Lok Sabha Question No. 445 (UNSTARRED), answered on 2019-11-19
Subject: New Drugs in NLEM
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Dr. T. Sumathy (a) Thamizhachi Thangapandian

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

LOK SABHA UNSTARRED QUESTION No. 445 TO BE ANSWERED ON THE 19 th  November, 2019

## New Drugs in NLEM

## 445. DR. T. SUMATHY (a) THAMIZHACHI THANGAPANDIAN:

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

- (a) whether the Government has included cancer drugs as well as drugs for heart and lung ailment  under  the  Drug  Price  Control  Order  as  a  part  of  the  New  List  of  Essential Medicines;
- (b) if so, the details thereof;
- (c) whether the Government is aware that due to shortage of supply, life saving drugs are being sold at high prices in market by private pharma companies and by private hospitals;
- (d) the steps taken by the Government to ensure affordability and availability of drugs for cancer, lung and heart ailments in the country; and
- (e) the total volume and value of the cancer drugs produced and supplied in the country during the last five years along with imported drugs and medicine from countries abroad?

## ANSWER

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

- (a) & (b): Yes, Sir. The medicines for cancer, heart and lung ailment have been included in the  National  List  of  Essential  Medicines  (NLEM),  2015.  Details  of  prices  fixed  for  anticancer, heart and lung medicines is as follows:
- (c): The Government is not aware of any such report.
- (d): (i) National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling prices of 859  scheduled  formulations  and  Retail  prices  of  1067  new  drugs  under  para  2(u)  of DPCO'13 till 31 st October, 2019. These formulations include drugs for cancer, heart and lung ailments.
- (ii) The prices of non-scheduled formulations are monitored so that their MRP is not increased by more than 10% of MRP during preceding twelve months.
- (iii) NPPA has also fixed prices of 106 non-scheduled Anti-diabetics and Cardiovascular medicines under paragraph 19 of the Drugs (Prices Control) Order, 2013 in July, 2014.
- (iv) NPPA vide order SO 1041(E) dated 27 th February, 2019 put a cap on Trade Margin of  42  select  non-scheduled  anti-cancer  medicines  under  'Trade  Margin  Rationalisation'

|   S. No. | Particulars           |   No. of Formulations (Prices fixed by NPPA) |
|----------|-----------------------|----------------------------------------------|
|        1 | Anti-Cancer Medicines |                                           81 |
|        2 | Heart Medicines       |                                           70 |
|        3 | Lung Medicines        |                                           26 |

approach.  By  this  approach,  the  MRP  of  526  brands  of  these  medicines  have  been reduced by upto 90%. This move will result in an approx annual savings of around Rs. 984 crore to the patients.

- (e): As per the available data from various port offices of the Central Drugs Standard Control  Organization  (CDSCO),  the  total  volume  and  value  of  the  cancer  drugs  with quantum  and  value  of  imported  drugs  during  the  period  2014  to  2018  (January)  is  as under:

## Details of Import of Cancer drugs (Bulk Drugs):

|   Year |   Quantity (Kg) |   Value (Rs. in crore) |
|--------|-----------------|------------------------|
|   2014 |        15269    |                  29.24 |
|   2015 |        69628    |                  28.42 |
|   2016 |       141828    |                  58.51 |
|   2017 |       356387    |                  57.11 |
|   2018 |         2985.54 |                  86.27 |

## Details of Import of Cancer drugs (Finished Formulations):

|   Year | Quantity (Nos.)      |   Value (Rs. in crore) |
|--------|----------------------|------------------------|
|   2014 | 805189               |                 424.23 |
|   2015 | 1364869 +0.01kg      |                 855.01 |
|   2016 | 2153573              |                 914.54 |
|   2017 | 1532974 + 0.16005 kg |                 807.72 |
|   2018 | 1662577.00           |                  41.66 |

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