SC issues Notice to Centre, DBT and CMC over Rotavac

Supreme Court today issued notice to the Centre, Department of Bio-Technology (DBT) and Christian Medical College, Vellore in a PIL filed by S. Srinivasan seeking complete centre-wise results of the clinical trial of anti-diarrhea vaccine Rotavac.

Prime Minister Narendra Modi launched Rotavac, an antidiarrhoeal vaccine in March, 2015, manufactured by the Hyderabad-based Bharat Biotech and developed by Indian institutions in partnership with the National Institute of Health, USA. It received attention being an indigenous vaccine available at an affordable cost of Rs60 per dose.

However, the non-disclosure of data about the result of phase III of the clinical trial of the vaccine, conducted at three sites (Delhi, Pune and Vellore) that preceded the approval and subsequent launch of Rotavac raised questions. The Rotavac trial was meant to test the risks triggered by the potentially fatal side-effects of the vaccine. Without disclosing the segregated data from all the three centres where the clinical trial was conducted on infants, the government planned to escalate the research to Phase IV in which the vaccine was to be administered to another 100000 infants. The withholding of data is in clear violation of international ethics of medical research and global norms governing clinical trials. Dr. Puliyel repeatedly made requests for the said results but the results were not provided to him. The RTI application filed by an NGO was also not replied.

Consequently, a writ petition seeking the data was filed in the Delhi high court by a member of NTAGI, Dr. Puliyel. According to the petition, results of this trial were reported in the journal Vaccine in August 2014 by Jacob John and other investigators, and indicated a higher rate of intussusceptions (intestinal obstruction which could need surgery to prevent death) among the vaccinated children. Government pleaded its inability to share the data and it was argued that the “site specific data on safety is inappropriate for release as per protocol and its inappropriate interpretation or publication would lead to disinformation about the product (that has been) developed by government with great effort and expense, and will give unfair advantage to multinational products which were never tested in India, (and) yet (were) licensed.” Vide order dated 14.10.2015, Delhi High Court dismissed the petition on the ground that segregated trial result of all the three centres was available with the National Technical Advisory Group on Immunization (NTAGI) of which the petitioner is a member and that it was on the basis of this data that the NTAGI approved the said vaccine.

Aggrieved by the order, Dr. Puliyel filed an SLP (Civil) No.2532 of 2016 against the Order dated 14.10.2015 of High Court of Delhi, which was dismissed on the ground that the petitioner therein, who was a member of the NTAGI, cannot maintain a public interest petition by an order dated 05.02.2016 and stated, “Learned counsel for the petitioner seeks leave to withdraw this petition. This petitioner cannot maintain a petition in public interest since he was a member of the National Technical Advisory Group on Immunization which recommended the introduction of the vaccine in question. Leave to withdraw is granted. The special leave petition is dismissed as withdrawn. All questions are left open”.

The present petitioner has filed the instant writ petition espousing the same cause of ethical and complete disclosure of clinical trial conducted on human beings being, seeking the intervention of Supreme Court to set aside the Order date d 14.10.2015 of the High Court of Delhi and to direct the respondents to disclose and publish the segregated results of the clinical trial of Rotavac vaccine conducted on 6799 infants in the period between 2011-2013 at Delhi, Pune and Vellore. The petitioner also has also sought an interim direction that the segregated results from all the three centres be placed before the NTAGI, which is the expert body on immunization policy, for examination and scrutiny.

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