Lok Sabha Question No. 39 (STARRED), answered on 2020-02-04
Subject: Anti-diabetic and Cardiac Care Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Sudheer Gupta, Gajanan Chandrakant Kirtikar

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

LOK SABHA STARRED QUESTION NO. *39

TO BE ANSWERED ON 4 th  February, 2020

## Anti-diabetic and Cardiac Care Drugs

## *39. SHRI SUDHEER GUPTA: SHRI GAJANAN KIRTIKAR:

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

- (a) whether as per a market research the sale of anti-diabetic and cardiac care drugs in India in 2019 grew at the fastest rate during the last three years;
- (b) if so, the details thereof and the reasons for such increase;
- (c) whether India is home to one of the largest number of diabetes patients in the world, while heart diseases are one of the biggest causes of death in the country;
- (d)  if  so,  whether  the  Government  has  taken  any  steps  regarding  production  of  such drugs and checking the overcharging by the pharmaceutical companies in the country and if so, the details thereof; and
- (e)  the  steps  taken  by  the  Government  to  bring  all  such  drugs  under  the  National Pharmaceutical Pricing Authority (NPPA) to regulate and put a check on the pricing of the said drugs?

## ANSWER

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

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

## Statement referred to in reply to Lok Sabha Starred Question No. *39 for answer on 04/02/2020 regarding Anti-diabetic and Cardiac Care Drugs.

(a) & (b): According  to  market  research  organization  All  Indian  Origin  Chemists  & Distributors Limited (AIOCD)  Advanced  Working, Action & Correction  System (AWACS), Anti-diabetic medicine  sales  rose  12.6%  year-on-year,  with  a  new  class  of drugs  called  SGLT2  (sodium-glucose  co-transporter  2)  inhibitors  driving  growth,  while cardiac care drugs rose 11.7%. Among cardiac medicines, it was the combination drug of sacubitril and valsartan that led sales growth.

The growth in Anti-diabetic medicines was 13.4%, 12.9% & 12.6% for year 2017, 2018 and 2019 respectively on year to year basis. Further, the growth in Cardiac Care medicines was 5.5%, 10.7% & 11.7% for year 2017, 2018 and 2019 respectively on year to year basis.

- (c): Yes, Sir. India is home to one of the largest number of diabetes patients in the world estimated to be over 70 million, while heart diseases are known to be one of the biggest causes of death in the country.
- (d): National  Pharmaceutical  Pricing  Authority  (NPPA)  monitors  the  prices  of  both scheduled  and  non-scheduled  formulations  (including  Anti-diabetic  and  Cardiac  Care 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.

NPPA  has  detected and issued about 162 demand  notices against the pharmaceutical companies for overcharging consumers on the sale of Anti-diabetic and Cardiac Care formulations whose prices were fixed under para 19 of the Drugs (Prices Control) Order, 2013 (DPCO, 2013). Demand Notices have been issued for total amount of  Rs.  808.16 crore and an amount of Rs. 245.96 crore has been recovered from the Pharma  Companies  for  violation  of  price  fixed  under  para  19.  The  company  wise detailed list of overcharging cases for violation of ceiling price and price fixed under para 19  (Anti-diabetic  and  Cardiac  Care  formulations)  where  demand  notices  have  been issued is available on NPPA's website www.nppaindia.nic.in.

(e): NPPA has fixed the ceiling  price  of  860  formulations  included  in  Schedule-I  of DPCO, 2013 which also includes medicines relating to treatment of diabetes and cardiac problems as detailed below:

|   S. No. | Particulars             |   Medicines in NLEM,15 |   No. of Formulations (Prices fixed by NPPA) |
|----------|-------------------------|------------------------|----------------------------------------------|
|        1 | Anti-diabetic Medicines |                      6 |                                           12 |
|        2 | Cardiac Medicines       |                     30 |                                           70 |

NPPA  has  also  capped  the  prices  of  106  formulations  related  to  treatment  of diabetes and cardiovascular diseases under para 19 of DPCO, 2013 vide order dated 10th July, 2014.

Also, NPPA has fixed the price of coronary stents vide order dated 13 th February, 2017. By this, the price for coronary stents was reduced upto 85% for Bare Metal stents and  74% for Drug Eluting Stents. This has resulted in saving of Rs. 4547 crore annually to the consumers/patients.

Further, NPPA monitors the prices of non-scheduled formulations as per para 20 of DPCO, 2013 so that their MRP does not increase by more than 10% of MRP during preceding 12 months.

*****