Indu Malhotra, J. - (1.) Leave granted. 1. The issue which arises for consideration in the present appeals is the validity of the Notification dated 27.04.2018 issued under Section 26A of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the "Act") by the Ministry of Health and Family Welfare.The impugned notification restricts the manufacture of Oxytocin formulations for domestic use, only by public sector undertakings or companies, to the complete exclusion of the private sector companies. However, the manufacture of the drug for export purposes is open to both public and private sector companies.It was notified that the notification would come into force on 01.07.18.By a subsequent notification dated 29.06.2018, the date was extended to 01.09.18.
(2.) Till the issuance of the impugned notification, Oxytocin was being manufactured by private sector companies to meet the entire need in the country. After the issuance of the impugned notification, Karnataka Antibiotics & Pharmaceuticals Ltd. ("KAPL"), a public sector company has commenced the manufacture of Oxytocin in May 2018.
(3.) The Active Pharmaceutical Ingredient ("API") or the bulk drug is manufactured in India only by one private sector company in India, viz. Hemmo Pharmaceuticals Pvt Ltd. ("Hemmo Pharma").;