ID :
72972
Thu, 07/30/2009 - 17:35
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Shortlink :
http://m.oananews.org//node/72972
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Registration waived for imports of anti-H1N1 drugs
BANGKOK, July 30 (TNA) – Thailand’s Ministry of Public Health is now permitting the importation of anti-viral drugs for stockpiling without registration with the Food and Drug Administration (FDA), normally a requirement for any imported medication.
The ministry on Wednesday confirmed 21 more deaths from the Influenza type A (H1N1) over the past week, bringing the country’s total number of fatalities to 65.
Public Health Minister Witthaya Kaewparadai said the anti-viral Oseltamivir capsules produced by the Government Pharmaceutical Organisation (GPO) are adequate to treat patients who have contracted the influenza A(H1N1) in the country.
However, to ensure rapid access to the anti-viral medication in case of a severe outbreak, the ministry issued a ministerial notification to allow companies, juristic persons, embassies, and international organisations to order anti-flu drug into the country for stockpiling without drug registration with the FDA.
However, importers have to seek approval from the FDA and strictly conform to the agency's regulations.
Meanwhile, FDA Secretary-General Dr Pipat Yingseri said despite the waiver of technical formalities, importers of anti-viral drugs must nonetheless strictly follow the ministry's conditions.
He said the conditions include limiting the amount of imported anti-virals to amounts only sufficient for the pandemic, to be used only for medical treatment and disease prevention, as well as drug storage in hospitals or drug warehouses which have passed FDA quality control standards.
Dr Pipat added that only doctors are allowed to prescribe anti-viral drugs and the public health ministry will control the amount of drug use to avoid drug resistance.
Anti-viral drug importers are required to report their drug imports and uses to the FDA every four months. Those wanting to import anti-viral drugs must submit their request to the Drug Control Division which will consider whether such a licence will be issued or not, said Dr Pipat. (TNA)
The ministry on Wednesday confirmed 21 more deaths from the Influenza type A (H1N1) over the past week, bringing the country’s total number of fatalities to 65.
Public Health Minister Witthaya Kaewparadai said the anti-viral Oseltamivir capsules produced by the Government Pharmaceutical Organisation (GPO) are adequate to treat patients who have contracted the influenza A(H1N1) in the country.
However, to ensure rapid access to the anti-viral medication in case of a severe outbreak, the ministry issued a ministerial notification to allow companies, juristic persons, embassies, and international organisations to order anti-flu drug into the country for stockpiling without drug registration with the FDA.
However, importers have to seek approval from the FDA and strictly conform to the agency's regulations.
Meanwhile, FDA Secretary-General Dr Pipat Yingseri said despite the waiver of technical formalities, importers of anti-viral drugs must nonetheless strictly follow the ministry's conditions.
He said the conditions include limiting the amount of imported anti-virals to amounts only sufficient for the pandemic, to be used only for medical treatment and disease prevention, as well as drug storage in hospitals or drug warehouses which have passed FDA quality control standards.
Dr Pipat added that only doctors are allowed to prescribe anti-viral drugs and the public health ministry will control the amount of drug use to avoid drug resistance.
Anti-viral drug importers are required to report their drug imports and uses to the FDA every four months. Those wanting to import anti-viral drugs must submit their request to the Drug Control Division which will consider whether such a licence will be issued or not, said Dr Pipat. (TNA)
