The Indian Pharmacopoeia: Enabling Open Access and Crafting A ‘Sovereign Function Exception’ under Indian Copyright Law

Authors

Aparajita Lath, National Law School of India UniversityFollow

Abstract

Standardisation of drugs and access to such standards are important levers for effective drug regulation. The Indian Pharmacopoeia, the official book of standards for drugs in the country prescribed by the Union government under the Drugs and Cosmetics Act 1940, are legally binding and enforceable. Not only do the standards have the force of law but are also government-created. The Indian Pharmacopoeia Commission (IPC), a division of the Union Department of Health and Family Welfare, has a legal monopoly over creating and publishing this compendium. Though it is legally binding, the Indian Pharmacopoeia is neither in the public domain nor openly accessible. Indian copyright law does not place government works, created in exercise of sovereign functions, in the public domain. The government has exploited a gap in Indian copyright law, restricting access to it. As a result, the IPC claims exclusive rights over determining the mode and manner of its publication. Today, the Indian Pharmacopoeia must be purchased from the IPC for a high price.

Against this backdrop, the paper questions the policy of restricting access to government works—particularly legally binding regulatory standards governing drugs. Situated at the intersection of constitutional law, drug regulation, and copyright law, it does so from the dual lens of these public law considerations—(i) access to laws and the right to health and (ii) copyright law. The article proposes the creation of a ‘sovereign function exception’ under copyright law to push certain government-created works into the public domain. A sovereign function exception will appropriately resolve the tensions between public interest—in access to government works and the right to health—versus the state’s interest—in regulation.

Recommended Citation

Lath, Aparajita (2025) "The Indian Pharmacopoeia: Enabling Open Access and Crafting A ‘Sovereign Function Exception’ under Indian Copyright Law," National Law School Journal: Vol. 19: Iss. 1, Article 2.
DOI: https://doi.org/10.55496/FMVZ1991
Available at: https://repository.nls.ac.in/nlsj/vol19/iss1/2

Digital Object Identifier (DOI)

https://doi.org/10.55496/FMVZ1991