Scripting independent India’s pharma industry journey from non-existent to a world leader

“In the midst of every crisis lies opportunity” The COVID-19 pandemic resulted in a humanitarian crisis of enormous magnitude. It presented an extraordinary challenge to public health and highlighted the need for better healthcare systems. While it posed several new challenges, it also presented the industry with new opportunities. Supplying medicines to more than 200 countries in the fight against Covid, India met 62 percent of the global vaccines demand. As the pandemic crippled economies and healthcare systems around the globe, India held an enviable position. We supported several countries including the US, UK, Maldives, Bhutan, Bangladesh, Sri Lanka, Nepal, Myanmar, among others in the fight against COVID 19. We supplied close to 150 nations with medicines, 82 of them as grants from India. The Indian pharmaceutical industry, thus, emerged as a dependable partner and demonstrated tremendous commitment towards patients across countries by ensuring an uninterrupted supply of medicines.

Glimpse into the Indian Pharma Industry: Growth Story

From being non-existent in the 1960s, the Indian pharma industry today is a $42 billion industry and supplies over 60 percent of the global vaccine demand. It fulfils 40 percent of generic demand in the US, 25 percent of all medicine in the UK and exports $22 billion worth of medicines to the world. This significant contribution became possible because of various initiatives at the policy and entrepreneur levels. To reach this stage, the industry witnessed four distinct water-shed moments.

• Firstly, the Indian Patents Act, 1970. It made provision for process patent and prohibited for patenting of end-product enabling manufacturers to develop alternative processes for proprietary products that already existed in the market. This helped the Indian pharma industry to flourish.
• This was followed by The Drug Policy, 1978 along with the Price Control Order, 1979 which provided the foundation of the National Drugs Authority and intended to maximize production of bulk drugs locally providing leadership to public sector undertaking. This reduced dependence on imports and encouraged the local industry. The policy had a future of ‘Production of bulk drugs by high technology’ which forced International & Indian companies to produce newer bulk drugs with an intention of marketing formulation from basic starting materials that were either available locally or produced utilizing the local materials.
• The Hatch-Waxman Act, 1984, although is a legislation enacted in the US, it paved way for the proliferation of generic medicines and also helped the Indian generic industry. Propelling India towards market liberalisation, the launch of the Economic Reforms in 1991 synergised Indian industry with the world economy. It ended the era of ‘License Raj’ and allowed domestic players to operate freely.
• At the same time, the World Trade Organization (WTO) and its agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) came into existence that led to fundamental changes in the country’s patent regime. The amended patents Act in India, which is TRIPS compliant, has sought to balance pharmaceutical innovation and affordability of access to medicines in the public interest.

Looking into the Future

The pharma industry is poised for growth and can contribute significantly to the country’s ‘Make and Discover in India’ vision and achieve the USD ~120-130 billion by 2030. As we look at enhancing Indian pharma’s role from generics to new drug formulations, biologics, and incremental innovations, certain steps will make a big difference to reach the mark of the world’s largest and most reliable drug supplier. The following steps can be undertaken:

• Raising the product from branded generics to complex generics and new chemical entities.
• Widen the global reach with a stable and predictable pricing policy.
• Emphasis on creating industry-academia linkage for promotion of R&D activities.
• Upgrade pharmacy courses,
• Skilling of new talent with the changing needs of the industry with time.

The aspiration of creating an industry of US$120-130 billion would mean that India will be #1 in the world in terms of volume and among the top three countries in value. The author is the Secretary-General of the Indian Pharmaceutical Alliance