The Government of India, after becoming fully compliant with the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement in 2005, changed its rules in favor of the pharmaceutical companies to promote the conduct of new clinical trials in the country. The Government opened up India to concomitant Phase II and Phase III trials of new chemical entities (NCEs) discovered abroad as part of a larger slew of amendments in its Drugs and Cosmetics Act 1940, and Rules 1945, to ‘facilitate’ global clinical trials in India. It was felt this kind of ‘liberalisation’ would put India on the global clinical trials map.
Many major pharmaceutical companies and contract research organisations (CROs) started conducting their clinical trials in India because of the high costs of conducting clinical trials in developed countries, and the perceived advantages that India offered including an ethnically diverse population, premier medical institutions and other infrastructure and services available. A naïve patient pool, and most importantly, an accommodating regulatory environment were also perceived as important. Clinical trials account for a substantial amount of the costs of developing a new drug. India offers substantial advantages in terms of cost efficiency — the cost of conducting a trial in India is 50% lower than in the United States.1 The clinical trial market in India was estimated to reach US$2 billion annually in 2012, up from US $300 million in 2008.2 The country’s clinical research industry was [End Page 344] estimated at $100 million per annum with an annual growth of around 40 to 50 percent.3
However, the overall number of new applications and approvals for existing applications for clinical trials has been declining. This is evident from the fact that the Drug Controller General of India (DCGI) has cleared only 12 trials for 2013 till April as compared with 325 in 2011 and 2262 in 2012 and only 70 trial applications are pending in 2013.4 The reasons for this drop in 2013 are related to the changes in the regulatory mechanisms of clinical trials in India which resulted from the increased attention to the violation of rights of clinical trial subjects in India. This included the grossly inadequate compensation related to adverse events and deaths during clinical trials, which led to the demand for greater protection for the clinical trial subjects as well as strict regulatory provisions to govern the conduct of clinical trials in the country.
In May 2012, the 59th Report by a Parliamentary Standing Committee on the functioning of the Central Drug Standards Control Organisation (CDSCO), India’s main regulatory body for medicines and clinical trials, pointed to various irregularities in the functioning of the CDSCO. The Standing Committee Report described the many unethical practices followed for approval of drugs, which at times were made without any of the mandated trials being carried out. The report recommended major changes in the functioning of the office of the Drugs Controller General of India.5 Following this recommendation, in January–February 2013 two important changes took place. In January 2013, the CDSCO revised the rules for compensation and in May 2013, it was made mandatory for ethics committees to register with the DCGI.6
The year 2012–2013 also witnessed the filing of Public Interest Litigations (PILs) by civil society organisations with regard to the rampant unethical practices in the conduct of clinical trials in the country and reiteration of the demand for compensation for clinical trial subjects. The Supreme Court of India, on the basis of the PILs, has taken cognizance of the deaths that have occurred as a result of clinical trials and has directed the Ministry of Health and Family Welfare (MoHFW) to take necessary steps towards addressing the current scenario. The Court has demanded that the MoHFW and the CDSCO file the relevant data in this regard.
Increased activism and advocacy by organisations, media coverage on the violation of clinical trial participants’ rights, have resulted in some efforts to strengthen structures and processes towards ethical conduct of clinical trials. However, given the...