Lok Sabha Question No. 414 (UNSTARRED), answered on 2019-02-05
Subject: Guidelines by NPPA
Ministry: CHEMICALS AND FERTILIZERS
Asked by: RAHUL RAMESH SHEWALE, BHARTRUHARI MAHTAB, SANJAY SHAMRAO DHOTRE

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

LOK SABHA UNSTARRED QUESTION NO. 414

TO BE ANSWERED ON 5 th  February, 2019

## Guidelines by NPPA

414. SHRI RAHUL SHEWALE: SHRI BHARTRUHARI MAHTAB: SHRI SANJAY DHOTRE:

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

- (a) the criteria/guidelines laid down by the National Pharmaceutical Pricing Authority (NPPA) in determining and fixing the prices of essential/life saving medicines;
- (b) whether the cases of deviation from the said criteria/guidelines in fixing the prices of  essential/life  saving  medicines  by  the  drug  manufacturing  companies  have come to the notice of the Government during each of the last three years and the current year;
- (c) if so, the details thereof and the steps taken thereon, company-wise;
- (d) whether  all  the  drug  manufacturing  companies  have  updated  their  price  list  of medicines on their respective websites;
- (e) if so, the details thereof and if not, the steps being taken in this regard; and
- (f) the  other  steps  taken/being  taken  by  the  Government  to  bring  transparency  in fixing  prices  of  essential/life  saving  medicines  and  to  curb  deviation  from  the standard criteria/guidelines in fixing the prices of such medicines?

## 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): National  Pharmaceutical  Pricing  Authority  (NPPA)  fixes  the  ceiling  prices  of Scheduled  medicines  and  retail  prices  of  new  drugs  as  per  the  provisions  of  Drugs (Prices Control) Order, 2013 (DPCO, 2013).

(b) & (c): NPPA also monitors  the  prices  of  medicines  and  issues  notices  for  the violation  of  the  prices.  NPPA  initiates  action  against  manufacturers  which  have overcharged  patients.  In  the  last  three  years  demand  notices  have  been  issued  as follows:

| Year    |   Number of cases |   Demanded Amount (Figure in Rs Crores) |
|---------|-------------------|-----------------------------------------|
| 2015-16 |               264 |                                  931.18 |
| 2016-17 |               138 |                                  334    |
| 2017-18 |               217 |                                  704.48 |

The  detailed  list  of  overcharging  cases  where  demand  notices  have  been  issued  is available on NPPA website www.nppa.nic.in.

(d)  &  (e):   NPPA  could  not  verify  whether  all  drug  manufacturers  have  updated  their price list of medicines on their respective websites.

(f): In order to have transparency, a draft version of the Price Calculation Sheets for the  proposed  revised  price  notifications,  including  wherever  applicable,  the  Price  to Retailer (PTR) and Moving Annual Turnover (MAT) values adopted for calculations, is uploaded on the website of NPPA for 10 clear working days to invite comments from the pharmaceutical  firms.  Only  after  taking  into  account  the  comments  or  any  additional data thus received within the given time period, the NPPA finalizes the ceiling and the retail Prices. Thus the entire procedure of price fixation is available in the public domain which ensures transparency and accountability of the whole process.

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