The Serum Institute of India (SII) has been granted market authorisation by the Drugs Controller General of India (DCGI) to manufacture indigenously-developed India’s first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer, according to official sources.
According to the Indian Express, DCGI’s approval comes following recommendation by the Subject Expert Committee (SEC) on COVID-19 of the CDSCO on June 15 over the same Prakash Kumar Singh, director (government and regulatory affairs) at Serum Institute, had applied to the DCGI seeking market authorisation of qHPV after the phase 2/3 clinical trial was completed with support of the Department of Biotechnology to ensure its early availability, official sources said.
For the first time there will be an Indian HPV vaccine to treat cervical cancer in women that is both affordable and accessible. We look forward to launching it later this year and we thank the #DCGI @MoHFW_INDIA for granting approval today.
— Adar Poonawalla (@adarpoonawalla) July 12, 2022
After reviewing the clinical trial data of the vaccine, government advisory panel NTAGI too recently approved the qHPV.
In the application to the DCGI, Singh is learnt to have stated that qHPV vaccine CERVAVAC has demonstrated robust antibody response that is nearly 1,000 times higher than the baseline against all targeted HPV types and in all dose and age groups.
The application further mentions that lakhs of women are diagnosed every year with cervical cancer as well as few other cancers and death ratio is also very high.
Cervical cancer in India ranks as the second most occurring cancer among women between the ages of 15 and 44 years.
