‘Drug controller, ICMR violated norms in clearing HPV project'

Our Bureau New Delhi | Updated on May 10, 2011

Serious violation of norms and ethical standards by Drugs Controller General of India (DCGI) and ICMR was found in the approval of the HPV ( human papilloma virus) vaccine project. This has been brought out in the discussions of the enquiry panel set up by the Health Ministry.

The final report was made public on Monday by people's health and women's organisations such as Jan Swasthya Abhiyan, SAMA Resource Group for Women and others.

Speaking on the occasion, Ms Brinda Karat, CPI(M) Rajya Sabha MP, said the procedures followed by the Drugs Controller General of India (DCGI) for approving licences for import and sale of the products by the companies concerned were in violation of Schedule Y of the Drugs and Cosmetics Act.

In a letter to the Health Minister, Mr Ghulam Nabi Azad, she sought action against those responsible in the two institutions as well as PATH, a foreign NGO which was carrying out the trials.

The project was being implemented in Andhra Pradesh and Gujarat but was stalled in April following uproar over the death of seven girls, allegedly after being vaccinated.

The final report clearly raises questions about ‘whether the entire project was designed to promote the interests of companies', the organisers said. The vaccine is manufactured by Merck.

They also questioned the role of ICMR in signing a memorandum of understanding in 2007 committing its support to ‘the use of HPV vaccine” even before it was licensed for sale in India.

The organisations said the credibility of the Universal Immunisation Programme and National Rural Health Mission (NHRM) had been damaged by the ‘wrongful use' of NHRM's logo for a project implemented by a private agency and its identification with the Government's immunisation programme.

Published on May 10, 2011

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