Qualifications For Drug Inspectors Must Be As Prescribed Under Drugs & Cosmetics Act; States Cannot Modify Criteria: Supreme Court

The Court held that qualifications for Drug Inspectors must strictly conform to those prescribed under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, and that State service rules introducing experience requirements as an essential qualification are impermissible.

The Court was hearing a batch of civil appeals arising from judgments of the Punjab and Haryana High Court and the Karnataka High Court, which had quashed recruitment advertisements and selection processes for Drug Inspectors on the ground that State-prescribed qualifications were inconsistent with Rule 49 of the Drugs and Cosmetics Rules, 1945.

A Bench comprising Justice J.K. Maheshwari and Justice Vijay Bishnoi which examined whether States could prescribe qualifications for Drug Inspectors beyond those notified by the Central Government, held: “we have examined the scheme of the D&C Act and the Drug Rules, whereby it is clear that power of appointment may be co-extensive, but the person selected or appointed must possess the qualifications as prescribed under the D&C Act.”

Background

The controversy arose from recruitment processes initiated by the States of Haryana and Karnataka for appointment to the posts of Drug Inspector and Drug Control Officer.

In Haryana, recruitment advertisements issued by the Haryana Public Service Commission prescribed experience in manufacturing or testing drugs specified in Schedule C of the Drugs and Cosmetics Rules as an essential qualification, in terms of State service rules framed under Article 309 of the Constitution.

Similarly, in Karnataka, recruitment notifications issued by the Karnataka Public Service Commission required candidates to possess a minimum of eighteen months’ experience in manufacturing or testing Schedule C or C-1 drugs, in addition to the educational qualifications.

Candidates who did not possess the prescribed experience challenged these requirements before the respective High Courts, contending that the Drugs and Cosmetics Act, 1940, occupies the field with respect to qualifications of Drug Inspectors and that States lack competence to prescribe additional qualifications.

The High Courts accepted the challenge and quashed the recruitment processes, leading to the present appeals before the Supreme Court.

Court’s Observation

The Supreme Court undertook an extensive examination of the legislative history of the Drugs and Cosmetics Act, 1940, noting that the Federal Legislature enacted the Act before independence, after Provincial Legislatures resolved to confer legislative competence on the Centre for uniform regulation of drugs.

The Court observed that post-independence, by virtue of Article 372 of the Constitution, the Drugs and Cosmetics Act continued in force as a central law unless amended or repealed by a competent legislature. No such amendment altering the rule-making power with respect to qualifications of Drug Inspectors had been made by any State.

Interpreting Sections 21 and 33 of the Drugs and Cosmetics Act, 1940, the Court clarified that although both the Central and State Governments may appoint Drug Inspectors, the expression “having the prescribed qualifications” in Section 21 must be read in conjunction with Section 33(2)(b), which confers exclusive power upon the Central Government to prescribe qualifications through rules.

The Court emphasised that the term “prescribed” under Section 3(i) of the Act expressly means “prescribed by the rules made under this Act”, thereby excluding qualifications prescribed under State service rules or executive notifications.

It was noted that Rule 49 of the Drugs and Cosmetics Rules, 1945, lays down the educational qualifications for appointment as Drug Inspector, while the proviso to Rule 49 prescribes experience only for the limited purpose of authorising inspectors to inspect the manufacture of drugs specified in Schedule C. The proviso does not elevate experience to an essential qualification for initial appointment.

The Court held that State service rules which convert such experience into a mandatory eligibility condition for appointment impermissibly override the central rules and encroach upon a field fully occupied by Parliamentary legislation.

Rejecting the contention that Article 309 empowers States to prescribe additional qualifications, the Court observed that the rule-making power under Article 309 is subject to constitutional limitations and cannot be exercised in derogation of an existing central statute operating in the same field.

The Court also took note of Section 38 of the Drugs and Cosmetics Act, which requires rules framed under the Act to be laid before both Houses of Parliament, underscoring the legislative supremacy and exclusivity of the central rule-making mechanism.

The Supreme Court concurred with the reasoning of the High Courts that prescribing experience as an essential qualification through State rules was inconsistent with Rule 49 of the Drugs and Cosmetics Rules and violative of Articles 14 and 16 of the Constitution.

“In view of the above, it is concluded that the powers so exercised either by the State of Haryana or Karnataka to prescribe such qualifications for appointment of Inspector, over and above the provisions of the Drug Rules, is completely alien, in particular when the subject was already occupied by the Central Government and the rules have been framed by it”, the Apex Court affirmed.

Conclusion

Accordingly, the Court upheld the judgments of the Punjab and Haryana High Court and the Karnataka High Court, dismissed the appeals filed by the States, and affirmed that recruitment to the posts of Drug Inspector and Drug Control Officer must be conducted strictly in accordance with Rule 49 of the Drugs and Cosmetics Rules, 1945.Cause Title

Cause Title: State of Haryana v. Krishan Kumar & Ors. and connected matters (Neutral Citation: 2026 INSC 63)

Appearances

Appellants: Vikramjeet Banerjee, A.S.G. Lokesh Sinhal, Sr. A.A.G., Hemant Gupta, A.A.G., Samar Vijay Singh, AOR with Advocates Kartik Dey, Shrisha Chandra and others

Respondent: Senior Advocate P. Vishwanatha Shetty, with Advocates Mahesh Thakur, AOR, Vibhav Chaturvedi, Ranvijay Singh Chandel, Darpan K.M., Amrita Sharma, and others

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