical trials in 162 cases.
As per the directions by the SC to consider the views of all the states, a meeting of the Chief Secretaries, Health Secretaries of the State Governments and the Administrators of the Union Territories was convened by the Union Health Ministry. With a view to further streamlining clinical trials and minimizing the irregularities in the sector, some states have suggested restricting the trials only to the government-run hospitals in the country.
Keen on improving the current scenario, government has proposed a new Drugs and Cosmetic (Amendment) Bill, 2013, now under the scrutiny of the Parliamentary panel. The idea is to have a separate chapter on clinical trials and put all the existing guidelines and instructions from the DCGI under the framework of law. It has comprehensive provisions to monitor the trials and also deciding compensations to the victims. Further, an expert panel has been appointed under Prof Ranjit Roy Chaudhury, which recommended several changes including creation of a Central Accreditation Council to oversee the accreditation of institutes, clinical investigators and institute ethics committees for clinical trials in the country. It also suggested that trials should be carried out only at centers which have accreditation.
PSA view - India needs a robust system for conducting clinical trials and to ensure that trials are conducted in a scientific and ethical manner and in compliance to the regulatory provisions. There have been allegations that the approvals to the clinical trials are coming hard and slow after the SC order thereby impacting the overall performance of the clinical trials sector. This sector has great potential to grow but the slew of legislations and guidelines has already stopped several CROs to suspend trials here. As the government is aware of the implications from investments perspectives, it has started taking proactive measures to streamline the sector and gain back the confidence of the foreign players in the market, while also keeping the concerns and safety of subjects involved in the overall process.
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