The Drugs Controller General of India (DCGI) has limited the sale of key TB drugs—bedaquiline, delamanid, pretomanid, and rifapentine—exclusively to government healthcare systems under the NTEP to combat rising drug-resistant TB cases.
In a significant move to curb the growing threat of drug-resistant tuberculosis (TB), the Drugs Controller General of India (DCGI) has issued a directive restricting the sale of certain critical TB medications exclusively to government-run healthcare channels. This regulatory action is aimed at preventing the misuse of essential anti-TB drugs that are now widely available through private retail pharmacies.
🦠 Which TB Drugs Are Affected?
The directive covers four major anti-TB medicines:
Bedaquiline (20 mg and 100 mg)
Delamanid (25 mg and 50 mg)
Pretomanid (100 mg)
Rifapentine (150 mg and 300 mg)
These drugs are considered vital for the treatment of Multi-Drug-Resistant TB (MDR-TB) and Latent TB. Until recently, many of these medicines, including generic versions, were available in the open market, raising alarms among public health experts.
🔒 Restricted Use Under National TB Elimination Programme (NTEP)
As per the DCGI’s order, these drugs must now be:
Supplied only under the NTEP, the government’s national TB control initiative.
Marked with a label caution reading: “For use in National TB Elimination Programme only.”
Distributed exclusively to government hospitals and NTEP-authorized centers.
Removed from private retail and online pharmacy sales.
Drug manufacturers and distributors have been instructed to revise their licenses and update labeling and packaging to comply with the directive. State-level drug regulators are required to ensure compliance and report back to the Central Drugs Standard Control Organization (CDSCO).
📉 Concerns Over Drug Resistance
The DCGI’s move was prompted by concerns from the Central TB Division over the increasing availability of TB drugs in the private sector, which has the potential to:
Promote irrational use or incorrect dosing,
Contribute to the emergence of drug-resistant TB strains,
Undermine India’s efforts to eliminate TB by 2025.
The patent expiry of bedaquiline and delamanid in 2024 had led to a surge in generic production and uncontrolled distribution.
💊 Background on Drug Regimens
The affected medications are part of advanced treatment regimens, including:
BPaL regimen (Bedaquiline + Pretomanid + Linezolid): Recommended by the WHO and already adopted by India.
Short-course latent TB therapy: Combining rifapentine with isoniazid for 3–4 months.
These regimens have demonstrated high cure rates and fewer side effects compared to older protocols.
🏥 Expert and Public Health Response
Health experts and TB advocacy groups have welcomed the move, noting that:
It aligns India with international best practices.
It enhances treatment supervision, drug tracking, and patient adherence.
It prevents commercial exploitation of life-saving drugs.