14-Dec-2018: Delhi HC sets aside govt order banning private firms from producing, selling oxytocin

The Delhi High Court has set aside a government order banning private firms from producing and selling oxytocin- a drug commonly used during childbirth to induce contractions and control bleeding.

A bench of Justices S Ravindra Bhat and A K Chawla said there was no scientific basis behind the Centre’s decision restricting private companies from making or supplying the drug, which helps new mothers lactate, to prevent its alleged misuse in the dairy sector for increasing milk production. The court said the centre’s order was “arbitrary and unreasonable.”

Oxytocin is naturally secreted by the pituitary glands of mammals during sex, childbirth, lactation or social bonding, and is sometimes called “love hormone”. It is chemically synthesised and sold by pharmaceutical companies across the world. It’s used during childbirth because it can contract the uterus and induce delivery, control bleeding, and promote the release of breast milk. An oxytocin injection is generally available for Rs 3-20 at any chemist.

As per the Centre’s April 27 notification, the state-run Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) was solely allowed by the Centre to make the drug to meet the country’s needs. The high court on August 31 had suspended till September 30 the central government’s prohibition on sale and manufacture of oxytocin by private companies for domestic use. The stay was later extended till December 15.

6-Apr-2018: Government bans import of the hormone oxytocin

The Union government banned import of the hormone oxytocin to stop its misuse in the livestock industry. It's been reported to cause hormonal imbalances and shorten the lives of milch animals.

Often called the ‘love hormone’, oxytocin is released naturally in human bonding activities such as reproduction, childbirth and breastfeeding.

The government also asked customs officials to step up vigilance against those likely to try and smuggle oxytocin into India. The government has decided to rely on domestic production to satisfy requirements of the hormone.

The drug’s abuse in animals shortens their lives and makes them barren sooner. India halted retail sales of the prescription-only drug in 2014, but regulators have struggled to curb illegal sales, and the volume of imports is unclear.

The ban follows an order by the drugs regulator last year for officials to clamp down on factories that produce the hormone in bulk despite not meeting manufacturing standards. A panel of top drug experts had recommended an import ban in February, the minutes of their meeting, posted on the drug regulator’s website.

It also recommended that sale be limited to registered government hospitals and clinics, a bar code system used on all forms of the drug to ensure tracking and prevent abuse.

14-Dec-2018: Delhi HC sets aside govt order banning private firms from producing, selling oxytocin

The Delhi High Court has set aside a government order banning private firms from producing and selling oxytocin- a drug commonly used during childbirth to induce contractions and control bleeding.

A bench of Justices S Ravindra Bhat and A K Chawla said there was no scientific basis behind the Centre’s decision restricting private companies from making or supplying the drug, which helps new mothers lactate, to prevent its alleged misuse in the dairy sector for increasing milk production. The court said the centre’s order was “arbitrary and unreasonable.”

Oxytocin is naturally secreted by the pituitary glands of mammals during sex, childbirth, lactation or social bonding, and is sometimes called “love hormone”. It is chemically synthesised and sold by pharmaceutical companies across the world. It’s used during childbirth because it can contract the uterus and induce delivery, control bleeding, and promote the release of breast milk. An oxytocin injection is generally available for Rs 3-20 at any chemist.

As per the Centre’s April 27 notification, the state-run Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) was solely allowed by the Centre to make the drug to meet the country’s needs. The high court on August 31 had suspended till September 30 the central government’s prohibition on sale and manufacture of oxytocin by private companies for domestic use. The stay was later extended till December 15.

6-Apr-2018: Government bans import of the hormone oxytocin

The Union government banned import of the hormone oxytocin to stop its misuse in the livestock industry. It's been reported to cause hormonal imbalances and shorten the lives of milch animals.

Often called the ‘love hormone’, oxytocin is released naturally in human bonding activities such as reproduction, childbirth and breastfeeding.

The government also asked customs officials to step up vigilance against those likely to try and smuggle oxytocin into India. The government has decided to rely on domestic production to satisfy requirements of the hormone.

The drug’s abuse in animals shortens their lives and makes them barren sooner. India halted retail sales of the prescription-only drug in 2014, but regulators have struggled to curb illegal sales, and the volume of imports is unclear.

The ban follows an order by the drugs regulator last year for officials to clamp down on factories that produce the hormone in bulk despite not meeting manufacturing standards. A panel of top drug experts had recommended an import ban in February, the minutes of their meeting, posted on the drug regulator’s website.

It also recommended that sale be limited to registered government hospitals and clinics, a bar code system used on all forms of the drug to ensure tracking and prevent abuse.

2017

8-Jun-2017: Only PSUs should manufacture Oxytocin

After being banned in retail markets, the Drug Controller will soon restrict manufacturing of controversial hormone drug Oxytocin to public sector undertakings (PSUs). The drug is used by diary owners and farmers to boost milk production and make vegetables look bigger and fresher.

Oxytocin is a hormone known to trigger a wide variety of physical and psychological effects and is commonly used to facilitate childbirth. The Government of India banned retail sale of the hormone in 2014 after it was found that indiscriminate use of Oxytocin in milch animals and by farmers was causing irreversible hormone damage.

Misuse of Oxytocin is leading to early sterility in milch animals at an unprecedented rate. Despite it being a Schedule H drug, it is impossible to prevent its manufacturing at registered private factories. Implications to human health are humongous, from reproductive complications to hormonal imbalances. One major reason for such blatant misuse of this drug is the absence of robust veterinary services in India. It would be in the interest of the dairy industry and consumers to restrict manufacture and import of Oxytocin as has been directed by the Himachal Pradesh High Court.

In March 2016, the Himachal Pradesh High Court directed the Central government to “consider the feasibility of restricting the manufacture of Oxytocin only in public sector companies and also restricting and limiting the manufacture by companies to whom licences have already been granted.”