Drugs and Cosmetics Act | States Cannot Prescribe Higher Qualifications for Drug Inspectors Overriding Central Rules: Supreme Court

“Once the Centre has consciously and expressly occupied the field by placing the Drug Rules framed under the D&C Act before both Houses of the Parliament... any inconsistent exercise of power by the State... stands impliedly excluded.”— In a seminal ruling, the Supreme Court of India, comprising Justice J.K. Maheshwari and Justice Vijay Bishnoi, has held that State Governments lack the legislative competence to prescribe "experience" as an essential qualification for the appointment of Drug Inspectors (DI) or Drug Control Officers (DCO) when the Central Rules do not mandate it.

The judgment settles a significant legal battle involving the States of Haryana and Karnataka, affirming that the Drugs and Cosmetics Act, 1940 (D&C Act) and the Drugs and Cosmetics Rules, 1945 (Drug Rules) occupy the field regarding the qualifications of Drug Inspectors, thereby precluding States from enforcing higher eligibility criteria under Article 309 of the Constitution.

The Core Controversy: Central vs. State Rules

The dispute arose from recruitment notifications issued by the Haryana Public Service Commission (HPSC) and the Karnataka Public Service Commission (KPSC). Both States had framed service rules—the Haryana Food and Drugs Administration Department, Subordinate Offices (Group B) Service Rules, 2018 and the Karnataka Health and Family Welfare Services (Drugs Control Department Non-teaching staff) (Recruitment) Rules, 2013—which mandated 18 months of manufacturing or testing experience as an essential qualification for the post of Drug Inspector.

Aggrieved candidates challenged these notifications, arguing that Rule 49 of the Central Drug Rules, 1945 prescribes only an academic degree (Pharmacy, Pharmaceutical Sciences, or Medicine with specialization) for appointment, without mandating prior experience. They contended that the experience requirement in the Central Rules is only a condition for authorizing an inspector to inspect specific drugs (Schedule C), not a prerequisite for recruitment.

“The power to prescribe qualifications and conditions for appointment of Inspectors vests exclusively with the Central Government under the D&C Act.”

Doctrine of Occupied Field

The Supreme Court conducted a deep historical analysis of the D&C Act, noting that it was enacted by the Federal Legislature pre-independence with the concurrence of Provincial Legislatures to ensure uniformity. The Court applied the Doctrine of Occupied Field, holding that since the Central Government has exercised its power under Section 33 of the D&C Act to prescribe qualifications via Rule 49, the subject is fully "occupied."

The Bench observed that while States have the power to appoint inspectors under Section 21, they cannot alter the "prescribed qualifications." The Court rejected the States' reliance on Article 309 of the Constitution, stating that the rule-making power of the Governor is subject to the provisions of the Central Act in the Concurrent List.

Interpretation of Rule 49: Experience is for Duties, Not Appointment

A pivotal aspect of the judgment was the interpretation of the proviso to Rule 49. The Court clarified that the substantive part of Rule 49 prescribes the educational qualifications necessary for appointment. The proviso, which mentions 18 months of experience, acts as an embargo on duties, not an eligibility barrier.

The Court explained that a person can be appointed as a Drug Inspector based on their degree. However, they can be authorized to inspect the manufacture of Schedule C drugs (biological and special products) only after acquiring the requisite experience. Elevating this "authorization requirement" to an "initial recruitment eligibility" by the States was held to be ultra vires and inconsistent with the Central scheme.

“Possessing an experience of a specific nature shall not be included within the qualification prescribed for initial appointment as Inspector.”

Distinguishing Previous Precedents

The States relied on the judgment in S. Satyapal Reddy vs. Govt. of A.P., arguing that States can prescribe higher qualifications than the "minimum" set by the Centre. The Supreme Court distinguished this, noting that in Satyapal Reddy, the Central Act (Motor Vehicles Act) explicitly prescribed a "minimum" qualification, leaving room for States to set higher standards. In contrast, the D&C Act and Rule 49 do not use the term "minimum"; they prescribe the specific qualification required for the post to ensure uniform standards across India.

The Supreme Court dismissed the appeals filed by the States of Haryana and Karnataka and allowed the appeal of the private candidate, Parveen Kumar. The Court issued the following directions:

1. Quashing of State Criteria: The requirement of experience in the State advertisements was quashed as ultra vires.

2. Redrawing Selection Lists: HPSC and KPSC were directed to redraw the selection lists within eight weeks, considering only the qualifications prescribed in Rule 49 of the Drug Rules (ignoring the experience requirement).

3. Protection of Appointees: Recognizing that some appointments had already been made in Haryana, the Court invoked its powers under Article 142. It directed that appointees who make it into the new merit list should continue without interruption.

4. Supernumerary Posts: For those appointees who fall out of the new merit list, the State Government has the discretion to continue their employment by creating supernumerary posts, ensuring they do not occupy vacancies meant for the meritorious candidates under the corrected list.

Date of Decision: January 13, 2026