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

Jerin Jose Cherian, Manju Rahi, Shubhra Singh, Sanapareddy Eswara Reddy, Yogendra Kumar Gupta, Vishwa Mohan Katoch, Vijay Kumar, Sakthivel Selvaraj, Payal Das, Raman Raghunathrao Gangakhedkar, Amit Kumar Dinda, Swarup Sarkar, Puroshottambhai Devshibhai Vaghela and Balram Bhargava
Additional contact information
Jerin Jose Cherian: Division of Basic Medical Sciences, Indian Council of Medical Research, New Delhi 110029, India
Manju Rahi: Division of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi 110029, India
Shubhra Singh: National Pharmaceutical Pricing Authority, New Delhi 110001, India
Sanapareddy Eswara Reddy: Central Drugs Standard Control Organization, New Delhi 110002, India
Yogendra Kumar Gupta: Standing National Committee on Medicines, Department of Health Research, Ministry of Health and Family Welfare, New Delhi 110001, India
Vishwa Mohan Katoch: Department of Health Research (ICMR), Ministry of Health and Family Welfare, New Delhi 110001, India
Vijay Kumar: Division of Basic Medical Sciences, Indian Council of Medical Research, New Delhi 110029, India
Sakthivel Selvaraj: Health Economics, Financing and Policy, Public Health Foundation of India, New Delhi 110017, India
Payal Das: Division of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi 110029, India
Raman Raghunathrao Gangakhedkar: Division of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi 110029, India
Amit Kumar Dinda: Department of Pathology, All India Institute of Medical Sciences, New Delhi 110029, India
Swarup Sarkar: Translational Global Health Policy Research Cell, CG Pandit Chair (Medical), Indian Council of Medical Research, New Delhi 110029, India
Puroshottambhai Devshibhai Vaghela: Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, New Delhi 110001, India
Balram Bhargava: Department of Health Research (ICMR), Ministry of Health and Family Welfare, New Delhi 110001, India

Economies, 2021, vol. 9, issue 2, 1-18

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.

Keywords: active pharmaceutical industry; domestic manufacturing; essential medicines; import dependence; India; pharmaceutical policy; public health (search for similar items in EconPapers)
JEL-codes: E F I J O Q (search for similar items in EconPapers)
Date: 2021
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