August 9, 2010
Information on the demonstration project and licensing of two vaccines to prevent cervical cancer has been exempted from public disclosure under Section 8 of the Right to Information Act, 2005.
This is the reply received in response to an RTI application, submitted to the Union Ministry of Health and Family Welfare, seeking information on the status and basis of approval granted to Merck Sharp and Dohme (MSD) Corp. and GlaxoSmithKline (GSK) to import, sell and market Gardasil and Cervarix in India, and the status, design and intent of the trials conducted by MSD and the Indian Council of Medical Research (ICMR). It also sought information on the protocols adopted for granting permission to the Program for Appropriate Technology and Health (PATH), a non-governmental organisation, and the ICMR to conduct the ‘demonstration project.’
All RTI applications have evoked a stock reply from the office of the Drugs Controller-General of India: the requested information is a “trade secret and commercial confidence of the third party and exempted from disclosure under Section 8 (1) (d) of the RTI Act.”
The applications were filed by health activist Deepa Venkatachalam of Sama-Resource Group for Women and Health. The Union Ministry of Health and Family Welfare directed them to the Central Drugs Standard Control Organisation, which responded to the applications. Another application is still pending with the ICMR.
The ‘clinical trials’ of Gardasil (of Merck) and Cervarix (of GSK) in Gujarat and Andhra Pradesh were suspended in April this year after allegations emerged of violations of ethical norms by PATH, which conducted the trials for MSD and GSK. Some girls suffered side-effects after being administered the vaccine.