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Union of India & Anr. v. Pfizer Limited & Ors.

Civil Appeal · 2017 INSC 1248Decided 15 Dec 2017
Civil Appeal No. 22972 of 2017
Justice Rohinton Fali Nariman · Justice Sanjay Kishan Kaul

Background

Following reports that many unapproved "Fixed Dose Combination" (FDC) drugs, medicines combining multiple active ingredients, were being sold in India without adequate safety or efficacy testing, the Central Government banned 344 such FDCs in 2016 under Section 26A of the Drugs and Cosmetics Act. Drug manufacturers challenged the ban in the Delhi High Court, which ruled that the government was required to first consult the Drugs Technical Advisory Board (DTAB), a specialized expert body, before banning any drug, and struck down the ban notifications for failing to do so. The Union of India and pharmaceutical companies on both sides of the dispute brought the matter to the Supreme Court, along with related cases transferred from the Delhi and Madras High Courts.

Decision Breakdown

The Supreme Court held that Section 26A, unlike several other provisions of the Drugs Act, does not expressly require consultation with the DTAB before the Central Government bans a drug, and this omission was a deliberate choice by Parliament, not an oversight to be filled in by the courts, reading in such a requirement would improperly rewrite the statute. The Central Government's power to act under Section 26A instead depends on it being "satisfied," based on any relevant material, that a drug poses a risk, lacks therapeutic value, or contains unjustified ingredients. However, given the peculiar facts of this case, the Court directed that the list of banned FDCs be referred to the DTAB (or a sub-committee) for a fresh, more detailed review, one that must specifically justify why an outright prohibition, rather than mere regulation or restriction, was necessary, with a report due to the government within six months, while leaving status quo in place in the meantime.

Lesson Learnt

When a law gives the government power to act "if satisfied" on certain grounds, courts generally will not add extra procedural requirements (like mandatory expert consultation) that Parliament chose not to include, especially where the law elsewhere shows it knew how to require such consultation explicitly; but courts can still direct a more rigorous and transparent process on the specific facts of a case to ensure government action is well-reasoned, even without changing what the law itself requires.

Official source (sci.gov.in)View Judgment (PDF)

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