AEGiS-Bangkok Post: Certification urged for Aids drug: New GPO production plant is needed first

Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.

Certification urged for Aids drug: New GPO production plant is needed first

Bangkok Post - January 5, 2006
Apinya Wipatayotin

The Public Health Ministry has told the Government Pharmaceutical Organisation (GPO) to obtain good manufacturing practices (GMP) certification for its HIV treatment drug from the World Health Organisation as soon as possible, to sell the drug on the international market. Deputy Public Health Minister Anuthin Charnveerakul said the GPO should follow guidelines provided by WHO representatives to obtain the WHO/GMP certification for its anti-retroviral drug known as GPO/VIR.

The GPO/VIR drug has already been approved by the Thai Food and Drug Administration (FDA). However, to be sold abroad, it needs the WHO/GMP certification. To date, no domestically-produced drugs have received such certification.

Lt-Gen Monkol Jivasantikarn, GPO managing director, said WHO had sent its staff to inspect the state-owned pharmaceutical factory and its production processes twice. He said it was hard for the GPO to follow WHO guidelines.

"Our factory is too old and the production system does not meet WHO standards.

"We have two options to get the certification - either we modify the factory to bring it into line with WHO guidelines, or build a new factory. The second option is more likely, as we are building a new plant," Lt-Gen Monkol said.

The certification could be given in the next six months once the requirements are met, he said.

The GPO produces about 300,000 tablets of GPO/VIR for 150,000 people living with HIV/Aids. Its new factory would be able to produce 500,000 tablets a day. Currently, Thailand supplies GPO/VIR drugs to neighbouring countries such as Indonesia and Cambodia.

The agency would build the plant in Pathum Thani province on a budget of 940 million baht. However, construction had been delayed by bidding problems.

The plant would enable the GPO to make annual income of more than four billion baht, with over 900 million baht in profits, from locally-made generic drugs, including GPO/VIR, he said.

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