The
Supreme Court has directed all States to file affidavits responding to concerns
over periodic stockouts, transparency in procurement, and drug quality of
Anti-Retroviral Therapy (ART) drugs for People Living with HIV/AIDS (PLHIV).
The order was issued by a bench comprising Justice Abhay Oka and Justice Ujjal
Bhuyan in response to a Public Interest Litigation (PIL) filed by the Network
of People Living with HIV/AIDS.
The
petition highlights systemic failures in the procurement of ART drugs, leading
to frequent shortages that disrupt treatment for PLHIVs, thereby endangering
their health and violating their fundamental rights.
Court's Directives to States
The
Supreme Court has granted States one month to file affidavits addressing six
key issues raised by the petitioners in a letter dated August 23, 2024. The
Court specifically emphasized that States must address clause 'c' of this
letter, which pertains to drug quality and certification processes.
The case
has been scheduled for its next hearing on April 4, 2025.
Key Concerns Raised by Petitioners
Following
discussions between petitioners and officials from the National AIDS Control
Organisation (NACO) on August 1, 2024, a list of six issues was submitted for
resolution:
- Periodic Stockouts – The petitioners
highlighted past shortages in 2004, 2009, and 2022, as well as
recent disruptions in the supply of HIV kits and TB medicines. They urged early
procurement and strict measures to prevent contracts from being
awarded to blacklisted companies.
- Transparency in Tendering
and Procurement – A
demand for greater transparency in the procurement process,
including making tender details publicly accessible on the NACO website.
- Drug Quality and
Certification –
Concerns over state-level drug approval processes, particularly
regarding the stability and taste of TLD tablets. The petitioners
advocated for stricter prequalification criteria to ensure
high-quality drug standards.
- Re-establishment of a
Coordination Committee – Petitioners called for reinstating a
previously functional Coordination Committee for real-time stock
monitoring and transparent communication with affected communities.
- Independent Monitoring Body – Proposal to establish an independent
monitoring committee comprising retired judges, health officials,
community representatives, and quality control experts to investigate
stockouts.
- Consent Order for Systemic Reforms – A request for a formal consent
order to implement the proposed changes and ensure long-term
solutions.
Background of the Case
Filed in August
2022, the PIL alleges that severe ART drug shortages occurred due to delays
in the 2021-2022 procurement cycle. The tender originally scheduled for
August 2021 was issued in December 2021 but failed, leading to a second attempt
in March 2022, which also faced delays. As a result, emergency procurement
was required to prevent treatment disruptions for PLHIVs.
In
response, the Union of India stated that there was no nationwide
stockout, maintaining that adequate supplies were ensured even during the
COVID-19 pandemic. The government further clarified that the 2022-2023
procurement cycle covered a two-year supply, expected to last until 2025.
During
the hearings, Senior Counsel Anand Grover pointed out that ART drug
quality is centrally regulated for the first four years post-release,
but regulatory responsibility shifts to the States thereafter, leading to
concerns over inconsistent quality standards.
While the
Supreme Court has not made any final observations on these issues, it has
allowed petitioners to continue discussions with NACO and the Ministry
of Health and Family Welfare to explore concrete solutions.
Case
Details:
- Case No.: Writ Petition (Civil) No.
686/2022
- Case Title: Network of People
Living with HIV/AIDS & Ors. v. Union of India & Ors.
- Next Hearing Date: April 4, 2025
