WHY INDIA'S REJECTION OF A TB DRUG PATENT MATTERS

06 Nov 2026

Tags: Social Justice   Social Services   Health sector issues

Source: The Indian Express

Context: The Indian Patent Office has rejected a patent application for BPaL, a combination of three medicines used to treat drug-resistant tuberculosis (TB).

• The application was filed by the US-based Global Alliance for TB Drug Development (TB Alliance).
• The decision could facilitate competition among generic manufacturers, reduce procurement costs and improve access to treatment for drug-resistant TB.
• India has the world's highest TB burden, accounting for nearly one-fourth of global cases. Its TB incidence rate was 187 cases per 100,000 population in 2024.
• The ruling is significant for access to affordable medicines, particularly for patients with multidrug-resistant and rifampicin-resistant TB.

What is BPaL?

• BPaL is a six-month, all-oral treatment regimen recommended by the World Health Organization (WHO) for eligible patients with drug-resistant TB.
• It combines three medicines:
  • B – Bedaquiline: An antibiotic that inhibits the energy production mechanism of TB bacteria.
  • Pa – Pretomanid: An anti-TB drug that acts against actively multiplying and certain dormant TB bacteria.
  • L – Linezolid: An antibiotic that inhibits bacterial protein synthesis.
• BPaLM: A related regimen that adds a fourth medicine, moxifloxacin (M), to BPaL.
• The BPaLM regimen recorded a treatment success rate of 89%, compared with 52–75% for standard treatment regimens.
• More than 15,000 patients have started BPaLM treatment under India's National TB Elimination Programme.

Why is the Patent Rejection Significant?

• Promotes generic competition: Rejection removes the possibility of exclusive rights under this particular patent application, potentially allowing more manufacturers to produce the combination, subject to other applicable legal and regulatory requirements.
• Reduces procurement costs: Greater competition could lower the price at which the government purchases medicines for its national TB programme.
• Improves treatment access: Lower costs could enable the government to cover more eligible patients within the existing healthcare budget.
• Reduces dependence on limited suppliers: A larger pool of quality-assured manufacturers could improve supply reliability and reduce the risk of shortages.
• Strengthens public health interests: The decision recognises the importance of balancing pharmaceutical innovation and patent protection with access to essential medicines.

Pre-grant Opposition: Role of Civil Society

• The patent application faced two formal challenges in 2020 through pre-grant oppositions.
• The first opposition was filed by Eldred Tellis of Sankalp Rehabilitation Trust and Ganesh Acharya, with support from the Lawyers' Collective and Médecins Sans Frontières (MSF) Access Campaign.
• The second was filed by the Delhi Network of Positive People (DNP+), supported by the Third World Network.
• These challenges highlighted concerns about extending patent protection over existing medicines through minor modifications.

Evergreening of Patents

• Evergreening refers to attempts by pharmaceutical companies to extend their period of market exclusivity by seeking additional patents for minor modifications, new formulations or other incremental changes to existing medicines.
• Patient groups argue that such practices can delay generic competition and keep essential medicines expensive.
• India's patent framework seeks to prevent the grant of patents for certain minor modifications without sufficient therapeutic advancement.

Potential Financial Benefits

• Patients receiving drug-resistant TB treatment through the public healthcare system already receive medicines free of cost.
• Therefore, the immediate financial benefit of lower drug prices would primarily accrue to the government through reduced procurement expenditure.
• According to the article, the cost of a six-month BPaLM treatment course has fallen from $588 in 2022 to $284, following generic competition after the rejection of the patent relating to bedaquiline fumarate salt.
• Further price reductions could allow the government to treat more patients using the same budget.
• Patients may also benefit indirectly through improved availability and reduced delays in starting treatment.

What Steps Are Needed for Wider Access?

• Scale up treatment: Ensure that every medically eligible patient diagnosed with rifampicin-resistant TB can access BPaL/BPaLM under the National TB Elimination Programme.
• Expand generic manufacturing: Encourage multiple quality-assured suppliers to enter the market.
• Strengthen public procurement: Use competitive procurement and long-term purchasing arrangements to secure affordable medicines.
• Ensure uninterrupted supplies: Strengthen distribution, storage and supply-chain monitoring.
• Maintain quality standards: Conduct regular quality checks even as the number of manufacturers increases.
• Improve patient access: Address geographical, financial and institutional barriers that delay diagnosis and treatment.

Patent Rejection vs Drug Regulatory Approval

• The rejection of a patent application does not automatically authorise unrestricted manufacture, marketing or sale of a medicine.
• These are two separate processes:

Patent approval	Drug regulatory approval
Determines whether an invention qualifies for exclusive patent rights.	Determines whether a drug meets prescribed standards for quality, safety and efficacy.
Governed by patent law and the Indian Patent Office.	Governed by drug regulatory authorities, including CDSCO.
Rejection may permit other manufacturers to avoid the exclusivity barrier created by that patent.	Marketing and use still require applicable regulatory permissions.

• Central Drugs Standard Control Organisation (CDSCO): India's national drug regulatory authority, responsible for regulating the quality, safety and efficacy of drugs and approving specified categories of medicines.
• WHO Prequalification: An assessment programme that evaluates whether medicines meet international standards of quality, safety and efficacy. It does not replace marketing authorisation by national drug regulators.

Generic Medicines: Quality and Safety

• Generic medicines contain the same active pharmaceutical ingredients as their corresponding reference medicines and are expected to meet prescribed quality and regulatory standards.
• Greater generic competition does not necessarily mean compromised quality.
• Regulatory authorities must ensure that all manufacturers comply with quality standards through inspections, testing and post-marketing surveillance.

Important Institutions and Programmes

• National TB Elimination Programme (NTEP): India's flagship programme for preventing, diagnosing and treating TB, with the goal of eliminating TB as a public health problem in India.
• National Tuberculosis Elimination Programme and WHO: WHO provides global technical guidance and treatment recommendations, while NTEP implements India's national TB response.
• Indian Patent Office: Administers India's patent system under the Patents Act, 1970.
• World Health Organization (WHO): Provides global public health guidance, including recommendations for the diagnosis and treatment of drug-resistant TB.