The Serum Institute of India 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 2/3 clinical trials to ensure its early availability in the country, official sources said on Sunday.
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 of Government and Regulatory Affairs at 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 age group.
“Currently, our country is fully dependent only on foreign manufacturers for vaccine against cervical cancer and the citizens of our country are bound to buy these vaccines at a very high price.
“We have been working for more than five years under the leadership of our CEO Adar C Poonawalla for making available indigenous world-class vaccine against cervical cancer i.e. Quadrivalent Human Papillomavirus vaccine,” Singh is learnt to have said in his letter.
“In line with the clarion call of our Prime Minister Narendra Modi (for) ‘Making in India for the World’ and ‘Affordable Vaccines for All’, we assure you that this year our qHPV vaccine will be available for the people of our country and the world at large,” he said.
An official source aware of the development said if the government approves the SII’s proposal, then it will save a significant amount of time to include the indigenously developed qHPV in the Universal Immunisation Programme.