DCGI recommends allowing SII to manufacture, stockpile life-saving qHPV vaccine against cervical cancer
Cervical cancer is the second-most frequent type of the disease in India among women aged between 15 and 44 years.
New Delhi: The Drugs Controller General of India has recommended allowing Serum Institute of India to manufacture and stockpile their life-saving qHPV vaccine against cervical cancer, official sources said on Wednesday. The recommendation has been sent to the Union Health Ministry which may issue a gazette notification shortly, they said.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, had written to the Health Ministry on February 4 seeking approval to manufacture and stockpile the qHPV vaccine as a priority for public health, to save time in making it and to ensure its early availability, an official source said.
At present, the government allows manufacturing and stockpiling of only Covid-related vaccines and drugs before marketing approval.
Based on Singh's letter, the ministry sought comments from the DCGI about the provision of manufacturing and stockpiling of non-COVID vaccines.
"After examining the matter, the DCGI last week recommended allowing Serum Institute to manufacture and stockpile non-Covid vaccine qHPV to the Health Ministry. The ministry is likely to issue a gazette notification in this regard shortly," an official source said.
"Currently, our country is fully dependent only on foreign manufacturers for vaccines 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 -- Quadrivalent Human Papillomavirus Vaccine," Singh is learnt to have said in his letter.
The letter mentions that every year lakhs of women are diagnosed with cervical cancer and the death rate is also very high. Cervical cancer is the second-most frequent type of the disease in India among women aged between 15 and 44 years.
The government advisory panel NTAGI has already recommended vaccination against cervical cancer examining the data in this regard in June, according to sources.
The separately constituted HPV working group of NTAGI had on June 8 reviewed the clinical trial data and the usefulness of SII's indigenously-developed and India's first qHPV vaccine against cervical cancer for inclusion in the National Immunization Programme.
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