New Delhi: In a significant move aimed at curbing prevalent malpractices related to MRP and over-invoicing via the “Institutional Consumer” route while boosting domestic manufacturing, the Government has plugged in loopholes related to labelling requirements of imported medical devices. It has been alleged that the loopholes had been used in the past to evade taxes, hype up the MRP while eroding the competitiveness of domestically manufactured medical devices.
The Government in a letter to domestic medical device manufacturers’ apex body AiMeD has clarified that all imported (and indigenous) devices, irrespective of being notified as ‘Drugs or Not” will have to comply with all labeling requirements as per the existing Legal Metrology (Packaged Commodities) Rules, 2011 in addition to compliance with GSR 629 (E) which was issued on June 23rd, 2017. The Government has also plugged in loopholes which were used in the past by certain hospitals to ‘buy cheap, sell dear’ by taking advantage of their status as “Institutional Consumer”.
The Association of Indian Medical Device Industry (AiMeD) has lauded the move as a significant step towards consumer protection and a big boost for domestic manufacturers “The directives will help curb marketing malpractices, over invoicing and boost the competitiveness of domestic medical device,” mentioned Mr Rajiv Nath, Forum Coordinator, AiMeD.