Satish Wagh, Owner, Supriya Lifescience and Chairman Export Promotion Council (CHEMEXCIL)
Market Access Initiative is a very good initiative of Commerce Ministry. At present, under the scheme, the government reimburses pharma exporters 50 per cent of the government fees paid to FDAs of importing country upto a maximum of ` 50 lakhs per year per company. Registrations of all active pharmaceutical ingredients (APIs) and formulations are covered irrespective of the company size. But in recent years, several countries like the US, the EU and China have imposed / increased the fees drastically and ` 50 lakh incentive is not covering even one product registration cost against 20 to 30 product registrations being done by small and big countries in one or more countries. With the proposed revision in reimbursement, the maximum ceiling is increased to ` 2 crore per company, per year. This is a very useful and export-friendly initiative and certainly will go a long way for the growth of small and medium size exporters. The new announcement to extend one time grant of upto ` 25 lakhs towards barcoding expenditure is also a great support to small and medium exporters. This will be of great help to a lot of pharma exporters, especially the SSI sector.
I want the Ministry of Commerce to pay fees irrespective of the size of the company who do business with the US by paying the Generic Drug User Fee Amendments (GDUFA). We are all aware that it is tough to do business with the US.
This is my utmost submission to the Ministry of Commerce, Government of India under MAI.