A serious move is on to launch Merck's controversial cervical cancer vaccine in India in collaboration with Indian Council of Medical Research. A memorandum of agreement is understood to have been signed in this regard by the US multinational with the Institute of Cytology and Preventive Oncology, an arm of ICMR some times.

The compulsory vaccination of this product for prevention of treating human papillomavirus (HPV) among all school going girls, proposed in the state of Texas of the US by its governor Rick Perry, has attracted strong opposition from parents and public health bodies.

The governor's order directs the Texas health and human services commission to require that by September 2008, all girls entering sixth grade receive Gardasil, the new three-stage HPV vaccine produced by Merck and Co. The vaccine is expected to protect against the varieties of HPV known to cause most cases of cervical cancer.

Informed sources here said, that it was surprising that Merck has rushed to have a marketing arrangement for the vaccine with an Indian government body when the MNC is facing public anger over its success in convincing the Texas governor to issue an order for compulsory vaccination of school girls.

The sources said, that the talks in this regard are in an advanced stage and the Merck is calculating the price at which it can provide the vaccine to India. As the currently quoted price of around Rs 30,000 for a 3-dose regime is quite high, Merck is working out a different price for India.

Interestingly, no trials of the vaccine were so far conducted in India by Merck and DCGI has not granted marketing approval for the drug as yet. A senior scientist from ICPO said, "Since the Ministry of Health is involved, there will not be any problem of getting the nod from DCGI or ICMR. Once the rate is fixed and approved, the 'bridging study' will take only 2-3 months".

A leading medical expert said, that in the backdrop of the experience in the US, the initiative of ICMR raises several questions about its marketing in India. Will the government make it mandatory to vaccinate girls against HPV at the behest of its producers. As the Indian market is a huge one, such a scenario in future cannot be ruled out, the expert said. Another important question mark is on the efficacy of the vaccine. In the US itself the opinion is vertically divided on HPV vaccine as the only prevention for cervical cancer.

Terming the vaccine as medical madness, a section of medical experts in the US are of the view that cervical cancer is prevented in a hundred other ways, including adequate sunlight exposure and vitamin D consumption, supplementation with probiotics, adequate intake of selenium and zinc, increased consumption of trace minerals and iodine, regular physical exercise and many other safe, natural, non-patented strategies.

"As of now we cannot say the exact efficacy of the vaccine. It will take at least another 25 years when we come to know about the efficacy of the vaccine. When all the vaccinated girls become free from cervical cancer even in their low-immunity age, then only we get the exact picture", the scientist said.