The Paradox of TB Drug Market Restriction in India

📘 A UPSC Current Affairs Blog for GS II/GS III (Health, Governance, Policy, AMR)

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🧭 Context

On July 14, 2025, India’s Drugs Controller General (DCGI) proposed that newer anti-TB drugs like Bedaquiline, Delamanid, Pretomanid, and Rifapentine should be restricted from open market sale and made available only through the National Tuberculosis Elimination Programme (NTEP).

This policy aims to prevent antimicrobial resistance (AMR) due to irrational prescriptions but raises concerns about access, especially during drug shortages.

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🧬 Understanding TB and New Drug Access

🔹 Tuberculosis (TB) in India:

• 28% of global TB cases (WHO Global TB Report 2023)

• 3.2 lakh deaths annually

• Target for elimination: 2025 (India) | 2030 (UN SDG)

🔹 TB Drug Types:

Type	Drugs Used
DS-TB	Isoniazid, Rifampicin (1st-line)
DR-TB/XDR-TB	Bedaquiline, Delamanid, Pretomanid
Preventive	Rifapentine

These drugs are free under NTEP and mostly patents expired (except Pretomanid), allowing generic production in India.

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⚖️ Why Restrict Open Market Sales?

✅ Government Rationale:

1. Prevent misuse by private sector overprescription

2. Control rising drug resistance in TB strains

3. Ensure standardized treatment via NTEP

4. Preserve the effectiveness of new drugs

🧪 Global Practice:

• South Africa restricts Bedaquiline via public systems → 33% drop in MDR-TB

• Bangladesh allows open sales → higher resistance

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🚨 Problems with Restriction

⚠️ Key Concerns:

• India’s 2023-24 stock-out crisis showed NTEP vulnerabilities.

• If supply fails, patients can’t access these life-saving drugs.

• Missed/incomplete doses → greater resistance, delayed recovery

• Loss of trust in public health system

• Increase in out-of-pocket expenses (OOPE)

📊 BMJ Global Health (2024): 44% rise in TB treatment defaults during drug shortages in India.

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🛠️ Way Forward

✅ 1. Strengthen NTEP Supply Chain

• Train peripheral health workers on Ni-Kshay Aushadhi portal

• Ensure real-time digital drug tracking

• Create buffer stocks at State & District levels

✅ 2. Transparency & Accountability

• Make Ni-Kshay Aushadhi stock data public (like disease dashboard)

• Use civil society & TB Mukt Panchayats for vigilance

✅ 3. Allow Emergency Access

• Permit limited emergency private sales with NTEP authorization

• Authorised pharmacies can dispense with prescription + digital reporting

✅ 4. Public-Private Collaboration

• Incentivise private doctors to treat under NTEP protocols

• Enable Public-Private Mix (PPM) integration

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📚 UPSC Previous Year Questions

🧾 Prelims 2020

Q. Consider the following about Tuberculosis:

1. India aims to eliminate TB by 2025

2. Bedaquiline is part of first-line TB treatment

3. TB is a notifiable disease in India

Correct Answer: 1 and 3 only

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🧾 Mains 2021 – GS II

Q. The COVID-19 pandemic worsened India’s progress in controlling other diseases. Discuss this in the context of TB and public health infrastructure.

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📝 Mains Practice Question

Q. Discuss the challenges and implications of restricting newer anti-TB drugs to government channels in India. Suggest a balanced policy approach to ensure accessibility and prevent drug resistance.
(250 words)

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✅ Conclusion

The proposal to limit access to new anti-TB drugs through NTEP is well-intentioned to combat AMR. However, unless supply chains are foolproof and emergency access mechanisms exist, the move may do more harm than good. UPSC aspirants must understand this as a classic policy paradox involving health, governance, equity, and technology in public service delivery.