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Home News and Update Year 2009 Govt's Wait for Trial May Delay Cervical Cancer Immunisation Drive

Govt's Wait for Trial May Delay Cervical Cancer Immunisation Drive

The Economic Times
20 October 2009
New Delhi, India

The government will wait for full clinical trial reports on new vaccines for cervical cancer, the most prevalent form of cancer in the country, delaying the plans of multinational drug makers such as GlaxoSmithKline India (GSK) and Merck to benefit from a national immunisation drive.

In September, a 14–year old girl in the UK had died after taking GSK’s product, although a study later found that the death was not linked to the vaccine. The incident had raised alarm among health experts, but last week, the US drug regulator FDA approved the vaccine after seeking additional details.

Globally, GSK and Merck are the only manufacturers of cervical cancer vaccines. While Merck launched its vaccine ‘Gardasil’ in India late last year, GSK followed with the launch of its brand ‘Cervarix’ in March.

Drug Controller General of India Dr Surinder Singh said clinical trial results are yet to come in and the government would take a call based on the outcome. “But, at the moment, we don’t see any urgency to include cervical cancer in the immunisation programme,” he said.

The disease is under immunisation programmes of about 50 countries. An industry executive told ET that there are other important diseases like rotavirus and pneumonia that are a priority for the government.

Sanjiv Navangul, director for sales and marketing at Merck USA’s Indian arm (MSD), said the government has been positive towards immunisation and efficacy concerns can be addressed by the industry. “The medical result of the studies will have to be examined and if there are other concerns, that can also be addressed,” he said. Given the wide prevalence of the disease, the government is looking at including the disease under the national immunisation programme.

The national body on immunisation has also supported the move and in a meeting on August 3, a decision has been taken to form a sub–committee to take forward this plan, the industry executive said, requesting not to be named. A World Health Organisation (WHO) study said cervical cancer is the most common form of cancer in India, with more than 1.3 lakh new cases reported each year and 74,000 women dying from the disease every year.

The Indian Council of Medical research (ICMR) along with Merck is conducting a study to examine the drugs safety in immunisation. Separately, the NGO, PATH, funded by the Melinda and Gates Foundation, is jointly conducting studies with these two pharma companies in Andhra Pradesh and Gujarat to examine the feasibility of immunising cervical cancer which targets young girls.

India’s existing programmes are only for infants. The PATH study is expected to submit its second stage finding by 2010 end.

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