The Delhi High Court asked the Centre on May 30 to file a counter affidavit explaining its proposed ban on Oxytocin production by private firms, and on Oxytocin sale by private retail chemists. While this ban would come into effect from September 1, Centre is yet to submit its counter affidavit. Last Thursday, Centre pleaded for more time to submit it.
The Delhi High Court on last Thursday was listening to a Public Interest Litigation (PIL), filed by All India Drug Action Network (AIDAN), requesting an interim stay on the central government’s April 27 notification, which proposed the ban related to Oxytocin’s sale and production. The PIL has also requested the high court for an interim stay on Centre’s April 24 notification, which banned the import of Oxytocin. Thursday’s hearing was the first hearing of this PIL.
The court order of this hearing — dated August 16, 2018 — stated that Kirtiman Singh, Central Government Standing Counsel (CGSC) has sought “time to file the counter affidavit”. Therefore, the court decided that this counter affidavit should be “filed before the next date of hearing”, which is August 24. The court added that the PIL as well as the writ petition filed by BGP Products Operations Gmbh would be heard together on August 24.
The Delhi High Court has already been hearing a writ petition filed by BGP Products Operations Gmbh, which is a subsidiary of Mylan Laboratories, requesting for a stay on the proposed ban. Currently, Pfizer and Mylan are two leading producers of Oxytocin in India. Both — being private firms — would not be permitted to make and distribute Oxytocin from September 1.
While listening to BGP’s petition, the Delhi High Court had said on May 30 that Centre would need to file a counter affidavit. The court also said that the next date of hearing would be September 4. Since the ban would come into effect from September 1, BGP filed a Special Leave Petition (SLP) in Supreme Court. On July 9, the Supreme Court requested the Delhi High Court to “ensure expeditious disposal of stay application” filed by BGP, “preferably before September 1, 2018”.
Therefore, the Delhi HC heard BGP’s case on July 16 and asked the Centre again to file its counter affidavit “for possible disposal before the next date of hearing”, which was set at August 20. The court also asked the Centre on July 16 to “keep all the relevant files and documents” — related to April 27 notification — “for court’s scrutiny”. The Centre is yet to place these relevant documents before Delhi HC.
At its meeting on February 12, the Drugs Technical Advisory Board (DTAB) — a Health Ministry body that advises Centre and state governments on matters related to the provisions of The Drugs and Cosmetics Act, 1940 — “agreed on a draft notification for regulating, restricting the Oxytocin formulations for human use to be supplied only to registered hospitals and clinics in public and private sector”.
Therefore, on April 27, Centre in a gazette notification said that from July 1, private firms would not be allowed to manufacture oxytocin for domestic use, and private retail chemists would not be allowed to sell it. The government subsequently pushed the deadline to September 1. The import of oxytocin was banned by a separate notification on April 24.