Summary
The Court referred to a three-judge Bench the Union’s appeals concerning the 27 April 2018 notification reserving manufacture of oxytocin formulations for domestic use to public-sector entities. It identified unresolved questions about the drug-control power, essential-medicine regulation, monopoly, classification, public interest and the evidentiary basis for restricting licensed private manufacturers. Both judges agreed on referral and did not decide the notification’s validity.
Issues
- Whether section 26A applied to an essential medicine regulated under the Essential Commodities Act and whether the notification lawfully restricted private manufacturers.
- Whether the measure created a constitutionally protected monopoly, rested on relevant material and served the stated public-health purpose.
- Whether section 26A power was legislative or executive, with corresponding implications for review.
Held
- The appeals raised competing concerns about clandestine misuse of oxytocin and continued access to an essential life-saving medicine. The Court framed seven substantial questions and considered an authoritative decision by three judges necessary. (¶ Malhotra J: 12–13)
- Questions referred included interaction between essential-medicine regulation and section 26A, monopoly and classification under Articles 14 and 19(6)(ii), public interest in exclusive public-sector domestic manufacture, relevant material supporting satisfaction, the use of section 26A against licensed manufacture to curb illicit use, and the legislative or executive character of the power. (¶ Malhotra J: 12)
- Sapre J concurred in referral, emphasising that the nature of the statutory power affected the parameters of judicial review. He expressly declined to express a detailed merits opinion on the questions referred. (¶ Sapre J: 3–12)
Result
Appeals directed to be placed before the Chief Justice of India for reference to a larger Bench of three judges to answer the framed questions and dispose of the appeals. Notification validity and the competing merits contentions remained undecided.