India’s Supreme Court, in its July 26 order, has directed the Secretary, Ministry of Health to convene a meeting of the Chief Secretaries/Health Secretaries of the State Governments and the Administrators of the Union Territories to discuss all the facets and aspects concerning the legal framework for strengthening the regulation of clinical trials and other incidental matters. The centre has been given four weeks to conduct this meeting.
The SC order followed the hearing of a PIL filed by various NGOs criticising the conduct of clinical trials in the country. Even as the SC acknowledged the steps taken by the Ministry of Health to strengthen regulation of clinical trials in India, the petitioners submitted that the proposed measures do not answer many issues, particularly with regard to clinical trials of new chemical entities as well as the controlling and monitoring measures.
The SC has also granted two weeks time to the petitioners, National Human Rights Commission, NGOs and other proposed intervenors to submit their suggestions concerning the regulation and monitoring of clinical trials to the Secretary, Ministry of Health.
The SC order takes cognisance of Madhya Pradesh’s counsel submission that they had not been consulted on the measures needed to strengthen regulation of clinical trials, which was necessary as the state governments are directly concerned with the matter. The MP counsel indicated that this is the stand of almost all the States/Union Territories.
While an ISCR statement said that it was ‘fully supportive’ of these initiatives it also expressed its concern with regard to the slowdown in granting approvals for clinical trials in the country which has the greatest impact on patients for many of whom clinical trial provides early access to a new treatment and for others, the last option or hope of a cure. Without clinical trials there can be no new therapies, said the ISCR statement. The SC has also asked the Secretary, Ministry of Health to file an affidavit in compliance of this order within six weeks from July 26, with copies sent to the counsel for the petitioners, counsel for the states governments/Union Territories, Commission and proposed intervenors.
EP News Bureau – Mumbai