from Daijiworld's special correspondent
Panaji, Apr 23: The Confederation of Indian Industries would urge the Centre for amending the proposed medical devices regulation as it was likely to hit the medical instrument manufacturing and trading sector, following imposition of huge registration fee.
"Registration fee of USD 1,000 per device is proposed in the regulation which will increase the price of the devices," said Alok Mishra, CII Chairman, Medical EquipmentDivision.
Following concerns raised by the industry, CII has decided to initiate a dialogue with the central authorities recommending certain amendments in the regulation.
"We are not opposing the regulations as they are important for patients' safety but we are concerned about the issues related to this regulation", Mishra said.
A few clauses in the regulations is likely to affect USD 1.5 billion worth medical device market in India which will also take its toll on the patients as companies may pass on the additional financial burden to them.
The Central government has given two months' time for the industries to follow guidelines under the regulations.
"Two months' deadline gets over on May 2 and industries are not in a position to adhere to the guidelines within such a short span. We will ask the government to give us more time," said Mishra.
"Some companies may even stop producing few devices, if regulations are strict," he said.
The industry experts contend that few devices which are imported from the US and Europe already undergo FDA approval so there is no need to re-scanthem, Mishra stated.