Our Bureau The contentious drug oxytocin will now be allowed to be sold by private retail chemists, the Union Health Ministry has said. The alteration to its earlier ban order was notified in the gazette on August 21.
Earlier, in a notification dated April 27, the Ministry had said that it would not allow the sale of oxytocin through private retail chemists.
Suggestions were invited from persons likely to get affected by the ban, following which there was a furore amongst doctors and activists who expressed their concern on the potential shortage in the availability of the crucial drug that the ban could create. This led to the U-turn in the decision.
The Ministry, however, still maintains that the drug will only be manufactured by the public sector Karnataka Antibiotics and Pharmaceuticals Ltd, a clause which pharma giant Mylan is contesting in the Delhi High Court. The ban on the manufacture of oxytocin by private manufacturers will be rolled out on September 1. The Ministry deferred the ban by two months considering the uproar over concerns on the unavailability of the drug.
Oxytocin became a bone of contention when the drug — used to control bleeding in women during delivery — was banned citing its alleged misuse in the livestock industry.
In its latest notification, the Ministry has shifted oxytocin from Schedule H of the Drugs and Cosmetics Act, to Schedule H1. More stringent rules have to be followed now in order to sell drugs under Schedule H1, which was introduced in the amended law in 2013.
“The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection,” the law states.