Case Note & Summary
The Petitioner, Shrikrishna Homeo Pharmacy, a partnership firm registered under the Indian Partnership Act, 1932, carries on the business of manufacturing and selling homoeopathic medicines at a factory in Chinchwad. The challenge in these proceedings is to a notification issued by the Central Government on 22nd February, 1994, by which Rule 106-B was inserted in the Drugs and Cosmetics Rules, 1945, in exercise of the rule-making power under the Drugs and Cosmetics Act, 1940. Rule 106-B prohibits the packing and selling of homoeopathic medicines containing more than 12% alcohol v/v (Ethyl Alcohol) in packings or bottles of more than 30 millilitres, except that it may be sold to hospitals/dispensaries in packings or bottles of not more than 100 millilitres. The Petitioner contended that the rule is ultra vires the Act, as the Act does not empower the Central Government to impose restrictions on the basis of alcohol content in homoeopathic medicines, and that the rule is arbitrary and violative of Articles 14 and 19(1)(g) of the Constitution. The Respondents, Union of India and others, defended the rule as a measure to regulate the use of alcohol in homoeopathic medicines in the interest of public health. The Court analyzed the rule-making power under Section 33 of the Act, which empowers the Central Government to make rules to carry out the purposes of the Act, including regulating the manufacture, sale, and distribution of drugs. The Court held that homoeopathic medicines are drugs under the Act and that the rule is within the scope of the rule-making power. The Court further held that the restriction is reasonable and in the interest of public health, as it aims to prevent the misuse of alcohol in homoeopathic medicines. The classification between homoeopathic medicines and other medicinal preparations is based on an intelligible differentia and has a rational nexus with the object sought to be achieved. The Court dismissed the petition, upholding the validity of Rule 106-B.
Headnote
A) Constitutional Law - Delegated Legislation - Validity of Rule - Rule 106-B of Drugs and Cosmetics Rules, 1945 - The rule prohibits packing and selling of homoeopathic medicines with alcohol content above 12% in containers exceeding 30 ml, with an exception for hospitals/dispensaries up to 100 ml. The Court held that the rule is within the rule-making power under Section 33 of the Drugs and Cosmetics Act, 1940 and is not ultra vires. The rule is a reasonable restriction in the interest of public health and does not violate Article 19(1)(g) or Article 14 of the Constitution. (Paras 1-10) B) Constitutional Law - Right to Equality - Article 14 - Classification - The Court held that the classification between homoeopathic medicines and other medicinal preparations containing alcohol is based on an intelligible differentia and has a rational nexus with the object of regulating alcohol content in homoeopathic medicines. The rule does not discriminate and is not violative of Article 14. (Paras 8-10) C) Constitutional Law - Freedom of Trade - Article 19(1)(g) - Reasonable Restriction - The Court held that the restriction imposed by Rule 106-B is reasonable and in the interest of the general public, particularly public health. The rule aims to prevent misuse of alcohol in homoeopathic medicines and is within the ambit of Article 19(6). (Paras 8-10)
Issue of Consideration
Whether Rule 106-B of the Drugs and Cosmetics Rules, 1945, which prohibits packing and selling of homoeopathic medicines containing more than 12% alcohol in containers of more than 30 ml (except to hospitals/dispensaries up to 100 ml), is ultra vires the Drugs and Cosmetics Act, 1940 and violative of Articles 14 and 19(1)(g) of the Constitution.
Final Decision
The Court dismissed the writ petition, upholding the validity of Rule 106-B of the Drugs and Cosmetics Rules, 1945. The Court held that the rule is intra vires the Drugs and Cosmetics Act, 1940 and is not violative of Articles 14 or 19(1)(g) of the Constitution.
Law Points
- Rule 106-B is intra vires the Drugs and Cosmetics Act
- 1940
- Rule 106-B is not violative of Article 14
- Rule 106-B is not violative of Article 19(1)(g)
- Homoeopathic medicines are drugs under the Act
- Alcohol content regulation is a reasonable restriction in public interest
