• 11 February 2013
  • Features
  • By Manasi

Tighter clinical trial regulation is need of the hour

The Supreme Court of India, through a series of judgments, has been making officials from the government as well as the CDSCO accountable for alleged malpractices in clinical trials in India


Industry experts feel that the Apex Court orders will not affect the genuine CROs

Recently, the Supreme Court managed to stir the $600 million (Rs 3,246 crore) Indian bioservices industry, when it asked for greater accountability from the Drug Controller General of India (DCGI) for the conduct of clinical trials. The general perception was that, this would serve as a blow to the the sector, which witnessed a growth of over 15 percent in 2011-12 as against the previous year's growth of 23 percent.

However, at a recent annual conference on clinical research organized by Indian Society for Clinical Research (ISCR), industry experts opined that the court order should not be taken as a setback, but rather as a measure to keep spurious practices at bay. Ms Suneela Thatte, executive director, Customer Operations, Quintiles says, "The court order does not disempower clinical research organizations (CROs) in India and should not make a major difference. It only asks for the previous directives to be followed. This includes furnishing details in different cases such as the one where the relevant states are being asked to submit all the data surrounding the clinical trials for the Supreme Court to study."

A copy of the Supreme Court order, in possession of BioSpectrum, explicitly asks the Central Drugs Standard Control Organization (CDSCO), India's main regulatory body for pharmaceuticals and medical devices or the Ministry of Health and Family Welfare (MoHFW) to submit the affidavit as requested earlier within four weeks. It has also directed the chief secretaries of all states other than Madhya Pradesh, Manipur, Dadra Nagar Haveli, Daman and Diu to file written responses on an affidavit. Finally the Supreme Court reiterated by saying that, clinical trials regarding any new drug should be carried out under the direct supervision of the secretary, MoHFW until further notice. Besides, referring to the 59th Parliamentary Committee Report, which had indicated a collusion between pharma companies and regulatory authorities, the apex court further pointed out that the government needed to wake up and address the situation.

Last year, several media reports surfaced claiming that clinical trials were being conducted without the patient's consent, resulting in deaths of the patients in states such as Madhya Pradesh, Andhra Pradesh, and other North East states of the country. Considering the severity of cases, Swasthya Adhikar Manch, a Madhya Pradesh-based NGO, filed a Public Interest Litigation (PIL) with the Supreme Court. In response, the apex 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.

The Supreme Court then, on October 8, 2012, 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 noncompliance of this specific order, the Supreme Court reprimanded the representative of the ministry for "slipping into a deep slumber" and not submitting the information.


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