New Delhi: India’s first quadrivalent human papillomavirus vaccine made in the country for protection against cervical cancer in women will now be available in the market soon. The subject expert committee of the drug regulator has recommended approval for market authorization of this vaccine. Government sources gave this information. Serum Institute of India, which makes this vaccine, hopes that ‘Survac’ can be launched in the market by the end of this year.
Prakash Kumar Singh, Director (Government and Regulatory Affairs) at Serum Institute of India had applied for market authorization of papillomavirus vaccine from the Drug Controller General of India (DCGI) on 8 June. This was done after completing two out of three phases of clinical trials with the support of the Department of Biotechnology to ensure its early availability in the country.
Better results than ‘Servak’ found in trial
In this application, the SII states that the Papillomavirus Vaccine ‘Survac’ has shown a strong antibody response. Antibody responses to all HPV viruses have been observed to be 1000 times higher than baseline in women of all ages.
“The Subject Expert Committee, while considering the application on Wednesday, recommended the Serum Institute for market authorization for the manufacture of Papillomavirus Vaccine against Cervical Cancer,” the official source said.
In the application, Serum Institute of India stated that, every year lakhs of women face cervical cancer as well as some other cancers and its death ratio is very high. Cervical cancer in India is the second most common cancer among women aged 15 to 44 years.
Damages the cervical cells of women. Cervix is the small part below the uterus. Cancer in the cervix is usually caused by the Human Papilloma Virus. About 80-90 thousand cases of cervical cancer occur in India every year, which is the highest in the world.