DOES LOCAL PHARMACEUTICAL PRODUCTION TRANSLATE INTO ACCESS TO ANTI-CANCER MEDICINES? A COMPARATIVE ANALYSIS OF THREE MAJOR PRODUCER COUNTRIES IN SOUTH ASIA
Author(s)
Sundus Shukar1, Caijun Yang, Phd2, Zaheer-Ud-Din Babar, Phd3, Yu Fang, Phd2;
1Xi'an Jiaotong University, PhD Scholar, Xi'an, China, 2Xi'an Jiaotong University, Xi'an, China, 3Qatar University, Doha, Qatar
1Xi'an Jiaotong University, PhD Scholar, Xi'an, China, 2Xi'an Jiaotong University, Xi'an, China, 3Qatar University, Doha, Qatar
OBJECTIVES: Despite being a global hub for generic medicine production, South Asia faces persistent shortages, high prices, and treatment interruptions for anti-cancer medicines. It remains unclear whether local production reliably improves real-world access. To assess how local pharmaceutical production impacts access to essential anti-cancer medicines in three South Asian countries.
METHODS: A multi-method study was conducted across India, Bangladesh, and Pakistan. Document analysis evaluated regulatory maturity and production capacity. Policy alignment was assessed across NEML inclusion, regulatory registration, and local production. Availability and prices of 67 WHO-listed anti-cancer medicines were surveyed in public/private hospitals and pharmacies, stratified by origin. Semi-structured interviews with 15 stakeholders provided contextual insights. Ethical approval was secured in three countries.
RESULTS: India showed the strongest regulatory system (WHO Maturity Level 3) and production base (3,000 manufacturers; 80% local share), followed by Bangladesh (253 manufacturers; 98% share; NRA Level 2) and Pakistan (650 manufacturers; 90% share; NRA Level 2). Policy alignment was highest in India (43 NEML-listed, 65 registered, 63 locally produced medicines); Bangladesh (16, 37, 33) and Pakistan (67, 50, 41) showed significant misalignment. Only India met the WHO’s >80% benchmark for generic availability (89.6%). Locally produced generics dominated supply: >98% in India, ~90% in Bangladesh, and 65-75% in Pakistan. Prices of local generics were lower than imports in Pakistan, higher in Bangladesh, and highly variable in India. Qualitative data highlighted fragmented procurement, weak price regulation, API import dependence, and low public trust as key barriers.
CONCLUSIONS: Local production bolsters supply resilience but does not guarantee affordability or consistent availability. Realizing its HEOR value requires robust regulation, coherent pricing/procurement policies, and tight alignment with national medicines strategies.
METHODS: A multi-method study was conducted across India, Bangladesh, and Pakistan. Document analysis evaluated regulatory maturity and production capacity. Policy alignment was assessed across NEML inclusion, regulatory registration, and local production. Availability and prices of 67 WHO-listed anti-cancer medicines were surveyed in public/private hospitals and pharmacies, stratified by origin. Semi-structured interviews with 15 stakeholders provided contextual insights. Ethical approval was secured in three countries.
RESULTS: India showed the strongest regulatory system (WHO Maturity Level 3) and production base (3,000 manufacturers; 80% local share), followed by Bangladesh (253 manufacturers; 98% share; NRA Level 2) and Pakistan (650 manufacturers; 90% share; NRA Level 2). Policy alignment was highest in India (43 NEML-listed, 65 registered, 63 locally produced medicines); Bangladesh (16, 37, 33) and Pakistan (67, 50, 41) showed significant misalignment. Only India met the WHO’s >80% benchmark for generic availability (89.6%). Locally produced generics dominated supply: >98% in India, ~90% in Bangladesh, and 65-75% in Pakistan. Prices of local generics were lower than imports in Pakistan, higher in Bangladesh, and highly variable in India. Qualitative data highlighted fragmented procurement, weak price regulation, API import dependence, and low public trust as key barriers.
CONCLUSIONS: Local production bolsters supply resilience but does not guarantee affordability or consistent availability. Realizing its HEOR value requires robust regulation, coherent pricing/procurement policies, and tight alignment with national medicines strategies.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HPR12
Topic
Health Policy & Regulatory
Topic Subcategory
Health Disparities & Equity, Pricing Policy & Schemes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology, STA: Biologics & Biosimilars