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.