In response to India’s request for speedy registration of medicines by Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese government has asked India to provide details of specific cases where Indian companies have faced unreasonable delay or discrimination so that it could revise its procedure wherever necessary in granting the approvals.

According to industry analysts, the move from Japanese government is encouraging and it is seen as part of the Comprehensive Economic Partnership Agreement (CEPA) which is signed between Japan and India to increase trade relations through mutual cooperation.

As per IMS statistics for the year 2011, Japan is the second largest pharmaceutical market by value of domestic consumption of formulations which accounts for a market value of $111 billion in the world.  

At present, Japan is eager to increase its percentage of generics usage and the country is targeting to increase 30 per cent of the total market share by the end of 2012. In 2011 the generic usage was increased to 23 per cent. Since Japan is showing its keen interest to increase its generic usage, it is a huge opportunity for the Indian generic makers to grab this potential.  

Giving more details about the recent development Dr PV Appaji, DG, Pharmexcil, said, “In order to increase pharma exports our embassy at Tokyo has requested Japanese authorities to simplify its procedures for product registration and marketing approval for generic drugs. In view of this, the Japanese side had requested our embassy to share details of specific cases where Indian companies have faced unreasonable delay or discrimination so that it could revise its procedures wherever necessary.”

In view of this, the Pharmexcil had written to all its exporting members to provide details of doubts, apprehensions and problems they had faced with the Japanese regulatory authorities, especially with regard to unreasonable delays in registration of medicines by PMDA.

“We request immediate comments from all our exporting members with specific details of delays regarding registration of pharmaceuticals with Japan so that we will consolidate all such instances in a proper format for better representation, which would help achieve the set objective,” said Appaji.

Earlier, Pharmexcil had brought to the notice of union commerce ministry about the inordinate delays by Japanese authorities in granting requisite approvals and persuaded the Indian government to take up the matter with the Japanese authorities to speed up the registration process.