Updated on 10 January 2013
Swasthya Adhikar Manch's public interest litigation (PIL) leads Supreme Court of India to reprimand health ministry and CDSCO
Giving a clear call for accountability, the Supreme Court of India, on January 3, 2013, sternly reprimanded the Ministry of Health and Family Welfare and Central Drugs Standard Control Organization (CDSCO), India's main regulatory body for pharmaceuticals and medical devices, for not filing data regarding diverse aspects surrounding clinical trials, as per its an earlier order. Referring to the 59th parliamentary committee report that had indicated a collusion between pharma companies and regulatory authorities, the apex court pointed out that the government needs to wake up and address the situation.
The Supreme Court rap came following a public interest litigation (PIL) filed by the Swasthya Adhikar Manch, an NGO based out of Madhya Pradesh, a state in central India. Last year, several media reports surfaced claiming that clinical trials were being conducted in Indore, Madhya Pradesh, without patient consent. In response, the court asked the Madhya Pradesh government to constitute a committee to oversee the conduct of any clinical trials in the state and formulate guidelines to regulate the trials.
On October 8, 2012, the Supreme Court then asked the Ministry of Health and Family Welfare to submit an affidavit with the details of clinical trials conducted along with the deaths and compensation associated with them. Due to the non-compliance of this order, the Supreme Court on January 3, 2013, pulled up the representative of the ministry for "slipping into a deep slumber" and not submitting the information.
The Supreme Court order of January 3, a copy of which is with BioSpectrum, asks that the CDSCO or the ministry submit an affidavit as requested earlier within four weeks. It also directs the chief secretaries of all states other than Madhya Pradesh, Manipur, Dadra Nagar Haveli, Daman and Diu to file written responses within four weeks. The Supreme Court has also reiterated that clinical trials regarding any new drug should be carried out under the direct supervision of the secretary of the Ministry of Health and Family Welfare until further notice.
However, data regarding clinical trial sites, deaths associated, compensation etc., traditionally lies with Drug Controller General of India (DCGI), which is the central approving authority of clinical trials. Industry sources say asking the state governments to furnish these details, without outlining the procedure, will only result in more delays, since many would be ill-equipped to handle such requests.