Govt may relax supply norms of controversial drug oxytocin
Drug advisory body proposes allowing only licensed retailers to sell oxytocin to ensure it is for human use
New Delhi: Days after it restricted the sale and supply of the controversial but life-saving growth drug oxytocin, the government is likely to take a “u” turn.
The government is considering relaxation of norms for distribution and supply of the drug in the wake of strong resistance by drug firms and doctors all over the country to its move to restrict the distribution of oxytocin, according to two people aware of the matter.
The Drug Technical Advisory Board (DTAB) took up the matter at a meeting on 25 July and has proposed an amendment in the notification issued on 27 April. The notification will allow those licensed under the Drugs and Cosmetics Act, 1940, and Rules 1945 for sale or distribution of drugs to continue to sell the oxytocin formulation to ensure it is for human use, people with knowledge of the matter said.
The Union health ministry had in April come out with a notification banning the retail sale of oxytocin. The import of oxytocin formulations has been banned since 24 April 2018. “While the ban will stay, retailers and wholesalers can procure the drug for distribution. The proposal has been sent to health ministry,” one of the persons quoted above said.
The health ministry’s ban had sent gynaecologists and obstetricians into panic mode as oxytocin is prescribed to initiate uterine contractions and induce labour in women as well as to stimulate contractions during labour. It is also used to help abort the foetus in cases of incomplete abortion or miscarriage, and control bleeding after childbirth.However, it is controversial because it is used widely in the dairy industry, agriculture and horticulture. The misuse of this growth booster is reported among trafficked children and injected to accelerate puberty among girls.
The minister for women and child development, Maneka Gandhi, has been pushing for a ban and had taken up the issue with health minister J.P. Nadda.
As reported by Mint first, DTAB, in a meeting on 12 February, recommended various measures to check the drug’s misuse. Other than proposing curbs on imports, it also proposed the drug be manufactured by only one firm, Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), a public sector unit, and be marketed by another, HLL Lifecare Ltd.
The health ministry decided that from 1 July 2018 no private manufacturer will be allowed to manufacture the drug for domestic use and that it would only be manufactured by KAPL. Accordingly, KAPL would be the sole supplier to registered hospitals and clinics in both the public and private sectors. “The same order prohibited the retail sale of the oxytocin by chemists and druggists,” added the second person.
In the public notice on oxytocin formulations on 27 June 2018 the government suggested that the registered hospitals and clinics in the public and private sector contact KAPL to place their orders with the company. However, its own internal guidance note found that the distribution centres are not present in 19 states/UTs including Assam, Mizoram, Manipur, Tripura, Meghalaya, Nagaland, Arunachal Pradesh, Sikkim, Jammu and Kashmir, Himachal Pradesh, Haryana, Punjab, Uttarakhand, Goa, Dadra & Nagar Haveli, Andaman & Nicobar islands, Daman and Diu, Puducherry and Lakshadweep.
Doctors and domestic pharma companies have been questioning the Centre’s move to limit oxytocin procurement to a single public sector company and had urged the government to reconsider their decision as it may lead to acute shortage of the life-saving drug. To ensure hospitals don’t face any such shortage, a meeting was held in the Prime Minister’s Office Thursday with the additional secretary, Drug Controller General of India and secretary department of pharmaceuticals.