Building a home-grown biopharma sector in developing countries: The case of India

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Doctor with a little boy and his mother and father at a village healthcare center in rural India. Photo Credit: Adobe Stock
Doctor with a little boy and his mother and father at a village healthcare center in rural India. Photo Credit: Adobe Stock

The COVID-19 pandemic showed how public investments can help the private sector fast-track the development of vaccines, testing kits, drugs and therapeutics, and make personal protective equipment widely available.

Traditionally, most of these innovations have emerged from western nations. The Moderna vaccine, for instance, was supported by the US government, and BioNTech/Pfizer’s by Germany and the EU. 

Rich countries, however, tend to focus their ample capital and highly skilled labor on developing vaccines and drugs for rich-country diseases, leaving their innovations inapplicable, inaccessible, or unaffordable for the developing world.

India has now shown that an emerging country can also become a world-class contender in the crucial biopharma sector, developing drugs and vaccines for diseases that affect the developing world . Other countries can do so too, provided certain conditions are met.

Until now, however, India’s biopharma sector, while strong in basic research and manufacturing, had fallen short of its potential for innovation. It faced a number of challenges.

First the private sector was reluctant to take the risk of creating new products and navigating them through the long and tedious process of taking a pilot to market.

Second, there was little investment in public goods critical for turning scientific discoveries into real-world solutions. 

And third, returns on investment in diseases borne largely by the poor such as chikungunya and dengue, for which no effective vaccine existed, were not sufficient to incentivize private research and development.

Strong government support

So, what did India do?  In 2017, the Indian government launched a National Biopharma Mission (NBM) with support from the World Bank-financed Innovate in India for Inclusiveness Project. It supported a consortia of public, private, and academic institutions to bridge gaps that were holding back innovations in the sector. 

The project also supported the development of both the “tracks” and the “trains” needed to take a new product from pilot to market. For instance, it helped lay down the “tracks” – or the infrastructure needed to improve the biotechnology ecosystem. This included the establishment of clinical trial sites and upgrading laboratories and manufacturing facilities to internationally recognized standards.

In also supported the “trains” to run on these tracks by providing grants to companies that were keen on developing new vaccines, biosimilars, and medical devices.

The initiative has achieved several successes:

  1. COVID-19: Biotechnology companies from India and abroad were able to use the clinical trial networks created under the project to test their COVID-19 vaccines. They also used the certified laboratories for virological studies (such as the Interactive Research School for Health Affairs (IRSHA) in Pune), and the certified manufacturing facilities to produce the active drug ingredients for several biopharmaceuticals. Two of the COVID-19 vaccines supported by the project during Phase I clinical trials, ZyCOV-D and Corbevax, received emergency approval. In addition, NBM committed US$33 million for the development of test kits, ventilators, and COVID-19 vaccines.
  2. Chikungunya: The NBM also supported Bharat Biotech, a Hyderabad-based company, in developing a novel vaccine for chikungunya, an endemic mosquito-borne disease for which no vaccine exists. The new vaccine is currently undergoing clinical trials.
  3. Pneumonia: Another indigenously produced vaccine, the 15-valent pneumonia vaccine developed by the Telengana-based company, Tergene, has proven effective in children’s trials and received market authorization from regulators. Earlier, India primarily relied on a 13 valent and 10-valent pneumococcal vaccine. The new vaccine protects children against 15 types of pneumonia-causing bacteria. It will not only offer better protection, but also result in savings of over US$560 million. 
  4. Diabetes: Given the widespread prevalence of diabetes in India, the NBM is also supporting the development of a generic drug for the disease.  The new drug is expected to bring down the cost of treatment from an average of US$90 a month to US$29, effecting a savings of nearly US$630 million annually.
  5. Diagnostic medical devices: The NBM is supporting the development of cost-effective diagnostic tools that are essential for taking healthcare to India’s vast population. For instance, to alleviate the shortage of MRI scanners, the NBM has supported Voxelgrids, a Bengaluru-based company, in the development of India’s first locally produced and cost-competitive device. These indigenously developed devices will go a long way in expanding access to diagnostic services as India is estimated to need a minimum of 7,000 MRI scanners, but has only about half that number.  

These successes did not happen by accident. Rather, they were due to the government’s strong engagement in developing a home-grown biopharma sector that can innovate across the full spectrum of activity from basic research to validation, to bringing a new product to market.

To begin with, the NBM’s institutional arrangements struck a healthy balance between the roles of bureaucrats and the private sector, while providing the private sector with incentives to innovate.  Second, it targeted activities, not sectors, which were based on public health needs, informed by identifying specific shortcomings in the market with the private sector, academia, and public health officials. Thirdly, grant disbursements were tied to clear benchmarks and had built-in sunset clauses so that failing investments in the discovery process were not prolonged needlessly.

The lesson from India is clear: when governments create an enabling environment for innovation and collaboration, even daunting endemic challenges can be met with effective, life-changing solutions . Other developing countries can also turn their potential into reality by building the appropriate institutional structures for a vibrant biopharma sector.

 

With thanks to Dr. Shikha Malik, from the Biotechnology Industry Research Assistance Council, for her valuable insights and contributions to this blog. 

Authors

Rami Galal

Economist, Finance, Competitiveness, and Innovation (FCI) Global Practice, World Bank

Andres F. Garcia

Senior Economist, Finance, Competitiveness, and Innovation Global Practice, World Bank

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