Case Note & Summary
The dispute arose from a Notification issued by the Ministry of Health and Family Welfare on 27.04.2018, which restricted the manufacture of Oxytocin formulations for domestic use to public sector companies, while allowing private companies to manufacture for export. This Notification was challenged by various private sector companies before the Delhi High Court, which granted a stay and later quashed the Notification, deeming it arbitrary and unreasonable. The Supreme Court was approached by the Union of India to contest this judgment. The court noted that Oxytocin is an essential drug listed by the WHO and the National List of Essential Medicines, and its regulation was necessary due to concerns over misuse in veterinary practices. The court emphasized that the legislative powers under Section 26A of the Drugs and Cosmetics Act allow the government to regulate drugs in public interest, and that the High Court's review of the government's material was beyond its jurisdiction. Ultimately, the Supreme Court upheld the government's Notification, reinforcing the need for stringent regulation of essential medicines to prevent misuse while balancing public health interests.
Headnote
A) Administrative Law - Legislative Powers - Judicial Review of Legislative Actions - Section 26A of the Drugs and Cosmetics Act, 1940 - The court examined the extent of judicial review over legislative actions taken by the Central Government under Section 26A, emphasizing the presumption of constitutionality and the limited grounds for review. It held that the High Court exceeded its jurisdiction by questioning the sufficiency of material relied upon by the Central Government (Paras 8-10).
Issue of Consideration
Validity of the Notification dated 27.04.2018 under Section 26A of the Drugs and Cosmetics Act, 1940
Final Decision
The Supreme Court upheld the validity of the Notification dated 27.04.2018, affirming the government's authority to regulate the manufacture of Oxytocin in the interest of public health and safety.
Law Points
- Legislative powers
- Judicial review
- Public health regulations
- Essential medicines
- Drug misuse prevention
