Usha Sharma – Mumbai
Pharmaceuticals Export Promotion Council (Pharmexcil) and senior officials from Ministry of Health, Labour and Welfare (MHLW), Japan recently met to discuss regulatory compliances in Japan for pharmaceuticals. The Pharmexcil initiative kicked off with a meeting in Delhi on July 26 followed by a meeting in Mumbai on July 27.
While inviting India pharma companies to supply generic drugs at affordable prices in the Japanese market, Ministry of Japan officials outlined the steps being taken by their Ministry to promote generic drugs. Speaking at the Mumbai meet, Hiroyuki Kawabata, Deputy Director Economics Affairs Division, Health Policy Bureau said, “In Japan, 30 per cent of the treatment cost is borne by the patients while the remaining by the insurance companies. The Japanese Government also provides certain amount to individual insurance companies. To make drugs more affordable and more easily accessible, Ministry of Japan is trying its best to promote generic drugs. Currently, generic drugs have a 22.8 per cent share of the market and we aim to expand this to reach 30 per cent by this year end.”
Presently, the Japanese pharma market contributes 19.1 per cent new drugs, 34.3 per cent new drugs with generics, 22.8 per cent generic drugs and 23.9 per cent other drugs. Kawabata further said, “With an initiative to promote generic drugs in Japan, the Government has launched the public incentive programme in April 2012. Various groups, associations, insurance companies have come together and are in continuous discussions to promote generic medicines. And it seems that the entire country is now engaged in promoting generics medicines.” In addition to this, MHLW is continuing to reform and increasingly accepting non- Japanese Asian data as part of the regulatory approval process. The state gives a pharmacist JPY40 (US $ 0.45) per prescription if generic drugs account for at least 30 per cent of dispensed medicines over a three-month period. Doctors have to specifically indicate on the prescription if a drug can not be substituted by a bio-equivalent copy.
JJ Shah, Oceanic Pharmachem, Chairman said, “Indian pharma companies need to understand the regulatory framework, as the country has stringent regulatory policies.” Dr P V Appaji, Director General, Pharmexcil said, “This is only the beginning and I hope that Indian pharma players will utilise this opportunity, which exist in the Japanese market.” He also mentioned that all the regulatory issues faced by Indian pharma companies which remained unanswered till now, will be taken forward with the Japanese ministry.
“We invite Indian manufacturers to supply good generic medicines to the Japanese market,” Kawabata summarised.
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