The judgement of the Delhi High Court on December 14, 2018 setting aside the government’s ban on the private sector manufacturing oxytocin, has put an end to one of the most bizarre public health decisions in Indian history. If the government had its way in this case, only one public sector unit would have been able to manufacture oxytocin for the entire country leading to severe disruption of supplies of a drug considered crucial for maternal healthcare.
The judgment was delivered by Justice Ravindra Bhat who struck down the government order despite knowing fully well that his file was pending with the law ministry for a possible promotion as a Chief Justice of the Rajasthan High Court. His judgment was possible in large part because of resistance by a number of bureaucrats who actively recorded in writing their opposition to the proposal by Minister for Women and Child Development Maneka Gandhi to ban oxytocin in order to protect cattle for the alleged misuse of the hormone. Noting that idea of the ban originated with Gandhi in 2014, the judgment expressly points a finger at the minister stating that “the issue of banning drug manufacture appears to have been mooted at least on the file, on 05.11.2014 by the Ministry of Women and Child Development” despite “the expert group finding that there was no data to support such allegation of misuse”.
The two statutory expert bodies under the Drugs and Cosmetics Act – the Drugs Technical Advisory Board, or DTAB, and the Drugs Consultative Committee, or DCC – repeatedly rebuffed the minister and her activists in polite bureaucratese that was meticulously recorded in the minutes of the meetings and the file notings. These bureaucrats even commissioned scientific studies by government laboratories and advised Health Minister JP Nadda to cite the studies in Parliament in response to queries about the adverse effects of oxytocin. The judgment details this internal bureaucratic resistance in minute detail.
The tipping point
Ideally, the experts at DTAB and DCC should have had the final say on safety and efficacy of the drug. However, the experts were sidelined by two judges at the Himachal Pradesh High Court who initiated their own Public Interest Litigation by taking suo moto cognizance of news reports alleging the abuse of oxytocin by dairy farmers. The judgment of the Himachal Pradesh High Court was riddled with serious factual errors and critical omissions. As noted by the Delhi High Court while discussing its counterpart’s order, “Very significantly, the judgment did not consider the therapeutic uses of oxytocin in human beings and its critical role in pregnant women, particularly at the postpartum stage to stem haemorrhage”. It is rare for Indian judges to voice their criticism of judgments written by their colleagues in such candid detail.
The Himachal Pradesh High Court recommended the identical solution as Gandhi, that is, the private sector should be banned from manufacturing oxytocin. Gandhi did not even have to implead herself in the case to ensure this serendipitous judicial outcome. However, the Himachal Pradesh High Court limited its decision to ordering the government to examine the feasibility of doing this. Nevertheless, as noted by the Delhi High Court, the Himachal Pradesh High Court order was the “tipping point” which led to the problem being escalated to the highest level of the government. Soon the Prime Minister’s Office and the Niti Aayog joined the deliberations and the health ministry was forced to issue the ban on the private industry manufacturing oxytocin.
Striking down the ban
When the ban was inevitably challenged before the Delhi High Court by the pharmaceutical industry and civil society organisations, the government put up a full throated legal defence, fielding both the Solicitor General and the Additional Solicitor General. When the Delhi High Court asked the government to produce proof regarding the alleged misuse of oxytocin on cattle, the government produced reams of statistics whose authenticity the court seemed to suspect. The court commented, “Statistics, unless explained, can be highly misleading. Therefore, unless the details of raids and other connecting materials are disclosed, the bare statistics (without explanation) proves little. These figures and data were not part of the record, or proffered as justification at any time preceding the issue of the impugned notification”.
The judgment acknowledges several file notings and minutes of meetings noting that “there was no data to support the allegation of misuse of oxytocin” and that the viability of only the public sector manufacturing the drug was uncertain. These file notings made it possible for the Delhi High Court to question the government on whether it had considered all relevant factors while making its decision to ban the drug. Cases like this demonstrate that sometimes the system does work against the arbitrary exercise of political power.
The writer is a senior resident fellow at the Vidhi Centre for Legal Policy.