INDIA – The Drugs Controller General of India (DCGI) has granted market authorization to Serum Institute of India (SII) to manufacture the indigenously-developed India’s first Quadrivalent Human Papillomavirus vaccine (qHPV) against cervical cancer.

This is not the first HPV vaccine to be available in India, but it is the first home-grown one.

The two HPV vaccines available in India are Ceravix, produced by GSK pharmaceuticals, and Gardasil by MSD Pharmaceuticals. Both of which cost up to Rs 4000 (US$50) per dose.

According to US Centre for Disease Control and Prevention (CDC), Human Papillomavirus (HPV) is responsible for a wide variety of genital infections. It can also lead to cancer of the cervix, vulva, vagina, or penis.

According to research in the National Library of Medicine, globally 27 percent of total cervical cancer cases are from India, which is home to 16-17 percent of the world’s women population.

In India, cervical cancer ranks as the second-most common cancer among women between 15 and 44 years of age.

The Indian Express cites in citing a December 2021 report in the Indian Journal of Gynecologic Oncology, points out that in India, cervical cancer accounted for 9.4 percent of all cancers and 18.3 percent (123,907) of new cases in 2020.

The approval by the drug regulator of SII’s anti-cancer vaccine followed recommendation by the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on June 15.

Globally 27 percent of total cervical cancer cases are from India, which is home to 16-17 percent of the world’s women population.

In response to the approval by the drug regulator, Serum Institute of India’s CEO Mr. Poonawalla in a tweet said: “For the first time, there will be an Indian HPV vaccine to treat cervical cancer in women that is both affordable and accessible.”

Serum Institute of India had applied to the DCGI seeking market authorization of the qHPV after the phase 2/3 clinical trial was completed with support of the Department of Biotechnology to ensure its early availability in the country.

The vaccine prevents infection from four strains, which according to the company, is expected to give a coverage of approximately 90 percent against papilloma virus prevalent in the developing world.

The DCGI’s Subject Expert Committee recommended Serum Institute’s indigenously developed quadrivalent human papillomavirus (qHPV) vaccine for cervical cancer patients above 9 years to 26 years of age.

According to Aadar Poonawala, the vaccine will likely be available by the end of this year.

“We look forward to launching it later this year and we thank the #DCGI @MoHFW_INDIA for granting approval today,” Mr Poonawala said in a tweet.

The National Technical Advisory Group on Immunization (NTAGI) had recently also approved the qHPV after reviewing the clinical trial data of the vaccine.

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