The medical device industry expressed strong displeasure over the CDSCO's clarification on 14 notified medical devices as it no way addresses the core issues of an exporter and in fact only shows the overarching control they are trying to have on the industry through D&C Act.
The notification issued by CDSCO earlier this month clearly states that any devices other than the above 14 do not require any registration, license, permission or NOC for their import or export manufacture, sale and distribution so far as the provisions of the D&C Act & Rules. Association of Indian Medical Device Industry (AIMED) feels that the government had yet again very smartly excluded its exports, in spite of the fact that the industry has been in the past harassed by the customs and ADC officials at port to provide NOC for the export consignment even when they were never part of the D&C Act.
There is no law regulating the exports of the drugs and medical devices and it is even outside the purview of the D&C Act and Rules. It is usually the responsibility of importing countries to look into such imports. Rajiv Nath forum coordinator of AIMED points out that in spite of this, the exporters of medical devices are being harassed over the issue of NOC by the customs officers who refer it to the ADC of the port even if the medical devices are not notified leading to delay in exporting the consignments.
“This move comes in the wake of growing confusion among the industry and the regulatory agency on the doubts over the registered medical devices which were leading to a lot of regulatory complications for all. Though this clarification comes as a reprieve to address the confusion over the number of notified medical device as drugs, it still does not serve the purpose for an exporter as it fails to address our issues at length with respect to exports,” Nath stressed.
With a view to clear the ambiguity over the number of regulated medical devices in the country, the Central Drugs Standard Control Organisation (CDSCO) recently clarified that at present there are only 14 medical devices notified under the Drugs and Cosmetics (D&C) Act. However, the industry maintained that they are very concerned by attitude of the government which is leading to heavy losses to the industry due to the unreasonable and unjustified delays caused at the ports.