Drug regulation needs to be appropriately organized, and it is essential to have the necessary trained staff, resources and implementation tools. Moreover, enforcement powers are required in order to make regulation fully functional.

Responses to the questionnaires received from national counterparts and information gathered during the study revealed drug regulation to be ineffective in Myanmar but relatively better functioning in Viet Nam.

In both countries drug regulation activities were widely distributed among different agencies at central, provincial/state and peripheral levels without any clear definition of responsibilities, accountability or powers of enforcement. There was also a shortage of trained human resources and implementation tools.

Although each country’s national drug policy document indicates the government’s commitment to ensure the quality of drugs available on the market, in reality GMP were not a legal requirement nor were they implemented in either country. In Myanmar a checklist for GMP inspectors existed, but there were no GMP guidelines for manufacturers. Compliance with the checklist involved double standards in that industries owned by nationals were required to meet only a few of the conditions, whereas those owned by foreign investors were required to meet all of them. This suggests that there is no clear understanding of the principles and objectives of GMP and quality assurance among decision-makers. In Viet Nam too there were no GMP guidelines for manufacturers or inspectors. In both countries, manufacturers not complying with GMP requirements produce and distribute drugs.

A system of product assessment and registration exists in both countries. Nevertheless, out of products collected from Myanmar and Viet Nam for the survey, 57% and 26% respectively did not have marketing authorization.

In Viet Nam, it was found that importation of pharmaceutical products was not linked to the WHO certification scheme, whereas in Myanmar the scheme was a prerequisite. In both countries smuggling of drugs from neighbouring countries was reported to exist.

A basic but by far the most important activity in drug regulation is to ensure that drug manufacturing, importation and distribution are carried out in approved premises by qualified people and are regularly monitored by the competent national authorities. This requires the availability of written procedures for issuing and revoking licences and their strict implementation. In both countries, the study team observed drugs being sold in market places and booths. The storage conditions in some places were extremely bad.

In Myanmar, people without a licence or qualifications manufacture and distribute drugs. Vendors repack drugs in plastic bags and sell them without labels.

Distribution channels and manufacturing plants are seldom inspected, and there is a lack of adequately trained people in both countries. The countries gave less emphasis to preventive inspection, particularly at ports of entry. Consequently, illegally imported drugs were found on the markets of both countries.

In Viet Nam, more emphasis was given to quality control services than to inspection services. Because the powers and responsibilities of the inspection services at the different administrative levels are not clearly defined, enforcement was very weak.

Laboratory tests carried out on 500 samples of 12 pharmaceutical products collected from both countries in order to determine the identity and content of the active ingredients yielded the combined results shown in Table 15. Among these samples, one contained the wrong ingredient, while 54 contained between 2 and 89% of the correct ingredient and one contained above 110% of the labelled amount. These figures do not include the five samples reported to be mislabelled with respect to their source but which contained the labelled amount of active ingredients. The failure rates were 16% for Myanmar and 8% for Viet Nam.

Table 15: Combined results of laboratory tests on samples collected from Myanmar and Viet Nam

In both countries high failure rates were observed in the case of unregistered drugs. For instance, in Myanmar (Table 7) 5 (6%) out of the 89 registered products failed compared with 29 (24%) out of 123 unregistered products.

In Viet Nam (Table 12) the failure rate for registered products was 7 (3%) out of 212, compared with 15 (20%) out of 76 for unregistered products. This confirms the argument that implementing an effective drug registration system can improve the quality of drugs in the market.

Of the 12 products, rifampicin showed the highest failure rate (26%), whereas salbutamol, co-trimoxazole and ranitidine had failure rates of 24%, 24% and 20% respectively (Table 16).

Table 16: Combined results of investigation of 214 samples and laboratory tests on 500 samples from Myanmar and Viet Nam

* The names of the countries of manufacture on the label were incorrect, but all samples contained correct quantities of the active ingredients.

** One product contained the wrong ingredient but was reported to have been produced by a legitimate manufacturer.

Investigation of 214 samples collected from both countries yielded the combined results shown in Table 17. Of the 169 samples of products for which replies were received, 6 (4%) were reported to be counterfeit (one wrong ingredient and five wrong sources) and the remaining 163 samples of products were reported as genuine (i.e. manufactured by licensed manufacturers). It was not possible to confirm the genuineness of the remaining 45 samples.

Laboratory tests on the 163 samples of genuine products showed that 145 (89%) contained active ingredients as claimed on the label. The contents of the other 18 samples (11%) were below the labelled amount. In the case of the 45 samples for which replies were not received, 10 contained active ingredients at substandard levels.

Table 17: Results of investigation and laboratory testing of 214 samples from Myanmar and Viet Nam