India has waived a requirement that pharmaceutical companies conduct local clinical trials before they’re approved for marketing in the country, if those drugs have been approved in select other countries. The move will fast-track approvals and benefit patients, India’s government says.
The New Drugs and Clinical Trials Rules, released last month, allows drugs to be approved in India if they’re already approved in the US, UK, EU, Japan, or Australia. Previously, it took three to six months to get a drug approved in India. The new rules will reduce that time to one month for drugs manufactured in India and three months for those made elsewhere. The clinical trial waiver will also extend to drugs that receive marketing approval elsewhere while a trial is underway in India.
The new regulation also includes provisions for compensation for clinical trial participants who suffer death, permanent disability, or injury as a result of a trial.
The Indian Society for Clinical Research welcomes the new approach to clinical trials, saying that the new rules “protect the rights, safety and well-being of patients, while ensuring a strong scientific base for the conduct of clinical trials.”
But Chinu Srinivasan, co-convener of the All India Drug Action Network (AIDAN), an advocacy group focused on access to health care and medicines, says the rules will affect quality and also harm safety. He is concerned that trials done in other countries will not have the ethnic diversity to ensure that drugs can be appropriately prescribed in India. “It is acceptable to have such waivers only in terms of national health emergency,” he says.
Srinivasan is also concerned that drugs will be automatically approved if companies do not hear from the Drugs Controller General of India (DCGI) within 30 days of submitting an application. “This is dangerous and is an invitation for corruption. This is washing of hands by the DCGI—it may not pass muster in courts if somebody challenges it,” he says.
India holds 1.2% of clinical trials globally, despite having 17% of the world’s population and 20% of the world’s disease burden, according to the World Health Organization. Trials conducted in India dropped from 500 in 2010 to 17 in 2013 following new rules instituted in response to allegations of lack of consent and other irregularities.