Oxytocin is an essential and life saving drug frequently used for women during delivery, for induction and augmentation of labour, to make childbirth safe and prevent death from postpartum haemorrhage (bleeding) and in the Active Management of Third Stage Labour (AMTSL).
The Government of India had appealed earlier this year in the Supreme Court against the Delhi High Court’s order quashing the government notification banning private sector production of Oxytocin for domestic use.
A Supreme Court bench of Justices AM Sapre and Indu Malhotra heard both sides and refused to opine in favour of either party. Instead they identified, in their final order of August 22, 2019, seven issues that need to be deliberated further by a larger three-judge bench as these issues have larger implications. At least one of them, issue (vii), certainly does: “Whether the exercise of power (to regulate, restrict or prohibit a drug) by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940 is legislative or executive in nature?”
The Government had argued that the Oxytocin ban on private sector production was legislative in nature and hence beyond judicial review, or at least required judicial restraint.
“Unfortunately or fortunately, the scope of judicial review either over an administrative action or over legislative action or over quasi judicial action, is not defined in India by any statute, but is mostly judge made, based to a great extent, upon Western precedents,” according to the learned judge of the Madras High Court in para 88 of the Macleods vs Union of India (2012) judgement.
On the contrary, the Delhi High Court judgement of December 2018 on the Oxytocin production ban was very clear, and opined, after a long exegesis, that even legislative actions of laws like the Drugs and Cosmetics Act need to be, and can be, examined for arbitrariness, reasonableness and Constitutional validity, and “do not per se carry a threshold of immunity greater than what any other instrument, either statutory or non-statutory would.”
If scientific issues, like the ban of Oxytocin production in private sector or, say, a ban of irrational fixed dose combination (FDCs) medicines, were beyond judicial purview because it was based on a legislative decision, the court must nevertheless (after the Delhi HC judgment) check for arbitrariness. A process that may involve taking a call on whether the scientific exercise leading up to a legislative decision was logical or not and whether it was bereft of arbitrariness. However, courts opining on scientific matters is a slippery terrain.
But to concede scientific expert judgement as necessarily beyond bias and unreasonableness is also unacceptable, as scientists and technocrats can be doctrinaire in their world view. The issue hinges on what the court feels on the extent of deferential treatment that needs to be given to expert opinions.
In the Oxytocin case under discussion, the Delhi High Court noting, among other things, that the government ignored its own experts like DTAB (Drugs Technical Advisory Board) and DCC (Drugs Consultative Committee) , decided to quash the ban. It found the ban neither justified nor reasonable.
The question of scope of judicial review of legislative exercise of power does need clarity, especially in issues involving science and technology. The opinion of the proposed three-judge bench, any which way, will be far-reaching, and hopefully settles the issue for some time at least.
For lack of space, we cite two other questions, of the seven, flagged by Justices Sapre and Malhotra:
(iii) Whether the classification made by the impugned notification between licensed public sector and private sector companies, in the manufacture of the drug Oxytocin for domestic use, would achieve the object and purpose of preventing the unregulated and illegal use of the drug?
(iv) Whether it would be in public interest to restrict the manufacture of a lifesaving drug for domestic use, to a single public sector undertaking, to the complete exclusion of the private sector companies, particularly in view of the high maternal mortality rates in the country?
The answer, in our humble opinion, is a firm no to both questions. The ban needs to go in the interests of safe delivery and reduction of maternal mortality.
The author is co-convener, All-India Drug Action Network (AIDAN), which was a respondent in the matter in the Supreme Court