The expiry of the semaglutide patent in India opens significant opportunities for the generic pharmaceutical sector but also poses serious public health governance challenges. Crit

GS2 Healthcare
The expiry of the semaglutide patent in India opens significant opportunities for the generic pharmaceutical sector but also poses serious public health governance challenges. Critically examine.

Examine

  • 15 marks
  • 8 min
  • 250 words
  • Medium

Business Standard

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Introduction

The expiry of the semaglutide patent (March 2026)—the molecule behind blockbuster drugs like Ozempic and Wegovy—marks a pivotal moment for India’s generics-led pharma sector, with simultaneous opportunities and governance risks.

Body

On the opportunity side, Indian firms (e.g., Cipla, Sun Pharma, Dr Reddy’s) are poised to leverage capabilities in complex generics and peptides, expanding access to affordable therapies for diabetes and obesity—conditions affecting over 100 million diabetics in India (ICMR estimates). Lower prices can improve adherence, reduce long-term complications, and create export potential in regulated and emerging markets. It also aligns with India’s ambition to move up the value chain in biologics and high-value generics.

However, the public health challenges are substantial. First, off-label and cosmetic use for weight loss may surge, distorting supply and prioritising affluent demand over medical need. Second, regulatory capacity (CDSCO) may be strained in ensuring bioequivalence, quality control, and pharmacovigilance for multiple entrants. Third, aggressive marketing could lead to irrational prescriptions, given side effects (e.g., gastrointestinal issues, rare pancreatitis risks). Fourth, inequities may persist if pricing, though lower, remains high for poorer patients without insurance coverage. There are also risks of counterfeit or substandard drugs in an expanding market.

Conclusion / Way Forward

India must pair market opportunity with robust governance: strict prescription guidelines, strengthened pharmacovigilance (PvPI), and price oversight (NPPA) where necessary. Integrating semaglutide into standard treatment protocols and expanding coverage under Ayushman Bharat can ensure equitable access. With calibrated regulation and industry responsibility, India can convert patent expiry into a public health gain rather than a governance gap.