The Central Drugs Standard Control Organisation (CDSCO), after a crucial meeting on February 22 with manufacturers and industry representatives, has mooted tougher regulations to check import and distribution of Oxytocin, a neurotransmitter and peptide hormone, which is widely misused in dairy and horticulture industry.

According to a circular issued on February 28 by newly appointed Drugs Controller General of India Dr S Eswara Reddy to industry associations and other stakeholders, the proposals being weighed by the government include prohibiting the import of Oxytocin and its formulations for human as well as animal use under section 10A of the Drugs and Cosmetics Act and regulating and restricting it under Section 26A of the Act.

The government also wants to restrict its manufacturing to public sector Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) in Bengaluru. If the proposals materialise, HLL Lifecare will be the sole distributor of the drug in the country. Another measure in the pipeline is a bar-coding system for Oxytocin formulations to ensure traceability. The proposals are not applicable to Oxytocin meant for export. The DCGI’s letter requests all stakeholders to submit their feedback within 15 days.

While welcoming the steps to increase traceability and control illegal imports of Oxytocin, Federation of Pharma Entrepreneurs (FOPE) President BR Sikri strongly opposed the move to restrict its manufacturing to PSUs. “This drug’s beneficial medical uses are well known. It is available in the country in various brand names and has a market worth Rs.50-60 crore. Its misuse should be tackled, but banning production in the private sector is not the way to do it. How is it possible for one PSU manufacturer and distributor to supply the product all over the country? This wonder drug will be in short supply if the government implements the Drug Technical Advisory Board’s recommendations,” Sikri, who attended the key meeting with CDSCO officials, told Pharmabiz.

Oxytocin causes uterine contractions thereby inducing labour naturally and controls post-delivery bleeding. But it is misused in the dairy industry where livestock are injected with it to make them release milk at a convenient time. Many farmers use it to plump up vegetables. Studies have proved that its sustained use can cause hormonal imbalance in humans and ruin the reproductive system of animals, cutting their life span substantially.

Following last week’s meeting with CDSCO experts, FOPE has written a letter to the ministry of health to put forth the viewpoint of the industry and propose suggestions to stop the misuse of the drug. In the letter, reviewed by Pharmabiz, the federation pitches for checks and balances to tighten the drug supply chain.

“One reason for blatant misuse is the absence of robust veterinary policies and treatment guidelines. Novel drug delivery systems should be explored in the dairy sector. But this will take time and needs the support of government agencies,” FOPE president pointed out. According to sources, the CSDSCO wants to implement restrictions in a month’s time. Industry stakeholders unanimously object to this move. “A formulator normally keeps raw material and packaging items for three months. Some stock will be in the market and some in the pipeline. A sudden production halt will take a heavy toll on the manufacturer and leads to drug shortage,” a drug company executive opined.

The ready availability of Oxytocin is high-priority for a country like India where, as per a WHO report, five women die every hour from complications developed during childbirth with heavy blood loss caused by haemorrhage being a major factor.“The government should think twice before banking on a single PSU for the production of an indispensable drug. The lack of Oxytocin in the armamentarium of gynaecologists would put lives of many pregnant women at risk,” a healthcare professional added.