Published on: November 30, 2025

Civil Society Charts Path Forward on Medicine Access at Hyderabad Strategy Meeting. Advocates, Experts Unite to Address Affordability, Quality, and Availability Challenges

The Third World Network’s Working Group on Access to Medicines and Treatments convened its Annual CSO Strategy Meeting in Hyderabad on November 22–23, 2025, bringing together patient advocates, legal experts, healthcare professionals, and policy researchers to address critical challenges threatening equitable access to medicines across India and the Global South. Over two intensive days, participants examined historical lessons, dissected current regulatory debates, and mapped collective strategies to defend health as a fundamental right in an era of rising pharmaceutical costs and monopoly pressures.

Day One: Histories, Lessons, and New Campaigns

Welcome remarks from co-convenors KM Gopa Kumar and Jyotsna Singh framed the gathering within India’s pharmaceutical journey—from the landmark 1975 Hathi Committee recommendations to two decades of navigating the TRIPS Agreement. Singh updated participants on Working Group activities in 2025, including campaigns around rare disease access, opposition to data exclusivity proposals, and efforts to strengthen public provisioning systems.

A plenary session titled “50 Years of the Hathi Committee and India’s Pharma Evolution to Two Decades of TRIPS” featured experts Biswajit Dhar and Dinesh Abrol, who analyzed how India strategically utilized TRIPS flexibilities—particularly Section 3(d) of the Patent Act—to maintain space for generic competition while facing continuous pressure from multinational corporations and trade agreements. Legal advisor Chetali Rao, along with advocates Loon Gangte and Brinelle D’Souza, connected these structural issues to everyday struggles for treatment access among communities living with HIV, tuberculosis, and other chronic conditions.

Rare Disease Crisis: A Tale of Three Countries

One of the meeting’s most powerful segments focused on rare disease treatments, particularly Spinal Muscular Atrophy (SMA), Cystic Fibrosis (CF), and Duchenne Muscular Dystrophy (DMD). Patient advocates from Bharath MD Foundation shared testimonies of families bankrupted by treatment costs and frustrated by opaque government negotiations with pharmaceutical manufacturers.

A presentation titled “Response to Rare Diseases in India” illustrated stark price disparities. Patients weighing 20 kg or more require about 36 bottles annually. In China, government negotiations achieved an annual cost of USD 6,540 (INR 5.37 lakh), while Pakistan’s NGO-negotiated price was USD 6,000 (INR 4.93 lakh). In contrast, Indian families faced INR 6.23 lakh per vial—over INR 72 lakh annually, more than ten times higher. Advocates requested transparent negotiations with Roche, but the Government of India conducted closed-door discussions, arriving at an undisclosed price estimated above INR 50 lakh per year. Families remain uncertain about eligibility and actual costs under government schemes.

Legal experts Maitreyi Hegde and Anand Grover, alongside Prasanna Shirol from the Organization for Rare Diseases India, discussed policy developments including the National Policy for Rare Diseases 2021 and the National Fund with Rs 974 crore allocated for 2024–26. While the revised treatment cap of Rs 50 lakh per patient marked progress from the earlier Rs 20 lakh limit, it remains inadequate given actual therapy costs. Speakers argued for compulsory licensing, pooled procurement, and robust support for domestic biosimilar manufacturing to achieve sustainable price reductions.

Expanding the Agenda: Palliative Care, Sickle Cell, and TB Elimination

Beyond rare diseases, the meeting addressed broader access gaps. Dr. Parth Sharma from the Association for Socially Applicable Research presented on integrating palliative care into India’s health system, emphasizing morphine access and the denial of pain relief due to restrictive opioid regulations, limited provider training, and inadequate reimbursement mechanisms. Pallium India was represented by Dr. Adarsh Varghese and Dr. Preeti Chauhan, who highlighted challenges under the NDPS Act, explaining how restrictive regulations and policies severely hinder access to morphine, leaving millions without adequate pain management.

Primary care physician Abhijit Gadewar presented the Sangwari Model for sickle cell disease management, showing how community-centred approaches—decentralized screening, counselling, and accessible medicines—can improve outcomes in tribal and underserved populations.

Tuberculosis advocates Ganesh Acharya and Atul Shendge discussed India’s commitment to the WHO’s End TB Strategy, targeting a 95% reduction in TB deaths, 90% reduction in incidence, and elimination of catastrophic costs by 2035. Achieving these goals requires not only better medicines and diagnostics but also comprehensive social protection to prevent treatment interruption due to financial hardship.

Eldred Tellis from Sankalp Rehabilitation Trust highlighted challenges in HIV treatment access, particularly around new long-acting antiretrovirals like Lenacapavir, introduced at premium prices that threaten earlier gains from generic competition.

Day Two: Public Provisioning and Supply Chain Realities

Day two opened with an examination of public medicine provisioning, reviewing ten years of the Free Drugs and Diagnostics Service Initiative under the National Health Mission. Researchers Santhosh MR and Indranil Mukhopadyay presented findings on financing mechanisms and Comptroller and Auditor General (CAG) studies documenting persistent stockouts despite program expansion.

