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Make in India: Country emerges as the new hub of vaccine research

More than 60% of the world’s vaccines are made here and India is a member of the International Vaccine Institute’s governing council, committing US $500,000 each year.

india Updated: Oct 16, 2017 10:08 IST
Malavika Vyawahare
Malavika Vyawahare
Hindustan Times
Vaccination,Human experimentation
Union minister of health & family welfare JP Nadda administers vaccine to a child during the launch of second phase Expansion of Rotavirus Vaccination at Pragna Bhawan, Agartala in February this year. A wide range of vaccines are now available in India and the World Health Organisation lists 26 of them. (HT File Photo)

India has marched from being one of the world’s top vaccine-manufacturing hubs to become an emerging player in research and development, a feat that gives the densely-populated tropical country a shot in the arm.

The nation makes more than 60% of the world’s vaccines. But back in 1985, none of the six vaccines that were part of the just-launched universal immunisation programme were “Made in India”. The programme today includes vaccines for a dozen diseases.

The swelling inventory is a reflection of the slow and steady focus on R&D alongside mass production of cheap and affordable medicine the country is famous for.

ROTAVAC, a Bharat Biotech vaccine that protects against diarrhoea became the first indigenously developed vaccine to be incorporated in the government-sponsored immunization campaign this year.

Besides, Bharat Biotech reported recently that its typhoid vaccine, Typbar TCVTM, has shown 87% efficacy in trials. The announcement showcases India’s vaccine development efforts.

Another sign of India taking a lead in R&D came this January when the nation took full membership of the International Vaccine Institute’s governing council, committing US$ 500,000 each year.

Discovering new vaccines is a risky venture that requires heavy investment over long periods. Only one in about 10,000 vaccine candidates makes it to clinical trials that involve tests on humans. It can take an average 10 years to progress from the pre-clinical to the manufacturing stage.

That makes public investment and government support indispensable for basic research.

From test tubes to clinical use
There are five key stages of vaccine development: Exploratory, pre-clinical, clinical development or human tests, regulatory review and approval, and manufacturing
Clinical development
Indian vaccines in the works
ROTAVAC, DEVELOPER: Bharat Biotech Status: Already in the market. Government placed orders for doses

ROTASIIL, DEVELOPER: Serum Institute of India in collaboration with PATH, an international non-profit

Status: Licensed by the government, applied for prequalification from the WHO. The government seeks to incorporate it in the universal immunisation programme
a) DEVELOPER: Technology transferred from International Centre for Genetic Engineering and Biotechnology (ICGEB) to Sun Pharmaceutical Industries Limited in Mumbai
Status: Ready for clinical development

b) DEVELOPER: SERUM Institute, Pune
Stage: Pre-clinical animal trials
a) DEVELOPER: Malaria Vaccine Development Programme (MVDP), a consortium of DBT, ICGEB, Multi Vaccine Initiative (MVI), PATH, European Vaccine Initiative (earlier EMVI) and WHO-TDR.
Status: Phase 1 clinical trials conducted, analysis on

b) DEVELOPER: Indian Institute of Science, Bengaluru
Status: Pre-clinical animal trials
DEVELOPER: Bharat Biotech
Status: Completed pre-clinical animal trials, ready for phase-1 clinical trials
DEVELOPER: AIIMS, Indian Institute of Science in Bengaluru, Translational Health Science and Technology Institute in Faridabad, YR Gaitonde Centre for AIDS Research and Education in Chennai, National Brain Research Centre in Manesar, and International AIDS Vaccine initiative
Status: Exploratory studies

Private companies take over a successful vaccine candidate, guide it through the final stages and bring it to the market.

But in a country where public expenditure in healthcare was abysmally poor until the turn of the century, money for research in vaccines was the least priority. It was easier to develop “me too” vaccines, building on basic research abroad.

The scenario looked up after the government formed a separate department of biotechnology in 1986, setting aside funds that drove a dedicated vaccine research programme.

The move “sent the message there was as much focus on biotechnology as science”, said Dinakar M Salunke of the International Centre for Genetic Engineering and Biotechnology (ICGEB), an international non-profit organization.

He said research was further accelerated after the Biotechnology Industry Research Assistance Council (BIRAC) was formed under the department of science and technology, a non-profit that links India’s scientific community with the industry and foreign collaborators.

Vaccine development mostly happens in two phases. The first challenge is to identify an antigen that will produce an immune response to a disease. The antigen can spawn different vaccines and this happens in the second phase.

Thus, making vaccines is not the same as reverse engineering and mass production of generic drugs. Extensive research goes into the second stage as well.

However, a Make in India vaccine would mean doing both.

The country’s position as a production hub helped build on its research capabilities, said Renu Swarup, the managing director of BIRAC.

A wide range of vaccines are available now and the World Health Organization lists 26 of them. Still, there is room for improvement — better efficacy, cheaper options and increasing the immunity period provided by a vaccine.

Research and development in India will let the government prioritise diseases that affect its 1.3 billion people such as the mosquito-borne dengue, which is of least bother for Europe but often a killer in tropical countries.

A partially effective dengue vaccine became available abroad in 2015. But research showed survivors inoculated with the vaccine ran an increased risk of contracting the disease again.

The ICGEB has developed a promising dengue vaccine candidate and gave the technology to Mumbai-based Sun Pharma last year.

Experts believe the future of vaccine research will be developing new technologies, not necessarily discovering new antigens.

Tech is India’s strong point and home-grown vaccines could complement efforts to save millions of people from preventable diseases and help Indian companies and scientists capture a larger share of the international market.

Industry players and scientists cautioned that the government cannot let the advantage slip.

“A major challenge in vaccine production in India is sub-optimal investment by public sector for vaccine research,” wrote Chandrakant Lahariya in his 2014 paper on vaccinations in India.

The prescription: More generous public funding to promote basic research. And bridge the gulf between research and manufacturing.

First Published: Oct 16, 2017 09:22 IST