New Delhi: The Indian government is likely to ban the import of controversial growth drug Oxytocin in a bid to curb its misuse by dairy owners and farmers who use it to boost milk production and increase size of vegetables.
The government’s top drug advisory board—the Drug Technical Advisory Board (DTAB)—in a meeting on 12 February recommended various measures to check widespread misuse of the hormone boosting drug.
Oxytocin is a controversial hormonal injection that is used widely in the dairy industry, agriculture and horticulture. Authorities are also concerned that the misuse of this growth booster is reported among trafficked children, injected to accelerate puberty among girls.
“The members of DTAB agreed to prohibit the import of oxytocin and its formulations for human use as well as animal use under section 10 of the drugs and cosmetics act 1940,” according to the minutes of the DTAB meeting, reviewed by Mint.
Oxytocin is a uterine stimulant hormone, prescribed for the initiation of uterine contractions and induction of labour in women as well as stimulation of contractions during labour. It is also used to help abort the fetus in cases of incomplete abortion or miscarriage, and control bleeding after childbirth. It may be used for breast engorgement. In India it’s available in various brand names including oxytocin.
Studies in Karnataka have shown that Oxytocin is being misused to speed up deliveries for pregnant women in overcrowded government hospitals. The drug has been under scrutiny for long, with its retail sale by pharmacies already banned.
However, the drug cannot be banned for its beneficial medical use. It is used for induction and augmentation of labour, control post delivery bleeding.
“It is a very important drug, it’s used for induction and augmentation of labour and to prevent postpartum bleeding,” said Dr Mala Srivastava, senior consultant, department of gynaecology, Sir Ganga Ram hospital.
Considering its wide misuse and its harmful effects, the DTAB also in principle approved that barcoding systems be adopted by manufacturers of the drug, in order aid tracking.
“The members deliberated the matter and agreed in principle on the proposal to amend rule 96 of the Drugs and Cosmetics Rules, 1945 to ensure that barcoding system is adopted for manufacture of Oxytocin formulations so as to ensure track and traceability of the product to avoid its misuse,” according to minutes of the meeting.
“We have to ensure that there is no shortage of the drug in the country. But the DTAB agreed that to regulate and restrict the Oxytocin formulations for human use, it is supplied only to registered hospitals and clinics in public and private sector,” said two people aware of the matter. The government will come out with a draft notification to this effect soon, added one of the people cited above.
Earlier in 2014, the government had restricted sales to only veterinary hospitals and to those with licences to make drug formulations that involve Oxytocin.
The ban restricted Oxytocin bulk drug manufacturers from selling it to only those with licences to make formulations with the drug. Drug makers on the other hand can supply it directly only to veterinary hospitals.
Under Schedule H of the Drugs and Cosmetics Rule, 1954, the drug can be distributed by prescription and only by a registered medical practitioner. Further, to avoid bulk sale, Oxytocin injections are packed in single packs.
Earlier, even the minister for women and child development Maneka Gandhi had raised concerns over the misuse of oxytocin by the dairy owners for extracting milk. “Banning its import is not a solution. It requires strict regulation. It is an internationally established first line drug used for active management of third stage labour and there is no substitute,” said B.R. Sikri, vice president of Federation of Pharmaceutical Entrepreneurs ( FOPE)
Oxytocin is listed in the National List of Essential Medicines (NLEM) for reproductive health. In India, according to central Drugs Standard Control organisation (CDSCO), many large Indian companies manufacture its formulation. Some of them are Hemmo Pharmaceutical Pvt. Ltd, Pfizer Ltd, Cadila healthcare Ltd and Troikaa Pharmaceuticals Ltd.
“It’s illegally imported into the country through the Afghanistan and Bangladesh borders and if the import is banned, local active ingredient manufacturers stand to benefit. In India, most companies formulate and sell them in the form of injections,” a pharma industry executive said on condition of anonymity.livemint