Indian government approves 50 clinical trials in one day

BMJ 2013; 347 doi: (Published 15 July 2013) Cite this as: BMJ 2013;347:f4455
  1. Meera Kay
  1. 1Bangalore

India’s health ministry approved 50 new clinical trials on 2 July, after a six month lull.

The Drug Controller General of India, who heads the Central Drugs Standard Control Organization, usually grants approval for clinical trials. But in January this year the Supreme Court of India told the health secretary to monitor clinical trials of drugs on humans to ensure that statutory procedures were followed.1

The court directive came after Swasthya Adhikar Manch, an independent group that works to increase health awareness, filed a public interest litigation in February 2012 about illegal clinical trials across the country after news surfaced of alleged illegal and unethical drug trials involving mentally challenged patients at the Mahatma Gandhi Memorial Medical College in Madhya Pradesh.2, the business news website, has reported that on 26 July the health ministry will present details of the new regulatory regime it has put in place for clinical trials.2

In the six months since the court’s ruling on 3 January, the ministry approved just six clinical trials, although the order was only about new chemical entities and the ministry could have approved other trials.

Jagdish Prasad, director general of health services, told Livemint that the 50 trials approved on 2 July include some for new drug approvals, experimental drugs, fixed dose combinations, and new chemical entities.

CM Gulati, editor of Monthly Index of Medical Specialities, told Livemint, “This is not simply about approving trials, as the health secretary will be held responsible for monitoring all aspects.”

The number of clinical trials approved in India has fluctuated over the last few years. Just 65 trials were approved in 2008, although this rose to 391 in 2009, 500 in 2010, and fell again to 262 in 2012.


Cite this as: BMJ 2013;347:f4455


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