Myanmar occupies an area of about 677,000 square kilometres. Administratively, the country is divided into seven states and seven divisions. Each state/division is further divided into districts and townships. The country’s population was estimated at 44 million in 1996. In 1991, the per capita income was US$ 178.

Pharmaceutical situation

The study found that the total public sector drug expenditure in 1994/1995 was US$ 6.5 million and the total value of drug imports during the same period was US$ 0.9 million. At the time of the survey the country had one school of pharmacy, 146 pharmacists, one state-owned pharmaceutical industry, about 60 private small-scale pharmaceutical industries, 20 importers and 275 wholesalers. In the public sector there were 144 drug outlets. The number of private pharmacies was estimated at 8500. The total number of products registered in the country up to 1995 was 1600.

Drug supply

Over the years there was a proliferation of drug shops, including booths located in market places in the country. Some of the drugs sold were of unknown quality, efficacy or safety and were imported/smuggled into the country through unauthorized channels.

Authorized manufacturing, importation and distribution of drugs are carried out by the private and public sectors. In the public sector, the MoH, the Ministry of Trade and Commerce and the Ministry of Industry are involved. The MoH has a Central Medical Stores Depot (CMSD) which imports drugs and distributes them to government hospitals and health care facilities. Nearly all its supplies of drugs are purchased from the Myanmar Pharmaceutical Factory, the only state-owned pharmaceutical plant in the country, which is under the Ministry of Industry. The Ministry of Trade and Commerce also runs Medicines and Medical Equipment Trading (MMET), which imports drugs and distributes them to the public and private clinics.

At the time of the study, about 60 small-scale private manufacturers were known to exist, but none of them had been issued with a licence from the MoH to manufacture drugs. During the study, products manufactured by these industries were seen on the market.

During the field survey it was noted that both the state-owned and private industries do not comply with GMP requirements. In Yangon, one of the cottage industries visited was found to be operating in a building partly used as a residence. Production activities were carried out using inappropriate machines and under extremely unhygienic conditions. The industry was managed and operated by people who had no qualifications or training in pharmaceutical production or quality control. The plant did not have a quality control laboratory or any means of quality assurance.

Drug regulation

Until 1992, the Public Health Law enacted in 1972 served as the legal instrument for drug control. However, there were no specific activities to exercise regulatory control over importation, manufacture and distribution of medicines. In 1991, Myanmar adopted a National Drug Policy (NDP). The policy clearly delineates objectives, which include ensuring the availability of effective and safe drugs of acceptable quality. The National Drug Law was enacted in 1992 and regulations for enforcement were issued by the MoH in 1993. The drug law and regulations cover importation, manufacture, distribution, drug registration, inspection and quality control of drugs. Under the National Drug Law, terms such as “fake drugs” and “drugs differing from standards” defined, and there are prohibitions with regard to those drugs.

Several authorities are responsible for enforcement of the drug law. The Myanmar Food and Drug Board Authority (MFDBA), under the chairmanship of the Minister of Health, provides guidance on the implementation of the NDP and for establishing the Food and Drug Supervisory Committees (FDSCs) at central level as well as in states/divisions, districts and townships.

The State/Division Food and Drug Supervisory Committees, under the Director General of the Department of Health (who is chairman of the Central Food and Drug Supervisory Committee (CFDSC)), license drug wholesalers and retailers. The CFDSC licenses the local drug manufacturers and gives drug importation approval certificates to the importers. At township level the FDSCs are managed by the Township Medical Officers. The committees consist of the Township Medical Officer, the Commander of the Police, and the representatives of the City Development Committee and the General Administration Committee.

Applications for licences are submitted to the respective Township Food and Drug Supervisory Committee, which will inspect the shops, and then refer them to the State/Division Food and Drug Supervisory Committee for decision. Licences are issued by the Township Medical Officer on the basis of the decision of the State/Division Food and Drug Supervisory Committee.

