The Delhi High Court Friday passed an interim order to put on hold for one month the Union Health Ministry’s decision banning Oxytocin production by private companies for domestic use. The Centre had issued a notification to implement this ban from September 1. A bench of Justice S Ravindra Bhat and Justice A K Chawla passed this order, as it continues to hear three petitions to stop the government’s move.
“Considering all circumstances, we are prime facie of the opinion that complete prohibition by way of… on manufacture, sale and distribution for domestic use of Oxytocin should be suspended for one month,” the bench stated, and directed that all parties concerned should file written submissions before it on the next date of hearing, September 12.
The bench noted in its order that the material placed before it showed that when the decision was taken in February this year to restrict the sale of Oxytocin, state-run Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) was not even licenced to manufacture the drug and it was issued the licence only this April. The Centre had stated earlier that only KAPL would be manufacturing and distributing Oxytocin in India from September 1.
Before passing interim order on Friday, the court raised various questions to the Centre. Discussing Oxytocin leakage by private companies, Justice Bhat asked the Centre if it has revoked the licenses of all 120 private companies for this drug’s production. The Drugs Controller General of India (DCGI) S Eswara Reddy, who was present in the court, replied that licenses of two private companies have been revoked as yet. Justice Bhat then said: “Only two (licenses) have been suspended … it means the problem is with the unlicensed manufacturers, right?”
Currently, around 120 private companies have the license to produce Oxytocin in India. Justice Bhat stated during the hearing that all private companies would be free to purchase bulk drug and manufacture Oxytocin for export purposes even when the ban is imposed. (Bulk drug is the raw material used to produce finished drug Oxytocin). Therefore, how does the Centre “plan to plug it (leakage)” then, if it is happening due to private manufacturers, he asked.
The government counsel replied that since the central drug controller has an office at customs office, it is easier to collate the data about Oxytocin export and match it with the usage of bulk drug by the company. “The problem is with the domestic use,” the government counsel added.
However, the government counsel clarified: “We don’t know anywhere if it has been mentioned (in the minutes of DTAB or DCC meetings) that the bulk drug is leaking because of the licensed manufacturers.”
Both Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC) work under Union health ministry as advisory bodies.
Justice Bhat also asked the Centre: “Since you (KAPL) are substituting and taking over Oxytocin production, can you tell me what the total capacity of the private producers is today?” The central government counsel told the court that KAPL has a production capacity of 51 lakh ampoules per month, which is sufficient for Indian consumption as per their calculations, and “this capacity can be increased as per the need”.
The three petitioners in this case are BGP Products Operations Gmbh, a subsidiary of Mylan Laboratories; Neon Laboratories; All India Drug Action Network (AIDAN). Currently, Pfizer and Mylan are two leading producers of Oxytocin in India. Oxytocin is used to induce labour contractions during child birth and control bleeding after it.
The Centre had stated before the court that despite the provisions contained in the Drug and Cosmetic Act and Rules, the reports of manufacture and sale of the Oxytocin in large quantity and its misuse by the farmers and dairy owners have been received from time to time and the matter was raised at various forums. According to Centre, Oxytocin is misused by the farmers in growing abnormally large sized vegetables and by dairy owners to extract larger amounts of milk from cows and buffaloes.