ASEAN drug firms discuss standardization plan
ASEAN drug firms discuss standardization plan
Zakki P. Hakim, Jakarta
Pharmaceutical delegations from seven countries of ASEAN met on
Monday to discuss measures to establish a standard manufacturing
process as the region aims to liberalize the industry in 2006.
The delegates, gathering at the first ASEAN Pharmaceuticals
Club (APC) congress, focussed discussion on two areas: the ASEAN
Common Technical Requirements (ACTR) and the ASEAN Common
Technical Dossier (ACTD), both of which are the basis for the
implementation of the Good Manufacturing Process (GMP).
The ACTR concept includes common technical requirements such
as drug registration, information on side effects, indications,
ingredients and how the drugs are manufactured, while the ACTD
mostly deals with packaging, said Lucky S. Slamet, first deputy
at Indonesia's Food and Drug Monitoring Agency (BPOM).
Lucky told reporters that the ACTR and ACTD had been partially
applied in several member countries of the Association of
Southeast Asian Nations (ASEAN) including Indonesia starting last
year and is scheduled for evaluation next month prior to regional
implementation.
She explained local pharmaceutical companies in the country in
general were willing to comply with the standardization
requirements.
"Standardization in pharmaceutical products is a strategic
step to increase the industry's competence and competitiveness
both on a regional and global scale," Lucky said on the sidelines
of the congress.
She explained that the early implementation of GMP would push
member countries to be prepared with the liberalization drive
under the ASEAN Free Trade Area, or AFTA.
APC secretary-general Ferry Soetikno said that the GMP would
increase the quality of drugs produced in the region, improve the
health of the people living in the area and lure foreign
pharmaceutical firms to make new investments.
"Pharmaceutical companies, with or without an export
component, will have to comply with the GMP. If they fail to
comply, they won't be allowed to produce drugs because the
regulation will be imposed on all companies within ASEAN," said
Ferry.
The ASEAN regions offers a huge market for pharmaceutical
companies.
According to data from the APC, the market value of the
pharmaceutical industry in ASEAN (with a population of nearly 600
million) is currently between US$6 billion and $7 billion.
APC chairman Anthony Ch. Sunaryo predicted the market value to
increase to between $8 billion to $9 billion in five years time.
The local pharmaceutical industries are capable of supplying
$2 billion of Indonesia's $2.5 billion drug market and export
$100 million to neighboring countries and to Africa.
The APC now groups pharmaceutical associations from five ASEAN
countries: Singapore, Thailand, Malaysia, the Philippines and
Indonesia. Indonesia is represented by the Indonesian
Pharmaceutical Association (GPFI). Vietnam and Cambodia also sent
delegates to the three-day congress.
APC is expected to unveil the blueprint of the GMP at a press
conference on Tuesday.