Japan: MHLW Deregulates 350 Drugs

A Ministry of Health, Labor and Welfare (MHLW) panel has recommended reclassifying 350 drugs and allowing them to be sold as over the counter (OTC) medications at convenience stores. Types of drugs include intestinal remedies, gargles, antiseptics, vitamin-based remedies and cough rubs. These medications will be reclassified as quasi-drugs, which means they can be sold at shops without licensed pharmacists. The Ministry hopes to finalize all plans and allow sales to begin by the end of the year.

Left off the list were medicines to treat colds, fevers and pain, a decision that caused contention between the MHLW, drug companies, and retailers. The Ministry basically excluded drugs with a high risk of side effects, habitual drugs, and those that should not be taken by children or pregnant women. Drug companies and retailers say cold, fever, and pain medications are most in demand by consumers and should have been included in the deregulation. There has been deregulation, but it is not meeting the needs of the people, said a representative of Lawson’s, one of Japan’s major convenience store chains. A Sato Pharmaceutical official said, our main products are not on the list, so the positive effects will be limited.

Another controversial point is a requirement that a drug’s contents be explained to customers at the point of sale. It would be too demanding to require part-time workers at convenience stores to perform what is not even being done by pharmacists at drugstores, said an industry official. Ministry regulations would also require drug packages to feature a clear explanation of usage, dosage, and potential side effects.