Lok Sabha Question No. 1588 (UNSTARRED), answered on 2020-09-20
Subject: Price Control of Essential Life Saving Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Dean Kuriakose

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

LOK SABHA UNSTARRED QUESTION NO. 1588

TO BE ANSWERED ON 20 th  September, 2020

## Price Control of Essential Life Saving Drugs

## 1588. ADV. DEAN KURIAKOSE:

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

- (a) the number of drugs put under 'price control' in the country;
- (b) whether the Government has any proposal to increase the number by including more lifesaving drugs and if so, the details thereof;
- (c) whether cases of selling such drugs at 'high price' have come to the notice of the Government; and
- (d) if so, the details of such cases reported and the action taken in this regard?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI D.V. SADANANDA GOWDA)

- (a):       The National Pharmaceutical Pricing Authority (NPPA) fixes the ceiling price of  scheduled  formulations  adopted  from  the  National  List  of  Essential  Medicines (NLEM) and new drugs as per the provisions of Para 4, 5 and 6 of the Drugs (Prices Control) Order, 2013 (DPCO, 2013). The details of medicines under price control are as below:
- (i)         There were 348 medicines in the National List of Essential Medicines 2011 (NLEM) which were included in the First Schedule of the DPCO, 2013. The NPPA fixed the ceiling prices of 530 scheduled formulations of such medicines based on market based pricing methodology.
- (ii)         Schedule  -I  of  the  DPCO,  2013  was  amended  by  adopting  NLEM,  2015 consisting of 377 medicines. The NPPA has fixed the ceiling prices of 871 scheduled formulations  of  medicines  under  the  NLEM,  2015.  The  detail  of  price  fixed  is available on the NPPA's website www.nppaindia.nic.in.
- (iii)       The NPPA has also fixed the retail price of 1373 new drugs under the DPCO, 2013 till date.
- (iv)       The NPPA fixed prices of 106 Anti-diabetic and Cardiovascular drugs under Para 19 of the DPCO, 2013 in public interest.

(v)         The  NPPA  has  fixed  ceiling  price  of  Cardiac  Stents  being  scheduled formulation under the DPCO, 2013, resulting in price reduction for Coronary Stents which worked out up to 85% for Bare Metal Stents and 74% for Drug Eluting Stents.

(vi)       The NPPA has fixed ceiling price of Orthopaedic Knee Implants under Para 19 of the DPCO, 2013 in Public interest, resulting in price reduction for Orthopaedic Knee Implants which worked out up to 69%.

(vii)       The  NPPA  capped  the  Trade  Margin  of  non-scheduled  formulations  of  42 Anti-cancer medicines under 'Trade Margin Rationalization' approach as a Pilot for proof of concept, wherein price of more than 500 brands of medicines were reduced up to 90%.

The fixation of  prices has  resulted  in  a total  saving  of  Rs.  12,447  crore  per annum to the public after the implementation of the DPCO, 2013.

(b):       As an ongoing process, the NPPA fixes the ceiling prices of the formulations as and when formulations are included in the National List of Essential Medicines (NLEM).

(c) & (d):         The NPPA monitors the prices of both scheduled and non-scheduled formulations on regular basis to check overcharging by pharmaceutical companies. Whenever  companies  are  found  to  be  overcharging  the  consumer  in  sale  of medicine,  the  NPPA  issues  notices  to  the  companies  to  deposit  the  overcharged amount along with applicable interest under the DPCO, 2013 read with Section 7A of the Essential Commodities Act, 1955.

Since  inception  of  the  NPPA,  2086  demand  notices  have  been  issued  to pharmaceutical companies for overcharging consumers on the sale of formulations at prices above the ceiling price notified by the NPPA. Demand Notices have been issued for total amount of Rs. 6411.28 crore. Amount to the tune of Rs. 965.81 crore has been deposited by the companies to the Government. An amount of Rs. 4081.93 crore  is  under  litigation.  The  detailed  list  of  overcharging  cases  where  demand notices have been issued is available on NPPA's website www.nppaindia.nic.in.

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