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Saturday, November 27, 2021

Pharma: Clinical trials

Confusing clauses in the law


The amended law needs to be relooked by the Health Ministry
AMIR HOSSAIN | Issue Dated: November 30, -0001, New Delhi
Tags : Clinical trials | Central Drugs Standard Control Organisation |

Over time, the Indian pharmaceutical industry has come under the scanner several times on issues ranging from counterfeit medicines to clinical trials and absence of regulations. However, the Health Ministry has tried to regulate clinical trials in India at last by implementing the Drugs and Cosmetics (First Amendment) Rules, 2013. But the government measures still appear to fall woefully short of the requirements. Since 2010, about 26 new drugs have been approved by the country's apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), without conducting any clinical trials on local populations. Such lapses can only create fresh problems for the regulator and for the industry.  Astonishingly, these 26 drugs have been approved even in the wake of a disclosure in India’s Parliament that “38 drugs were sold without trials between January 2008 and October 2010.”

As is often the case, even the newly amended law is not above criticism. As per the law, it is mandatory for all companies and institutions to meet all the medical expenses for any illness or injury of those subjected to clinical trials. Consequently, many American and Canadian companies have stopped clinical trials in India with the help of a clause called "unreasonable claims" by subject-patients. Suneela Thatte, President of the Indian Society for Clinical Research, has criticised the amended rules by saying that “This does not specify what type or cause of illness or injury. Thus a trial participant may be involved in a traffic accident or assaulted by someone, but under the open-ended clause, the trial sponsor has to cover all costs. This is unreasonable.”

The Ministry of Health should revisit the amended laws in the interest of not stalling clinical trials in India. Otherwise, the country may be forced to approve more of such drugs without clinical trials.

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Issue Dated: Feb 5, 2017