Against the backdrop of increasing opportunities for Indian pharma exporters to boost their sales of generic medicines in Japan, the commerce ministry has started measures to negotiate more conducive bilateral deal for the benefit of domestic players.
The Commerce Ministry has already launched consultations with the industry and agencies like Pharmexcil in this regard amidst indications that Japan is trying to push one sided trade agreement with little concessions for Indian medicines, sources said. A meeting has already been held at the senior level to get the feedback from the industry.
Indian manufacturers are worried about the attempt by Japan, a major emerging market for Indian generic players, to reserve the right to modify or withdraw its proposals with regard to the term of 'generic medicines' in the article for cooperation on generic medicines under the proposed bilateral treaty.
As Japan is trying to expand its generic market share to 30 per cent by 2012, the Pharmexcil has suggested a number of steps to seize the opportunity for the Indian companies. It has mooted creation of a help desk to provide information on all related issues and facilitate approvals on fast track in an agreed time period.
Bioequivalence studies conducted between Japanese innovator and the test drug conducted in reputed centres in India may be accepted by Japanese authorities for products where the approval is based on in vitro studies and bioequivalence tests (where approval is not based on clinical trials measuring the therapeutic efficacy), it suggested.
The DMFs, ANDAs, facilities, BE centres approved by leading agencies like US FDA may be considered for fast track approval in specified time frame. The need for trading agreement with local firms for filing formulation dossiers may be demanded at the time of product launch and not at the application stage for Indian companies. It also suggested that fee for MF filings and review process must be waived for five years to promote Indian companies.
"Indian companies may be waived from the requirement of applying and holding inventory of all strengths fro a generic medicine which often is very unviable. Or in the case of multiple filings from Indian companies, the collective availability may be sufficient instead of each firm holding inventory," the Pharmexcil suggested.
Japan is world's second largest market worth 61 billion dollars in 2008 and is growing at five percent. The generic market is growing at eight per cent and is expected to grow faster as the government has started promoting it to reduce healthcare burden. India, currently placed as 27th largest exporter to Japan, holds higher opportunity for pharma companies, it is pointed out.