Context: Yesterday Supreme Court has referred the case to a larger bench to decide on whether imposing a ban on manufacturing and selling of oxytocin by the private firms and restrict its manufacture to a single public sector undertaking would be in public interest. What is the case? In April 2018, the central government notified the ban on manufacturing and selling of Oxytocin by the private firms. The government said that they wanted to restrict the responsibility of supplying the drug to Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) to avoid the misuse of oxytocin in the veterinary field. All India Drug Action Network (AIDAN) resisted the government decided to regulate the lifesaving drug and approached to the Delhi High Court. In December 2018, High court quashed the ban on various grounds including that it lacked scientific basis. After the High Court decision, the government has appealed at the Supreme Court saying that the Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) has the capability to manufacture and supply the required quantity of oxytocin. What is Oxytocin? Oxytocin, also known as the “love hormone”, is a hormone made in the brain and then transported to the pituitary gland of mammals and secreted by them during sex, childbirth, lactation or social bonding. The release of oxytocin regulates female reproductive functions like breastfeeding and childbirth. The hormone can be chemically manufactured and sold by the pharmaceutical companies to use in childbirth. It is administrated to humans through injection or a nasal solution. Uses of Oxytocin

  • At childbirth: the hormone helps to contract the uterus and induce delivery and promote breast milk after childbirth. It is also very important to prevent excessive bleeding in new mothers after giving birth to the child which is a common cause of maternal deaths in India.
  • It helps to abort the fetus in the cases of miscarriage and abortion.
  • Oxytocin also affects the social behavior of the people and can be a possible treatment for social anxiety, autism, and postpartum depression.
  • It helps to improve an individual’s personality and also useful to the people suffering from neuropsychiatric disorders.
Reasons for banning Oxytocin: Oxytocin is banned due to its misuse by people like:
  • It is misused to extract more milk from the livestock which makes them barren and decrease the lifespan of the animal.
  • Oxytocin is used to increase the size of vegetables like Bottle gourds, cucumbers, watermelons, brinjals, pumpkins, etc. to boost production.
  • Oxytocin consumption in food can cause diseases like breast and uterine cancers, male impotence, tuberculosis and increases risk of hemorrhage in pregnant women.
  • Oxytocin is also injected to attain puberty earlier than usual in girls especially by the human traffickers.
  • Oxytocin is also misused in the overcrowded government hospitals to speed up deliveries of pregnant women.
  • Overuse of the drug can cause dizziness, mood swings, erratic heart rate, etc.
Concern over the ban of Oxytocin by the government
  • The ban has been imposed without any formal discussions. Some of the counter-view of banning oxytocin are:
    • According to the report by Indian Journal of Medical Research“exogenous OT (Oxytocin) injections do not influence its content in milk”, and that “OT present in milk is rapidly degraded during intestinal digestion, ruling out its intestinal absorption and associated adverse health consequences, if any”.
    • on December 2015, the then Agriculture Minister said in Loksabha that “The National Dairy Research Institute has informed that there is no scientific evidence that artificial use of Oxytocin has adversely affected progeny of cattle and buffaloes resulting in dwindling of livestock. However, continuous Oxytocin use could lead to a progressive addiction and lack of response to normal let down of milk.”
    • Several gynecologists have said that no international study has so far definitively demonstrated the harmful effects of oxytocin on humans when consumed through vegetables or milk.
  • Ban on manufacturing and selling by the private firms can result in the shortfall of Oxytocin as if only a single public sector enterprise is permitted for the production of oxytocin.
  • There are only 17 distribution centers of Karnataka Antibiotics & Pharmaceuticals Limited (KAPL) in the whole country and there is no center in 19 states and UTs including all North-East states, Jammu and Kashmir, Himachal, Haryana, Punjab and Goa which is raising concern over the ban on manufacturing.
  • The ban can intensify the inflow of illegal version of the drug into the Indian market from other countries.
  • Oxytocin doesn’t have any proper alternative and it is used all over the world during the pregnancy.
Way forward:
  • Central Drugs Standards Control Organisation (CDSCO), an agency mandated for the drug regulation in India. The agency would determine that if the rules and laws are implemented efficiently in public interest. So CDSCO should keep an eye on the regulatory framework system in the developed countries for better results.
  • Action against the CDSCO functionaries who due to their private interest approve the drug in violation of rules and laws.
  • The government should consult stakeholders before banning of any drugs.
  • Awareness among people against these artificially ripen fruits and vegetables through awareness programs and media.
  • The drugs should be evaluated periodically.
  • should make legislation for strict regulation on illegal imports of the oxytocin.
Conclusion Oxytocin has an important role in maternal health and the WHO has recommended it which make it very crucial. The government ban is ignoring this and motivated with the misuse of the drug in the dairy sector. However even there are ill-effects of oxytocin but a ban is not a solution. Restricting the manufacture of a drug to a single PDU will put the lives of many women at risk as the hormone is widely used to prevent maternal deaths in India. So the government should reconsider its ban by keeping in mind uses of the drug. For Prelims: Read the facts about Oxytocin and how the drugs are regulated in India. For mains: Oxytocin use, the reason for ban and concern over the ban. Source: The Indian Express Read More: Daily News Prescription 14th August 2019