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 CDSCOs 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 SCs 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 Chaudhary report came out in July.
Some of the changes to the medicine regulations that have come into force since January 2013 have resulted in uncertain regulatory approval timelines for clinical trials, which potentially hinders
Indias participation in global trials, Chandrashekhar Potkar, country medical director, Pfizer, said. The ultimate impact of a slowdown in clinical research is on patients. Any future proposed changes to the clinical trial regulations in India should focus on matters such as patient safety and data integrity.
Potkar added that the company has conducted more than 250 clinical trials in India over the last 13 years and currently has 13 trials in various stages of progress in 2014.
The CRO industry was the worst hit. The industry, which was slated to touch $1 billion in 2016 according to a 2012 Frost and Sullivan report, is trying to cope with the rapid and constant changes to the regulatory rules.
The CRO industry was considered as a sunrise industry at one point of time and created a significant number of technical jobs. There was also a considerable amount of forex revenue that the industry was earning and it was only expected to grow, Suneela Thatte, president, Indian Society for Clinical Research, said.
The key thing is that the process currently in place for the approval of clinical trial is unpredictable and complicated. Nobody can predict the timelines with reasonable accuracy, which can be of hindrance while planning a global clinical trial, she added.
India also stands to lose out on significant drugs that can serve unmet medical needs in India.
A trial testing an experimental regimen for tuberculosis treatment, specifically for drug-sensitive and multi-drug-resistant variants of the infectious disease, received CDSCO approval in January, nearly 10 months after its application. The drug has been engineered by New York-based non-profit organisation TB Alliance. It is partnering with the Council of Scientific and Industrial Researchs (CSIR) Open Source Drug Discovery platform to handle regulatory approvals in India. TB Alliance did not conduct phase 2 trials of (the regimen) in India. Our phase 2 trials were conducted in Africa (South Africa and Tanzania). CSIR-OSDD, however, has conducted research on the regimen within India, TB Alliance spokesperson Derek Ambrosino said. The phase 2 trials were initiated in 2010 while phase 2b trials began in 2013.
A CSIR spokesperson said that the organisation did not face any issues while seeking approval for the trial, adding, however, that the regulator faces shortage of funds and manpower and needs to upgrade itself technologically.