Veterinary medicine producers afraid of… GMP

06:00' 15/04/2008 (GMT+7)
VietNamNet Bridge – The Vietnam Veterinary Medicine Producers’ Association (VVPA) has sent a petition to the government, proposing a delay of the deadline for obtaining GMP (good manufacturing practice) certificate to 2012 instead of 2008 in order to rescue 90% of producers from being eliminated.
At the end of March 2008, VVPA and 37 enterprises, representing veterinary medicine producers, signed a document, asking the Ministry of Agriculture and Rural Development (MARD) and the Vietnam Veterinary Agency to delay the implementation of GMP for four years so that producers have more time to arrange capital, expand production scale to obtain a GMP certificate.
The story originated from a document released earlier this year by the Vietnam Veterinary Agency, which said that veterinary producers must apply GMP for their production of injectable drugs and solution-formed orally administered drugs by the end of 2008 at the latest.
Meanwhile the production of medicinal powders for taking orally or adding into cattle food must get the GMP certificate by the end of 2010. The producers which cannot obtain GMP certificates by then will be able to circulate their products until the end of December 31, 2010 only.
The deadline for getting GMP for the production of other types of medicine is 2012.
In Vietnam, the Ministry of Health began applying GMP requirements on medicine in 1996. MARD announced the roadmap for implementing GMP on veterinary products, stipulating that GMP implementation must begin in 2004 and producers must get GMP certificates by 2006. However, as producers were not prepared for this, the deadline was delayed to 2008.
According to Vu Huy Tan, Chairman of VVPA, only 7 of 177 veterinary medicine companies nationwide have GMP certificates so far, all of which are big producers and joint ventures with foreign partners.
The other 170 companies, though having agreed to implement GMP, still find it difficult to meet the requirements of GMP. According to VVPA, GMP requirements prove to be too strict for Vietnamese companies. Therefore, though MARD delayed the deadline for GMP application to 2008, only 2-3 more companies were able to get the certificate.
Tan said that producers must have VND17bil at least to build workshops and train staffs, overly high capital for these companies, most of which are small- and medium-size. Companies which have the capital of VND7bil and less now account for 50% of total companies.
If MARD insists on applying GMP by the end of 2008, it will push 90% of existing producers into a corner. If these companies go bankrupt, thousands of labourers will become jobless.
Tan said that in 2006 and 2007, the husbandry industry was afflicted with blue ear and bird flu epidemics. Cattle and poultry were slaughtered in big quantities, and veterinary producers were involved in the misfortune as they could not sell products. Some companies have reported 40% decreases in sales. The producers need more time to recover their production and save more money for re-investment and GMP application.
“We need some more time to get stronger. The companies that cannot get GMP certificates after four years of grace will have to accept dissolution.”
Head of the Vietnam Veterinary Agency Bui Quang Anh on April 10 said that it has received the petition on delaying the application of GMP. Anh said that the agency has reported to the MARD for final decision.
“The viewpoint of the agency is to ‘accept pains’ to restructure the market. However, if the government decides to delay the deadline, we will follow the instruction,” Anh said.
He added that the market of veterinary medicine is now in chaos with too many workshops, which provide many bad-quality products. GMP would serve as a tool to filter the companies, as only good manufacturers would be able to survive.
Anh also said that GMP is the only solution to help Vietnam-made products survive, develop and successfully compete with foreign made products.