Viet Nam has an area of about 330,000 square kilometres and is divided into 53 provinces. In 1995, it had an estimated population of 75 million and the annual per capita income was US$ 280.

In 1986, the Communist Party congress adopted a new economic policy - “doi moi” (economic renovation) - which brought about changes from a command economy to a free market economy but with many sectors still managed by the Government. In the last ten years many private companies have sprung up. In the pharmaceutical sector these changes have caused a considerable increase in the number of private pharmaceutical companies. Also, pharmaceutical imports into Viet Nam have increased very substantially since the introduction of “doi moi”.

Pharmaceutical situation

The value of drug expenditure in the public sector in 1995 was estimated at US$ 240 million. Local production and total imports during the same year amounted to US$ 87 million and US$ 195 million respectively. There were 7500 pharmacists and 16,376 pharmacy technicians. An NDP was established in 1996. One of its specific objectives is to ensure drug quality in production, storage and distribution.

Drug supply

Viet Nam has a fairly large domestic pharmaceutical industry, which may be divided into two groups. The first group consists of state-owned manufacturing industries. There were 154 such industries in 1995. These industries are organized into 35 different companies under one corporation, called the General Pharmaceutical Company. The MoH is the supervisory body. These companies manufacture, import, export and distribute (wholesale and retail) finished products and raw materials.

The second group consists of 135 manufacturing plants owned by different provinces/cities. They are managed by the People’s Committee of the respective province/city. A small number of these companies are engaged in manufacturing and import-export activities, while most of them also distribute pharmaceuticals and manufacture traditional medicines. In addition, the Ministries of Internal Affairs, Defence and Transportation run companies which manufacture and distribute pharmaceuticals.

In 1995, there were 265 wholesalers, 22,450 public drug outlets and more than 7000 private pharmacies throughout the country. Pharmacists working in government institutions, with the exception of those holding high government posts, are allowed to open their own private pharmacies and run them outside office hours. According to information provided informally during the survey, drugs are also smuggled into the country.

Drug regulation

Drug regulation is the responsibility of the MoH of Viet Nam. The Drug Law provides for regulation of the manufacture, importation and distribution of drugs.

Three bodies, each reporting directly to the Vice Minister for Pharmaceuticals, are charged with drug regulation. These are the Drug Administration, formerly known as the Pharmacy Department, the Pharmaceutical Inspection Department and the National Institute of Drug Quality Control.

(a) drug registration

The Drug Administration is responsible for coordinating and monitoring the implementation of the NDP, developing drug legislation/regulations, registering drugs, issuing import-export licences, and controlling manufacture, importation, and promotion and advertising. It also carries out post-marketing surveillance and dissemination of drug information. At the time of the survey, it had about 20 staff members working in its various sections.

The Drug Administration is assisted by the Drug Registration Commission in the registration of drugs. In addition, part-time experts assist in the evaluation of drug submissions. Registration applies to both imported and locally manufactured drugs. At the time of the study there were 8000 products registered. All locally manufactured products were reported to be registered. In the case of drugs imported by the public sector, only 75% were said to be registered.

Different fee rates are applied for the registration of domestically produced and imported products. The time required for drug approval varies from 12 months for imported drugs to three months for locally manufactured products. Registration is valid for five years.

During the study several unregistered imported drugs were seen on the market. Although the process of registration is said to include the colour, imprint, trademark etc. of the product, several different preparations with identical distinguishing marks, imprints and colours (lookalikes) were seen on the market.

(b) inspection

Drug inspection responsibility is divided between the central and provincial authorities. At central level inspectors of the Drug Administration carry out inspection. In 1995, there were only two inspectors at national level and one or two in each province. The total number of inspectors in the country was 61. There were no inspection services provided by the MoH at customs warehouses or ports of entry. In general, the emphasis was on strengthening laboratory services rather than inspection services, which is contrary to what one would expect in view of the large number of pharmaceutical industries in Viet Nam.

There were no GMP guidelines and no manual for inspectors and manufacturers at the time of the survey in 1996. But it was reported that ASEAN GMP guidelines would be adopted. Only a few of the manufacturing plants complied with GMP requirements. Most of the plants had old equipment and inadequate premises. Inspections of industries were very weak and were not carried out very often.

