TWN Info Service on Health Issues: (Oct25/01)
1 October 2025
Third World Network

Health: Perilous Delay in Lenacapavir Registration Compromises Access in Developing Countries

New Delhi, 1 Oct (Chetali Rao) – Delay in registration to secure market authorization of a groundbreaking HIV prevention treatment undermines timely access, notwithstanding the existence of a voluntary license for the majority of low-and-middle income countries (LMICs).

The recent announcement of the $40 price agreement for Lenacapavir, a long-acting treatment for prevention of HIV as pre-exposure prophylaxis (PrEP), represents a breakthrough and may accelerate access to millions who need them.

Yet, important challenges remain.

Patients and communities watch with growing concerns over the future availability of Lenacapavir due to uncertainties surrounding its supply, regulatory approvals and current licensing deals that excludes many developing countries which need them the most. Developed by Gilead Sciences, Inc this twice yearly injectable has shown remarkable efficiency in HIV treatment and prevention, offering hope to millions living with the virus. Yet, Gilead’s decision to exclude many developing countries from the voluntary licensing agreement, and not register the products in many countries like India threatens to transform this scientific triumph into an unending wait for patients.

According to a report by Health Gap, in its initial access strategy Gilead had prioritized 18 LMICs for registration; however, it has filed for initial regulatory approval in only 8 countries (via EU-M4all or direct filing). Lenacapavir still remains unregistered in 127 LMICs, which account for approximately 60% of the new HIV infections annually. It has also been noted that in countries which accept or rely on the European Union Regulatory approval (including Latin American countries like Argentina, Colombia, Cost Rica, Ecuador among others) and 15 Caribbean states utilizing the Caribbean Regulatory System, Lenacapavir could be registered quickly after approval by the European Medicines Agency (EMA), provided Gilead submits the necessary application to each National Regulatory Agency. Nonetheless, the entire process remains hostage to Gilead’s willingness to submit its applications in these countries.

At the heart of the crisis is the voluntary license (VL) signed by Gilead in 2024, which was meant to facilitate access. On paper the VL allows generic manufacturers to produce and distribute Lenacapavir at low cost, yet this arrangement seems to be a hollow promise. Given Gilead’s tight control over the registration process to extend its exclusivity period despite issuing a VL, the VL becomes little more than an empty gesture.

Further, the restrictive terms of the license include anti-diversion clauses, right management provisions and exclusion of many middle-income countries, who not only participated in the trials but are also where 41% of new infections occur and 37% of the global population resides. This undermines the VL’s intent despite the claim of access expansion. Excluded countries cannot benefit from generic access under the current price agreements until separate arrangements are made.

Uncertainty Surrounding Registration in India

In India, a nation which carries the highest HIV burden in the world (with approximately 2.5 million people living with HIV) the absence of Lenacapavir registration by Gilead with the Indian regulatory body, the Central Drugs Standard Control Organization (CDSCO), creates a regulatory  predicament.

Lenacapavir has not been registered in India and does not appear on the list of new approved drugs in India in 2024 and 2025. The New Drugs and Clinical Trial Rule, 2019 (NDCTR),  mandates that for a new drug approved outside India which does not have a marketing approval in India, a generic manufacturer must conduct local clinical trials (or bioequivalent studies) – to demonstrate the safety and efficacy for the Indian population before the generic drug can be marketed.

However, Rule 75 of the NDCTR (2019) provides a significant provision for waiver of local clinical trials in India. Under this, when a drug is already approved and marketed in certain “specified countries” as notified by the Central Licensing Authority under Rule 101 namely the United States, United Kingdom, European Union, Japan, Canada or Australia, the Drug Controller General of India may waive the clinical trials. This waiver is granted subject to the generic manufacturer providing an undertaking to conduct a Phase-IV post marketing study in India to monitor safety and efficacy of the product concerned.  For Lenacapavir this is a viable pathway but the discretionary nature of granting the waiver introduces a concerning element of  arbitrariness, where delays could hinder timely affordability.

Additionally, a Certificate of Pharmaceutical Product (CPP) from the Indian Regulatory Body is required by all the three Indian licensees namely Dr Reddy’s Laboratories Ltd, Hetero Labs and Emcure to export the drugs outside India.  The CPP is a critical credential, ensuring regulatory trust and market eligibility of the product in India, thereby fostering international confidence and commercial feasibility. Although the typical processing time is up to 30 days, depending on the product category, generic manufacturers report that actual timelines often exceed more than the given timeline. Current delays in the process have been attributed to regulatory bottlenecks, onboarding challenges with the digital platform and procedural inefficiencies. Export councils and industry associations have expressed concerns to CDSCO that such delays risk disrupt timely exports.

India, a major supplier of generic HIV/AIDS medicines, must leverage its regulatory autonomy to ensure expedited access to Lenacapavir. The Indian regulatory body should waive clinical trial requirements for Lenacapavir, relying on the FDA/EMA data as permitted under the NDCTR (2019) and expedite the CPP issuance to the three Indian generic manufacturers to supply generic Lenacapavir globally, when the supply is ready. A delay in generic availability of Lenacapavir casts a significant shadow, particularly given the fact that Indian manufacturers are renowned for bringing out low-cost HIV medicines globally.

Lenacapavir’s registration delay by Gilead in many countries is not merely a regulatory bottleneck – it is a strategy to delay access and keep prices of Lenacapavir high. Gilead’s voluntary license in all senses seems a velvet glove over an iron grip and India’s regulatory inertia and discretion may exacerbate it. Delays will undermine HIV prevention efforts, especially given Lenacapavir’s game changing efficacy for PrEP.

Unfortunately currently international regulations favour the profit maximising business models of pharmaceutical transnational corporations by allowing them to make use of the product patent regime of the Trade-related Aspects of Intellectual Property rights Agreement to prevent generic manufacturing, without any corresponding obligations to market the products in developing countries, including those where clinical trials have been carried out.

Until these bottlenecks are addressed, Lenacapavir becomes a symbol of broken promises, leaving millions of people suffering from HIV in a limbo.

(With inputs from K M Gopakumar.)