The Central Drugs Standard Control Organization (CDSCO) ordered the inspections this week, giving regional regulators one month to make sure all firms manufacturing oxytocin are compliant with the Drugs and Cosmetics Act, 1940 and Rules 1945.
In addition to ordering inspectors to assess production, the CDSCO also said state regulators need to examine oxytocin manufacturers’ distribution activities to ensure the drug is only being supplied to parties cleared to use it.
Manufacturers that are found not to be up to code will be given three months to correct any problems according to CDSCO.
Any manufacturer which fails to comply after that will be banned from making active pharmaceutical ingredient (API).
Misuse
The crackdown on non-compliant oxytocin manufacturers is part of a wider effort to restrict access to the drug.
Oxytocin is a naturally occurring human peptide hormone produced during childbirth. It is legitimately used to stimulate labour and contractions in women at risk of miscarriage or other complications.
However, recent studies in India and Pakistan have suggested that oxytocin is frequently used to speed childbirth in “overcrowded labour wards” rather than for legitimate medical reasons.
Other reports suggest the drug is also often used by dairy farmers to boost milk production in cows.
Since 2014, only veterinary hospitals and licensed drug manufacturers have been able to buy synthetic oxytocin.
Last year, the high court in Himachal Pradesh rejected efforts to have the restrictions lifted.