Lok Sabha Question No. 2312 (UNSTARRED), answered on 2021-03-09
Subject: Drug Price Control by NPPA
Ministry: CHEMICALS AND FERTILIZERS
Asked by: K. Shanmuga Sundaram

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS & FERTILIZERS

## DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO. 2312 TO BE ANSWERED ON 9 th  March, 2021

## Drug Price Control by NPPA

## 2312.   SHRI SHANMUGA SUNDARAM K.:

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

- (a) the details of the total number of drugs which have been placed under price control by the National Pharmaceuticals Pricing Authority (NPPA) as on date;
- (b) whether the Government has received any objection from the multinational pharma companies as well as Indian pharma giants and if so, the details thereof;
- (c) whether the NPPA order will cover the National List of Essential Medicines (NLEM) as well as nonessential drugs; and
- (d) if so, the details thereof and if not, the reasons therefor?

## ANSWER

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

- (a): National Pharmaceutical Pricing Authority (NPPA)  under the Department of Pharmaceuticals  (DoP)  fixes  the  ceiling  price  of  scheduled  formulations  adopted  from  the National List of Essential Medicines (NLEM) and new drug 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) Ceiling price of 881 scheduled formulation under revised schedule-I of DPCO, 2013.
- (ii) Retail price of 1,495 new drugs under the DPCO, 2013.
- (iii) Prices  of  106  Anti-diabetic  and  Cardiovascular  drugs  under  Para  19  of  the DPCO, 2013 in public interest.
- (iv) Ceiling price of Cardiac Stents being scheduled formulation under the DPCO, 2013 affecting price reduction for Coronary Stents, which worked out up to 85% for Bare Metal Stents and 74% for Drug Eluting Stents.
- (v) Ceiling price of Orthopaedic Knee Implants under Para 19 of the DPCO, 2013 in Public interest affecting price reduction up to 69%.
- (vi) 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 the prices has resulted in a notional savings of Rs. 12,447 crores per annum to the public after implementation of DPCO, 2013.

- (b): The receipt  of  representations  from  the  Industry  and  consultations  on  issues  are  an ongoing process. NPPA examines any representation received from the companies and Pharma Associations and addresses them suitably.

(c) & (d): NPPA  fixes  the  ceiling  prices  of  scheduled  drugs  listed  in  the  NLEM  and included  as  Schedule  -  I  of  the  DPCO,  2013.  All  manufacturers  of  scheduled  medicines (branded or generic) have to sell their products within the ceiling price (plus applicable Goods and Service Tax) fixed by the NPPA.

A manufacturer is at liberty to fix the maximum retail price of a non-scheduled formulation (branded  or  generic)  launched  by  it.  However,  as  per  provisions  of  the  DPCO,  the manufacturers of non-scheduled formulations are not allowed to increase the maximum retail price of such formulations by more than 10% per annum.

*****