Application to conduct phase II trial of human papillomavirus (HPV) vaccine, Gardasil, to study its tolerance level in Indian population, is stuck with the office of the DCGI for several months now. The trial of the vaccine, already marketed by Merck in many countries, is planned by ICMR as early as March this year but is still waiting permission.

ICMR was to launch the trial of this cervical cancer vaccine, produced by US drug multinational Merck & Co, in April this year and had made all the necessary preparations. As per clinical research norms, permission from the DCGI is mandatory for commencing a clinical trial. The red-tapism in the DCGI office has resulted in the inordinate delay in launching the project, sources said.

Funded by ICMR, the study was to be conducted at multi locations in the country including at the Institute of Cytology & Preventive Oncology (ICPO), an arm of ICMR, at Noida near New Delhi. The HPV vaccine is expected to protect against a variety of human papillomaviruses which are known to cause most cases of cervical cancer.

Last year, Union health ministry had signed a memorandum of understanding (MoU) with the US company Merck & Co covering the entire gamut of the trial and its launch in the country. As per the MoU, this pre-introductory trial would be done at several centres in the country including ICPO and it would be done for a duration of 6 months as the three doses will be given at three stages of 0,2,6 months. The success or otherwise of this 'bridge study' would be known in a year's time after the commencement of the study as there would be a 6-month waiting period to observe the subjects, sources said.

Once the vaccine is found effective in the tolerance study, the price issue will be settled between the government and the company. As per the MoU, Merck is bound to provide the medicine at 'affordable prices'. 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 learnt to be working out a different price for India. But what exactly will be the affordable price is yet to be worked out, sources said.