In the distribution channels, it was found that private outlets had been tampering with labels, selling/dispensing drugs imported through unauthorized channels and counterfeit drugs. The drugs commonly sold through unauthorized outlets were antibiotics, analgesics, vitamins and traditional medicines. Inspectors had also come across mislabelled ampicillin, tetracycline and phenoxymethyl-penicillin preparations. In general, inspections of premises were found to be ineffective and the number of inspectors was inadequate.

In most of the wholesale and retail outlets visited, drugs were stored under poor conditions exposed to sunlight. Preparations in blister/strip packs were removed from their secondary containers (boxes) and displayed unprotected from sunlight, and inserts accompanying blister/strip packs were in most cases discarded.

(c) quality control

A system for quality control of drugs has existed in Viet Nam since 1958. Quality control 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 701 (42 with postgraduate degrees, 313 pharmacists, 212 technicians and 134 administrative personnel). The Institute and Sub-Institute are well equipped. In contrast, provincial laboratories have basic equipment only.

The institutes and the laboratories are engaged in post-marketing surveillance activities. In 1995, 31,125 samples collected from different parts of the country were tested and 1703 samples failed to meet quality standards. Of these, 1537 were substandard, while the remaining 166 were counterfeit. Reports show that the rate of failure of drugs has decreased very much after the introduction of an intensive post-marketing quality surveillance system using the simple testing kits developed by the National Institute of Drug Quality Control.

Results of assessment of registration status of samples

Investigation of the samples in collaboration with the Drug Administration produced the results shown in Table 10. Of the 288 samples collected, 127 were found to be samples of imported products, while the other 161 were domestically manufactured. Only 51 (40%) of the 127 samples of imported products were registered. The domestically produced products were all registered with the Drug Administration. Hence, 76 (26%) of the 288 samples were found to be non- registered.

Table 10: Registration status of samples collected from Viet Nam

Results of laboratory testing of samples

Laboratory tests on the 288 samples produced the results shown in Table 11. The findings indicate that 21 (7%) products contained active ingredients below the labelled amount (60-89%), one contained active ingredients above the pharmacopoeial limit and the remaining 266 (92%) samples contained active ingredients within the limits specified in the British Pharmacopoeia (BP) and the United States Pharmacopoeia (USP). The rate of failure was 8%.

Table 11: Summary results of laboratory tests on products collected from Viet Nam

Summary of results of assessment of registration status and laboratory testing of samples

Comparison of the results of the laboratory tests with registration status (Table 12) shows that among the 51 samples of imported but registered products, 3 (6%) failed the laboratory test, while out of the 76 samples of imported unregistered products, 15 (20%) contained active ingredients below the labelled amount. On the other hand, only 4 (3%) of the 161 samples of domestically produced/registered products failed the laboratory test. The failure rate among non-registered products (imported and domestically produced) was 20%, compared with about 3% in the case of registered products.

Table 12: Registration status and results of laboratory testing of samples from Viet Nam

Results of investigation of samples

A portion of each of 67 of the 288 samples collected was sent to the drug regulatory authorities of the ten countries and one region claimed to be the places of manufacture (Table 13). None of the samples investigated was registered with the drug regulatory authorities of Viet Nam.

Table 13: Samples collected from Viet Nam and investigated, shown by country of manufacture

Replies received from six countries confirmed 53 of the samples of products to be genuine, i.e. produced by licensed manufacturers. No replies were received for samples of 14 products, and it was therefore not possible to confirm their genuineness.

Summary of laboratory test results and investigation findings

Of the samples of 53 products reported to be genuine, 13 (19%) failed laboratory tests and the content of active ingredients ranged from 60 to 89% of the label claim. Of these, 11 were antimicrobial preparations - amoxicillin, ampicillin and rifampicin. The 14 samples of products for which replies were not received contained active ingredients within the limits specified in the British and United States pharmacopoeias.

Table 14: Summary of results of investigation and laboratory test of samples from Viet Nam