Lok Sabha Question No. 3712 (UNSTARRED), answered on 2020-03-17
Subject: Price Controlled Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Thomas Chazhikadan

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

LOK SABHA UNSTARRED QUESTION NO. 3712 TO BE ANSWERED ON 17 th  March, 2020

## Price Controlled Drugs

## 3712. SHRI THOMAS CHAZHIKADAN:

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

- (a) the number of drugs under price control in the country;
- (b) whether the Government has any proposal to increase the number of such drugs
- by including more lifesaving drugs and if so, the details thereof;
- (c)  whether  cases  of  selling  such  drugs  at  high  price  have  been  noticed  by  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 is 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  866 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) NPPA  has  also  fixed  the  retail  price  of  1250  new  drugs  under  the DPCO, 2013 till date.
- (iv) NPPA fixed prices of 106 Anti-diabetic and Cardiovascular drugs under Para 19 of the DPCO, 2013 in Public interest.
- (v) NPPA  has  fixed  ceiling  price  of  Cardiac  Stents  being  scheduled formulation  under  the  DPCO,  2013  affecting  price  reduction  for  Coronary Stents worked out up to 85% for Bare Metal Stents and 74% for Drug Eluting Stents .

(vi) NPPA has fixed ceiling price of Orthopedic Knee Implants under Para 19  of the DPCO,  2013  in  Public  interest  affecting price reduction  for orthopedic Knee Implants worked out up to be 69%.

(vii) 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 upto 90%.

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

(b): The  National Pharmaceutical  Pricing Authority  (NPPA),  as  an  ongoing process, 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, NPPA issues notices to the companies to deposit the overcharged amount along with applicable interest under section 7A of Essential Commodities Act, 1955.

Since  inception  of  the  NPPA,  2083  demand  notices  (including  suo-moto deposits) have been issued to pharmaceutical companies for their having overcharged consumers on the sale of formulations at prices above the ceiling price notified  by  the  NPPA.  Demand  Notices  have  been  issued  for  an  amount  of  Rs. 6406.33 crore. Amount to the tune of Rs. 960.38 crore has been deposited by the companies to the Government. An amount of Rs. 4032.91 crore is under litigation. The demand notices are issued under various provisions of the DPCO, 1995 and the DPCO,  2013  read  with  Section  7A  of  the  Essential  Commodities  Act,  1955.  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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