India Restricts Sale of Off-Patent TB Medicines to Government Channels to Combat Drug Resistance

New Delhi, June 24, 2025 — In a decisive move to curb rising drug resistance in tuberculosis (TB) treatment, the Indian government has restricted the sale of select off-patent anti-TB medicines exclusively to public health channels. The decision, announced by the Ministry of Health and Family Welfare, seeks to prevent irrational and non-standard use of key TB drugs—especially second-line treatments—by regulating their distribution and availability in the private sector.

This restriction will initially apply to a list of critical TB medicines that have lost patent protection but remain central to the treatment of multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB). The affected drugs include delamanid, bedaquiline, and linezolid among others.

Public Health Priority Over Private Access

In a statement issued on Monday, the ministry said the move is “aligned with India's National Strategic Plan to eliminate TB by 2025 and is crucial to preserving the efficacy of key drugs.” It emphasized that unregulated private-sector use of these medicines often leads to incorrect dosage, incomplete treatment regimens, and ultimately, drug resistance.

Dr. Rajesh Bhushan, former Union Health Secretary, welcomed the decision:

“We are witnessing a surge in drug-resistant TB cases. Restricting distribution to government-approved channels allows strict protocol-based treatment under supervision, thereby ensuring better outcomes and reducing resistance.”

The government aims to channel these medicines through its National TB Elimination Programme (NTEP), which provides free diagnosis and treatment across India’s vast public healthcare infrastructure. Private providers treating TB patients will now be required to notify cases and refer them to the NTEP for further treatment.

The Threat of Drug-Resistant TB in India

India bears the world’s highest TB burden, with over 2.8 million cases annually. According to the World Health Organization (WHO), around 150,000 of these are multidrug-resistant TB cases. The improper use of antibiotics, often in unregulated private settings, has exacerbated this problem.

“Drug resistance doesn’t just arise from poor quality medicines—it often results from improper usage,” said Dr. Anurag Bhargava, a leading infectious disease specialist. “By restricting access to potent second-line drugs, we improve surveillance, adherence, and efficacy, which are vital to preventing treatment failure.”

Pharma Industry Reacts Cautiously

The pharmaceutical industry has responded with cautious optimism. While companies understand the public health imperative, concerns remain about supply chain disruptions and market access limitations.

A senior executive at Lupin Ltd, a major supplier of TB medications to the government, said:

“This step may affect volumes in the private market temporarily. However, since most of our TB drug sales already happen through government tenders, the impact on revenues may be limited if procurement remains strong.”

Similarly, Cipla and Macleods Pharmaceuticals, both active players in the TB treatment space, are expected to focus on scaling up their engagement with public health tenders.

Regulatory and Legal Framework

The restriction is being implemented through amendments under Schedule H1 of the Drugs and Cosmetics Rules, 1945, which governs prescription medicines. These changes give state drug controllers the authority to bar private chemists from selling specified TB drugs without prescriptions issued by designated government facilities.

Legal experts note that while the move is within the regulatory framework, it will require coordinated implementation.
“Effective enforcement at the state level is key,” said Ramesh Iyer, a pharmaceutical policy consultant. “Coordination with state drug control authorities and private healthcare providers will determine how successful this policy becomes in practice.”

Investor and Market Outlook

Analysts believe that while this decision is not expected to significantly disrupt the revenues of major Indian pharma companies, it could shift their strategy toward public procurement and international TB tenders funded by organizations like the Global Fund and USAID.

“India's TB drug market is driven primarily by government programs. This regulation merely formalizes what has been happening for years,” said Nikhil Mathur, pharma analyst at Kotak Institutional Equities. “However, firms heavily reliant on private market TB sales might see short-term revenue compression.”

Investors are advised to keep an eye on procurement trends from the NTEP and international agencies, which may rise in volume due to centralized demand. Additionally, Indian firms compliant with WHO prequalification and GMP norms may benefit from increased exports.

A Model for Antimicrobial Stewardship?

Public health experts see India’s move as a model for managing antimicrobial resistance (AMR), a growing global threat. The success of this policy could serve as a blueprint for restricting non-judicious use of other high-risk antibiotics in the future.

“If implemented well, this can be a game changer,” said Dr. Soumya Swaminathan, former Chief Scientist at WHO. “It’s time for a paradigm shift—where national health interest supersedes market dynamics in the case of life-saving drugs.”

India’s decision to limit the sale of off-patent TB drugs to government channels reflects a bold and strategic push toward safeguarding public health. As the country marches toward its ambitious TB elimination target of 2025, this policy could be a critical step in ensuring that modern medicines remain effective for the next generation. For pharma firms, the road ahead lies in aligning with public health priorities and adjusting their strategies to an increasingly government-driven market.