By - Sanjay Kumar on March 22, 2021
“The purpose of the pharmaceutical industry is to bring patients innovative new therapies that help them to live longer, healthier lives”-Ian C. Read
The pharmaceutical industry around the globe consists of millions of people working to prioritize healthier lives. India stands as the third-largest pharmaceutical industry (production linked incentive scheme pharma) in terms of volume and USD 40 billion in terms of value. The country contributes 3.5% to the total global export of drugs and medicines which includes exporting to highly regulated markets such as the USA, the UK, European Union, Canada, etc. India has a complete ecosystem for developing and manufacturing pharmaceuticals with companies having state-of-the-art facilities, highly skilled and technical manpower, etc. Adding to this, the country also promotes pharmaceutical education and research in renowned institutes and a robust ecosystem of allied industries.
At present, a major component of Indian exports is low-value generic drugs while a large proportion of the demand for patented drugs is met through imports. The current scenario exists due to a lack of high value production along with world class R&D in the pharma sector. In order to incentivize the global and domestic players and to attract more investments and production, a well-designed and suitable target intervention is required. Adding to this, continuous support to domestic production capabilities in APIs/KMSs would ensure higher resilience of the Indian pharmaceutical industry to external shocks. These initiatives have the potential to contribute significantly to achieving the higher objective of affordable healthcare in the country and globally.
Accordingly, the Ministry of Chemicals and Fertilizers (Department Of Pharmaceuticals) issued notification dated 3rd March 2021 vide No. 31026/60/2020 policy on Production Linked Incentive Scheme (PLI) for Pharmaceuticals.
The objective of the scheme is in two folds. The first one being enhancing countries manufacturing capabilities by increasing investments and production and also by contributing to product diversification to high value goods in this sector. The second objective of the scheme is to create global champions from India who display the potential to grow in size and scale by using cutting edge technology.
The qualifying criterion of the three groups of applicants will be as follows:
Group A: Applicants having GMR (FY 2019-20) of pharmaceutical goods more than or equal to Rs. 5000 crore.
Group B: Applicants having GMR (FY2019-20) of pharmaceutical goods between Rs 500 crore (inclusive) and Rs. 5,000 crore.
Group C: Applicants having GMR (FY 2019-20) of pharmaceutical goods less than Rs. 500 crore. Within this group, a sub group for the MSME industry will be made given their specific challenges and circumstance.
Biopharmaceuticals; Complex generic drugs; Patented drugs or drugs nearing patent expiry; Cell based or gene therapy drugs; Orphan drugs; Special empty capsules like HPMC, Pullulan, enteric, etc.; Complex excipients; Phyto-pharmaceuticals: Other drugs as approved.
Active Pharmaceutical Ingredients / Key Starting Materials / Drug Intermediates.
Repurposed drugs; auto immune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular drugs, psychotropic drugs and anti-retroviral drugs; In vitro diagnostic devices; Other drugs as approved; Other drugs not manufactured in India.
 Financial Year 2019-21 shall be treated as the base year for computation of incremental sales of manufacturing goods.
Production linked incentive scheme pharma