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