Lok Sabha Question No. 1413 (UNSTARRED), answered on 2020-02-11
Subject: List of Essential Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Su Thirunavukkarasar

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

LOK SABHA UNSTARRED QUESTION NO. 1413 TO BE ANSWERED ON 11 th  February, 2020

## List of Essential Medicines

## 1413. SHRI THIRUNAVUKKARASAR SU:

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

- (a)  whether  the  Government  has  included  cancer  and  diabetes  drugs  as  well  as medicines for heart and lung ailments under the Drug Price Control Order as a part of the New List of Essential Medicines and if so, the details thereof;
- (b)  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;
- (c) the steps taken by the Government to ensure affordability and availability of drugs for cancer, diabetes, lung and heart ailments; and
- (d) the total volume and value of the cancer drugs produced and supplied within the country during the last five years and those of imported drugs and medicines from countries abroad?

## ANSWER

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

- (a): Medicines for Cancer, Diabetes, Heart and Lung ailments have been included in National List of Essential Medicines (NLEM), 2015 and listed in Section 8, 12, 21.4 and  28  of  Schedule  -  I  of  Drugs  (Prices  Control)  Order,  2013  (DPCO,  2013) respectively.
- (b): No, Sir. National Pharmaceutical Pricing Authority (NPPA) is not aware of any such report on drugs being sold at high price due to shortage of supply.
- (c): NPPA  has  fixed  the  ceiling  price  of  medicines  included  in  Schedule-I  of DPCO,  2013  (NLEM,  2015)  relating  to  treatment  of  Cancer,  diabetes,  Heart  and Lung ailments for making them affordable to patients, as detailed below:
- (ii) The prices of non-scheduled formulation 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 Drugs Prices Control Order, 2013 in July, 2014.
- (iv) NPPA has fixed ceiling price of Cardiac Stents being scheduled formulation under DPCO, 2013 affecting price reduction for Coronary Stents worked out up to 85%  for  Bare  Metal  Stents  and  74%  for  Drug  Eluting  Stents . This  has  ensured notional saving of around Rs. 4500 crore to the patients.
- (v) NPPA has put a cap on Trade Margin of 42 select non-scheduled anti-cancer medicines  under  'Trade  Margin  Rationalisation'  Approach  in  February,  2019.  The MRP of  526  brands  of  these  medicines  have  been  reduced  by  upto  90%  by  this approach. This has ensured an approx annual savings of around Rs. 984 crore to the patients.

|   S. No. | Particulars           |   No. of Formulations (Prices fixed by NPPA) |
|----------|-----------------------|----------------------------------------------|
|        1 | Anti-Cancer Medicines |                                           81 |
|        2 | Diabetes Medicine     |                                           12 |
|        3 | Heart Medicines       |                                           70 |
|        4 | Lung Medicines        |                                           25 |

The availability of scheduled medicines is regularly monitored by the NPPA. Whenever shortage  is  reported  by  the  State  Drug  Controllers  or  when  the  matter comes to the notice of NPPA through references received from Ministry of Health or NGOs or through individual complaints or through Pharma Jan Samadhan portal of NPPA,  remedial  steps  are  immediately  taken  for  ensuring  availability  of  drugs  by impressing upon concerned companies to rush the stocks to the places of shortage.

(d): As  per  available  data  from  various  port  offices  of  Central  Drugs  Standard Control Organization (CDSCO), the total volume and value of the cancer drugs with quantum and value of imported drugs are attached as Annexure.

Annexure Details of Import of Cancer drugs (Bulk Drugs)

|   Year |   Quantity (Kg) |   Value (Rs) |
|--------|-----------------|--------------|
|   2015 |        69628    |    284206651 |
|   2016 |       141828    |    585158510 |
|   2017 |       356387    |    571134825 |
|   2018 |         2985.54 |    862786496 |
|   2019 |         5837.71 |    408403831 |

Details of Import of Cancer drugs (Finished Formulations)

|   Year | Quantity (Nos/Pcs/Units.)   | Value (Rs)       |
|--------|-----------------------------|------------------|
|   2015 | 1364869 +0.01kg             | 855,01,30,314.63 |
|   2016 | 2153573                     | 914,54,13,020.67 |
|   2017 | 1532974 +0.16005 kg         | 807,72,74,923.85 |
|   2018 | 1662577.00                  | 41,66,27,372.29  |
|   2019 | 1114977                     | 9399248985       |

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