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Harmful Medicine for Hypertension Banned by the Ministry

A medicine identified as harmful in Saudi Food and Drug Authority and International regulatory authority for Drugs was found selling in the market without being registered in the medicine department.

Ministry of health and Prevention-MoHAP in the UAE has barred the selling of a medicine that may contain content harmful to human health. According to the resources, two variants of 150mg and 300mg of a medicine used to control High Blood pressure is feared to contain content that is carcinogenic.

Carcinogenic are those substances that have the ability to damage the genome or to the disruption of cellular metabolic processes resulting in promoting carcinogenesis that forms a Cancer.

The harmful content found in the high blood pressure medicine being sold in the market by the name of Irsotan is referred to as NDEA that stands for N-Nitrosodiethylamine which is part of an active ingredient “Irbesartan”.

Irbesartan is a famous ingredient used in medicines to cure hypertension and kidney diseases. It belongs to a class of drugs called angiotensin receptor blockers (ARBs).

Laws in the UAE for Medicinal Products

The medicinal products in the UAE are regulated under the “Pharmaceuticals law 1983”. This law defines all the provisions related to manufacturing, import, distribution, and sales of medicinal products.

No product can be manufactured or imported for sales in the UAE without being registered under the Ministry of Health and Prevention under the Pharmaceuticals law 1983. This law also defines the term medicine to omit any confusions and misuse of the law. Acquiring the licenses for medical importation and distribution is a must.

To acquire the license for the distribution of any medicine in the UAE, the contents used in the medicine must also be registered with the Ministry even that if there is any minor change in the content of the registered medicine happens, then the medicine and its content needs to be re-registered.

Federal laws 14 and 20 of 1995 also provide grounds for the regulation of medicines in the UAE.

Laws of the UAE are very strict about drugs control. The penalties for violators can vary from short term closure of premises where the violation was made to fines starting from AED. 2000 for minor violations. The violations of regulatory laws related to medicine in UAE can also result in the cancelation of license and imprisonment.

Hazim Darwish

Hazim Darwish, is a Senior Partner of HHS Lawyers in UAE. Practicing law for almost a decade, he has in-depth knowledge on UAE legislation with particular expertise on legal drafting, contract drafting, labor disputes, family law, and regulatory compliance for business organizations. Hazim Darwish also provides counsel on legal rights and obligations in the UAE to clients, including individuals and businesses subject to investigation or prosecution under Criminal Law by major regulators.