Drug row may land in court

Several public health activists across the country are preparing for a legal fight against the Centre’s notifications banning retail sale and imposing restrictions on the manufacture and supply of oxytocin for human use.

They fear it could result in serious disruptions in the supply of this life-saving drug and a catastrophic situation in labour rooms.

The Centre issued the said notifications quoting an order of the High Court of Himachal Pradesh, dated March 15, 2016 which observed that there is large-scale clandestine manufacture and sale of oxytocin leading to its misuse in the dairy sector.

By a PSU

The Central notification on April 27 restricts the manufacture of oxytocin to public sector units and bans retail sale of the drug.

The second one on June 27 says registered hospitals in the public and private sectors will be supplied the drug directly by a PSU, Karnataka Antibiotics and Pharmaceutical Ltd.

The activists say a reading of the High Court judgment will indicate that the Central notifications are against the spirit of the judgment.

‘Easy way out’

While the court gave several directives to the government to ensure that oxytocin is not misused, the Centre has chosen the easy way out by banning all retail sale and severely restricting the manufacture and supply to one PSU, they say.

“What the HP High Court said was that the Centre needed to think about the “feasibility of restricting the manufacture of oxytocin only in public sector companies and… by companies to whom licences have already been granted.”

“The court never said there should be no retail supply of the drug. It also never said those companies which already have oxytocin manufacturing licence should not produce the drug for domestic use,” points out K.V. Babu, a physician and public health activist in Kerala.

12 directives

In fact, the court during discussions, clearly said that “keeping in view the medical emergency in rural or remote areas, the drug could only be obtained from the sale outlets and its sale could not, therefore, be restricted to registered hospitals”, he says. The High Court gave 12 directives to the Centre for ensuring that there is no misuse of oxytocin.

Drastic measures

Yet, despite this being a life-saving drug, the Centre has chosen to adopt drastic measures to restrict its supply, choosing to ignore all other court directives.

“We are not disputing the need to prevent the misuse of oxytocin in dairy or other sectors. Our concern is that no mother should bleed to death because of the non-availability of oxytocin,” a gynaecologist said.

Professional organisations of gynaecologists and many public activists have taken up the issue with the Union Health Minister and Members of Parliament.

“We are awaiting the government response and are preparing to fight this issue in a court of law,” Dr. Babu said.

The court never said that companies which have oxytocin manufacturing licence should not produce it for domestic use

K.V. Babu

Physician

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