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India Prepares Uniform Semaglutide Standards Amid Counterfeit Concerns
India is preparing one official quality rulebook for semaglutide medicines.
Semaglutide is a drug used in products for which demand has risen sharply, including weight-loss medicines.
The rulebook will explain how manufacturers must test the drug’s identity, strength, purity and impurities.
It will cover both biological and chemical versions.
Until now, Indian manufacturers have used their own internal production standards.
Many companies began making or preparing generic versions after Novo Nordisk’s Indian patent expired on March 20.
Officials are also concerned about counterfeit semaglutide entering the market.
The new standards are expected to appear in the next official update to the Indian Pharmacopoeia.
The Indian Pharmacopoeia Commission is preparing an official monograph for semaglutide manufacturers in India.
The monograph will specify requirements for identity, purity, strength, assay and permissible impurities.
More than 20 to 30 companies have launched or received approval for generic semaglutide products after patent expiry.
Novo Nordisk’s Indian semaglutide patent expired on March 20, following a Delhi High Court order declining to block generic manufacturers.
The initiative follows alerts about counterfeit semaglutide batches and tighter nationwide supply-chain surveillance.
- Who
- The Indian Pharmacopoeia Commission, Indian semaglutide manufacturers, the Central Drugs Standard Control Organisation and State regulators are involved.
- What
- The Indian Pharmacopoeia Commission is preparing a monograph establishing uniform quality standards for semaglutide.
- Where
- India, including its pharmaceutical manufacturing and supply chains.
- When
- The article was published on September 7, 2026; the monograph is expected in the next addendum, after the patent expired on March 20.
- Why
- To create a common quality benchmark for semaglutide and address concerns about counterfeit batches amid rising demand.
Uniform Official Standard
Existing Manufacturer Standards
How quality is defined
Uniform Official Standard
The Indian Pharmacopoeia Commission’s monograph would give manufacturers a common specification covering identity, purity, strength, assay and impurities.
Existing Manufacturer Standards
Indian manufacturers currently follow their own in-house standards for producing semaglutide.
Regulatory context
Uniform Official Standard
Officials say a unified standard is needed as generic semaglutide production expands and counterfeit products become a concern.
Existing Manufacturer Standards
The available reporting does not identify specific manufacturers opposing the monograph or describe objections to it.
Key facts
- Regulator preparing standard
- Indian Pharmacopoeia Commission
- Drug covered
- Semaglutide
- Scope
- The monograph will cover biological and chemical versions.
- Patent expiry
- Novo Nordisk’s Indian semaglutide patent expired on March 20.
- Generic-market activity
- More than 20 to 30 companies have launched or received regulatory approvals for generic semaglutide brands.
- Counterfeit alert
- The Central Drugs Standard Control Organisation acted after an Interpol alert about counterfeit batches originating from Europe.
- Expected publication
- The monograph is expected in the next Indian Pharmacopoeia Commission addendum.
Sources
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