Hyderabad: Procuring oxytocin, the first choice of drug to prevent post-partum haemorrhage, is going to get very difficult with Centre and State drug controllers set-to introduce a slew of regulations over its availability.
From September 1, all the retail drug outlets will not be able to sell oxytocin. Doubling down on this decision, the regulators have also decided to shift the drug from Schedule H to Schedule H1 that makes it mandatory for all pharma companies, private maternity clinics and other healthcare establishments to keep clear records on the usage of drugs on patients.
The regulatory authorities including Drug Controller General of India (DCGI) had identified Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) as the sole agency to retail oxytocin in India from September 1.
Oxytocin is a hormone that has numerous medical applications but has acquired notoriety for all the wrong reasons. It is widely misused in the dairy industry to enhance milk yield and unnaturally ripen vegetables and fruits. The hormone has become a go-to drug to augment menarche among young girls.
Schedule H1 drugs entails lot of regulation and includes a clear-cut history of usage of the drug on patients in the form of a record that should be maintained for a minimum three years by health care establishments. The drug should also contain a label that clearly warns that it is dangerous to take it without medical advice.
Major corporate hospitals, clinics and government hospitals will now have to submit their oxytocin requirement to KAPL for procurement.
“We urge health care establishments and doctors not to believe in rumors that claim that there will be severe artificial shortage of the drug. Our estimates suggest that almost all the hospitals have enough stock to last for three months,” TS Drug Control Administration (TSDCA) officials.
The State health authorities on their part have already indicated that they have sufficient stock, and would also be placing orders to meet the requirement of government hospitals.
The Telangana State Medical Services and Infrastructure Development Corporation (TSMIDC) officials have approached KAPL with their requirement 3 lakh vials of oxytocin for government hospitals.
Meanwhile, according to agency reports, the Delhi High Court on Thursday sought the Centre’s stand on a PIL against the ban on private companies from producing and distributing oxytocin.
A bench of Chief Justice Rajendra Menon and Justice V K Rao issued notice to the Health Ministry and sought its response to the plea by August 26, the next date of hearing.
NGO All India Drug Action Network (AIDAN), which works towards ensuring access to essential medicines, in its plea sought setting aside of the government’s ban which would come into effect from September 1.