The Central Drugs Standard Control Organization (CDSCO), after an essential meeting on February 22 with manufacturers and industry representatives, has raised tougher regulations to check import and distribution of Oxytocin, a neurotransmitter and peptide hormone, which is broadly misused in dairy and horticulture industry.
As indicated by a circular issued on February 28 by newly named Drugs Controller General of India Dr S Eswara Reddy to industry associations and other stakeholders, the recommendations being weighed by the government include prohibiting the import of Oxytocin and its formulations for human and also 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 needs to restrict its manufacturing to public sector Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL) in Bengaluru. If the proposals appear, HLL Lifecare will be the sole distributor of the drug in the country. Another part in the pipeline is a bar-coding system for Oxytocin formulations to ensure traceability.
The recommendations are not appropriate to Oxytocin implied for export. The DCGI’s letter asks for all stakeholders to present their feedback within 15 days.
While welcoming the steps to build traceability and control illicit imports of Oxytocin, Federation of Pharma Entrepreneurs (FOPE) President BR Sikri firmly opposed the move to restrict its manufacturing to PSUs. “This drug’s medical uses are excellent. It is available in the country in different brand names and has a market worth Rs.50-60 crore.
Its misuse should be handled, yet banning production in the private sector is not the way to do it. How is it possible for one PSU maker and distributor to supply the product everywhere throughout the country? This wonder drug will be hard to supply if the government executes the Drug Technical Advisory Board’s proposals,” Sikri, who went to the key meeting with CDSCO authorities.
Oxytocin causes uterine contractions in this manner inducing labor naturally and controls post-delivery bleeding. In any case, it is misused in the dairy industry where livestock is injected with it to influence them to release milk at a convenient time.
Many farmers use it to plump up vegetables. Studies have demonstrated that its sustained utilize can cause hormonal imbalance in people and ruin the reproductive system of animals, cutting their lifespan significantly.
Following a week ago’s meeting with CDSCO specialists, FOPE has written a letter to the ministry of health to advance the viewpoint of the industry and propose suggestions to stop the abuse of the medication. In the letter, the federation pitches for checks and balances to fix the drug supply chain. “One reason behind blatant misuse is the absence of robust veterinary policies and treatment guidelines.
Novel drug delivery systems should be investigated in the dairy sector. However, this will require some investment and necessities the help of government agencies,” FOPE president pointed out. As indicated by sources, the CSDSCO needs to execute restrictions in a month. Industry partners collectively question this move. “A formulator normally keeps raw material and packaging things for three months. Some stock will be in the market and some in the pipeline.
A sudden production end will take a heavy toll on the maker and prompts drug shortage,” a drug company official opined. The ready availability of Oxytocin is high-priority for a country like India where, according to a WHO report, five women die every hour from complications developed during childbirth with heavy blood loss caused by hemorrhage being a major factor.
“The government should reconsider before banking on a single PSU for the production of a vital drug. The lack of Oxytocin in the armamentarium of gynecologists would put lives of many pregnant women at risk,” a healthcare professional included.