Dr KK Aggarwal & Advocate Ira Gupta
On Friday, 14th December, the Hon’ble Delhi High Court set aside the Govt.’s decision to ban private firms from producing and selling oxytocin, a drug used for inducing labour contractions & controlling bleeding.
A bench of Hon’ble Justice S Ravindra Bhat and Hon’ble Justice AK Chawla said that the government’s decision was arbitrary and unreasonable.
The bench also said that there was no scientific basis behind the Center’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.
As per a notification dated 27th April, the Ministry of Health and Family Welfare had restricted the manufacture of oxytocin formulations for domestic use to public sector only. It had also banned the import of oxytocin and its formulations. Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), a public sector company, was solely allowed by the Center to manufacture this drug for domestic use.
The reason for the ban was the misuse of oxytocin in dairy animals to increase milk production.
On 31st August, the High Court had suspended till 30th September the Central Government’s prohibition on sale and manufacture of oxytocin by private companies for domestic use. The stay was later extended till 15th December.
Post-partum hemorrhage, or PPH, is a major cause of maternal death in India accounting for about 38% of all maternal deaths due to hemorrhage. It is also one of the most preventable causes of maternal mortality.
Oxytocin is a time-tested drug that has been used to prevent maternal deaths due to PPH. WHO has also recommended IV oxytocin as the first line uterotonic drug for the treatment of PPH and has included it in the 20th Edition of its Model List of Essential Medicines, amended in August 2017.
In India, oxytocin is also included in the National List of Essential Medicines (NLEM) 2015 under section 26.1 (Oxytocics)
Hence, any difficulty or hurdles in procuring oxytocin would have only increased maternal mortality due to PPH.
Oxytocin is often a life-saving drug; hence, it should be available and accessible in all settings, including remote areas for use by doctors as well as nurses.
Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA