In order to monitor the price movement of medical devices notified as drugs under the Drugs and Cosmetics Act and to prevent the overcharging of these devices by the medical devices companies, the National Pharmaceutical Pricing Authority (NPPA) has asked all the medical device associations and manufacturers/importers /marketers to submit data as per the prescribed format in respect of all the 19 medical devices irrespective of their classification by May 31, 2017.
To monitor the price movement of 19 medical devices out of 23 medical devices notified as drugs under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, the NPPA had earlier developed a format and the same was shared with the medical devices industries and associations for their comments/views. A series of meetings were held with the medical devices industries and associations for the purpose of arriving at a consensus on the format which will be used for collecting data on medical devices for monitoring.
However, based on the feedbacks received from the members of medical devices associations, it was found that reaching a consensus on classification may not be possible due to diverse opinions about the classifications among the medical devices industries. So, a new format based on Form-V prescribed under DPCO, 2013 was prepared by the NPPA. The NPPA has now directed each company to give the information as per all the medical devices it is selling in the market with all necessary details.
All Medical Device Associations and Manufacturers/importers /marketers are hereby requested to submit data as per the prescribed format in respect of all the 19 medical devices as per list attached irrespective of their classification. It is requested to send hard copy of the data as per the attached format to NPPA by May 31, 2017. The hard copy should be duly signed by the authorized representative of the companies with office seal giving details about the name of the person, designation, mobile number and email id. Copies of the license issued by Drug Controller General of India for each medical device must be attached along with the data. A soft copy of the data and license may be sent through email to nihalpedric@nic.in. All manufacturers/importers of medical devices are advised to ensure compliance of provisions of DPCO, 2013 to avoid action against any violation under the provisions of DPCO, 2013 read with Essential Commodities Act, 1955, the NPPA in its directive to the medical device companies said.
(Reference: http://www.pharmabiz.com/NewsDetails.aspx?aid=102105&sid=1)