The recommendations of the expert committee, headed by Prof Ranjit Roy Chaudhury to formulate policies and guidelines on approval of clinical trials and new drugs, are still under the consideration of the Union Health Ministry and no final decision has been taken yet, it is learnt.

The Ministry is learnt to be still examining the main suggestions of the report, submitted to the Ministry on August 8, 2013, even though the Government had submitted before the Supreme Court that recommendations would be considered for further streamlining the clinical trials sector.

The Ministry is expected to take a final view on the report before the next hearing of the ongoing case, filed by Swasthya Adhikar Manch in the Supreme Court. The hearing is scheduled for December 16 now. The court during, the last hearing on October 21, had asked the government to re examine the approvals given to 157 clinical trials given in 2012.

The Supreme Court is also expected to consider the suggestions from various stakeholders like the National Human Rights Commission, SAMA Resource Group for Women and Health & Low cost Standard Therapeutics and Indian Society for Clinical Research, apart from the views of petitioner and the  Central Government on the matter.

Meanwhile, the court had also allowed the petition by Indian Pharmaceutical Alliance seeking to intervene in the present case. The case was filed in February, 2012 by the NGO alleging that Indians were being made victims of unregulated clinical trials.

The Prof Ranjit Roy Chaudhury panel, among many recommendations, suggested that the Central Drugs Standard Control Organisation (CDSCO) should be upgraded to a separate organisation/authority, with the DCGI at par with heads of similar organisations of the government. The committee said that all drug approvals, whether new or existing or generic, should lie only with the CDSCO, but some of the functions related to inspections, monitoring clinical trials and pharmacovigilance can be shared with the state authorities.