(a) drug registration

The Food and Drug Administration (FDA), which was established in January 1995, is responsible for issuing marketing authorization for pharmaceutical products, inspection of manufacturing plants and importers, and testing the quality of drugs. There is a Drug Advisory Committee (DAC) delegated to evaluate and register drugs. Prior to submission to the DAC, applications are reviewed by the staff of the registration section of the FDA, which consists of the Assistant Director of the Drug Control Section and two pharmacists.

Registration applies to imported as well as domestically manufactured products, and covers both the public and private sectors. Guidelines for drug registration have been formulated and they require that anyone applying for registration should be a resident of the Union of Myanmar. In the case of foreign companies, the applicant must be a legal representative domiciled in Myanmar but need not be the sole importer of the drug. Once a drug is registered, it can be imported into the country by anyone who has a licence to import pharmaceuticals.

For a product to be registered, clinical trials have to be carried out in Myanmar. The WHO-type Certificate of a Pharmaceutical Product is a prerequisite for registration.

There is a fee system consisting of an assessment fee of US$ 100, a registration fee of US$ 200, a renewal fee of US$ 200 and a variation fee of US$ 100. Fees collected go to the DAC’s account. Registration is valid for five years.

Over 50% of the drugs seen in the market, including those domestically produced, had not been registered by the FDA at the time of the study.

(b) inspection

Inspection of manufacturing plants is carried out by two inspectors of the FDA. The FDA has a non-descriptive list (checklist) of GMP requirements for manufacturers. Industries owned by nationals of Myanmar are expected to meet only a part of these requirements, while foreign companies are obliged to comply with all the requirements. There were no standard procedures for inspectors. The inspectors need training and experience in GMP inspection. Their number was inadequate at the time of the study.

Inspection of drug distribution channels is the responsibility of the Food and Drug Supervisory Committees at the different levels. In reality, inspection services exist at the central level only. Even there, they are not fully operational and inspection is rarely carried out. Members of the committees do not have expertise in pharmaceutical matters. Moreover, there is no post-marketing surveillance. According to information gathered during the study, drugs are known to enter the country through unauthorized channels. Tampering with labels and transferring products from one container to another are reported to be common practices.

The drug law requires distribution channels to operate under the supervision of technically qualified persons. During the survey, it was noted that most distribution outlets were being run by unqualified people. The storage and distribution conditions were very bad and needed drastic improvement.

In all the four geographical areas surveyed, drugs were sold in booths as well as in shops. Preparations in solid oral dosage form, capsules and tablets, coming in hospital packs, were removed from their original containers and repacked in transparent plastic bags and displayed for sale. Dealers identified the preparations by their colours. In some of the market places visited, expired drugs, drugs without expiry dates and drugs without the names of manufacturers were being sold.

(c) quality control

The quality control laboratory under the FDA tests the quality of drugs in connection with registration. Very little analytical activity was noted during the visit. In 1994-1995, the laboratory tested only 32 samples. Out of these, 8 (25%) failed to meet quality standards. Three of the failed samples were substandard and 5 (15.6%) contained no active ingredients.

Results of assessment of registration status of samples

The registration status of the 215 samples in the first group of samples was assessed in collaboration with the FDA. The result (Table 4) shows that of those samples, 201 (93%) were imported products, while the remaining 14 (7%) were samples of locally manufactured products. Of the 14 samples of domestically manufactured products, 6 (43%) were not registered. In the case of samples of imported products, 117 (58%) out of 201 were not registered.

Table 4: Registration status of samples of pharmaceutical preparations collected from Myanmar

Of the 215 samples, only 92 (43%) were confirmed to be registered with the FDA.

It was not possible to assess the registration status of the second group, consisting of 23 samples (Table 2) collected in Yangon, since they were not contained in their original primary containers, having been repacked in unlabelled plastic bags by the dealers.

Results of laboratory testing of samples

Out of the 215 samples, 212 were submitted to the WHO collaborating laboratory in Thailand to determine the identity and content of the active ingredients. Tests were carried out according to the specifications of the British and the United States pharmacopoeias. Table 5 shows the results of the tests.

