The Food and Drugs Authority (FDA) has cautioned the public that there is unregistered oxytocin either imported or manufactured by some pharmaceutical companies, and on sale in the Ghanaian market.
One of the companies involved is Entrance Pharmaceutical owned by a leading pharmaceutical distributor in Ghana, Tobinco Group of companies.
This is not the first time the company, with over 20 years’ experience, has been in the news for importing and distributing unregistered medicines.
Oxytocin injection is used to begin or improve contractions during labor, it is used to reduce bleeding after childbirth and may also be used along with other medications or procedures to end a pregnancy.
In a statement issued on Friday (21 April 2023), the FDA said “the pharmaceutical products are not registered with the FDA and therefore their quality, safety and efficacy cannot be ascertained”.
Other manufacturers mentioned in the statement were Belco Pharma PVT Ltd from India, AMROS Pharma from Pakistan, Anhui Hongye Pharmaceutical Company Limited from China, Jackson Laboratories PVT Ltd from India, Jiansu Ruinian Quianjin Pharmaceutical Company Ltd from China and Health Care Pharma.
Some of the named companies, have in the past been accused of importing these medicines from China, but lied that they were from respected Indian companies. They had some labels on them to give them authenticity, but the FDA found them to be of substandard even fake.
Few years ago, the FDA busted some companies with oxytocin which had caused the death of some pregnant women across the country. Most of the women had bled to death after childbirth and although the oxytocin was used on them, it could stop the bleeding.
“The FDA is therefore informing all health facilities and medical stores of the above-mentioned products to stop using them immediately and return them to the nearest FDA offices throughout the country. Meanwhile, the FDA is liaising with importers to ensure that the market is rid of these unregistered pharmaceutical products,” the statement said.
“In this regard, the Authority is taking the necessary regulatory actions to prevent any such future occurrence,” the statement added.
However, the FDA has assured the public that it is taking all the necessary precautions to ensure that medical products on the Ghanaian market are safe, efficacious and of the right quality.
