Thanks to central government’s rigorous efforts to make India self-dependent in pharma research and manufacturing added with continuous support to domestic companies in this direction, India is on the verge of having its own vaccine against one of the most dangerous cancer ailments among women – the cervical cancer. After the completion of second phase clinical trials of Quadrivalent Human Papillomavirus (qHPV) – vaccine against cervical cancer, the Serum Institute of India (SII) has sought central government’s nod for manufacturing and stockpiling indigenously developed drug to ensure its early availability in India.
SII will soon seek market authorisation as well as a manufacturing licence from the Drugs Controller General of India (DCGI) for the vaccine.
In a letter to the union Health Ministry, Prakash Kumar Singh, Director (government and regulatory affairs), SII said that the manufacturing of qHPV takes five-six months. Singh said that the company was ready to manufacture qHPV at their own risk in view of early availability of this life-saving vaccine for the citizens of country.
As per National Health Portal of India, a large population of women aged 15 years and above in country are at risk of developing cervical cancer. Every year lakhs of women diagnose with cervical cancer, and thousands of them die of the disease.
In India, cervical cancer is the second most common cancer among women between 15 and 44 years of age.
Currently, country is fully dependent 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.
Singh said that the company has been working for over five years under for making indigenous world-class vaccine against cervical cancer available.
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.
If the government approves the SII's proposal, then it will save significant amount of time to include the indigenously developed qHPV in the Universal Immunisation Programme.
India has 25 per cent of the global cervical cancer burden and its growing middle class is a potentially large private market for HPV vaccines.
The increasing prevalence of cervical cancer among female, increasing need to reduce Human Papillomavirus Infection(HPV) infections, large number of pipeline products, increasing research for therapeutic vaccine, growing investments in research and development for introduction of novel immunization remedies for this virus are likely to create lucrative growth opportunities for the market.
However, the high cost of vaccine which are available in India is hindering the HPV infection vaccine market growth.
SII To Establish R&D Centre In SIU
Meanwhile, in another development, to improve immunisation coverage and equity, the SII and Symbiosis International University (SIU) have signed an MoU for setting up an early research centre for vaccines and biologicals.
The Research and development (R&D) centre will lead the development of new vaccines, technologies, products, and innovations in immunisation practices that provide equitable access to life-saving interventions, especially across Low-and middle-income countries (LMIC's).
The SII will help set up an early R&D facility within the Symbiosis campus in Pune. The research centre will build and harness commitment to action by identifying opportunities that strengthen, establish global immunisation agenda in pursuit of universal health coverage.
Poised as a futuristic global knowledge platform, the entity will work toward improving health equity against future pandemics, and infectious diseases.
CEO, SII Adar Poonawalla said that the research centre will be instrumental in advancing indigenous capabilities for end-to-end development of any futuristic technology and projects in the field of vaccines and biologics in collaboration with global partners.
The HPV vaccines used in the project are commercially available in India and more than 100 other countries.