Madras High Court
Health and Medical LawCriminal Law

Promotional supply of physician samples to medical representatives is not a sale under drug-licensing conditions.

Alken Laboratories Limited vs State of Tamil Nadu Represented by the Drugs Inspe

Madras High CourtJUDGMENT: October 14, 20262 MIN READSOURCE JUDGMENT
Promotional supply of physician samples to medical representatives is not a sale under drug-licensing conditions.. Alken Laboratories Limited vs State of Tamil Nadu Represented by the Drugs Inspe. Madras High Court. LawLens
THE ORIGINAL LAWLENS SUMMARY
01

Facts

The respondent filed a complaint alleging contraventions of Sections 18(c) and 18A of the Drugs and Cosmetics Act, 1940, punishable under Sections 27(b)(ii), 28 and 27(d), arising from physician samples found at a medical representative’s residence.

Source reference: pp. 2–3

The complaint alleged that the samples had been supplied without the recipient holding a drug licence and that distribution records had not been maintained.

Source reference: pp. 2–3

The petitioners sought quashing of the proceedings in C.C. No. 2787 of 2025, after the Magistrate took cognizance and issued summons.

Source reference: pp. 2–3

The petitioners maintained that the samples were supplied for medical campaigning and promotional purposes, not for sale, and relied on the delivery challan and company policy.

Source reference: pp. 3–4, 6–7
02

Issues

Whether the alleged supply and possession of physician samples, on the facts pleaded, prima facie constituted offences under Sections 18(c) and 18A of the Act and the relevant licence conditions.

Source reference: pp. 4–9

Whether the sanction for prosecution and the Magistrate’s order taking cognizance were legally sustainable in the absence of reasoned consideration of the relevant materials.

Source reference: pp. 8–9
03

Law Applied

Section 18(c) of the Drugs and Cosmetics Act prohibits the manufacture for sale or distribution, sale, stocking, exhibiting or offering for sale, or distribution of a drug except under and in accordance with the requisite licence; Section 27(d) prescribes punishment for contraventions of Chapter IV or the Rules.

Source reference: p. 5

Conditions 3(ii) of Form 20B and 4(ii) of Form 21B restrict sale of drugs to persons who do not hold the requisite licence; the Court construed these conditions as requiring a sale, rather than every supply or transfer, irrespective of its purpose.

Source reference: p. 5

Rule 65(18) of the Drugs Rules, 1945 regulates physician samples and requires them to be labelled “Not for Sale”.

Source reference: p. 7

The Court also applied the principle that a Magistrate must apply judicial mind to the complaint and supporting materials before taking cognizance and issuing process.

Source reference: pp. 8–9

No judicial precedent was cited.

Source reference: no citation
04

Reasoning

The Court found that the complaint and seizure materials described the drugs as physician samples marked “Not for Sale” and that the prosecution’s own case was that they had been supplied to a medical representative for promotional and medical-information purposes.

Source reference: pp. 6–7

In the absence of material showing a sale to an unlicensed person, mere possession of those samples did not prima facie establish a contravention of Section 18(c) or the relevant licence conditions.

Source reference: pp. 7–8

The Court further held that the sanctioning authority had merely rejected the explanations as unsatisfactory without addressing them, and that the Magistrate’s brief cognizance order did not show discernible application of judicial mind to the allegations or materials.

Source reference: pp. 8–9

It also noted that the accused had not been given an opportunity to present their case before cognizance was taken.

Source reference: p. 10
05

Holding

The Court held that the complaint could not be sustained and allowed the petition.

It quashed the proceedings in C.C. No. 2787 of 2025, insofar as they concerned the petitioners, and closed the connected miscellaneous petitions.

Source reference: p. 10
06

Acts & Sections Cited

6 provisions across 2 statutes referred to in this judgment. Each provision opens on LawLens.

Bharatiya Nagarik Suraksha Sanhita, 20233

Drugs and Cosmetics Act, 19403

Madras High Court

Original Court PDF

Alken Laboratories LimitedvsState of Tamil Nadu Represented by the Drugs Inspe

Madras High Court · October 14, 2026

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