Last chance for medical devices firms to submit price data: NPPA
PTI|
Mar 04, 2018, 12.21 PM IST
National drug pricing regulator NPPA has said medical devices makers and importers are being given the last opportunity to submit data regarding price movement of 19 medical devices notified as drugs by March 15, 2018.
This is in order to monitor the price movement of 19 medical devices out of 23 medical devices notified as drugs under the Drugs and Cosmetics Acts, National Pharmaceutical Pricing Authority (NPPA) said in a memorandum.
The devices include catheters, heart valves, orthopaedic implants, disposable hypodermic syringes and needles, surgical dressings and internal prosthetic replacements.
The regulator said it had asked them to submit the data as per the prescribed format in May 2017 and had even extended the deadline till June 9, 2017 from the earlier one of May 31, 2017.
"It has been observed that many manufacturers/ importers have not submitted the requisite price data in prescribed format, it added.
"The manufacturers/importers who have not submitted the data so far are hereby given a last opportunity to submit the requisite data as per prescribed format in respect of medical devices...by March 15, 2018" NPPA said.
They are also required to send hard copy of the data to NPPA by the same date, it added.
The regulator has also asked for the copies of license issued by Drug Controller General of India for each medical device to be attached with the data.
"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 the act...," NPPA said.
Failing compliance by manufacturers/importers, NPPA may request Central Drugs Standard Control Organisation (CDSCO) to revoke manufacturing/import license issued, apart from taking legal follow up action under Para 29 and 30 of DPCO 2013 and also under Essential Commodities Act, it added.
While Para 29 of DPCO 2013 states that government shall have the power to call for any record and to inspect such records at the premises of the manufacturer, Para 30 deals with power of entry, search and seizure.
This is in order to monitor the price movement of 19 medical devices out of 23 medical devices notified as drugs under the Drugs and Cosmetics Acts, National Pharmaceutical Pricing Authority (NPPA) said in a memorandum.
The devices include catheters, heart valves, orthopaedic implants, disposable hypodermic syringes and needles, surgical dressings and internal prosthetic replacements.
The regulator said it had asked them to submit the data as per the prescribed format in May 2017 and had even extended the deadline till June 9, 2017 from the earlier one of May 31, 2017.
"It has been observed that many manufacturers/ importers have not submitted the requisite price data in prescribed format, it added.
"The manufacturers/importers who have not submitted the data so far are hereby given a last opportunity to submit the requisite data as per prescribed format in respect of medical devices...by March 15, 2018" NPPA said.
They are also required to send hard copy of the data to NPPA by the same date, it added.
The regulator has also asked for the copies of license issued by Drug Controller General of India for each medical device to be attached with the data.
"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 the act...," NPPA said.
Failing compliance by manufacturers/importers, NPPA may request Central Drugs Standard Control Organisation (CDSCO) to revoke manufacturing/import license issued, apart from taking legal follow up action under Para 29 and 30 of DPCO 2013 and also under Essential Commodities Act, it added.
While Para 29 of DPCO 2013 states that government shall have the power to call for any record and to inspect such records at the premises of the manufacturer, Para 30 deals with power of entry, search and seizure.
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