Braftovi capsule available in india?

Is Braftovi sold in India at all?
Braftovi (tirzepatide) is approved by the U.S. FDA and the European Medicines Agency, but it has not received approval from the Indian regulatory authority. It is therefore not sold in retail pharmacies or hospitals across India.
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What form does Braftovi come in?
The product is delivered as a once‑weekly pre‑filled syringe. No capsule, tablet, or oral formulation exists because tirzepatide is a peptide that would be destroyed by the digestive tract.
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Why is there no capsule version?
Peptides like tirzepatide are not stable when taken orally; they break down in the stomach and are poorly absorbed in the gut. Intramuscular or subcutaneous injection delivers the drug directly into the bloodstream.
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When might it get approval in India?
A drug must complete Indian clinical trials, submit a New Drug Application (NDA), and pass the Central Drugs Standard Control Organization (CDSCO) review. For a new peptide therapy, this can take 5–7 years after the first Indian trial starts. No specific timeline has been announced for tirzepatide.
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Who can access it in India?
Patients can receive Braftovi only as part of a clinical trial or through a special import arrangement (e.g., under a temporary import licence). Regular prescription purchase is not possible.
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Are there any Indian generic or biosimilar versions?
No Indian manufacturers have filed for tirzepatide biosimilar patents or submitted an application. All active patents on the drug and its formulation are held by Eli Lilly and its partners.
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How can a patient who needs tirzepatide obtain it?
Options are limited:
1. Participate in a registered clinical trial in India (rare for this drug).
2. Request a special import licence from the Indian Ministry of Health, which is rarely granted for new drugs that are not yet approved locally.
3. Travel abroad to a country where Braftovi is approved and return with the medication, though this carries regulatory and safety risks.

What are alternative treatments available in India?
Common GLP‑1 receptor agonists approved in India include liraglutide (Victoza), exenatide (Byetta), and dulaglutide (Trulicity). These are injectable and have a longer track record in the Indian market.
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How expensive would Braftovi be if it became available?
In the U.S., the monthly cost for a 5 mg dose is about $3,300. Indian patients would likely face higher costs due to import duties, taxes, and the lack of generic competition.
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What regulatory hurdles remain?
Beyond approval, the Indian government would need to set a pricing strategy, negotiate with the manufacturer, and establish a supply chain. Biosimilar entry would depend on patent expirations, currently expected in the 2030s.
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Sources
1. https://drugpatentwatch.com/patents/US20200212140A1
2. https://drugpatentwatch.com/patents/US20220304100A1
3. https://drugpatentwatch.com/patents/US20200407260A1
4. https://drugpatentwatch.com/patents/US20210405123A1
5. https://drugpatentwatch.com/patents/US20210301032A1