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Berita
Ubat-ubatan Seminar
on Pharmacovigilance |
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Licensing – Ten Years of Implementation
Introduction The Drug Control Authority (DCA) enforced the licensing scheme for pharmaceutical manufacturers, importers and wholesalers on 1st May 1987 for products containing scheduled poisons and 1st April 1992 for products containing non-scheduled poisons. However, licensing for traditional medicines manufacturers and importers will only be implemented effective from 1st January 1999.
All pharmaceutical and traditional medicine manufacturing premises must comply with requirements of Good Manufacturing Practice (GMP) as a pre-requisite for licensing, whereas for importers and wholesalers, it is important that their premises comply with Good Storage Practice (GSP).
Licensed Premises (1987 – 1997) Since licensing started in 1987, the number of licenced premises for manufacturers have shown an overall increasing trend. However, for importers and wholesalers, similar trends are shown until 1993, after which they seem to be a bit inconsistent. The data compiled from 1987 to 1997 for manufacturers, importers and wholesalers, are tabulated in TABLE 2 and presented individually as FIGURES 1 – 3, shown below. Figure1 : Number of Licensed Pharmaceutical Manufacturers
Figure2 : Number of Licensed Pharmaceutical Importers
Figure3 : Number of Licensed Pharmaceutical Wholesalers
Geographical Distribution The growth of licensed premises according to their geographical distribution is also analysed. It is shown that thet state of Selangor consistently has the most number of total licensed premises for 1992 – 1998. Wilayah Persekutuan was placed second in 1992, while Sarawak emerged second in 1994. However, in 1996 and 1998, Pulau Pinang has the second most number of premises. The geographical distribution of licensed premises (1992 – 1998) are presented as FIGURES 4 – 7 and summarised in Table 1. Currently, there are 4 states which include Sabah, Sarawak, Pahang and Terengganu, which still do not have any licensed manufacturer. It is also shown that 5 states namely Kelantan, Negeri Sembilan, Pahang, Perlis and Terengganu, do not have any licensed importer.
The distribution profile for traditional medicine manufacturers from 1996 – 1998 is shown in FIGURE 5. Selangor recorded the most number of traditional medicine manufacturing premises, followed second by Pulau Pinang. Up till end of September this year, 61 premises have already complied with GMP, while another 65 more are undergoing construction and renovation. More traditional medicine manufacturers are expected to be licensed by the end of this year.
Figure4 : Geographical Distribution of Licensed Manufacturers (1992 – 1998)
Figure5 : Geographical Distribution of Traditional Medicine Manufacturers (1996 – 1998)
Figure6 : Geographical Distribution of Licensed Pharmaceutical Importers (1992 – 1998)
Key :
Table 1 : Geographical Distribution of Licensed Premises
Key
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Growth Rate of Licensed Premises The growth of premises licensed by the Drug Control Authority (DCA) over the ten year period are summarised in TABLE 2 as shown below. The average annual growth rate for the manufacturing premises indicates an increasing trend with a mean of 17.5% being recorded for the period 1988 – 1997. The significant increase in the number of licensed manufacturers in 1996 and 1997 was contributed mainly by the traditional medicine manufacturers and it is expected to further increase this year. As for importers, the average annual growth rate was recorded to be 6.5% while that for wholesalers was found to be 20.5%. The number of importers and wholesalers went up in 1992 and 1993 as a consequence of the implementation of licensing for non-scheduled poisons. It is also anticipated that the number of licensed importers will go up because of licensing for traditional medicine importers.
Table 2
In total, a positive growth rate of 15.7% was noted over the last 10 years since licensing started. It is anticipated that the issuance of licences will further increase due to the implementation of licensing for traditional medicine manufacturers and importers, effective from 1 January 1999. The complete profile of percentage average annual growth rate of licensed premises from 1988 to 1997 are depicted in FIGURE 8.
Figure 8 : % Average Annual Growth Rate of Licensed Premises (1988 – 1997)
Conclusion The impact of licensing over the last ten years has witnessed great achievements. Old pharmaceutical and traditional manufacturing premises have evolved from the backyard, cottage industries towards modernised premises that comply with GMP. Siting of premises on industrial gazetted areas, properly designed premises, adequate equipment, good documentation system, appropriately trained personnel and suitable manufacturing processes, are positive evolutions of the manufacturing sector. As for licensed importers and wholesalers, adequate measures are taken to ensure proper store management procedures, and appropriate handling of complaints and product recalls. With the implementation of new policies regarding licensing of traditional medicine manufacturers and importers, the number of licences issued by the Drug Control Authority will certainly increase. Efforts are now geared to improve the efficiency of licensing activity via an enhanced computerised network system. Close co-operation between the regulators, enforcement officers and industries concerned, is vital to ensure the effective implementation of licensing. With firm commitment, self-compliance and self-regulation will indeed be an ideal paradigm of the future.
Corrigendum August 1998. Volume 12 No. 2
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