Out of the samples tested, 34 (16%) failed to pass quality tests because they contained active ingredients below the limits specified in BP93 and USP23. Of these, one sample contained the wrong ingredient. The content of active ingredients in six samples ranged from 2 to 60% of the labelled amount. Out of the 10 products sampled, chloramphenicol preparations showed a high failure rate (35%), followed by ranitidine, co-trimoxazole and amoxicillin with failure rates of 20%, 19% and 16% respectively. All the samples tested had a shelf-life ranging from one to three years at the time of testing.

Table 5: Summary of results of laboratory tests on samples from Myanmar

Table 6 sets out the results of laboratory tests of the unlabelled samples collected in Yangon. Thirteen of the preparations contained ingredients other than those claimed by the dealers, three preparations contained no active ingredients, and the remaining seven preparations contained in varying quantities the active ingredients claimed by the vendors.

Table 6: Results of laboratory tests of unlabelled samples collected from Myanmar markets

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

Table 7 combines information on the registration status of the 212 samples and the respective results of laboratory testing. Out of the 14 samples of domestically manufactured products, eight registered products contained active ingredients within the limits specified in the British and United States pharmacopoeias. Two of the 6 samples of domestically manufactured but unregistered products failed the tests. Of the 81 samples of imported but registered products, 5 were found to be substandard. Of the 117 samples of imported but unregistered products, 27 failed laboratory tests. The failure rate in the case of domestically produced products was 14%, while for imported products it was 16%. On the other hand, the failure rate among non-registered products (both imported and domestically produced) was 24%, which is four times greater compared with the failure rate among registered products, which was 6%. Among both the domestically produced and imported samples, a high failure rate was observed in the case of unregistered products. The overall rate of failure was 16%.

Table 7: Summary of registration status and results of laboratory testing of samples from Myanmar

Results of investigation of samples

Out of the 215 samples collected in the first group, 147 manufactured in 17 countries (Table 8) were sent for investigation to the drug regulatory authorities of the countries of manufacture. The samples sent were those reported as non-registered by the regulatory authorities of Myanmar and those suspected, on the basis of physical examination, of being counterfeit.

Only 14 countries replied. Of these, 10 confirmed that the products were genuine and the manufacturers were licensed. The remaining four countries provided the information given below.

One country reported that the samples sent for investigation represented products which were traded in transit via a free port and that the products were not registered in the country. The report also indicated that the company mentioned on the label of the samples was licensed to manufacture pharmaceuticals in the country, but the products under investigation were produced by contract manufacturers outside the country. The products were confirmed to be genuine.

The second country responded that the company in question was licensed to manufacture veterinary pharmaceuticals. Medicines for human use were said to be produced by the company for export only, and the product under investigation was not registered with the drug regulatory authority.

The regulatory authorities of the other two countries replied that the products sent to them were mislabelled with respect to their source. They said that the companies whose names appeared on the labels of the products existed in their countries but they were not licensed to manufacture, import or distribute pharmaceutical products in their countries. They confirmed that although the products were labelled as though they were manufactured in their countries, they were actually produced, packaged and labelled by manufacturers operating in other countries and exported direct to the countries under study. They indicated that the products were neither registered nor distributed in their countries.

Table 8: Samples of products collected from Myanmar and investigated, shown by country of manufacture

* Did not reply.

Summary of laboratory test results and investigation findings

Table 9 summarizes the laboratory test results and the investigation findings for 147 samples from Myanmar. Of those samples, 110 were confirmed to be genuine and 5 mislabelled with respect to their source, and 1 contained the wrong ingredient. No reply was received for the remaining 31 samples. The five mislabelled products contained the claimed active ingredients in quantities within the pharmacopoeial limits. Of the 110 genuine products, 5 contained active ingredients below the pharmacopoeial limits. The content of active ingredients ranged from 80 to 87% of the labelled amount. Ten (32%) of the 31 samples for which investigation replies were not received were found to be substandard and the content of active ingredients ranged from 26 to 89%. However, since no replies were obtained from the drug regulatory authorities of the countries approached, it was not possible to be certain whether the 31 products were genuine or not.

Table 9: Summary of laboratory results by outcome of investigation, Myanmar