Even as the Union health ministry is weighing options for prohibiting the import of oxytocin and its formulations for human as well as animal use under section 10A of the D&C Act and regulating and restricting it under Section 26A of the Act, the Karnataka drugs control department has seized sale of oxytocin in Belgavi district of Karnataka for its misuse by a dairy farmer.
The enforcement team has detected a case of misuse of oxytocin by a dairy farmer. The bulk drug is sourced from Maharashtra and the matter is now being investigated. The sale of oxytocin without license is a gross violation of the Drugs and Cosmetics Act and Rules.
Our department’s assistant drugs controller and deputy drugs controller seized 393x100ml oxytoxcin from a dairy farmer. The seized samples were tested and the drug was proven to be oxytoxcin in bulk quantities which was being sold by the accused to other dairy farmers. This is a violation as per the Drugs and Cosmetics Act & Rules and Indian Penal Code section 272, 273 and 420. The case is registered at the police station at Khade Bazar at Belagavi, Karnataka drugs controller Bhagoji Khanapure told Pharmabiz.
According to a media report quoting Union Minister of State for Chemicals and Fertilisers Mansukh L Mandaviya, the government is considering to regulate and restrict oxytocin for human use so that the drug is supplied only to registered hospitals and clinics in public and private sector. The report also added that efforts by the government are to adopt bar coding system for manufacture of oxytocin formulations to enable easy track and traceability of the product to avoid its misuse, the minister added.
“The Drugs Technical Advisory Board (DTAB) in its 78th meeting held on February 12, 2018 has also agreed to prohibit the import of oxytocin and its formulations for human use as well as animal use under Section 10 of the Drugs and cosmetics Act, 1940, The government is looking to ban the import of oxytocin as cases of its misuse by some dairy owners and farmers to boost milk production and increase size of vegetables has come into light,” stated the report.
Karnataka has not issued a single license to pharma manufacturers for the production of oxytocin. By virtue of a High Court order, in March 2017, the drugs control department issued a test license to the public sector undertaking Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) to validate the drug in its R&D lab. However recently after the government’s intent to permit oxytocin manufacture only by a public sector undertaking, the company has now applied for grant of permit and its license application is under scrutiny, said drugs controller Khanapure.