Lok Sabha Question No. 5071 (UNSTARRED), answered on 2018-03-27
Subject: New Monitoring Format
Ministry: CHEMICALS AND FERTILIZERS
Asked by: M. UDHAYAKUMAR

5071. ADV. M. UDHAYAKUMAR:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether the Government has come out with a new format to collect data to monitor the price movement of 19 medical devices;
- (b) if so, the details thereof;
- (c) whether a new format based on Form V prescribed under DPCO, 2013 has been prepared; and
- (d) if so, the details thereof?

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS & FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO. 5071 TO BE ANSWERED ON 27 th  March, 2018

## New Monitoring Format

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY OF SHIPPING AND MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

(a) to (d): Yes, Madam. National Pharmaceutical Pricing Authority (NPPA) has developed a format based on Form-V prescribed  under  the  Drugs  (Prices  Control)  Order,  2013  (DPCO,  2013)    for  collecting  data  in  respect  of  19  medical devices  notified  as  drugs  under  the  Drugs  and  Cosmetics  Act,  1940  and  the  Drugs  and  Cosmetics  Rules,  1945  for monitoring  purposes.  The  new  format  prepa  by  NPPA  is  placed  at  Annexure.  This  format  has  been  developed  in consultation with the Medical Device Industries and Associations, and uploaded on the website of  NPPA www.nppaindia.nic.in  on 12 th May 2017.

## Format for Collecting  Data on Medical Devices for Monitoring Name of the Medical Device:

Name of the Manufacturer/Importer with address, contact Numbers and Email id:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

| Product Name/ Specific ation as per DCGI approva l   | Product name/brand and other specifications relating to its material/size/ application or any other specification.   | Date of launch in India   | Minimal Unit of Sale/ Retail pack size   | Price to Stockist/ Distributor (excluding local taxes) as on April 1st, 2017   | Price to Retailers/ Hospitals as applicable (Excluding local taxes) as on April, 1st 2017   | Applica ble VAT rate   | Moving Annual turnove r (MAT) * ( ₹ in lakhs)   |   MRP (year to year in the last four years) Inclusive of all Taxes. (As on April 1st) |   MRP (year to year in the last four years) Inclusive of all Taxes. (As on April 1st) |   MRP (year to year in the last four years) Inclusive of all Taxes. (As on April 1st) |   MRP (year to year in the last four years) Inclusive of all Taxes. (As on April 1st) | Remar ks if any   |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|
|                                                      |                                                                                                                      |                           |                                          |                                                                                |                                                                                             |                        |                                                 |                                                                                  2014 |                                                                                  2015 |                                                                                  2016 |                                                                                  2017 |                   |
| 1                                                    | 2                                                                                                                    | 3                         | 4                                        | 5                                                                              | 6                                                                                           | 7                      | 8                                               |                                                                                     9 |                                                                                    10 |                                                                                    11 |                                                                                    12 | 13                |

Note: Attach a copy of the License obtained from DCGI for each medical device

The information furnished aboave is correct and true to the best of my knowledge and belief.

Place:

Date

Name: Designation with office seal: Mobile No: Email id: