LOCAL PHARMACEUTICAL PRODUCTION AND ACCESS TO ANTI-CANCER MEDICINES: A COMPARATIVEEVIDENCE FROM INDIA, BANGLADESH, AND PAKISTAN...
Author(s)
Sundus Shukar, Pharm-D, MSc1, Caijun Yang, Phd2, Yu Fang, Phd2.
1PhD Scholar, Xi'an Jiaotong University, Xi'an, China, 2Xi'an Jiaotong University, Xi'an, China.
1PhD Scholar, Xi'an Jiaotong University, Xi'an, China, 2Xi'an Jiaotong University, Xi'an, China.
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, affordability 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.
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%) and affordability was also very low. 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 regulatory policies, weak oncology infrastructure, financial constraints, and API import dependence as key barriers.
CONCLUSIONS: Local production strengthens supply resilience but does not guarantee affordability or consistent availability. Realizing its HEOR value requires robust regulation, pooled pricing/procurement policies, and pooled manufacturing strengthened by a public-private partnership along with regional collaboration.
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, affordability 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.
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%) and affordability was also very low. 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 regulatory policies, weak oncology infrastructure, financial constraints, and API import dependence as key barriers.
CONCLUSIONS: Local production strengthens supply resilience but does not guarantee affordability or consistent availability. Realizing its HEOR value requires robust regulation, pooled pricing/procurement policies, and pooled manufacturing strengthened by a public-private partnership along with regional collaboration.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
HPR6
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology, STA: Biologics & Biosimilars, STA: Generics