Clinical trials are picking up pace with 76 trials having got a no-objection certificate till May 2014, more than three times the number in the corresponding period of 2013. Nevertheless, the approvals are coming in slowly and the numbers seen in 2010 and 2011, when 500 and 321 trials were approved, respectively, is unlikely to be reached. The Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulatory body, had approved 24 trials till May 2013.
Conducting clinical trials had hit a roadblock in January 2013 when in January, following a public interest litigation filed by the non-profit Swasthya Adhikar Manch, the Supreme Court halted clinical trials of 157 studies until they were cleared by a three-tier system, consisting of three separate committees.
Of the 107 studies approved in 2013, trials to verify efficacy and safety of biologics — substances derived from living entities — ranked highest with 39 approvals. In comparison, till May this year only one experimental biological entity received approval to be tested on Indian subjects. Thirteen global clinical trials, usually a late-stage study that evaluates the efficacy of an experimental drug on a varied study group, got the CDSCO’s nod. Last year, a total of 17 global clinical trials were approved till December 2013.
Eight clinical research organisations (CROs) are among the entities that got the green signal to run the studies. Five Indian companies and six multinational companies also got the go-ahead.
Following the SC’s judgment, a six-member committee was constituted under Ranjit Roy Chaudhary in February, which gave a wide range of suggestions.
It said only accredited institutions and clinics can conduct clinical trials; consent should not just be on paper but an audio-visual recording is a must; and the sponsor is responsible for the medical expenses of any adverse event arising from the experimental therapy.
The government accepted these recommendations but with a slight variation. It said that a patient who faces any adverse medical event while participating in a trial would be compensated by the sponsor.
The above point, coupled with the necessity of an audio-visual consent, caused concern in the industry with companies saying that patients are hesitant to come on video while participating in trials for diseases such as AIDS, which have the perception of societal stigma attached to them.
Subsequently, many companies moved their trials offshore due to lack of clarity of regulations that were revised several times since the