(1.) The petitioner is a partnership firm registered under the Partnership Act, 1932, and carries on the business of manufacturing and selling homoeopathic medicines at a factory situated at Chinchwad. The homoeopathic medicines manufactured by the firm are broadly categorised into: i) Homoeopathic potential dilutions; ii) Mother tinctures; iii) Bio-Chemic Tablets; iv) Specialities and tonics; and v) Sundries including Globules, Diskets and ointments.
(2.) The challenge in these proceedings is to a notification issued by the central Government on 22nd February, 1994 by which the provisions of Rule 106-B of the drugs and Cosmetics Rules, 1945 were inserted in exercise of the rule making power under the drugs and Cosmetics Act, 1940. Rule 106-B provides as follows :"106-B. Prohibition of quality and percentage no homoeopathic medicine containing more than 12% alcohol v/v (Ethyl Alcohol) shall be packed and sold in the packing 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 prohibition in Rule 106-B is hence on the packing and selling of homoeopathic medicines with an alcohol content of more than 12% in containers of more than 30 millilitres. An exception has been made in the case of sale to hospitals and dispensaries where the dimensions of the container are not to exceed 100 millilitres.
(3.) On behalf of the Petitioner, it has been submitted that - (i) Rule 106-B violates the fundamental rights of the Petitioner under Articles 14 and 19 (1) (g) of the Constitution; (ii) Rule 106-B makes an unreasonable discrimination between Homoeopathic and Ayurvedic manufacturers, since there is no such prohibition in the case of Ayurvedic medicines; (iii) Rule 106-B is ultra vires the provisions of the Drugs and Cosmetics Act, 1940 and that the requisite procedure was not followed while enacting the Rule; (iv) The Drugs Technical Advisory Board was not competent to advise the government in respect of Homoeopathic medicines since the Board did not have any representative with expert knowledge in the field of Homoeopathy.