Pharmaceutical manufacturers in Vietnam have gained a reprieve after the Ministry of Health (MoH) informed them that those without good manufacturing practice (GMP) certificates can continue production for now.
It had been expected that those who were not compliant with the World Health Organization's (WHO) GMP standards would be forced to cease operations but the MoH has now softened its stance.
The body's new position is that each company's circumstances will be assessed on a case by case basis, with provisory regulations brought in. Companies now have until 2010 to comply with GMP.
Vietnam's MoH believes that making the nations facilities GMP compliant is essential if they are to evolve into entities capable of competing with foreign competitors.
This is intended to ensure that Vietnam's small but growing local pharmaceutical production industry, which grew by 18 per cent in 2007 to $560m, is equipped to combat international rivals.
However, the MoH has now adjusted its timeframe for GMP compliance following a petition from Vietnam's pharmaceutical manufacturers, which explained the difficulties they faced in adopting and maintaining the standards.
Companies felt more time was needed to arrange capital, modify practices and expand production to bring them into line with the GMP criteria.
The difficulties faced by companies were highlighted by Le Ngoc Phan, chairman of the Central 2 Pharmaceutical Joint Stock Co's management board.
He explained how the company has taken two years and spent $6.7m getting the facility GMP compliant but despite this effort and expenditure the site would not be operational until next year.
Despite these difficulties 61 local pharmaceutical companies have obtained GMP compliance, with a further 19 adhering to the GMP-ASEAN standards implemented by the Association of Southeast Asia Nations.
This leaves 16 companies without any certification but they appear to have the support of their peers in shifting the deadline for compliance.
Further support may be required over the coming years as the MoH seeks to avoid a production shortfall by urging GMP compliant companies to help out those yet to meet the criteria.
Companies who have no plans in place to establish GMP at their facilities they will have to cease production of pharmaceuticals and switch to other sectors or traditional medicines.
The MoH's insistence on GMP compliance is part of a broader programme aimed at raising standards, which recently saw Vietnam and the US enter into an information sharing agreement to ensure the safety of goods traded between the nations.