With two weeks to go for the Government’s Oxytocin ban on private companies to kick in, the All India Drug Action Network (AIDAN), a civil society group, has filed a Public Interest Litigation (PIL) in the Delhi High Court opposing the ban.
Confirming the development, S Srinivasan of AIDAN told BusinessLine that they were challenging the Government’s order which bans private companies from producing and distributing Oxytocin. The group has also asked to be heard along with the ongoing Mylan writ petition, expected to be heard next week.
AIDAN’s move follows concerns raised by doctors over constraints that could emerge in the supply of Oxytocin, used to treat excessive bleeding in women during child birth. The Government’s restriction on private companies supplying the drug is to come into effect from September 1.
Preventing misuse
The Government crack down on the private distribution and manufacture of Oxytocin is to prevent its misuse in the dairy and poultry sector where it is overused to increase milk secretion and production. The ban was also necessitated by concerns over its misuse among young girls to induce puberty.
Along with the ban on private companies, the Government had mandated public sector unit Karnataka Antibiotics & Pharmaceuticals Ltd to make the drug to meet the country’s needs. The PIL also pointed out the perils of depending entirely on one company, especially when it had not made the product earlier.
Only last month, US generics drugmaker had approached the Delhi HC challenging the Government notification disallowing private companies like them from producing and marketing Oxytocin. Pointing out that the many technical committees on Oxytocin had not quite suggested a ban on the drug, AIDAN said that its misuse could be stopped through better surveillance and labelling.
Categorising Oxytocin
In fact, the Health Ministry has recently come out with a draft notification shifting the categorisation of Oxytocin from Schedule H to Schedule H1 of the Drugs and Cosmetics Rules 1945. A final notification on this would mean more documentation at the retailer level, where details will have to be kept of the doctor prescribing the drug, the patient getting it and the quantity sold.