Drug safety policy by year end

The move comes at a time when the department of Food and Drug Administration (FDA) is battling with sub-quality drugs, unregistered, fake and expired medicines sold in local pharmacies – largely procured from neighbouring countries.

The number of deaths related to fake drugs and patients who have no resistance to substandard and fake drugs is on the rise, according to medical experts.

“Our country needs safety policy. The National Drug Safety Policy will be formulated before the National Food Safety Policy. Our country faces a high risk from substandard, fake and illegal medicine, so a national drug safety policy is crucial,” said Dr Than Htut, director general of FDA, on Monday.

The comprehensive policy will set a new tone for the drug market – tighten import and manufacturing regulations, sale and distribution, curtail source of fake drugs, storage, punishment for violators, creating awareness among public, hospitals and pharmacies and ways to protect consumers from counterfeit medical products.

FDA also aims to formulate the National Food Safety Policy by year end.

On July 31, FDA held a workshop in Yangon to educate about the risk of using substandard, fake and illegal medical products, which are worrying authorities.

Dr Zaw Than Htun, professor of Yangon Hospital, described the workshop as very important and timely, saying, “It is important to protect the danger of fake drugs as number of people who die due to fake drugs is increasing day by day. Recently, we met some patients who have no resistance to substandard and fake drugs”.

“People have to do everything they can without waiting for the National Drug Safety policy,” said Dr Than Htut.

This second meeting will be held in Nay Pyi Taw in September to further fine-tune the policy before it is enforced.

The government will consider the views of various experts – doctors, pharmacists, medical equipment makers, drug associations, lawmakers, regional government and consumer bodies before the policy is finalised, said Dr Than Htut.

While Myanmar has had a National Drug law to protect citizens from dangerous fake medicine since 1992 and amended it in 2014, the country needs a systematic and detailed policy to protect public health and keep spurious medical products off the market, said Dr Than Htut.

FDA officials had been carrying out raids in various townships and has sued 25 pharmacies in the first half of the year for having no valid licenses to sell medicines and medical products.

Last year, the FDA sued 99 pharmacies for similar violations.

Some pharmacies sell expired medicines as compounded medicines, which could lead to drug resistance or to life-threatening negative reactions.

FDA officials who made surprise inspections found several shops around Myanmar selling food that contained illegal chemicals.

For instance, FDA officials discovered the use of formalin in bean cake factories in Yadanarpon market in Chan Mya Tharsi township in Mandalay in June. The two factories have been temporarily suspended since June 19.

Source: Myanmar Times