CII to seek lower tariffs for medical instruments sector

With concerns raised by the industries over the proposed medical devices regulation, Confederation of Indian Industries (CII) plans to initiate dialogue with the central government for amendments in the regulation, as the existing laws are likely to hurt medical instrument manufacturing and trading sector.

"Registration fee of $1,000 per device is proposed in the regulation which will increase the price of the devices," said Alok Mishra, chairman, CII committee on medical equipment.

He added, "We are not opposing the regulations as they are important for patients' safety, but we are concerned about the issues related to this regulation." A few clauses in the regulations are likely to affect $1.5 billion medical devices market in the country, and will result in additional financial burden on patients as companies would be forced to pass on the cost burden.

The UPA government has given the industry two months to start following guidelines under the regulations.

"The two-month deadline ends 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 for more time," Mishra said, pointing out that some companies may even stop producing a few devices, if regulations are too strict.

The industry experts contend that some of the devices, which are imported from the United States and Europe have already been approved by the Food and Drug Administration (FDA) which preempts any need to re-scan them, following the imposition of a huge registration fee.