‘Health’ for first time approves purchase, sale of generic drugs
Product must be registered in country of origin
KUWAIT CITY, Oct 16: The Ministry of Health (MoH) has for the first time approved the specifications for the purchase and sale of generic drugs in the State of Kuwait, in order to lay the foundations and standards to ensure the safety of all generic drugs and follow-up the marketing of branded drugs, reports Al-Rai daily.
The Assistant Undersecretary for Drug and Food Control Affairs at the Ministry of Health, Dr Abdullah Al-Bader said in a press statement that generic drugs have the same quality, effectiveness and safety as branded drugs, and that the use and dosage have the same effect, but the form and color may vary from company to company, and this difference does not affect the effectiveness and safety.
He said that generic drugs are 85 percent cheaper than branded drugs, especially when marketing more than one generic drug for the branded drug, because there is no need for testing and scientific studies as happens with branded drugs.
He stressed the decision pertaining to conditions and specifications for the purchase and sale of generic drugs is in the interest of rationalization and budgeting since generic drugs are cheaper. He added, 9 out of 10 prescription drugs in the United States are generic.
Buying
He said that one of the conditions is when buying generic drugs through local tenders, the generic product must be registered in the country of origin and the registration and control of medicinal and phytosanitary medicines at the Ministry of Health. Differentiation criteria ensure the selection of the highest quality, effectiveness, registration in reference countries, price and technical specifications such as package size, pharmaceutical form, safety reports and good practice of pharmacovigilance i.e the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions.
Al-Bader stated that one of the conditions that have been taken into account is that the price difference between the generic and the branded product should be 30% or more.
The Sub-Committee on Drugs determines the percentages of the required quantities of generic medicines, so that the percentage is 20 percent for the generic product and 80 percent for the branded product.
He pointed out that doctors are obliged when prescribing the drug to use the scientific name and not by trade name, in order to ensure that the name of a particular company is not promoted when dispensing the medicine, as in the reference countries.
In order to explain the mechanism of drug registration, the department, in cooperation with the heads of medical departments, exchanges information on medicines and their effectiveness and follow-up after use and monitor any possible side effects of any drug, in accordance with the rules and principles of drug vigilance approved by the registration and control of medicines and medical control and plant medicines.
Generic medicines are prescribed only after the approval of the Sub-Committee for the purchase of medicines. It is required that the generic product be registered with the Department of Registration and Control of Medicinal and Phytosanitary Drugs and that it is equivalent to the formula of the branded.