Lok Sabha Question No. 511 (STARRED), answered on 2018-04-03
Subject: Drugs under Price Control
Ministry: CHEMICALS AND FERTILIZERS
Asked by: JYOTI DHURVE

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

LOK SABHA STARRED QUESTION NO. *511 TO BE ANSWERED ON 03 rd  April, 2018

## Drugs under Price Control

†*511. SHRIMATI JYOTI DHURVE:

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

- (a) whether the Government has any proposal to bring more drugs including all the essential medicines under price control;
- (b) if so, the details thereof;
- (c) the  details  of  drugs  brought  under price  control  along  with  the  reduction  in  the prices in the recent past;
- (d) whether the consumers have benefited as a result thereof; and
- (e) if  so,  the  details  thereof  along  with  the  efforts  being made  to monitor the  price control mechanism?

## ANSWER

## MINISTER   IN    THE      MINISTRY      OF      CHEMICALS      &      FERTILIZERS  AND PARLIAMENTARY AFFAIRS (SHRI ANANTH KUMAR)

- (a) to (e): A statement is laid on the Table of the House.

## Statement referred to in reply to Lok Sabha Starred Question No. *511 for answer on 03/04/2018 regarding Drugs under Price Control.

(a) & (b): The  Government  has  notified  National  Pharmaceutical  Pricing  Policy, 2012 (NPPP-2012) on 7 th December, 2012 with an objective to put in place a regulatory framework  for  pricing  of  drugs  so  as  to  ensure  availability  of  required  medicines  'essential medicines' - at reasonable prices. Pursuant to the announcement of National Pharmaceutical  Pricing  Policy,  2012  (NPPP,  2012),  Government  notified  the  Drugs (Prices  Control)  Order,  2013  (DPCO,  2013)  on  15 th May,  2013.  All  the  medicines specified in the National List of Essential Medicines prepared by the Ministry of Health and Family Welfare and revised from time to time are included in the Schedule - I of DPCO, 2013 which are under price control in accordance with provision of DPCO 2013.

As  per  para  17  of  the  Drugs  (Prices  Control)  Order  2013  (DPCO,  2013),  a decision to amend the first schedule, clearly stating the reasons thereof, shall be taken by the Government within sixty days of receipt of communication from the Ministry of Health  and  Family Welfare  and  the  amendment(s)  or  revision,  if  required,  in  the  first schedule shall be notified and thereafter, the ceiling price(s) for the medicine(s) added in the first schedule shall be fixed as per the provisions of this order within a period of sixty days from the date of the notification.

(c): The National Pharmaceutical Pricing Authority (NPPA) fixes the ceiling prices of medicines  listed  in  the  Schedule  -  I  of  Drugs  (Prices  Control)  Order,  2013  (DPCO, 2013). Till February 2018, the Government has fixed the ceiling prices of 851 medicines (including 4 medical devices i.e. Cardiac stents, drug eluting stents, condoms and intra uterine  devices)  under  Revised  Schedule  -  I  based  on  National  List  of  Essential Medicines, 2015 (NLEM, 2015).

The details of reduction in prices of scheduled formulations effected under DPCO, 2013 as compared to the highest price prevailing prior to the announcement of DPCO, 2013 for formulation of NLEM, 2015 (Revised Schedule - I) are as follows:

| Statement showing reduction in ceiling prices of scheduled formulations with respect to maximum price under NELM 2015 as on 28.02.2018   | Statement showing reduction in ceiling prices of scheduled formulations with respect to maximum price under NELM 2015 as on 28.02.2018   |
|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| %reduction with respect to Maximum Price                                                                                                 | No. of scheduled formulations                                                                                                            |
| 0<= 5%                                                                                                                                   | 234                                                                                                                                      |
| 5<=10%                                                                                                                                   | 134                                                                                                                                      |
| 10<=15%                                                                                                                                  | 98                                                                                                                                       |
| 15<=20%                                                                                                                                  | 98                                                                                                                                       |
| 20<=25%                                                                                                                                  | 93                                                                                                                                       |
| 25<=30%                                                                                                                                  | 65                                                                                                                                       |
| 30<=35%                                                                                                                                  | 46                                                                                                                                       |
| 35<=40%                                                                                                                                  | 24                                                                                                                                       |
| Above 40%                                                                                                                                | 59                                                                                                                                       |
| Total formulations in NLEM, 2015                                                                                                         | 851                                                                                                                                      |

(d): The fixation of ceiling prices/MRP is estimated to have resulted in a total saving of Rs. 11,463 crores to the public after implementation of DPCO, 2013. This includes the saving of Rs. 4,547 crores on account of fixation of ceiling price of coronary stents (including  re-fixation)  and  Rs.  1,500  crores  on  account  of  price  fixation  of  Knee implants. Details are as under:

| Particulars                                               | Estimated Saving to consumer ( Rs. in Crores)   |
|-----------------------------------------------------------|-------------------------------------------------|
| Under NLEM 2011 from May 2013 to Feb 2016                 | 2,422                                           |
| Under NLEM 2015 from March 2016 to till date (31.01.2018) | 2,644                                           |
| Cardio vascular and Anti-diabetic medicines               | 350                                             |
| Coronary Stents in Feb 2017 (including re-fixation)       | 4,547                                           |
| Knee Implants in Aug 2017                                 | 1,500                                           |
| TOTAL                                                     | 11,463                                          |

(e): NPPA is effectively monitoring the prices of scheduled as well as non-scheduled medicines under DPCO, 2013 so that these formulations are available to public at  or below ceiling prices notified and increase in price is limited to the provisions of DPCO, 2013. It takes action against companies found overcharging the consumers based on the  references  received  from  the  State  Drugs  Controllers  /  individuals,  samples purchased  from  the  open  market,  reports  from  market  based  data  and  complaints reported  through  the  grievance  redressal  websites;  'Pharma  Jan  Samadhan'  and 'Centralized  Public  Grievance  Redress  and  Monitoring  System  (CPGRAMS)'.  The monitoring of prices of formulations is also done on the basis of market data submitted by All Indian Origin Chemists & Distributors Limited (AIOCD) (Pharma Trac Data) and individual complaints received.

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