Faculty Seminar | Presentations by Aparajita Lath and Jai Brunner

There will be two presentations by NLS Faculty in this week’s seminar. The first presentation will be by Aparajita Lath, followed by Jai Brunner.

Presentation 1

Title: “The Indian Pharmacopoeia: Crafting A ‘Sovereign Function Exception’ Under Indian Copyright Law” by Aparajita Lath.

Abstract

Standardization of drugs and access to standards are important levers for effective drug regulation. In India, the Indian Pharmacopoeia is the official book of standards for drugs prescribed by the Central Government under the Drugs and Cosmetics Act, 1940 (D&C Act). The Indian Pharmacopoeia is legally-binding and enforceable. These law-like standards form part of the D&C Act and are necessary for its effective implementation. The standards are also government created. The Indian Pharmacopoeia Commission (IPC), described as an ‘autonomous’ organisation of the Department of Health and Family Welfare (Central Government), has a legal monopoly of creating and publishing the Indian Pharmacopoeia. However, unlike other laws, the Indian Pharmacopoeia is not openly and freely published. Instead, the Government has exploited a gap in Indian copyright law to restrict access. Indian copyright law does not put ‘government works’ or ‘government-funded works’ in the public domain. As a result, the IPC claims exclusive rights over determining the mode and manner of publication. Today, the Indian Pharmacopoeia must be purchased from the IPC.

In this context, this article questions the Government’s policy of restricting access to law-like standards such as the Indian Pharmacopoeia. It does so from the dual lens of public law considerations of access to laws and copyright incentives. The article proposes the creation of a ‘sovereign function exception’ under copyright law to force certain categories of government works into the public domain. A sovereign function exception will appropriately resolve the tensions between public interest in access to government works and the State’s interest in limiting such access.

Parts: Part II traces the history of the establishment of the Indian Pharmacopoeia and the IPC. Part III outlines the key characteristics of the IPC, and analyses the extent of State intervention in its management, financing and operations. This examination is central to understanding whether the IPC is an autonomous organisation and whether the Indian Pharmacopoeia is ‘sufficiently law-like’. To put the Indian approach of standard-setting in perspective, Part IV discusses international standard-setting approaches, using the United States and Japan, as contrasting models. Part V analyses legal and policy concerns from the dual lens of access to laws and copyright protection. Part VI recommends the creation of a ‘sovereign function exception’ under Indian copyright law.

Presentation 2

Title: “The Promise of Substantive Equality? Transplanting the Indirect Discrimination Test into India” by Jai Brunner.

Abstract

In 2021, the Supreme Court of India expressly applied an indirect discrimination analysis for the first time in Lt. Cl. Nitisha v. Union of India. Directly borrowing the test formulated by the Canadian Supreme Court in Fraser v. Canada, the Court held that the Indian Army’s recruitment practices indirectly discriminated against certain women officers, in violation of Article 15(1) of the Constitution. In laying down the test of indirect discrimination, the Court emphasised that its overarching aim was to further substantive equality, in particular a version of substantive equality formulated by Sandra Fredman. However, as Vandita Khanna has shown, the Court lays down standards that fall short of this stated aim, thus risking ‘[to dilute] substantive equality…to rhetorical flourish’. How could the judgment have so fatally undermined itself? I ask whether the Court’s conceptual confusion is symptomatic of an underlying flaw in the Court’s reasoning? I examine the Court’s method for formulating the test of indirect discrimination – legal transplantation. I argue that the judgment engages in a type of comparative reasoning that is highly formalistic and abstract. The Court transplants Canadian doctrine into India in a manner that presumes that law is universal, irrespective of social context. The Court’s comparative method is divorced from what Mari Matsuda calls the ‘concrete realities of social life’. I argue that to completely abstract law out of the social context within which law exists, is not consistent with the mandate of substantive equality. Thus, though the Court sets forth to develop anti-discrimination doctrine with the stated aim of furthering substantive equality, it undermines itself by using a method of comparative law that is inconsistent with substantive equality.