The collaborative research of Merck Sharp & Dohme Pharmaceuticals Pvt Ltd (MSD India), the wholly owned subsidiary of Merck & Co Inc, USA, and the Indian Council of Medical Research (ICMR) on the former's cervical cancer vaccine Gardasil will kick-start within a month.
The long-term study on feasibility of the drug in Indian population, which may lead inclusion of the drug to get a place in the universal vaccination programme in the country, will be conducted on 600 patients in a period of six months. Approval from concerned authorities has been received and the first patient will be recruited soon, informs Naveen A Rao, managing director, MSD India.
"All the approvals for the project are in place and we will start recruiting patients within a month or two. The study will take six months to complete and a follow up for two and a half years will be conducted. At the completion, we will supply the drug at a very affordable cost for the Indian population," says Rao.
The ICMR and MSD, which earlier conducted studies on the same product prior to its launch in India in October, 2008, is conducting long-term study on a larger number of subjects through a public private partnership programme. Gardasil, a quadrivalent human papillomavirus (HPV) types 6, 11, 16, 18, recombinant vaccine for the prevention of fatal cervical cancer and genital warts caused by certain types of HPV, could be used in young girls and women as a preventive care.
The company is also currently working on building up awareness among the population on HPV through its integrated disease management programme - Guard Yourself. The helpline fixed under the programme receives nearly 4000 calls every month with queries on various details and seeking support in managing the disease, reveals Rao.
After nine months of its launch in the country, Gardasil currently occupies 79 per cent of the cervical cancer market in India, says Rao. According to World Health Organisation (WHO), cervical cancer is the most common form of cancer in India with more than 130,000 new cases reported each year and 74,000 women dying annually from the disease.
Figures reveal that cervical cancer takes the lives of eight women every hour in India. It is the commonest cause of cancer deaths among Indian women, and the second most common cause of cancer deaths among women worldwide. About 510,000 cases of cervical cancer are reported each year with nearly 80 per cent occurring in developing countries.