Supreme Court Directs All States To Address Concerns About ART Drugs For People Living With HIV/AIDS

The Supreme Court has directed all States to respond to concerns relating to periodic stockouts, transparency in tendering and procurement, and drug quality and certification processes of the of Anti-Retroviral Therapy (ART) drugs for People Living with HIV/AIDS (PLHIV).

A bench of Justice Abhay Oka and Justice Ujjal Bhuyan ordered the States to file affidavits addressing six issues detailed by the petitioners in a PIL filed by the Network of People Living with HIV/AIDS regarding 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.

The Court had in January also sought the centre's response to the concerns raised by the petitioners. The case has been listed for its next hearing on April 4, 2025.

The petition alleged systemic failures in the procurement system, leading to repeated shortages of ART drugs, which disrupted the treatment of PLHIVs. The petitioners state that this increases the risk of illness and death among PLHIVs, violating their right to health and life.

The Supreme Court issued notice in the matter on September 12, 2022. During a hearing on July 10, 2024, the petitioners stated that while there was no shortage of ART drugs at that time, they raised concerns about procurement processes and drug quality. The Court then allowed the petitioners to engage in discussions with representatives of the National AIDS Control Organisation (NACO) and the Union Ministry of Health and Family Welfare to address their concerns.

As per the affidavit, a meeting was held on August 1, 2024, between the petitioners and NACO officials. Following this meeting, the petitioners sent a letter on August 23, 2024, to NACO, listing six issues that needed to be addressed:

1. Periodic Stockouts: The petitioners highlighted recurring stockouts of HIV ARVs in 2004, 2009, and 2022, as well as recent shortages of HIV kits and TB medicines. They stressed the need for early procurement processes and urged NACO to avoid awarding contracts to blacklisted companies.

2. Tendering and Procurement Transparency: The petitioners called for greater transparency in the procurement process, including making tender details publicly accessible on the NACO website.

3. Drug Quality and Certification Processes: Concerns were raised about the certification and quality control processes conducted by State Licensing Authorities, particularly regarding the stability and taste of TLD tablets. The petitioners demanded stringent prequalification criteria to maintain high drug quality standards.

4. Coordination Committee: The petitioners suggested re-establishing the previously functional Coordination Committee for real-time monitoring of stockouts, ensuring transparent communication and community participation.

5. Independent Monitoring: They proposed setting up an independent committee comprising retired judges, health officials, community representatives, and quality experts to investigate stockouts.

6. Consent Order: The petitioners suggested issuing a consent order to formalize the proposed changes and re-establish the Coordination Committee.

The case was initially filed in August 2022, alleging that there were severe shortages of ART drugs due to delays in the tendering process for 2021-2022. According to the petitioners, the tender meant for August 2021 was issued in December 2021 but failed, prompting a fresh tender in March 2022, which was also delayed. This situation, they argued, necessitated emergency procurement to ensure uninterrupted treatment for PLHIVs.

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

During the hearings, Senior counsel Anand Grover pointed out that the initial four years after a drug's release are centrally regulated, ensuring quality, but issues arise when approval and regulation shift to the States afterward.

The Supreme Court did not express any opinion on these issues but allowed the petitioners have discussions with NACO and the Ministry of Health and Family Welfare. The petitioners were also permitted 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.

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