Insights from a qualitative study of the procurement and manufacture of active pharmaceutical ingredients in India (Peer-reviewed)

This paper published in BMJ Global Health, delves into the complexities of medicine supply systems, emphasizing the significance of Active Pharmaceutical Ingredient (API) production. Medicine supply systems are pivotal for health systems, and access to effective essential medicines is a cornerstone of Universal Health Coverage. However, the proliferation of substandard and falsified medicines hampers these efforts. Most research has concentrated on the formulation and distribution of the finished product, neglecting the vital steps of API production. This study employs qualitative interviews with manufacturers and regulators in India to explore these overlooked areas of medicine supply chains.

The research underscores that medicine supply chains are intricate, and this paper focuses on parts often ignored: the procurement of raw materials and the production of APIs. The study reveals that the Indian pharmaceutical industry, being the world's third-largest by volume, faces challenges in ensuring consistent quality across its supply chains. The complexity arises from sourcing raw materials and intermediates from multiple suppliers, often across international borders, making quality assurance a daunting task. The market's competitive nature, combined with the need to cut costs, can lead to compromises in quality. The paper suggests that despite regulatory compliance at each stage, the overall quality of medicines might be compromised due to the intricate and opaque nature of transnational pharmaceutical supply chains.