Rakesh Kumar Jain, J. - (1.) The petitioner, a wholesaler chemist and druggist, has challenged the validity of the notification dated 17.01.2014, issued under Sec. 26 -A of the Drugs and Cosmetics Act, 1940 (for short "the Act") by which sale/supply of the Active Pharmaceutical Drug/Ingredient (for short "API") has been regulated to the effect that the manufacturers of the bulk Oxytocin drug shall supply the API only to the manufacturers, licensed under the Drugs and Cosmetics Rules, 1945 (for short "the Rules") for manufacture of formulations of the said drug. The text of the notification, for the ready reference, is reproduced as under: - "G.S.R. 29 (E) - Whereas the Central Government is satisfied that the Drug Oxytocin has a definite therapeutic use in certain medical conditions; And whereas the Central Government is satisfied that it is necessary and expedient to regulate the restrict the manufacture, sale and distribution of the said drug in the country to prevent its misuse in public interest. Now therefore, in exercise of the powers conferred by Sec. 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby directs that drug Oxytocin shall be manufactured for sale or for distribution or sold in the manner specified below, in addition to the provisions contained in the said Act and Rules made thereunder, namely: - 1. The manufacturers of bulk Oxytocin drug shall supply the active pharmaceutical drug only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug. 2. The formulations meant for veterinary use shall be sold to the veterinary hospitals only. The order shall come into force on the date of its publications in the Official Gazette."
(2.) Oxytocin is a prescription drug mentioned at Sr. No. 382 of Schedule -H in the Rules. It is provided in Sec. 65(2) of the Rules that the supply, otherwise than by way of wholesale dealing of any drug, on the prescription of a Registered Medical Practitioner shall be effected only by or under the personal supervision of a registered pharmacist. It is further provided in Rule 97(1)(b) of the Rules that the container of a medicine specified in Schedule H be labelled with the symbol Rx, conspicuously displayed on the left top corner of the label and be also labelled with the following words: - "Schedule H drug Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only"
(3.) The petitioner's grievance against the notification is regarding its exclusion from the chain of supply of API (bulk drug) from its manufacturer to the manufacturer of the formulations/injections, by illegally invoking the provisions of Sec. 26 -A of the Act.;