MADRAS PHARMACEUTICAL WHOLE SALERS ASSN Vs. UNION OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH NIRMAN BHAVAN NEW DELHI 110 011

JUDGEMENT

(1.) THE petitioner challenges in this writ petition the amendment to Rule 65 of the Drugs and Cosmetics Rules, 1945. Rule 65 deals with the condition of licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B. Rule 65 suggests that licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B shall be subject to the following general conditions:- Conditions (1) to (4) not relevant. " (5) (1) Subject to the other provisions of these rules the supply of a drug by wholesale shall be made against a cash or credit memo bearing the name and address of the licensee and his licence number under the Drugs and Cosmetics Act, in which the following particulars shall be entered (a)the date of sale; (b)the name, address of the licensee to whom sold and his sale licence number. In case of sale to an authority purchasing on behalf of Government, or to a hospital, medical, educational or research institution or to a Registered medical Practitioner, for the purpose of supply to his patients the name and address of the authority, institution or the Registered Medical Practitioner, as the case may be; (c)the name of the drug, the quantity and the batch number; (d)the name of the manufacturer; THE following sub-clause was inserted by GSR496 (E), dated 9. 6. 1995 with effect from 9. 6. 1995. (e) the signature of the competent person under whose supervision the sale was effected. " It is this addition which has irked the petitioner, which is an association of wholesale dealers to file this petition. THE main stay of the challenge to the constitutionality or as the case may be the validity of the rule is that the said rule is unreasonable and therefore, does not stand the acid test of Article 14 of the Constitution. THE argument is also that the rule is not in conformity with or has no nexus with the object of the Act.

(2.) LEARNED counsel appearing on behalf of the Central government has opposed the petition on the ground that the object of the amendment is itself laudable. He points out that there is nothing wrong if the person who is controlling the business is asked to put his signature on the document of sale. It is also pointed out that it is only in order to curb the dealing in the spurious drugs that rule is introduced.