Supreme Court issues notices to Government, US-Based NGO PATH, and DCGI in two HRLN vaccine matters 1 Sept 2013


1 September 2013: SUPREME COURT ISSUES NOTICES TO GOVERNMENT, US-BASED NGO, AND VACCINE MANUFACTURER IN TWO HRLN VACCINE PILS: Kalpana Mehta vs. Union of India & Ors. WP (C) 558/2012: The first case involves the 2009 Human Papilloma Virus (HPV) vaccine clinical trial conducted by the US-based NGO, PATH in collaboration with ICMR and the Governments of Gujarat and Andhra Pradesh. In late 2012 the Supreme Court issued notices to the Government of India. The vaccine was tested on about 24,000 tribal and marginalized girls in AP and Gujarat. On Friday, the Parliamentary Standing Committee unequivocally concluded that PATH's project is a clear case of child abuse and that the vaccine project violates myriad fundamental rights. The synopsis of the petition and the 72nd report are attached to this mail. Today, the Supreme Court expanded notices issued to include PATH and issued notices to all the respondents for interim reliefs requested by the Petitioner including an in-depth medical follow up for the girls involved. For further information about this matter please contact Sarita Barpanda; or Petitioner No. 1, Kalpana Mehta (09425056985, Dr. Yogesh Jain vs. Union of India & Ors., WP (C) 697/2013: The second matter, listed in the Chief Justice's Court deals with the Pentavalent vaccine, a 5-in-1 vaccine that is being pushed as a replacement for the DPT (diphtheria, pertussis, tetanus) vaccine given to infants. While DPT costs Rs. 5 per unit, the Pentavalent vaccine, which adds Hep B and Hib, costs Rs. 525 per unit. After much debate, the vaccine was launched for a limited a year-long trial in Kerala and Tamil Nadu. Soon after initiation in the state UIPs, infant deaths were reported. Til date at least 21 deaths have been reported in India. Experts estimate that many more deaths have gone unreported. In reality, the disease burdens of Hib and Hep B in India are so low that the deaths from the vaccine outnumber lives saved from diseases. The vaccine has either been banned or is not used in Europe, Japan, the UK, Canada, and the United States. Pakistan, Vietnam, Bhutan, and Sri Lanka immediately halted use of this vaccine after reports of serious adverse events and deaths. India, on the other hand, has forged ahead. Although the data from Tamil Nadu and Kerala has not been reviewed, the vaccine has been initiated in Goa, Haryana, Pondicherry, Gujarat, Jammu & Kashmir, Delhi, and Karnataka. Today the Supreme Court issued notices to the Respondents, including the manufacturer, Serum Institute (Pune). The Court will hear the matter in four weeks. For more information about this case, please contact Sarita Barpanda;