August 5, 2018 1:57:48 am
Drug Technical Advisory Board (DTAB), a health ministry advisory body, has gone back on its suggestion that the Central government should not ban the sale of Oxytocin via private retail chemists, proposed to come into force from September 1. On Saturday, Central Drugs Standard Control Organisation (CDSCO) issued a notification stating that the Oxytocin recommendation would be deleted from the minutes of the DTAB meeting because “some” members stated that the recommendations were not circulated in the meeting’s agenda “in advance” so they “were not prepared for the deliberation”. The Indian Express – after reviewing the minutes of the July 25 meeting — had reported on Friday that DTAB had suggested that Centre should not ban the sale of Oxytocin through private retail chemists to “ensure the availability” of this life-saving drug for “human use”.
Government-run chemist shops would not be affected by this ban. However, Saturday’s notification stated: “…availability of Oxytocin due to its restriction on manufacture and sale was taken up as an additional agenda in the meeting itself. However, some members of DTAB have expressed their views that as the agenda no S5 (relating to Oxytocin) was discussed in DTAB without its agenda being circulated to the members in advance, they were not prepared for the deliberation and hence requested to withdraw the agenda as well as delete the same from the minutes.”
It further stated: “In view of the above, the agenda number S5 relating to the sale of Oxytocin formulation stands withdrawn and deleted from the minutes of the meeting.” CDSCO also removed the original minutes of the meeting from its website on Saturday. S Eswara Reddy, Drug Controller General of India (DCGI), did not respond the queries sent by The Indian Express. Reddy heads the CDSCO and is also member-secretary of the DTAB.
“The retraction from the minutes is unprecedented and the wavering indicates that the government is unprepared,” said Malini Aisola, co-convenor, All India Drug Action Network (AIDAN). On April 27, the Centre issued a notification stating that private companies would not be permitted to manufacture and distribute Oxytocin in India from July 1. The notification also stated that sale through private retail chemists would be banned from July 1. However, fearing Oxytocin shortage, the government postponed the date to September 1.Currently, Pfizer and Mylan are two leading producers of Oxytocin in India. Both — being private firms — would not be permitted to manufacture and distribute Oxytocin in India from September 1.
Mylan’s spokesperson told The Indian Express: “We have challenged the notification, issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, placing restrictions on the manufacture and supply of Oxytocin, before the Honourable Delhi High Court and the matter is sub judice”.
Pfizer did not respond to the queries sent by The Indian Express. Oxytocin’s import has already been banned by Centre. From September 1, only Karnataka Antibiotics & Pharmaceuticals Limited (KAPL), a public entity, would be permitted to manufacture and distribute Oxytocin in India. According to a source privy to the development, the KAPL started production of Oxytocin for the first time from July 2.
Oxytocin is widely misused in the dairy industry where this drug is injected into livestock to increase milk production artificially. It is also misused in the agriculture industry where vegetables are injected with this drug as it helps in increasing their weight. Oxytocin is administered to pregnant women to “prevent and treat” postpartum haemorrhage (PPH), which is the leading cause of maternal mortality across the world. PPH accounts for about 35 per cent of all maternal deaths, according to World Health Organisation.
DTAB on July 25 “deliberated and agreed” that April 27 notification should be amended “to continue the sale of Oxytocin formulation” through licensed retail chemists across India, according to its original minutes of the meeting. It was the DTAB only that recommended on February 12 that Oxytocin formulations should be regulated for human use.
Himachal High Court, on March 15, 2016, observed that “there is large scale clandestine manufacture and sale of the drug Oxytocin leading to its grave misuse, which is harmful to animals and humans”. The high court also observed that “the feasibility of restricting the manufacture of Oxytocin only in public sector companies” and “restricting and limiting the manufacture of Oxytocin by companies to whom licenses have already been granted” should be considered.
📣 The Indian Express is now on Telegram. Click here to join our channel (@indianexpress) and stay updated with the latest headlines