India to make Ozempic-like drugs for diabetes, obesity under PLI by 2026

Popular peptide drugs for diabetes and obesity — Glucagon-like peptide receptor agonist (GLP-1RA) — will be manufactured in India under the production linked incentive (PLI) scheme from 2026 when the patents expire, a senior government official said on Thursday.

GLP-1RA works by activating GLP-1 receptors in the pancreas, which leads to enhanced insulin release and reduced glucagon release responses.

GLP-1 class of anti-diabetic drugs have been in news recently for their off label usages and shortages, and even instances of fake drugs making their way into circulation (thanks to huge demand). As these drugs aid in weight loss, the off-label usage is on the rise. 

 

Innovators like Eli Lilly and Novo Nordisk are trying to scale up production as a result of this overwhelming demand. Recently, Lilly said that it would invest $5.3 bn to increase manufacturing capacity. Novo Nordisk too has said that it would spend $4.1 bn to make a fill-and-finish plant in North Carolina. The Danish drug maker plans to make Ozempic (diabetes), Wegovy (obesity) at the site. 

In 2023, Lilly's GLP-1 drug Mounjaro witnessed $5.1 billion in sales, while Novo's Ozempic sales crossed $13.9 bn. 

Speaking to the media, Arunish Chawla, secretary, department of pharmaceuticals (DoP), said that the local pharmaceutical industry is already working on producing these drugs here after the patents expire around 2026. Without divulging details of which companies are working on it (citing competition sensitivity), Chawla said work has already begun on the same and soon GLP-1RA drugs would be made in India under the PLI scheme.

Clinical trials of these drugs have shown to lower glycaemic parameters and promote weight loss. In 2022, the market size of GLP-1RA was evaluated to be around $22.4 billion globally. It is anticipated to exhibit sustainable growth at a CAGR (compounded annual growth rate) of around 9.6 per cent till 2032.

Chawla also added that 300 drugs are slated to lose patent in the next five years globally, and of these around 24 are blockbuster drugs. India is trying to make the most of this opportunity and the PLI scheme would play a part. Moreover, for bulk drugs and intermediates, he said 50 such molecules were identified under the PLI and 40 projects were taken up. Out of these, 30 projects are complete, which have also started manufacturing 30 molecules.

Meanwhile, to boost pharma research and innovation, DoP is setting up a project monitoring unit to identify projects that have a proof of concept and can be eligible for disbursement under the Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) scheme. The Centre has sanctioned an outlay of ~5,000 crore for five years, from 2023-24 to 2027-28. Centres of Excellence at the National Institutes of Pharmaceutical, Education & Research (NIPER) will be working to drive such innovation. This apart, research-driven pharma firms, and also clinical research organizations (CROs), or contract development and manufacturing organizations (CDMOs) would be eligible along with startups.

Chawla said they are trying to identify at least 30 projects that can develop technology or molecules for the future.