A: Some problems that had been solved have re-emerged as the country undergoes political changes. One major challenge is the implementation of regulations at the directorate level. At the ministry, or policy level, there is much good will to improve business-friendly regulations, but there are challenges in implementing the policies down the line.
For example, under the Union Tax Law, there is a commercial tax exemption for pharmaceutical products and medical devices, on which customs is not supposed to collect any import tax.
Now when we apply for an import license, an import recommendation letter or an approval letter from the FDA is required to identify it as a medical device. But customs officials may claim not to know if it is a medical device or not, or interpret the letter as not being addressed to them. This can cause delays up to two months to clear goods.
Q: What about the infrastructure challenges?
A: Air-conditioned transport is an issue in this country. Traffic congestion is common here. For products that need to be stored at less than 25 degrees, this poses a logistical challenge, as they can be exposed to high temperatures for many hours on the road.
The power supply is another challenge, especially for storage. This is because pharmaceutical businesses need up to three types of storage conditions, each at a different temperature, for their products. To create these conditions, we need air-conditioned rooms. The irregular electricity supply means we must have a backup diesel generator.
As part of good storage practice, we need a contingency plan. When there are frequent power blackouts, backup generators are no longer for backup, but normal daily use. For distribution warehouses, we must be prepared for the backup generator’s failure, which necessitates a secondary backup generator.
These are costs that add up, on top of the product cost. Companies that can afford this can invest, but retail outlets may find these conditions for storage challenging. In Yangon, companies can only build new generators behind buildings, due to the Yangon City Development Committee’s revision of the law, and not all buildings have enough room to house such generators.
Q: What facilities exist for storage?
A: Under FDA standards, companies must have their storage facilities audited before they can begin importing pharmaceutical products, which improves storage conditions. The FDA also requires companies to have a backup generator— but not a secondary backup generator.
Problems occur at the retail level too. The FDA carries out inspections of outlets. But if they shut down all the pharmacies that don’t have good air-conditioned storage, that would probably affect more than 90 percent of the pharmacies across the country.
FDA is working with the Myanmar Pharmaceuticals and Medical Equipment Entrepreneurs Association to hold seminars about storage conditions. In November, we held a seminar at the Shwe Mingalar market, in Yangon’s Mingalar Taung Nyunt Township on a Sunday, not in a meeting room, so people could easily listen. We hoped they would see the seminar as motivational and inspirational.
We have also launched a pharmaceutical management course to explain how to implement good pharmacy practice, and we have invited officials from the FDA to talk about regulations.