NDA withdraws dangerous drugs, vaccines

Some of the recalled drugs include Univittal manufactured by Unichem Laboratories Ltd, hydrapres injection supplied by Laboratorios, SA-Bercelona, Spain and Agonal whose generic name is Nalidixic Acid from Agog Pharma Ltd, India.

Others are Vitamin B Complex injection manufactured by Anhui Chengshi Manufacture Medicine Co., China, Lyopox + PPR manufactured by MCL Santé Animale based in Morocco and Netvaicain plain manufactured by Swiss Parenterals Pvt Ltd, of India
In an interview yesterday, Ms Kate Kikule, the head of NDA Drug Inspectorate Services said after investigations, some drugs were found to have questionable efficacy whereas others had been wrongly branded by the manufacturers.

“We routinely conduct investigations following complaints from the people, hospitals and clinicians. If a drug does not meet safety standards after laboratory tests, it is recalled through the manufacturer,” Ms Kikule said.

She added: “After tests, we found out that the powdered substance of Hydralazine injection, a medication used to treat hypertension was not dissolving.”

As result, she said that once a substance fails to dissolve that means a drug cannot be used by the consumer.

National Medical Stores general manger Moses Kamabare said he had earlier complained to NDA over the effectiveness of one of the drugs.

He said the drugs were recalled by the supplier about two months back and they are now waiting for replacement.

Ms Kikule said a wrongly branded drug such as the Bupivacaine Injection BP 0.5% can misleed clinicians while administering these drugs thus causing adverse side effects to patients. She said Agonal, whose tablets had turned moldy and black, can cause pain and also stomach upsets once taken by a patient. “Samples of Lyopox + PPR (Sheep Pox and Peste Des Petits Ruminants Vaccine), vaccine for animals were taken for testing in Ethiopia and did not comply with the standards of the World Organisation for Animal Health,” she said.
“Laboratory tests indicated that Multivitamin whose product name is Univittal had poor quality gelatin capsules. Its capsules were sticking to the Aluminum foil used for packaging,” she added.

This, according to Ms Kikule, means the drugs cannot perform its therapeutic role of curing ailments. “We have written to the importers or the local technical representatives of the manufacturers of the products to have these drugs recalled and destroyed,” she said.

However, she said the public should not worry about the recall because it is a normal process that happens worldwide.

The acting director general health services in the Ministry of Health, Prof Anthony Mbonye, said he had not seen the report on the recalled drugs.

Asked to comment on the circumstances under which a drug can be withdrawn from the market, Prof Mbonye said a drug can be recalled due to several reasons, giving an example of drugs which are smuggled into the country and not registered on the drug register.

According to NDA spokesperson Frederick Ssekyana, recalled drugs are collected by the local representative of the manufacturer and taken for destruction at the main incinerator in Nakasongola District.

He said the destruction process is done under the supervision of NDA but at the cost of the manufacturer.
Ms Kikule said the affected drug suppliers have to compensate all the pharmacies and hospitals affected.

eainebyoona@ug.nationmedia.com

Source: http://www.monitor.co.ug/News/National/NDA-withdraws-dangerous-drugs--vaccines/688334-3407702-item-01-119snxlz/index.html