The semaglutide episode isn’t just a provide chain downside or missed first mover place, however fairly exposes systemic deficiencies that may very well be pricey for India’s pharmaceutical trade, which provides about 20% of the world’s generic medicine by quantity.
With the expiration of Novo Nordisk’s key patents in India in March this yr, semaglutide, the energetic ingredient within the Danish firm’s diabetes and anti-obesity medicine Ozempic and Wigovy, has emerged as one of many world’s most commercially vital drug molecules, doubtlessly making a multi-billion greenback alternative for India’s pharmaceutical trade, which ranks third on the planet by quantity and eleventh by worth.
Greater than 40 Indian firms have reportedly introduced plans to launch low-cost merchandise, reflecting the home pharmaceutical trade’s sturdy curiosity in creating their very own generic merchandise.
Solar Pharma, Mankind Pharma, Dr Reddy’s, Zydus, Lupine and Alkem are among the many native producers which have outlined plans to launch generic variations of semaglutide in India. India is estimated to have greater than 10 million adults residing with diabetes, the second-highest quantity on the planet after China.
Development on account of expiration
Indian drugmakers additionally hope to capitalize on markets in Brazil, Canada, China, South Africa and Turkey, the place patents are about to run out.
Collectively, these 5 international locations account for greater than $350 billion in annual pharmaceutical spending and are key catalysts for important new avenues for export-led progress for complicated merchandise corresponding to semaglutide, biosimilars and specialty generic medicine, in keeping with IQVIA, which makes use of large information and synthetic intelligence to assist biotech and pharmaceutical firms speed up drug growth.
Patent expiry has traditionally pushed the expansion of India’s pharmaceutical trade. Following the expiration of the patent on atorvastatin (Lipitor) developed by Pfizer in 2011. Indian firms have rapidly entered the market with low-cost generic medicine to decrease unhealthy ldl cholesterol and triglycerides, strengthening their foothold in regulated markets corresponding to america and Europe.
The patent expiration in 2012 for the antiplatelet drug clopidogrel (Plavix), bought by Sanofi and Bristol-Myers Squibb, introduced a serious alternative for Indian firms to rapidly introduce reasonably priced alternate options which have change into broadly utilized in cardiovascular care.
When sildenafil (Viagra) misplaced patent safety in 2012, a number of Indian producers entered the fray.
The patent dispute over imatinib, developed by Novartis, was a landmark case within the historical past of Indian prescription drugs. A 2013 Supreme Courtroom ruling allowed Indian firms to proceed producing reasonably priced generic medicine for leukemia sufferers, chopping the annual price of remedy from greater than $25,000 to a fraction of that quantity.
The principle underlying patent for sofosbuvir expires in 2025, although Gilead Sciences has granted voluntary licenses to a number of firms in India to fabricate generic variations to deal with continual hepatitis C virus (HCV) infections.
Indian pharmaceutical firms have turned the lack of patent exclusivity into a chance to develop exports, decrease drug costs and develop entry to healthcare.
Business estimates counsel that competitors from generic drug producers may considerably cut back remedy prices by greater than 65% in the long run by eliminating patent charges as a substitute of cheaper manufacturing, whereas leaving sustainable revenue margins for environment friendly drug producers.
If Indian pharmaceutical firms can supply high-quality peptide medicine, they might additional penetrate rising markets earlier than patents expire within the US and Europe within the early 2030s.
The federal government’s production-linked incentives – an outlay of Rs 15,000 crore to encourage home manufacturing of high-priced medicine, complicated generic medicine and energetic pharmaceutical elements (APIs) – additionally favor home firms.
reputational danger
High quality defects carry financial prices that far exceed the worth of the affected product itself, and for India, which contributes considerably to making sure reasonably priced medicines around the globe by supplying greater than 50% of Africa’s generic drug demand, about 40% of america’ generic demand, and about 25% of all medicines in the UK, the stakes are excessive and we can’t afford to stay silent.
Nevertheless, the incident started as a home matter and will additional exacerbate India’s reputational dangers. Current quality-related stumbles haven’t solely garnered world consideration however may additionally damage optimism amongst Indian generic drug makers, at the least within the quick time period.
Dr Reddy’s Laboratories, India’s largest generics firm within the sector, just lately suspended the availability of generic semaglutide, a posh peptide formulation made by way of a complicated biotechnology course of, after inner testing detected impurities within the drug substance throughout manufacturing scale-up, amid New Delhi’s ‘Make in India’ mission for key drug substances.
Provide of the brand new injectable batch may very well be anticipated by late October or early November. Whereas the monetary loss from delayed gross sales could also be non permanent, the injury to investor sentiment and export credibility may final for years. This vulnerability is regarding as there are roughly 500 API producers, representing practically 8% of the worldwide API trade.
The estimated measurement of the Indian API market in 2025 is estimated to be round Rs 1,31,700 crore, assembly home and export formulation necessities.
India has all the time had the historic benefit of low-cost, high-volume generic drug producers, however that’s not a adequate situation for the subsequent technology of therapies. Constant manufacturing high quality is simply as vital as price competitiveness.
Impurity-related debacles not solely disrupt native provides, but in addition influence exports, contract manufacturing preparations, and accomplice firms that depend on the identical provide chain.
Indian pharmaceutical firms have frequently confronted regulatory motion from world our bodies such because the US Meals and Drug Administration, the European Medicines Company, the UK Medicines and Healthcare merchandise Regulatory Company, and the World Well being Group.
These lawsuits usually relate to violations of excellent manufacturing practices, information integrity points, contamination, insufficient high quality management, or noncompliance with manufacturing requirements, fairly than issues about drug efficacy.
Greater than two years in the past, cough syrup imported from India killed 66 youngsters in The Gambia. The US had reported a number of deaths and severe accidents associated to eye drops brought on by contaminated merchandise manufactured by India’s World Pharma Healthcare.
Such incidents have attracted important world consideration as they’ve the potential to delay India’s entry into one of many quickest rising segments of the worldwide generic drug trade. World regulatory oversight is predicted to extend as authorities businesses more and more concentrate on manufacturing practices fairly than simply bioequivalence.
Reputational danger (from the semaglutide difficulty) briefly led to a decline within the worth of the pharmaceutical sector, as brokerages lowered earnings estimates and worth targets to replicate issues about delayed earnings and lack of aggressive benefit.
Redefining the panorama
The manufacturing disruption is reportedly not non permanent and will final till October 2026. This marks a shift within the Indian pharmaceutical trade from competing totally on low-cost manufacturing to competing on technological sophistication, course of reliability and high quality compliance with world requirements.
Though it has the potential to redefine India’s pharmaceutical trade, the semaglutide difficulty is testing the nation’s capacity to compete with complicated peptide therapeutics, as earlier successes (on account of patent expirations) have largely been with small-molecule medicine whose manufacturing processes had been comparatively easy.
Scaling up the manufacturing of peptide-based medicine with out compromising high quality stays a serious technological problem. Success on this market subsequently relies upon not simply on patent expiration dates, but in addition on manufacturing excellence and regulatory compliance, as regulatory credibility is a strategic asset.
