Clinical drug trials: registration of contract research organisations put on hold

Absence of regulatory infrastructure to assess them cited as reason

By Jyotsna Singh
Published: Tuesday 22 January 2013

Even as the Supreme Court has slammed the government for allowing unethical drug trials in the country, the Centre seems to be dragging its feet over regulating them. A panel set up by the government to look into the matter has deferred the decision to register contract research organisations (CROs) that help pharmaceutical companies conduct clinical drug trials with the Drugs Controller General of India (DCGI).

The government had formed a committee, headed by Y K Gupta, head of department of pharmacology at the All India Institute of Medical Sciences, to examine the draft proposal for amendments to the Drugs and Cosmetics Rules of 1945. Registering CROs with drug regulatory authorities like the DCGI and Central Drugs Standard Control Organisation, is part of the proposal of the government. A meeting of the committee was held last week which decided to defer the decision on the issue, citing lack of capacity of the authorities to assess CROs.

Clinical drug trials have been under attack after it was found that unethical practices are being employed in conducting such trials in the country, leading to deaths and adverse health impact on people subjected to the trials. Postponement of the decision to register CROs is likely to affect compensation to victims of clinical drug trials.

At present, 2,122 registered clinical trials are under way in the country.

In the meeting it was noted that the system does not have the requisite ability to objectively assess a CRO's capacity. It was decided that till such capacity building of the regulatory authorities is not in place, decision of registration should be deferred. No time frame was set up in the meeting, said a source.

There was substantial difference of opinion among the members of the committee regarding responsibility in case of compensation. Once a CRO is registered, the division of responsibility to provide compensation in case of death or disability in a clinical trial between the CRO and the sponsor will emerge as a crucial question.

An official who is a member of the committee said: "Many issues have to be looked into. Firstly, we will have to set minimum standards for infrastructure and expertise. Secondly, we will have to decide on the duration for which a CRO can be registered. Thirdly, once registered, the authority will have to periodically inspect the CROs. We will also have to figure out provisions for punitive action, punishment and responsibility if rules are violated."

Public health experts have expressed dissatisfaction with the meeting. "It was a meeting of stakeholders as many people with conflicting interests were also present. It was not a meeting of the expert panel alone," said Mira Shiva, coordinator of All India Drug Action Network and a member of the expert panel. She said only the expert panel set up by the government should decide without influence from the industry which promotes its own interests.


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