New Delhi – Supreme Court issued a notice on Tuesday to Centre and CMC, Vellore on a PIL demanding complete information on clinical trial results of Rotavac, an anti-diarrhoeal vaccine for Rotavirus conducted between 2011 and 2013 at Delhi, Pune and Vellore. Rotavirus vaccine was launched officially on March 26 by Ministry of Health to reduce the deaths caused by diarrhoea in infants.
A phase III clinical trial was conducted before launching vaccine to measure the safety and efficacy parameters for protecting infants from viruses, which are the cause for severe diarrhoea in them. Justice Madan B Lokur and RK Agarwal and Medical College have issued notices to Ministry of health and family welfare & Department of bio-technology of the Ministry of Science and technology on plea filed by S Srinivasan, managing trustee of “LOCOST” (Low Cost Standard Therapeutics) based in Vadodara, Gujarat .
The plea sought direction to Centre and others to disclose to the public “segregated data” on the phase III clinical trial results of ‘Rotavac’ involving 6,799 infants. Prashant Bhushan, advocate who filed plea said that disclosing the segregated data was crucial to know if the vaccine is safe in all areas or some groups are more susceptible to adverse effects of vaccine. The plea further stated that data should have been examined by National Technical Advisory Group on Immunization (NTAGI) in “public interest but such is the secrecy surrounding it, it has not been provided even to this apex body”.
It also needed a direction to frame guidelines regarding disclosing the complete segregated results on clinical trials on humans according to a WHO statement on April 2015 on the issue. The plea urged the apex court to set aside the order given by Delhi High Court on October, 2015 to dismiss the plea to hold back the Centre on further conducting any clinical trials for rotavirus vaccine in India. The high court order had come on a plea filed by Dr.Jacob Puliyel, NTAGI member, stating to hold back the government from conducting phase IV trials where over 1Lakh children would be given the vaccine.