R S BHARGAVA PHARMACY Vs. UOI

JUDGEMENT

(1.) IN this batch of writ petitions, the petitioners challenge the constitutional validity of Rule 106b of the Drugs and Cosmetics Rules, 1945 inserted by notification dated 22nd February, 1994. The challenge arises in the following circumstances:-

(2.) A tragedy resulting in loss of human lives and involving the use of spurious alcohol based medicinal preparations led to the constitution of a one-man Inquiry committee under the Chairmanship of Justice Jagdish chandra. Among other recommendations, the committee suggested that medicinal preparations containing more than 12% alcohol should be packed in smaller packages. These recommendations in turn led to the initiation of a process by which Rule 106b was introduced by way of an amendment to the Drugs and Cosmetics Rules. The Rule so introduced prohibits packing of homeopathic medicines containing more than 12% Ethyl Alcohol in packings or bottles of more than 30 ml except in cases where the medicine is being sold to hospitals or dispensaries in which case the packings in bottles cannot be of a capacity more than 100 ml. The Rule reads as under:-

(3.) LEARNED counsel for the petitioners strenuously argued that Rule 106b (supra) is discriminatory inasmuch as it singles out the homeopathic medicines for a hostile treatment. There was, according to the learned counsel, no such provision applicable to allopathic medicines which continue to be packed and sold in bigger containers even when the alcohol content in them may be more than 12%. It was argued that the Rule under challenge placed an unreasonable restriction on the right to free trade and commerce. Besides there was, according to the learned counsel, no justification for the rule making authority to restrict the size of the bottles or the packings nor was there any nexus between the measures enforced by the Government and the mischief sought to be cured by the same. It was also contended that Rule 106b was ultra vires of the provisions of Section 12 of the Drugs and cosmetics Act, 1940 which did not empower the Government to make a Rule regulating the packaging or the containers to be used for the same. On behalf of the respondents, it was per contra argued that the Rule 106b was intra vires of the Constitution as also the Drugs and Cosmetics Act, 1940. The charge of discrimination was also unfounded according to the learned counsel for the respondent who submitted that the rule was introduced to deal with a mischief which could result in grave danger to human lives if left without remedy or regulation. Three questions, under these circumstances, arise for consideration of this court. These are: