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After Stents, NPPA shifts its focus to 19 other Medical Devices, Check out details


After Stents, NPPA shifts its focus to 19 other Medical Devices, Check out details

New Delhi: After slashing the prices of cardiac stents in the country Drug price regulator NPPA has now moved on its focus towards monitoring the prices of another 19 important medical devices notified as drugs under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 For the same, it is reported that the NPPA  has finalised a new format to collect data to monitor price movement of 19 medical devices.

The move allows the government to make sure that no manufacturer or importer or distributor is allowed to increase the maximum retail price (MRP) of a non-scheduled pharmaceutical product by more than 10% of MRP during the preceding 12 months.

Many commonly used Medical Devices are under the NPPA radar . These 19 medical devices include :

1.Disposable Hypodermic Syringes

2.Disposable Hypodermic Needles

3.Disposable Perfusion Sets

4.In vitro Diagnostic Devices of HIV, HBsAg and HCV

5.Catheters

6.Intra Ocular Lenses

7.I.VCannulae

8.Bone Cements

9HeartValves

10.Scalp Vein Set

11.Orthopedic Implants

12.Internal Prosthetic Replacements

13.Blood Grouping Sera

14.Ligatures, Sutures and Staplers

15.Tubal Rings

16.Surgical Dressings

17.Umbilical Tapes

18.Blood/Blood Component Bags.

19.Ablation Devices

In a recent notification, National Pharmaceutical Pricing Authority (NPPA) said it has come out with a new format as reaching a consensus on classification may not be possible due to diverse opinions among the medical devices industries.

In order 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, NPPA has developed a format and the same was shared with the Medical Devices Industries and Associations fortheir comments/views. A series of meetings have been 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 has been found that reaching a consensus on classification may not be possible due to diverse opinions about the classifications among the medical devices industries. In view of this, a new format based on Form-V prescribed under DPCO, 2013 has been prepared and the same is enclosed as Annexure to this letter. Now each company has 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 are hereby requested to submit data as per the prescribed format in respect of all the 19 medical devices, the notification added.

Currently, the government monitors the price movement of 19 medical devices which have been notified as drugs under the Drugs and Cosmetics Act.

Attached is the notification:-



Source: self
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