The Hindu Business Line : MSD India, ICMR sign pact for studies on cervical cancer drug

Dr Leonard Tauro, Managing Director, MSD India, and Dr N.K.Ganguly, Director-General, ICMR, addressing a press conference after signing an MoU in the Capital on Tuesday. — Kamal Narang

New Delhi , Dec 20

MERCK & Co, known as MSD India, has entered into a collaboration with the Indian Council of Medical Research (ICMR) to conduct studies on the former's investigational cervical cancer drug, Gardasil.

The New Jersey-headquartered pharma company has already applied for permission from the Food and Drug Administration (FDA) to launch the vaccine in the US market and is likely to apply for regulatory approval for the EU region soon.

Upon completion of the study in India, the two partners will work together to access the role of the vaccine in the Indian population and identifying ways of providing the same.

This study is in addition to the Phase III clinical trials that have to be completed for any drug to be approved by the regulator. According to Dr Leonard Tauro, Managing Director, MSD India, "We want to know how the vaccine would respond to the Indian conditions."

The company will supply the vaccine free of cost for its use in the study. Gardasil is designed to protect against four types of human papillomavirus (HPV) - 6, 11, 16 and 18. Besides Merck, GSK too is working on a similar vaccine.

"Our aim is to work closely with the private player and operationalise the vaccine. The model, if successful, can be replicated in other parts of the country as well," said Dr N.K. Ganguly, Director-General ICMR. "We are also in talks with other players including the Bill Gates Foundation to get involved in the process," he said without divulging further details.

World-over, about 5.1 lakh cases of cervical cancer are reported every year with nearly 80 per cent occurring in developing countries. The World Health Organisation terms cervical cancer the most common form of cancer in India with over 1.3 lakh cases reported each year and 74,000 women dying annually.

On the price of the vaccine, when launched in India, Mr Tauro said, "We will follow a tier system. For private players the price would be set according to company's decision at that point in time, while in the public system it would be decided on the affordability."

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