Japan’s PMDA Clarifies India Plans Amid Asia Cooperation
This article was originally published in PharmAsia News
Executive Summary
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has indicated that it isn't planning an India office, at least for now, but expects to co-operate closely with foreign regulatory authorities as it strives to "meaningfully" contribute to the health and healthy life expectancy of people in Japan.
Recent reports in the Indian media have suggested that Japan’s drug and device regulator, the PMDA, was expected to open an India office soon – a move that was expected to facilitate Indian exports in the attractive but tightly regulated Japanese market.
But the PMDA told PharmAsia News’s sister publication Scrip Intelligence that it "does not determine" to establish its overseas office at the "current stage" but did refer to its International Strategic Plan 2015 of June this year.
Towards realizing this strategic plan, the Japanese regulator said that it would deal with "necessary issues" between two countries by traveling to the location as necessary. "If there will become the situation beyond short-term stays, PMDA will begin consideration of setting up PMDA's office overseas," the agency said.
The PMDA's International Strategic Plan outlines, among a host of other global initiatives, plans to interact with Asian and other countries to enhance mutual understanding and co-operation.
One top industry official in the know told Scrip that the "load" that the PMDA currently has perhaps does not justify an India office, though there have apparently been some early discussions on whether the regulatory agency could be "positioned" in the Japanese embassy in New Delhi.
The official, though, spoke of a spurt in activity in the Indian market because of the "surprising" pace of generics penetration in Japan.
"Some manufacturing and trading companies are looking at back-end manufacture in India for the generics strategy of the Japanese government. As of today, a large percentage of prescriptions in Japan are already for generics, which was not really expected. In this situation, I see multiple companies in Japan looking for some kind of partnership in India," the official said.
Generics currently account for close to 50% of the substitutable sector by volume and roughly a quarter by value of Japan's prescription drug market, and the government is said to have raised its volume target to at least 80% by the end of March 2021.
In September this year, Pharmexcil, the Pharmaceutical Export Promotion Council of India, indicated that about 20 Japanese companies have expressed an interest in leveraging the contract manufacturing benefits from US FDA-approved facilities in India.
It has, however, thus far been a generally mixed bag for Indian firms in the Japanese market, with some like Zydus Cadila exiting and others like Lupin Ltd. well entrenched there and still others like Sun Pharmaceutical Industries Ltd. and Cipla Ltd. believed to be prepping for an entry in Japan.
Strategic Plan
Significantly, the PMDA's International Strategic Plan sets forth, among a host of other initiatives, plans to collaborate in the areas of consultations and reviews to promote "smooth" product development in the Asian region.
Deepening "mutual understanding and trust" of key ASEAN countries, China/Korea, BRICs, and others through bilateral meetings and symposia is also part of the strategic plan as are efforts to contribute to the improvement of safety measures in the Asian region, by "providing" Japan's safety information and responding to the diverse needs of partner countries.
The strategic plan also envisages establishing the "Asian Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs" that design training programs for regulators in Asia in response to the demand of Asian regulatory authorities or industry.
"The training will be provided continuously in key ASEAN countries or in Japan (within three years)," the PMDA strategic plan said.
PMDA's strategic plan on international activities is expected to be conducted in the period defined in the third and fourth mid-term plans (FY2014–2023).
(This article also appears in Scrip Intelligence
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