India’s Road to Independence in Manufacturing Active Pharmaceutical Ingredients: Focus on Essential Medicines

Abstract

Background: Active Pharmaceutical Ingredient (API) manufacturing is an important segment of the Indian pharma industry. India ranks third in terms of volume of medicines produced, and is a major global supplier of generic medicines. However, India depends heavily on the import of several raw materials used to produce some of these medicines. Main Body: This paper highlights how the situation emerged, as well as the various steps taken by the government to reduce import dependency and promote domestic manufacturing of APIs. Through various consultations with government officials, policy analysts and academicians, and interactions with key industry experts, the paper also highlights the public health perspectives of such dependence, especially regarding the secure access to essential medicines. India needs a conducive ecosystem to capitalize on the full potential of its API manufacturing capabilities, which may require some short-term and some mid/long-term interventions. Conclusions: It concludes by providing certain short-, medium- and long-term recommendations in the policy, fiscal and technology domains, to promote API independence. It also summarizes the various steps taken by the government in moving towards domestic manufacturing of APIs.