|
The Pharmacueticals Export Promotional Council (Pharmexcil) urged the Union health ministry to grant a hearing to the Council and other pharma associations before making a final decision on proposed licence fee hike for renewal and new approvals of drugs in the country. The proposed fee structure is unreasonable high and can affect the export as well as SME sector.
Dr P V Appaji, director general of Pharmexcil says, “We have sent our comments and suggestion to the health ministry. We have tried to convince the government based on the information received from our members. Our members are upset due to the hike in the licence fee, especially the SMEs. At the same time, along with SMEs, pharma export will also be affected due to the licence fee hike. We have informed that proposed licence fee is very high and suggested the health ministry to give us and other associations a hearing before making final decision as it is a draft and yet to be finalised. This move by the government is likely to have significant adverse impact both on domestic and export sectors.”
The DCGI last month issued a draft order proposing a hike in the licence fee for domestically manufactured new products and imported pharmaceutical products. The annual licence fee for pharmacies is proposed to be increased to Rs.30,000 from the current level of Rs.3,000. For domestic manufacturing licence and loan licence the fee will go up to Rs.50,000 from the existing fee of Rs.6,000. And the charge for site inspection will increase to Rs.15,000 from Rs.1,500 now. Registration fee for imported drugs will go up to 5000 dollars from the current rate of 1000 dollars. Again, the fee hike proposed for registration of locally manufactured products is Rs.2,50,000 from the existing fees of Rs.50,000.
The council is worried as this move of the government will mostly affect the medium and small scale drug sector, and would also burden its SMEs members. Many of the small scale drug units may get seriously affected as they are already facing hardships because of the need for upgradation of plants, denial of adequate opportunities in government tenders, high interest rate and difficulty in getting and retaining technically qualified personnel.
On the other hand, the DCGI is of the view that fee hikes in pharmaceutical industry and trade are required and long overdue considering the growth achieved by the sector over the years with steep increase in revenues year after year. To tackle the corresponding increase in application load efficiently, the government needs funds and this has to be generated from the industry.
|