A key conceptual clarification distinguished between “shortage” and “stockout.” Shortage refers to systemic, national-level inadequate supply caused by manufacturing disruptions or policy failures, while stockout refers to facility-level zero inventory due to local supply chain issues even when national supplies exist. This distinction is crucial for designing appropriate interventions—whether industrial policy reforms, better demand forecasting, or strengthened logistics and accountability.

Quality, Safety, and the Bioequivalence Debate

A technical session on “Quality, Safety & Efficacy of Medicines” addressed evolving regulatory requirements for generics. Uday Bhaskar, Director General of the All-India Drugs Control Officers’ Confederation Training Centre, presented on directives from the Drugs Controller General of India (DCGI) concerning GSR 327(E) of April 2017, mandating bioequivalence (BE) studies for oral solid dosage forms in BCS Categories II and IV.

Industry concerns centred on prohibitive costs—Rs 25–50 lakh per study, multiplied if repeated—potentially passed on to patients and public health systems. To address this, the session introduced “biowaivers,” a WHO-endorsed pathway for BCS Class I drugs where in vitro dissolution tests can demonstrate equivalence instead of expensive in vivo studies. Discussion emphasized balancing rigorous quality standards with practical compliance pathways that don’t eliminate smaller domestic manufacturers supplying affordable generics.

A diagram depicted India’s pharmaceutical regulatory ecosystem as multi-faceted, involving regulators, ministries, technical experts, prescribers, patients, manufacturers, and supply chain actors. Participants stressed that patient groups must have stronger voices in regulatory rule-making and post-marketing surveillance to ensure decisions align with public health priorities rather than commercial interests.

Monitoring Infrastructure and Quality Assurance

India’s quality monitoring infrastructure currently includes eight central and thirty-eight state drug testing laboratories analysing about 100,000 samples annually, with investigations conducted jointly with State Drug Control authorities. Three additional central labs are planned, though capacity remains inadequate relative to market scale.

Civil society representatives called for mandatory public disclosure of testing outcomes, digital batch tracking, and stronger whistle-blower protections for inspectors. Transparency reforms were emphasized as equally important as new legal instruments.

Chinu Srinivasan from LOCOST discussed the impact of mandatory BA(Bio-Availability)/BE (Bio-Equivalence) requirements on MSME generic manufacturers, emphasizing the need for graduated regulatory approaches that maintain quality while supporting domestic production capacity.

Strategic Priorities for 2025

The Working Group outlined four focal areas:

  1. SMA and High-Cost Rare Diseases: Advocacy for transparent pricing negotiations, sustainable public financing, and policies encouraging generic and biosimilar competition.
  2. Free Trade Agreements (FTAs): Resisting TRIPS-plus provisions introducing extended patent terms, data exclusivity, and stronger enforcement delaying generic entry.
  3. Biologics and Cancer Medicines: Establishing clear biosimilar pathways, public investment in manufacturing, and international collaboration among developing countries.
  4. Patent Barriers and Data Exclusivity: Opposing data exclusivity proposals that create “backdoor monopolies” by blocking reliance on existing trial data even without valid patents.

Organizational Workstreams and Collective Action

Four specialized clusters were showcased:

  • Patients/Community Organizing: Legal aid, family alliances, and political advocacy.
  • IP and Access: Holding the Patent Office accountable, tracking applications, opposing data exclusivity, and supporting domestic companies in challenging weak patents.
  • Medicine Prices and Free Medicines: Monitoring price trends, identifying DPCO gaps, and documenting free medicine scheme challenges.
  • Industrial Policy: Engaging domestic manufacturers through incentives, public-sector support, and procurement rewarding quality and affordability.

Karnataka’s Campaign Model

Gopal Dabade and Mahesh Patil from Drug Action Forum Karnataka presented their state-level campaign mobilizing for free and quality drugs through the Samagra Arogya Andolan Karnataka initiative. Their experience demonstrated how grassroots organizing, media engagement, and legislative advocacy can strengthen public provisioning systems even in challenging political environments.

The Road Ahead

The meeting concluded with a forward-looking session facilitated by Singh and Gopa Kumar on “Shaping the Road Ahead: Strategies for Collective Action.” Participants committed to strengthening alliances between patient groups, health workers, legal advocates, researchers, and progressive industry actors to confront common challenges while insisting on robust, evidence-based quality regulation.

Civil society reaffirmed that access to quality-assured, affordable medicines is a fundamental component of the right to health, not a market privilege. The Hyderabad gathering positioned itself as a crucial platform for shaping India’s and the Global South’s response to evolving pharmaceutical and regulatory landscapes. It carried forward decades of activism into new terrain marked by biologics, rare diseases, palliative care, and digital health, while defending hard-won gains in generic medicine access for millions.

By spotlighting rare disease crises, opioid access barriers under the NDPS Act, and systemic challenges in public provisioning and regulation, the meeting underscored the urgency of collective action. The presence of diverse voices—from grassroots advocates to technical experts—ensured that strategies were grounded in lived realities as well as policy frameworks.

As participants dispersed, the consensus was clear: only through transparent negotiations, stronger domestic manufacturing, inclusive regulatory processes, and sustained civil society mobilization can we give equitable access to medicines. The Hyderabad strategy meeting thus set the stage for coordinated campaigns in 2025 and beyond, reaffirming health as a right and charting a path toward justice in medicine access.

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