|Theme Paper for Discussion - Effective Drug Regulation: What Can Countries Do?, Geneva, 16-19 March 1999
(1999; 53 pages) [French
Índice de contenido
Annex 1. Status of drug regulation and drug quality assurance in WHO African Region and selected countries
WHO African Region
• A survey conducted during 1992-1993 using a questionnaire to assess the existence of quality assurance systems in the WHO African Region (AFRO) found that of the 26 countries that completed the questionnaire, 11 had a quality assurance system (including quality control laboratory), but that it was not functioning well. A further nine countries had some kind of quality assurance system without quality control laboratory and six did not have any quality assurance system. Nineteen countries mentioned illegal importation as a serious problem. Of 21 countries that had domestic pharmaceutical manufacturing, six did not have a quality control laboratory and four were without an inspectorate.
• A study carried out during 1992-1993 on the quality of drugs available in Cameroon, Chad and Madagascar showed that of 429 products tested, only 352 (82%) complied with specifications. The remaining 77 (18%) samples were found to be substandard and failed laboratory tests. Of these, 16 (3.7%) contained no active ingredient.
Lao People’s Democratic Republic
Before 1988 there were no private manufacturers, importers or pharmacies in the Lao People’s Democratic Republic. All drugs were distributed by the public sector. At present, there are six manufacturing plants, 32 private importers and 2018 private pharmacies - eight/class I, run by pharmacists, 67/class II, run by pharmacy assistants, and 1943/class III, run by persons without pharmaceutical education (only a few are doctors/nurses).
The Food and Drug Department (FDD) under the Ministry of Health is responsible for the registration of drugs, inspection and licensing of manufacturers, importers, and class I and class II pharmacies. It is also responsible for public sector drug supply, as well as the control of narcotic drugs and psychotropic substances. It has ten inspectors at central level. All of them are both food and drug inspectors. The Food and Drug Quality Control Centre (FDQCC) which was established in 1995 undertakes chemical analysis of drugs.
Three papers, one published in 1997 and the other two (unpublished) which were written in 1997 and in 1998, reported the following:
• Drugs are repacked in plastic bags and sold without labels.
• Drugs are smuggled from neighbouring countries.
• The number of drugs on the market is estimated to be about 3000 of which only 1600 (53%) are registered.
• There are three types of product registration fee: a registration fee (US$ 1.40), a service fee (US$ 2.80), and an analysis fee (about US$ 3.60). Collected fees go to the Ministry of Finance.
• Inspection carried out in 1995 found two cases of counterfeit drugs, 23 cases of banned drugs, and 19 cases of expired drugs, eight cases of drugs without labels and eight cases of substandard drugs.
• A study initiated by the Asian Development Bank in 1993 showed that of 112 drug samples collected from five provinces and tested, 37 products (33%) were substandard. The products that failed the tests included antibiotics and antimalarials.
• A similar test carried out in 1996 on 102 samples showed that 10.2% were substandard. Similarly, a study in 1997 of 405 samples from Savannakehet Province showed that 12% were substandard and 4% did not contain any active ingredient.
Kenya has one public sector drug procurement agency, over 135 private importers/wholesalers and about 40 pharmaceutical manufacturers.
The legal instruments for regulating drugs are the Pharmacy and Poisons Act of 1957, and the revisions made in 1972 and 1989. The Pharmacy and Poisons Rules of 1981 (revised in 1983) apply to the registration of drugs. The Pharmacy and Poisons Board established under the Pharmacy and Medicines Act, Chapter 244, is responsible for the registration of pharmacy professionals, market authorization of drugs, and issuing licences to manufacturers, wholesalers and retail pharmacies. The Pharmacy Department of the Ministry of Health (MoH) headed by the Chief Pharmacist, who is also the Registrar of the Pharmacy and Poisons Board, is responsible for administering the Board’s day-to-day activities. The Registrar and associated personnel (a secretary, two pharmacists and a pharmacy technologist) are MoH employees. The Board has nine members and is chaired by the Director of Medical Services. Three committees, whose members are not MoH employees, support the Board: the Committee of Finance, the Committee of Pharmacy Practice and the Drug Registration Committee.
