The Supreme Court has instructed all States to address concerns regarding periodic stock shortages, transparency in the tendering and procurement process, and the quality and certification of Anti-Retroviral Therapy (ART) drugs for People Living with HIV/AIDS (PLHIV).

A bench comprising Justice Abhay Oka and Justice Ujjal Bhuyan has directed the States to submit affidavits addressing six specific issues raised by the petitioners in a PIL filed by the Network of People Living with HIV/AIDS, highlighting systemic failures in the procurement system.

“we direct all the respondents/States to file their affidavits in response to the affidavit dated 5th September, 2024 filed by the petitioners and in particular six points specified in the letter dated 23rd August, 2024 annexed to the said affidavit. The learned senior counsel appearing for the petitioners states that in particular, all the States will have to deal with clause 'c' of the letter dated 23rd August, 2024 very specifically. Finally we grant time of one month to all the respondents/States to file their affidavits in terms of the above directions”, the Court stated.

In January, the Court had also sought the Centre’s response to the concerns raised by the petitioners. The case is scheduled for its next hearing on April 4, 2025.  

The petition highlights systemic failures in the procurement system, resulting in recurring shortages of ART drugs and disrupting the treatment of PLHIVs. The petitioners argue that these disruptions heighten the risk of illness and death among PLHIVs, thereby violating their right to health and life.

The Supreme Court issued notice in the case on September 12, 2022. During a hearing on July 10, 2024, the petitioners acknowledged that there was no ART drug shortage at the time but expressed concerns regarding procurement processes and drug quality. In response, the Court permitted them to engage in discussions with representatives of the National AIDS Control Organisation (NACO) and the Union Ministry of Health and Family Welfare to address these issues.

As per the affidavit, a meeting between the petitioners and NACO officials took place on August 1, 2024. Following this, the petitioners sent a letter on August 23, 2024, highlighting six key concerns:

1. Stockouts: Recurring shortages of HIV ARVs (2004, 2009, 2022) and recent HIV kit and TB medicine shortages. They urged early procurement and avoiding blacklisted suppliers.
2. Procurement Transparency: Called for public disclosure of tender details on the NACO website.
3. Drug Quality: Raised concerns over certification by State Licensing Authorities, particularly the stability and taste of TLD tablets, demanding stricter quality controls.
4. Coordination Committee: Proposed reviving the committee for real-time stock monitoring and transparency.
5. Independent Monitoring: Suggested a panel of retired judges, health officials, and experts to investigate stockouts.
6. Consent Order: Recommended formalizing these changes and reinstating the Coordination Committee.

The case was originally filed in August 2022, alleging severe ART drug shortages due to delays in the 2021-2022 tendering process. The petitioners contended that the tender scheduled for August 2021 was issued only in December 2021 but failed, leading to a fresh tender in March 2022, which also faced delays. As a result, emergency procurement became necessary to ensure uninterrupted treatment for PLHIVs.  

In response, the Union of India submitted a brief note asserting that there was no nationwide ARV drug stockout and that adequate supplies were maintained even during the COVID-19 pandemic. The government further stated that the procurement cycle for 2022-2023 covered a two-year supply, expected to last until 2025.  

During the hearings, Senior Counsel Anand Grover highlighted that while drug quality is centrally regulated for the first four years after its release, regulatory control later shifts to the States, leading to potential issues. The Supreme Court did not express any opinion on these concerns but allowed the petitioners to engage in discussions with NACO and the Ministry of Health and Family Welfare. The petitioners were also given the opportunity to present concrete suggestions to resolve the issue.

Case no. – Writ Petition (Civil) No. 686/2022

Case Title – Network of People Living with HIV/AIDS & Ors. v. Union of India & Ors.