1968 (5) TMI 56 - SC - Indian Laws

Summary

Issues Involved:

1. Interpretation of Section 3(b) of the Drugs Act 1940.
2. Determination of whether Bindra's Antiphlogistic Plaster is a "drug" under the Act.
3. Jurisdiction of the Court at Mathura.
4. Compliance with labeling requirements under Rule 96 of the Drug Rules 1945.
5. Qualification of the Government Analyst to assess Ayurvedic and Unani medicines.

Issue-wise Detailed Analysis:

1. Interpretation of Section 3(b) of the Drugs Act 1940:

The primary issue revolves around the interpretation of Section 3(b) of the Drugs Act 1940, particularly whether the term "exclusively" governs both "used" and "prepared for use." The appellants argued that "exclusively" only modifies "used," suggesting that medicines prepared for use in Ayurvedic or Unani systems should be exempt even if they contain components common to other systems. The High Court, however, held that "exclusively" governs both "used" and "prepared for use," meaning that only medicines used or prepared exclusively for Ayurvedic or Unani systems are exempt from being classified as drugs under the Act.

2. Determination of whether Bindra's Antiphlogistic Plaster is a "drug" under the Act:

The appellants claimed that Bindra's Antiphlogistic Plaster was a Unani preparation and thus should be exempt from the definition of "drug." The Inspector of Drugs argued that the plaster contained Glycerine, Kaolin, and Boric Acid, which are pharmacopoeal drugs and not exclusive to Ayurvedic or Unani systems. The Government Analyst confirmed these ingredients, classifying the plaster as a misbranded drug under Section 17(e) and (f) of the Act. The High Court concluded that whether the plaster falls within the exception is a factual question requiring expert evidence, which should be decided by the trial court.

3. Jurisdiction of the Court at Mathura:

The appellants questioned the jurisdiction of the Mathura court to entertain the complaint. This issue was raised in their petition under Section 561A of the Criminal Procedure Code. However, the judgment does not provide a detailed analysis of this jurisdictional challenge, focusing instead on the substantive issues concerning the definition and labeling of the drug.

4. Compliance with labeling requirements under Rule 96 of the Drug Rules 1945:

The Inspector of Drugs noted that the label of Bindra's Antiphlogistic Plaster did not bear the manufacturing license number and other particulars required by Rule 96 of the Drug Rules 1945. This non-compliance led to the classification of the plaster as a misbranded drug. The appellants did not directly dispute this labeling issue but focused on the broader argument that their preparation was a Unani medicine and thus should not be subjected to these labeling requirements.

5. Qualification of the Government Analyst to assess Ayurvedic and Unani medicines:

The appellants challenged the qualifications of the Government Analyst, arguing that he was not competent to assess medicines prepared according to Ayurvedic or Unani systems. They contended that the Analyst's expertise was limited to pharmacopoeal drugs and not traditional medicines. The judgment does not delve deeply into this argument but implies that the trial court should consider expert evidence to resolve such factual disputes.

Conclusion:

The Supreme Court upheld the High Court's interpretation that the term "exclusively" in Section 3(b) of the Drugs Act 1940 governs both "used" and "prepared for use." The court emphasized that the trial magistrate must determine whether Bindra's Antiphlogistic Plaster is a medicine exclusively used or prepared for use in the Ayurvedic or Unani system based on the evidence presented. The appeals were dismissed, affirming the High Court's decision.