IMPORTANT POINT
The Drugs and Cosmetics Act, 1940, as amended by Act 68 of 1982, is intra vires the Constitution and does not violate the fundamental rights guaranteed under Articles 14 and 19(1)(g) of the Constitution.

Headnote:Constitution of India-Articles 14 and 19(1)(g)-Drugs and Cosmetics Act, 1940, as amended by Act 68 of 1982-Sections 3(h) and 33C- Validity of Section 3(h) as amended-Challenged-Order prohibiting manufacture of Ayurvedic drugs by petitioners-Challenged as ultra vires legislative power-Whether amendment of Section 3(h) is ultra vires provisions of Constitution ?-(No)-Act is intra vires the Constitution-It does not violate fundamental rights guaranteed under Articles 14 and 19(1)(g)-Whether drugs manufactured by petitioners can be prohibited for administration within exclusionary clause u/s 3(h) ?-Question of fact-Government of India directed to constitute an expert body as contemplated u/s 33-C-Interim stay would continue.
       Held : Under Entry 19 of List III read with Entry 49 of List I of the Seventh Schedule, the Parliament is competent to enact and to amend the Act. Therefore, the legislative competence is beyond pale of question. The arbitrariness of a legislation violating Article 14 cannot be adjudged to be arbitrary when the Parliament is of the view that it is to ensure safety of the life of human beings or animals. The regulation of manufacture of drug and patenting it are necessary and are in public interest as the evil is sought to be remedied by legislative measure. When drugs are administered to human beings/animals, they are required to be regulated as adumbrated under the Act. As a consequence, though by implication the right to practice of medicine or manufacture of the drugs has been guaranteed under Article 19(1)(g), it is a regulation within the meaning of Article 19(6) of the Constitution. As a consequence, it is a reasonable restriction on the right to carry on the trade or business of manufacture of the ayurvedic drugs by the petitioners. (Para 5)
       If the drug manufactured by the petitioners is found to be not in conformity with the prescribed standard, and is likely to cause injurious to health or to endanger the life of a patient, by necessary consequence, prohibition is implicit and therefore, there is no need for an express prohibition under the Act. It is now well settled legal position that regulation includes total prohibition, if it is found necessary in the public interest. Manufacture of drugs for administration to human beings/animals is regulated by the Act and therefore, it attracts Article 19(6). We hold that the Act is intra vires the Constitution and does not violate the fundamental rights guaranteed under Articles 14 and 19(1)(g) of the Constitution. (Para 6)

ORDER

These three Writ Petitions, filed under Article 32 of the Constitution of India, raise common question of law, challenging Section 3(h) of the Drugs and Cosmetics Act, 1940, as amended by Act 68 of 1982 (for short, the Act") with effect from February 1, 1983 as unconstitutional, being arbitrary and violative of Article 14 and 19(1)(g) of the Constitution. The grievance of the petitioners is that while the Act amends the definition of "Patent and Proprietary Medicine" under Section 3(h) of the Act, the definition drugs under Section 3(b) read with the definition Ayurvedic drug under Section 3(a) has not been changed; as a consequence, there is no prohibition for patenting the Ayurvedic drugs manufactured by the petitioners whereas under the impugned order of the Drug Controller dated February 16, 1983 it is so construed and manufacture of those drugs is prohibited. Therefore, the Amendment Act 68 of 1983 and the order passed by the Drug Controller, Government of India, are ultra vires the legislative power.

2. Shri M.N. Krishnamani, learned senior counsel and Shri Pankaj Kalra, learned counsel appearing for the petitioners, seek to support their grievance, but we are unable to agree with the learned counsel. It is seen that patent and proprietary medicine was defined in the pre-Amendment Act under Section 3(h) thus :

" Patent or Proprietary Medicine means a drug which is a remedy for prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other pharmacopoeia authorised in this behalf by the Central Government after consultation with the Board."

3. "Drug" had been defined under Section 3(b), and continues under the Amendment Act, to read as under :

"Section 3(b) "drug" includes :

(i) All medicines for internal or external use of human belongs or animals and all substances intended to be used for or (in the diagnosis, treatment), mitigation or prevention of disease in human beings or animals.......; and

(ii) Such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of (vermin) or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette."

"Ayurvedic (Including Siddha) or Unani Drug" has been defined under Section 3(a) of the Act, which reads as under :

"Ayurvedic (including Siddha) or Unani drug" includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease in human beings mentioned in, and processed and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic (including Siddha) and Unani (Tibb) systems of medicine, specified in the First Schedule."

Under the Amendment Act 68 of 1983 Section 3(h) has been amended, and reads as under :

"Patent or proprietary medicine means-

(i) in relation to Ayurvedic Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurvedic, Siddha or Unani Tibb systems of medicine specified in the First Schedule but does not include a medicine, which is administered by parental route and also a formulation included in the authoritative books as specified in clause (a);

(ii) in relation to any other systems of medicine a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other pharmacopoeia authorised in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board constituted u

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1997 Supreme(SC) 603

IMPORTANT POINTThe Drugs and Cosmetics Act, 1940, as amended by Act 68 of 1982, is intra vires the Constitution and does not violate the fundamental rights guaranteed under Articles 14 and 19(1)(g) of the Constitution.

IMPORTANT POINT
The Drugs and Cosmetics Act, 1940, as amended by Act 68 of 1982, is intra vires the Constitution and does not violate the fundamental rights guaranteed under Articles 14 and 19(1)(g) of the Constitution.