Supreme Court Upholds Amendment to Drugs and Cosmetics Act, 1940 — Regulation of Ayurvedic Drugs Validated. The amendment was found to be within legislative competence and did not violate fundamental rights.

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Case Note & Summary

The case involved three writ petitions challenging the constitutionality of Section 3(h) of the Drugs and Cosmetics Act, 1940, as amended by Act 68 of 1982. The petitioners contended that the amendment was arbitrary and violated their rights under Articles 14 and 19(1)(g) of the Constitution. They argued that while the definition of 'patent or proprietary medicine' was amended, the definitions of 'drugs' and 'Ayurvedic drugs' remained unchanged, leading to a prohibition on the manufacture of Ayurvedic drugs. The court examined the legislative competence of Parliament to enact the amendment and concluded that it was valid, aimed at ensuring public safety. The court emphasized that regulation of drug manufacture is necessary and does not violate fundamental rights. It also noted that the prohibition of certain drugs must be based on evidence and expert opinion. The court directed the Government of India to form an expert committee to evaluate the drugs in question and make recommendations. The interim stay on the prohibition of the drugs was extended until the expert body submitted its report. The court disposed of the writ petitions without costs, emphasizing the need for expeditious action by the Government.

Headnote

A) Constitutional Law - Legislative Competence - Amendment Validity - Drugs and Cosmetics Act, 1940, Section 3(h) - The amendment to the definition of 'patent or proprietary medicine' was upheld as within the legislative competence of Parliament, ensuring public safety and health. The court found no violation of Articles 14 and 19(1)(g) of the Constitution. Held that the amendment was intra vires (Paras 1-5).

B) Public Interest - Regulation of Ayurvedic Drugs - Drugs and Cosmetics Act, 1940, Section 3(h) - The court held that the regulation of drug manufacture, including Ayurvedic drugs, is necessary for public interest and safety, allowing for reasonable restrictions under Article 19(6). Held that the prohibition of certain drugs was justified (Paras 6-10).

C) Expert Body - Constitution of Expert Committee - Drugs and Cosmetics Act, 1940, Section 33-C - The court directed the Government of India to constitute an expert body to assess the conformity of Ayurvedic drugs with established standards, ensuring due process before any prohibition is enforced. Held that the decision must be based on expert recommendations (Paras 11-15).

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Issue of Consideration

Whether the amendment to Section 3(h) of the Drugs and Cosmetics Act, 1940 is unconstitutional and whether the prohibition of certain Ayurvedic drugs is valid.

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Final Decision

The Supreme Court upheld the amendment to Section 3(h) of the Drugs and Cosmetics Act, 1940, ruling it was constitutional and did not violate Articles 14 and 19(1)(g). The court directed the Government of India to constitute an expert body to evaluate the Ayurvedic drugs manufactured by the petitioners and extended the interim stay on prohibition until the expert's report was submitted.

Law Points

  • Constitutional validity
  • Article 14
  • Article 19(1)(g)
  • legislative competence
  • public interest
  • regulation of drugs
  • expert body constitution
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Case Details

1997 LawText (SC) (04) 16

Writ Petition (C) Nos. 3559 and 4572/83

1997-04-01

K. Ramaswamy, D.P. Wadhwa

M.N. Krishnamani, Pankaj Kalra

Pratap Pharma (Pvt.) Ltd. & Anr.

Union of India & Ors.

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Nature of Litigation

Challenge to the constitutionality of an amendment to the Drugs and Cosmetics Act.

Remedy Sought

Petitioners sought to declare the amendment unconstitutional and to allow the manufacture of Ayurvedic drugs.

Filing Reason

Alleged violation of fundamental rights and arbitrary prohibition of Ayurvedic drugs.

Issues

Constitutionality of the amendment to Section 3(h) Validity of prohibition on Ayurvedic drugs

Submissions/Arguments

Petitioners argued the amendment was arbitrary and unconstitutional. Respondents contended the amendment was necessary for public safety.

Ratio Decidendi

The amendment to the Drugs and Cosmetics Act, 1940 was upheld as intra vires, ensuring public safety and allowing for reasonable restrictions on the manufacture of Ayurvedic drugs under Article 19(6). The necessity of expert evaluation before prohibition was emphasized.

Judgment Excerpts

The amendment to the definition of 'patent or proprietary medicine' was upheld as within the legislative competence of Parliament. The regulation of drug manufacture is necessary and does not violate fundamental rights. The court directed the Government of India to form an expert committee to evaluate the drugs in question.

Procedural History

The writ petitions were filed under Article 32 of the Constitution, challenging the amendment to the Drugs and Cosmetics Act, 1940. The case was heard by the Supreme Court, which issued directions regarding the constitution of an expert body and the evaluation of Ayurvedic drugs.

Acts & Sections

  • Drugs and Cosmetics Act, 1940: 3(h), 3(b), 3(a), 33-C
  • Constitution of India: 14, 19(1)(g), 19(6)
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