Drug registration started in 1982, and covers both human and veterinary drugs. The registration fee is US$ 1000 for foreign products and US$ 500 for domestic products. The renewal fee is US$ 500.
A National Drug Control Laboratory was established in 1995 under the Pharmacy and Poisons Board. It carries out limited pre- and post-marketing quality control of drugs.
The Inspectorate, under the Director of Medical Services/MoH, undertakes surveillance of wholesale and retail outlets. Inspection is limited to enforcement activities and carried out by individuals (ex-police officers) who have not received any pharmaceutical education.
• The number of drugs on the market is not known but estimated at 12 000. Of these, only 6000 (50%) are registered.
• There is no inspectorate attached to the Board: GMP inspection is not carried out and inspectors of distribution channels do not have a pharmaceutical education.
• The Registrar has limited staff for discharging his/her functions.
• Ministerial salaries are not competitive with those in the private sector and as a result staff turnover is high.
• The WHO Certification Scheme is not applied as recommended by WHO when assessing the status of imported drugs.
• Although the exact figures are not reported, the National Quality Control Laboratory has recently detected counterfeit drugs on the market;
• Drugs are smuggled into the country.
• Kenya exports drugs to other African countries by issuing “free sale” certificates even though it has no inspectorate to assess GMP compliance.
In 1997, there was one state-owned manufacturing plant and about 60 small-scale private pharmaceutical industries, 20 importers, 275 wholesalers, 8500 private pharmacies and 144 public sector drug outlets.
Three authorities are responsible for drug regulation: the Myanmar Food and Drug Board Authority, the Food and Drug Supervisory Committees (FDSC) at central, state/division, district and township level, and the Food and Drug Administration (FDA). The Central Food and Drug Supervisory Committee issues licences and inspects drug wholesalers and retailers. At township level, the FDSC committee consists of the Township Medical Officer, the Commander of the Police, and the representatives of the City Development Committee and the General Administration Committee. The FDA issues marketing authorization, inspects manufacturing plants and importers, and tests the quality of drugs. There is also a Drug Advisory Committee (DAC). Applications are reviewed by the staff of the registration unit which consists of the Assistant Director of the Drug Control Section and two pharmacists. There is an assessment fee of US$ 100 and a registration fee of US$ 200. According to two reports that came out in 1997 and 1998:
• Private small-scale pharmaceutical industries do not have a licence even though they are known to produce and sell drugs. Also, they do not meet GMP requirements.
• Only 50% of the drugs on the market are registered.
• No post-marketing quality surveillance is undertaken.
• Drugs are sold in booths and most distribution outlets are run by unqualified people.
• Capsule and tablet preparations in hospital packs are removed from their original containers, repacked in plastic bags and sold without a label.
• Of 212 samples collected and tested in 1997, 34 samples contained active ingredients below the limits specified in pharmacopoeia, one contained a wrong ingredient and four were counterfeit with respect to their source.
Viet Nam has a fairly large domestic pharmaceutical industry. In 1996 it had 138 pharmaceutical manufacturers, 265 wholesale distributors, 22 450 public drug outlets, and more than 7000 private pharmacies. Viet Nam’s Ministry of Health (MoH) has dual responsibility. It is both the drug regulatory authority, and the manager of state-owned drug manufacturers and import-export companies. Three agencies under the MoH are responsible for drug regulation. The Food and Drug Administration has a staff of about 20 and is responsible for formulating drug legislation, registering drugs, issuing import-export licences, and controlling the manufacture, importation, promotion and advertisement of drugs. It also carries out post-marketing surveillance and dissemination of drug information. In 1996, 8000 products were registered. Of those imported by the public sector, only 75% were said to be registered.
