DRA: Health ministry’s Department of Medical Service notified all hospitals to stop dispensing three essential drugs, last week .
The three drugs are calcium lactate (300mg tablets), vitamin C (250mg tablets) and omeprazole (20mg capsules).
All three drugs are products of Park Pharmaceuticals Pvt Ltd in India.
According to Drug Regulatory Authority (DRA) officials, the drugs were recalled after it failed quality tests.
DRA officials said a product recall occurs when it is found that a drug maybe harmful to consumers.
DRA’s Post Marketing Control Division head, Ngawang Dema said the recall was a result of a Good Manufacturing Practice (GMP) compliance report of the manufacturing firms.
“In our case, it is mostly batch recall, which happens due to defective complaint reports of the medicinal products and through laboratory test report,” she said. “All product recalls takes place based on GMP poor compliance report. For Park Pharmaceuticals, it failed in both.”
After discussion with the health ministry and following an appeal to the Bhutan Medicine Board chairman, the drug importer, has asked for additional tests to confirm the quality in another Medicines Board approved laboratory. For this, samples are yet to be sent for testing.
“Let us first wait for the confirmatory tests on what kind of parameters the medicines failed to comply, accordingly appropriate action to be taken,” Ngawang Dema said.
She added that to ensure quality of medicinal products in the country, DRA sends samples for testing every year. The recall practice was instituted in September 2011 after the Bhutan Medicine Board chairman approved procedures.
The recalled drugs are available only for institutional supplies of the health ministry. They are not available in retail pharmacies, she said.
Meanwhile this not the first time drugs are being recalled in the country. In 2012 several samples of Vitamin C, Calcium lactate and Omeprazole were sent to Shriram Research Institute in New Delhi for testing. Following the tests, its usage was allowed until October 2014.
“We also had experiences of failed or quality non-compliance report of two batches of lactulose solution from Park Pharmaceuticals. It was recalled immediately,” Ngawang Dema said, adding that it called for a GMP inspection, and a site audit for GMP.
Cetrizine tablets and albendazole were two of the essential drugs that were recalled in 2012 for failing quality tests. Paracetamol (parkomol) was also recalled from retail sales in pharmacies after dark spots or foreign particles were observed in the drug in 2012.
Following the recall, the product recall committee meeting recommended recalling all products of Park Pharmaceuticals and deregister the company’s products. The committee also sought endorsement from the Bhutan Medicines Board.
By Nirmala Pokhrel