TB Drugs Off-Patent: Govt Channels Only Access

OFF-PATENT TB DRUGS RESTRICTED TO GOVT CHANNELS

Why in the News?

  • DCGI directive: India will restrict off-patent TB drugs like Bedaquiline and Delamanid to government supply chains
  • Policy aim: The move aligns with the National TB Elimination Programme (NTEP) to prevent drug resistance.
  • Regulatory order: All packaging must now carry the warning: “For use in NTEP only.”

TB Drugs Off-Patent: Govt Channels Only Access

Reason Behind Government Restriction

  • Drug resistance risk: Unregulated availability in private pharmacies risks indiscriminate use, leading to Multi-Drug-Resistant TB (MDR-TB).
  • Central TB Division alert: Raised concerns over open market access in October 2023, prompting DCGI’s intervention.
  • Treatment integrity: These drugs are critical to combination therapies for latent and drug-resistant TB

Implementation Mechanism and Tracking

  • Licensing change: States/UTs must amend licenses to include the restricted use clause.
  • Exclusive supply: Distribution only via NTEP-approved hospitals and TB treatment centres for better monitoring.
  • Drug tracking: Enables complete oversight of manufacturing and patient administration.

NATIONAL TB ELIMINATION PROGRAMME (NTEP)

●      Launch: Renamed from RNTCP in 2020 with a target to eliminate TB by 2025.

●      Key components: Early diagnosis, free treatment, Nikshay Poshan Yojana, and patient tracking via Nikshay portal.

●      Support system: Backed by universal drug susceptibility testing and public-private partnerships.

●      Global alignment: Supports WHO’s End TB Strategy aiming for zero TB deaths and suffering.

●      Challenges: Includes underreporting, drug resistance, and gaps in last-mile delivery.