Lok Sabha Question No. 1585 (UNSTARRED), answered on 2020-09-20
Subject: Life Saving Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Chandra Prakash Joshi, Sangamlal Kadedin Gupta

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

LOK SABHA UNSTARRED QUESTION NO. †1585 TO BE ANSWERED ON 20 th  September, 2020

## Life Saving Drugs

## †1585.SHRI CHANDRA PRAKASH JOSHI: SHRI SANGAM LAL GUPTA:

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

- (a) the numbers of life saving drugs whose prices have been decreased recently by the Government;
- (b) the details of the decrease in prices in terms of percentage;
- (c)  whether  the  Government  proposes  to  decrease  the  prices  of  more  life  saving drugs in the near future;
- (d) if so, the details thereof and if not, the reasons therefor; and
- (e) the current status of the availability of generic medicines in the country?

## ANSWER

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

(a)  &  (b):          'Life  Saving  drugs'  are  not  defined  in  the  Drugs  (Prices  Control) Order, 2013 (DPCO, 2013). The National Pharmaceutical Pricing Authority (NPPA) fixes  the  ceiling  prices  of  scheduled  formulations  as  adopted from  National  List  of Essential Medicines (NLEM) and included as Schedule - I of the DPCO, 2013.

The details of medicines under price control are as below:

(i)         The NPPA has fixed the ceiling prices of 530 scheduled formulations under NLEM, 2011. The details of reduction in prices of scheduled formulations effected under the DPCO, 2013 as compared to the highest price prevailed prior to the price fixation is as below:

| %reduction with respect to Maximum Price   |   No. of drugs |
|--------------------------------------------|----------------|
| 0<= 5%                                     |             80 |
| 5<=10%                                     |             50 |
| 10<=15%                                    |             57 |
| 15<=20%                                    |             43 |
| 20<=25%                                    |             65 |
| 25<=30%                                    |             49 |
| 30<=35%                                    |             26 |
| 35<=40%                                    |             34 |
| Above 40%                                  |            126 |
|                                            |            530 |

(ii)        Further, Schedule - I of the DPCO, 2013 was amended by adopting NLEM, 2015. TheNPPA has notified the ceiling prices  of 871 scheduled  formulations  under NLEM, 2015 including ceiling price of 5 medicines fixed recently in March, 2020. The details  of  reduction  in  prices  of  scheduled  formulations  effected  under  the  DPCO, 2013  as  compared  to  the  highest  price  prevailed  prior  to  the  price  fixation  is  as below :

| %reduction with respect to Maximum Price No. of   |   formulations |
|---------------------------------------------------|----------------|
| 0<= 5%*                                           |            241 |
| 5<=10%                                            |            138 |
| 10<=15%                                           |             99 |
| 15<=20%                                           |            100 |
| 20<=25%                                           |             92 |
| 25<=30%                                           |             69 |
| 30<=35%                                           |             46 |
| 35<=40%                                           |             26 |
| Above 40%                                         |             60 |
| Total formulations in NLEM, 2015                  |            871 |

(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%.

(c) & (d):         The fixation of the ceiling prices by the NPPA is an on-going process. As  and  when  the  formulations  are  included  in  the  National  List  of  Essential Medicines (NLEM), their prices are fixed by the NPPA.

(e):       The NPPA played a crucial role in ensuring the availability of essential drugs generic or branded at reasonable prices before and during the COVID-19 pandemic. Timely  and  effective  steps  were  taken  to  ensure  availability  of  drugs  during  the lockdown period throughout the country. Shortages of drugs reported were resolved in  coordination  with  the  State  Drug  Controllers,  ensuring  availability  of  medicines across  the  country.  The  office  of  Drug  Controller  General  of  India  (DCGI)  is  also monitoring the availability of critical drugs.

Further,  with  an  objective  of  making  quality  generic  medicines  available  at affordable prices to all, the Department of Pharmaceuticals has launched Pradhan Mantri  Bhartiya  Janaushadhi  Pariyojana  (PMBJP).  Under  this  scheme,  dedicated outlets  known  as  Pradhan  Mantri  Bhartiya  Janaushadhi  Kendras  (PMBJKs)  are opened to provide generic medicines at cheaper price to the citizens. The product basket  of  PMBJP  comprises  1250  medicines  and  204  surgicals  and  consumables covering all 37 major therapeutic groups such as Anti-infectives, Anti-allergic, Antidiabetics, Cardiovascular, Anti-cancers, Gastrointestinal medicines, Neutraceuticals, etc.  Presently,  825 medicines and 122 surgical  and consumables are available for sale at PMBJKs.

- *******