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India's Supreme Court wants tighter clinical trial regulation

Justice Lodha says illegal studies of investigational medicines causing “havoc to human life”

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The Indian government needs to do more to stop illegal, unregulated clinical trials, according to Supreme Court judge Justice RM Lodha.

Lodha made the comments during a hearing on a petition submitted by doctors and the non-profit organisation Swasthya Adhikar Manch, which claimed that citizens in the Madhya Pradesh region had been involved in drug trials without their permission.

As reported by the AFP, Lodha said: "Uncontrolled clinical trials are causing havoc to human life.

"There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far."

The matter is increasingly prominent, with India emerging as one of the main players in hosting clinical trials due to its relative low cost and recent improvements in access to healthcare.

However, this growth has not come with improved regulation or penalties for those who abuse the system, and Lodha, along with fellow judge Justice AR Dave, demanded the government do more.

As an interim measure they called for India's Health Minister Ghulam Nabi Azad to monitor all new applications from pharmaceutical companies wishing to launch trials in India.

Lodha, who has been a Supreme Court judge since 2008, has previously voiced his concerns about clinical trial practices in India, and in February 2012 he requested public-interest litigation in order to create a proper regulatory framework for checking illegal and unethical trials.

The regulatory system for medicines in India has also come under fire from the government itself in the past year, with the Ministry of Health calling for a revamp of the Central Drugs Standard Control Organization – the agency responsible agency responsible for regulating the pharmaceutical sector.

This followed an investigation from the Ministry of Health that implicated several companies, including Cipla, Sun Pharma, Novartis and Bayer, claiming that several studies had not met clinical trial requirements.

3rd January 2013

From: Regulatory

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