Archive · 24 Jun 2025
India Limits Sale of Off-Patent TB Drugs to Curb Resistance
India is changing how it handles some TB medicines.
New and off-patent TB drugs will now be sold only through the government.
This is because these drugs are very important for treating tough TB infections, and using them incorrectly can make the TB germs resistant.
The government wants to ensure these medicines are used correctly, and the changes are being made to help fight the disease.
The labels on the drugs will have a warning on them, and will primarily be distributed through government programs.
India restricts the sale of off-patent TB drugs to government channels.
The move aims to curb drug resistance and improve TB treatment.
The Drugs Controller General of India (DCGI) issued the directive.
Drugs affected include Bedaquiline, Delamanid, Pretomanid, and Rifapentine.
The decision follows concerns over the drugs' indiscriminate use in the open market.
- Who
- The Drugs Controller General of India (DCGI) issued the directive.
- What
- India is restricting the sale of off-patent tuberculosis drugs to government channels.
- When
- The directive was issued recently, following the expiry of patents for some drugs last year and concerns raised last October.
- Where
- India
- Why
- To curb drug resistance, improve treatment outcomes, and align with the National TB Elimination Programme.
Potential Challenges
Public Health Goals
Drug Access
Potential Challenges
Restricting access could create administrative hurdles, particularly for private healthcare providers.
Public Health Goals
Controlled distribution is crucial for ensuring the correct use and tracking of these essential medicines.
- Drugs Affected
- Bedaquiline, Delamanid, Pretomanid, Rifapentine
- Restriction Reason
- To prevent drug resistance
- Governing Body
- Drugs Controller General of India (DCGI)
- Targeted Programs
- National TB Elimination Programme
- TB Cases in India (Last Year)
- 2.6 million
- TB Mortality Decline (2015-2023)
- 21%