The Pasteur Institute of India at Coonoor (PIIC) has in a statement to Pharmabiz said that the rejection of its application for licence renewal by the Tamil Nadu Drugs Control Department through the letter dated 14.12.2010 was not in respect of the manufacture and supply of DPT vaccine, but of Tissue Culture Anti Rabies Vaccine (TCARV).

According to the statement, in a letter dated December 14, the director of drugs control has informed the Institute that the application for renewal of WHO/GMPC for the newly constructed unit of TCARV cannot be considered and is rejected.

The statement of the PIIC Director says that the letter rejecting the application of the GMPC for the new infrastructure facility was applied by the former director of the institute before the suspension of production licence on January 15, 2008. It further says, an inspection team had visited Pasteur Institute on 9th and 10th of August, 2007, noted the deficiencies and prepared a list of the inadequacies, for which rectification was recommended. But soon the union health ministry ordered to stop the production and since then the request for the renewal licence was pending with the drugs control department.

"An application for renewal of our production for DPT and TCARV in the existing facility was sent on 12.12.2007 which was well before the suspension in Jan. 2008. Subsequent to revocation of suspension of licence and to comply with the direction of competent authority production of DPT and TCARV was initiated", the statement of the director in charge of the institute says. This means that the institute has engaged in the production of DPT and TCARV after the revocation in February 2010 without getting new licence from the state drugs control department on the pretext of complying with the direction of competent authorities.