Responsibility for drug inspection is divided between the central and provincial authorities. In 1996, there were only two inspectors at national level and only one or two in each province. The total number of inspectors in the country was 61. Quality control of drugs is carried out by the National Institute of Drug Quality Control in Hanoi, the Sub-Institute of Quality Control in Ho Chi Minh City and the drug quality control laboratories of the provincial health departments. In 1995, the number of staff working in the two institutes and the provincial laboratories was estimated to be about 700 (42 with postgraduate degrees, 313 pharmacists, 212 technicians and 134 administrative personnel). Information was gathered in 1996:
• Only two of the manufacturing plants were said to comply with GMP requirements and to have GMP certification; most of the plants operate old equipment and are housed in inadequate premises.
• In 1996, investigation of samples collected from the market showed that only 51 (40.2%), of 127 samples of imported products had been registered.
• Private drug outlets were found to have been tampering with labels, and selling or dispensing counterfeit drugs and drugs imported through unauthorized channels.
• In 1995, 1350 samples were tested by the two institutes; 288 (16.9%) were found to be substandard. During the same year, 31 125 samples were tested by the provincial laboratories; 1703 (55%) of these failed to meet quality standards while a further 166 (0.5%) of the samples lacked active ingredients.
• Drugs are smuggled in and out of Viet Nam.
The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), created in 1993 by article 245 of law number 100, is Colombia’s drug regulatory authority (DRA). An autonomous body, whose head is appointed directly by the president of the country, INVIMA’s most important functions include:
• Controlling the quality and safety of medicines, biological products, foods, cosmetics, medical devices and natural products;
• Issuing licences concerning the manufacture of medicines;
• Issuing marketing authorizations.
Decree No. 1290 of 1994 includes a provision for decentralizing or delegating drug registration and licensing of manufacturing plants to district or provincial agencies that have the necessary resources. The law also includes provision to delegate inspection and analysis of drugs to other public institutions such as universities that have been accredited for this purpose by the Ministry of Health. New drugs require evaluation by the Ministry’s review committee, except when they have been approved in two or more of 11 reference countries considered to have well-developed regulatory systems.
A field report was received in 1997, containing the following information:
• INVIMA’s staff currently consists of permanent employees and others who are hired on a contractual basis. INVIMA is understaffed and unable to carry out its activities fully because of budgetary restraints.
• INVIMA does not charge any fees since collection of fees has been declared unconstitutional by the Constitutional Court.
• Owing to the low salaries that the government pays to INVIMA employees, personnel turnover is high.
Pakistan’s Drug Act of 1976 assigns responsibility for the licensing of manufacturing plants, importing and exporting, and the registration of medicines to the federal government. Regulation of the sale of medicine is the responsibility of the provinces. At federal level, the Central Licensing and Registration Board - consisting of the Federal Director-General, the drugs controller, all provincial Director-Generals of Health, together with senior representatives of the Ministries of Commerce and Industry, the Central Board of Revenue, and the Justice Division, and medical and pharmaceutical experts - is responsible for regulating manufacturing, registration and imports-exports. At federal level, about eight inspectors are working to monitor compliance with GMP. At provincial level, 81 regular inspectors of drugs at various grades have been appointed as district, divisional and chief inspectors, but in some places without a formal hierarchy. In addition, the district health officers also act as ex-officio inspectors in some provinces.
The country also has five drug-testing laboratories, four of which conduct routine analysis. However, the laboratories lack the necessary qualified personnel, chemicals and equipment.
According to a recent report, there are 16 000 drug stores and 114 pharmaceutical firms in Punjab State alone. Of the country’s 327 drug manufacturing plants, 52% of them are in Punjab State, of which 70% are concentrated in Lahore. Most of the province’s drug stores are run by unqualified personnel. Moreover, the stores lack adequate storage facilities and sell unregistered drugs. The ineffective monitoring and supervision of these outlets have also encouraged the manufacture and sale of spurious and substandard drugs. The infrastructure for monitoring cannot keep up with the speed with which licences are issued. In 1997, of 13 095 samples tested by the Punjab Drug Testing Laboratory, 526 (4%) were found to be substandard and 26 (0.2%) counterfeit.