Rules to regulate manufacturing of generic medicine

ABU DHABI — In order to ensure efficiency of the generic (medicines that do not have brand names), the Ministry of Health (MoH) has set new rules pharmaceutical companies will have to meet before registering their products, said a senior health official.

By Nada S. Mussallam

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Published: Sun 18 Feb 2007, 9:40 AM

Last updated: Sun 5 Apr 2015, 2:33 AM

Generic medicines which have the same active drug as a trademarked brand-named version and usually cost less are widely consumed in the country, especially because pharmacies get a bonus from manufacturers on purchased quantity.

When patent expires on a brand name drug, the US Food and Drug Administration (FDA) permits manufacturers other than the original developer to create a bioequivalent of the branded drug and make it available to the public.

However, some Arab, East Asian and African countries reportedly take out the active ingredient before expiry of the patency and develop their own generic, giving way to questions about efficacy of these medicines.

“Pharmaceutical companies in the country must obtain endorsement of bioavailability / bioequivalency centres that were employed by the manufacturing companies in order to have their products registered in the UAE”, an official at the Central Drug Control Department at the MoH told Khaleej Times.

Generic medicines in the local market are expected to flourish in the wake of the enforcement of an ambitious health insurance scheme countrywide, which some emirates have already started implementing.

Generally, more than one manufacturer will create the generic version, although in many cases the same pharmaceutical firm that produces the brand name drug also makes the generic version.

“In the UAE, drugs are registered for a renewable period of five years during which the company has to update the MoH on any minor changes that might occur in their drugs.”

However, he said, in the past 10 years no bioequivalence studies were conducted on registered medicines.

“The endorsement certificate should be submitted by the manufacturing companies and attached with a letter of authorisation to allow drug companies process their registration applications,” said the official.

Concerning bioequivalent centres in the country, the official said these facilities could not conduct any bioequivalence study unless they were accredited by international centres.



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