SII seeks government nod to manufacture and stockpile qHPV vaccine against cervical cancer
The firm will soon seek market authorisation as well as a manufacturing licence from the Drugs Controller General of India (DCGI) for the vaccine
The Serum Institute of India (SII) has sought the government’s permission to manufacture and stockpile indigenously developed Quadrivalent Human Papillomavirus (qHPV) vaccine against cervical cancer after the completion of the phase-II/III clinical trials to ensure its early availability in the country, official sources said recently.
The firm will soon seek market authorisation as well as a manufacturing licence from the Drugs Controller General of India (DCGI) for the vaccine, they said.
In a letter to the union health ministry, Prakash Kumar Singh, Director, Government and Regulatory Affairs, SII, is learnt to have said that the manufacturing of qHPV takes five-six months. “We are ready to manufacture and stockpile qHPV at our own risk in view of early availability of this life-saving vaccine for the citizens of our country,” an official source quoted Singh as having said in the letter.
The application mentions that every year, lakhs of women are diagnosed with cervical cancer and the death ratio is also very high. In India, cervical cancer ranks as the second most frequent cancer among women in the 15-44 years’ age group.
“Currently, our country is fully dependent only on foreign manufacturers for vaccine against cervical cancer and the citizens of our country a