Apex court notice to Centre, college on clinical trial results

New Delhi, July 5: The Supreme Court on Tuesday issued notice to the Centre and the Christian Medical College, Vellore, on a PIL seeking complete disclosure of centre-wise results of the clinical trial of anti-diarrhoea Rotavirus vaccine ‘Rotavac’ conducted between 2011a nd 2013 at Delhi, PuneandVellore.

The ministry of health officially launched the rotavirus vaccine on March 26 to combat deaths in infants caused due to diarrhoea. Before the launch of the vaccine, a clinical trial phase III was conducted to gauge the efficacy and safety of the vaccine meant to protect children from viruses, which are the leading cause of severe diarrhoea among them.

Besides the medical college, a bench of Justices Madan B Lokur and RK Agrawal also issued notices to the ministry of health and family welfare and department of bio-technology (DBT) of the ministry of science and technology, on the plea filed by S Srinivasan, managing trustee of ‘LOCOST’ (Low Cost Standard Therapeutics), based in Vadodara, Gujarat.

The plea has sought direction to the Centre and others to make public the “segregated data” on the results of third phase of clinical trial of ‘Rotavac’ involving 6,799 infants.

The plea filed through advocate Prashant Bhushan said these gregated data was crucial to know if the vaccine is safe in all areas or if some groups are more “susceptible toa dverse effects of the vaccine”.

The plea stated that the 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 provide deventothisapex body”. It also sought a direction for framing of guidelines regarding publication of complete and segregated research results in clinical trial sonhumans ,in accordance with WHO statement of April 2015 on the issue.

The plea urged the apex court to set aside the Delhi High Court's October 2015 order dismissing apleatorestrain the Centrefrom conducting any further clinical trials of rota virus vaccine in India.The high court order had come on a plea filed by Dr Jacob Puliyel, a member of NTAGI, seeking to restrain the government from moving on to phase IV trials in which over one lakh children would be administered the vaccine.