‘India to Stay World's Pharmacy’: Plan to Push Innovation in Meds, Devices to be Launched in Sept

The Modi government is ready with an elaborate plan to spur innovation in new medicine and medical device technology to strengthen India’s position as “pharmacy to the world”.

From discovering new molecules to complex generics, biosimilars to orphan drugs – the fine print of the new policy aims to cover all areas of pharmaceuticals and medical devices where future growth lies.

In July, the Cabinet approved the National Policy on Research & Development and Innovation in the Pharma-MedTech Sector and the Scheme for Promotion of Research and Innovation in Pharma-MedTech (PRIP). The schemes with a total outlay of Rs 5,000 crore for a period of five years till 2028 were approved.

While one scheme aims to boost innovation by creating an enabling environment, the other scheme PRIP aims to support the industry via financing options. The formal launch of the scheme is likely to take place in September.

“In several developed countries, big pharma companies invest more than or around 25% of their revenues on research and development. However, in India, pharma companies invest only around up to 8%… The reason is our public health approach due to which they are unable to fix high margins on their products, hence low revenue generation,” said Dr Mansukh Mandaviya, Union health minister, in a press briefing on Tuesday.

“This shows that these companies need financial support and this policy is the answer to all their concerns and limitations.”

According to the estimates of the Ministry of chemicals and Fertilizers, the parent ministry of the Department of Pharmaceuticals, the policy will create a pool of white-collar jobs to enhance India’s differentiation in comparison to other developing economies. It will also boost pharma exports by an additional $12 billion every year.

FINANCIAL PERKS ON CARDS

The six focus areas of the scheme are new chemical entities, including biological and phytopharmaceuticals, complex generics and biosimilars, precision medicines such as gene therapy and stem cells, medical devices using artificial intelligence and machine learning, orphan drugs and anti-microbial resistance.

Divided into three categories, the government will provide support to pharmaceutical companies and startups working in these focus areas.

In the first category, the policy will support nine pharmaceutical companies for “impactful research” across these six areas along with support from prestigious government institutions. Here, it will finance 35% of the total costs for over five years or up to Rs 125 crore.

In the second category, the focus shifts to bringing “high-potential products and technologies” to the market. The policy will take up 30 projects, which have reached TRL 5, from the six priority areas.

TRL stands for Technology Readiness Levels which is a method to estimate the phase of the research project. After the phase of proof of concept at phase 4, the product moves to clinical stages starting at phase 5. In Phase 9, the product is proven and ready for commercial deployment.

In the second category, the projects will be given support to reach stage 9 with the assistance of 35% of costs, up to Rs 100 crore for over five years.

In the third category, Indian startups and micro, small and medium enterprises (MSMEs) will be given support to reach TRL 4 or the proof of concept stage. “Around 125 research projects with commercial potential will be selected with funding of Rs 1 crore for over 5 years,” S Aparna, secretary at the Department of Pharmaceuticals, said in the briefing.

WHY THIS POLICY?

Despite strong fundamentals, the pharma sector in India faces various challenges, including a high degree of import dependence and a relatively low pace of development of biologics, biosimilars and other emerging products.

The government data shows that in the coming years, a third of the growth of the pharmaceutical industry is likely to come from innovative drugs. Hence, India needs to enter into the manufacturing of these products to protect its image as a “pharmacy to the world.”

In a press briefing on Tuesday, S Aparna said that the other important reason behind the making of the policy is the “public health goal”. “There are several expensive medicines which are presently imported. However, through our own R&D and manufacturing mechanisms, we can start making these products in-house for our own consumption as well.”

The third benefit is to manufacture our own medicines and devices for rare, neglected or tropical diseases. “The cost of procuring medicines for rare diseases is huge as there are not many buyers. Once we start manufacturing, the cost would go down for our own people,” Aparna said, adding, “Certain diseases are geography-based. For those diseases, big pharma companies don’t manufacture medicines for these tropical or neglected diseases. Hence, India can manufacture its own medicines for its own set of medical illnesses.”