Oxytocin and drug ban issue in India

Context

The government has banned production of oxytocin for domestic use by private companies, and its sale by private chemists from September 1.

What is Oxytocin?

Oxytocin is naturally secreted by the pituitary glands of mammals during sex, childbirth, lactation or social bonding, and is sometimes called “love hormone”.

Oxytocin is a neurotransmitter and a hormone that is produced in the hypothalamus. From there, it is transported to and secreted by the pituitary gland, at the base of the brain.

Uses of Oxytocin:

1. Used as a medication to facilitate childbirth.

• During labor, oxytocin increases uterine motility, causing contractions in the muscles of the uterus, or womb.
• Helps to abort the fetus in cases of incomplete abortion or miscarriage, and control bleeding after childbirth.

2. Oxytocin also has social functions.

• It impacts bonding behavior, the creation of group memories, social recognition, and other social functions.
• It may act as a possible treatment for social phobia, anxiety, autism, and postpartum depression.

3. It might help improve interpersonal and individual wellbeing, and that it could have applications for people with some neuropsychiatric disorders.

Issues with the use of Oxytocin

1. Misuse by farmers

• It is excessively used to extract more milk from the cows and buffaloes which makes the cows barren sooner and lowers the lifespan of the animal
• It is used to increase the size of vegetables such as pumpkins, watermelons, brinjals, etc
• Consumption of Oxytocin in food causes breast and uterine cancers, male impotence, increases risk of hemorrhage in pregnant women and is also responsible for high spike in tuberculosis cases.

2. Used by trafficker

• Drug is injected to ensure girls attain puberty earlier than usual.

3. Misuse In healthcare

• It is used to speed up deliveries for pregnant women in overcrowded government hospitals.
• Overuse causes symptoms of dizziness, nausea, early puberty, mood swings, erratic heart rate and fetal damage, among others.

Timeline of Government’s action to curb the misuse of Oxytocin

2014: Restrict sales to only veterinary hospitals and to those with licenses to make drug formulations that involve Oxytocin.

2016: Himachal Pradesh High Court observed that there is large scale clandestine manufacture and sale leading to its grave misuse, which is harmful to animals and humans.

February, 2018: Drugs Technical Advisory Board (DTAB) advisedrestriction of supply of Oxytocin only to registered hospitals and clinics in public and private sector

April 27, 2018: The MoHFW restricted the manufacture of Oxytocin formulations for domestic use to public sector only. It banned sell of oxytocin by private retail chemists.It has also banned the import of Oxytocin and its formulations

Regulation of manufacture, sale and import of oxytocin in India

• Oxytocin is listed in the National List of Essential Medicines (NLEM) for reproductive health.
• 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.

The Central Government has regulated the manufacture for sale or for distribution of Oxytocin under section 26A of the Drugs and Cosmetics Act, 1940 in the following manner:-

• For domestic use manufacture by public sector undertakings or companies only
• For export purposes, manufacture be open to both public and private sector.
• The manufacturers of active pharmaceutical ingredient (API) of Oxytocin shall supply the API only to the public sector manufacturers while for export it will be supplied to both public and private sector
• The manufacturers can also supply the formulations to the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) and Affordable Medicines and Reliable Implants for Treatment (AMRIT) outlets
• Oxytocin in any form or name will not be allowed to be sold through retail Chemist.

Issues with Government Action

1. Ban has been imposed without extensive deliberations with the various stakeholders.

• Indian Journal of Medical Research, reported that “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”.
• 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.
• Several gynecologists reported that no international study has so far definitively demonstrated the harmful effects of oxytocin on humans when consumed through vegetables or milk.

2. Supply and Monopoly

• Only Karnataka Antibiotics & Pharmaceuticals Limited (KAPL) can supply Oxytocin to the registered hospitals and clinics in public and private sector directly. Although it has very limited presence in many states which may impact genuine patients

3. No alternative

• It is used all over the world during pregnancy with no proper substitute

Issues with drug ban in India

1. Lack of Pharmacovigilance

• Absence of practice of monitoring the effects of medical drugs after they have been licensed for use.

2. No India specific testing

• The Indian institutions generally follow the grounds of efficacy and safety formulated by foreign companies and thus blindly bans those drugs which are banned abroad.

3. Absence of stringent norms for drug ban

Despite large number of analgesics and antipyretics in the Indian market, CDSCO still continues marketing Analgin, which has been banned in so many countries.

4. Drug Regulation

• In India, center is responsible to regulate the import, manufacture and sale of medicines contrary to the developed world.
• Central Drugs Standards Control Organisation (CDSCO), the agency mandated with the task of drug regulation in India is to determine if rules and laws were being implemented efficiently and honestly in the interest of patients.
• Recently, Government ban 344 FDCs on the recommendation of Kokate committee. There is case going on in SC court over the arbitrary ban. The issue is whether the government could ban such drugs by its own or only on the recommendation of regulatory body
  • If the Supreme Court interprets Section 26A of the DCA, 1940 as a legislative and not a quasi-judicial power in the FDC Case, it will mean that the government can ban any dangerous drug without giving the industry a hearing and without passing a reasoned order.

5. Mandate and Structure of CDSCO

In its Status Report on CDSCO, MoHFW stated that the mission of CDSCO was to meet the aspirations demands and requirements of the pharmaceutical industry. It is contrary to the stated missions of Drug Regulatory Authorities ofdeveloped countries where it is to protect the public health

6. Crony capitalism

• Drug companies easily flout post-market surveillance rules in connivance with politicians and bureaucrats.

7. Issue with pharmaceutical companies

• Pharmaceutical companies either produce or import drugs that they can profitably sell.

8. Community participation

• Banning of drugs without extensive deliberations with various stakeholders results in depriving customers of genuine drugs.

9. State Drug Regulatory Authorities:Some State Drug Authorities have issued manufacturing licenses for a very large number of FDC’s without prior clearance from CDSCO.

Way Forward

1. Strengthen the regulator: CDSCO should be mandated with more power to protect public health
2. Government should consult various stakeholders before banning of any drugs
3. The State Governments should educate the public through print and electronic media against consumption of such artificially ripened fruits and vegetables
4. Government must prepare India specific rules for any drugs rather than following the developed nation
5. Apart from serious side-effects, a drug also becomes candidate for withdrawal when more efficacious drugs are launched. Unfortunately, no attention is being paid on this issue. Therefore, all drugs need to be evaluated periodically.
6. Drug Controller General of India should take action against those CDSCO functionaries who colluded with private interests and got the drug approved in violation of laws
7. CDSCO should keep a close watch on regulatory developments that take place in countries with well-developed regulatory systems in the West.