Lok Sabha Question No. 2375 (UNSTARRED), answered on 2018-01-02
Subject: Inclusion of Drugs in NLEM
Ministry: CHEMICALS AND FERTILIZERS
Asked by: V. SATHYABAMA, R.K. BHARATHI MOHAN

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

LOK SABHA UNSTARRED QUESTION No. 2375

TO BE ANSWERED ON THE 2 nd  January, 2018

## Inclusion of Drugs in NLEM

2375. SHRIMATI V. SATHYA BAMA: SHRI BHARATHI MOHAN R.K.:

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

- (a) whether the Government has included the cancer drugs as well as drugs 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, lung and heart ailments in the country; and
- (d) the total volume and value of the cancer drugs produced and supplied from within  the  country  along  with  the  quantum  and  value  of  imported  drugs  and medicine from countries abroad during the last three years?

## ANSWER

## MINISTER  OF  STATE  IN  THE  MINISTRY  OF  ROAD  TRANSPORT  AND HIGHWAYS;  MINISTRY  OF  SHIPPING  AND  MINISTRY  OF  CHEMICALS AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

- (a): Yes, Madam. The Drugs (Prices Control) Order, 2013 (DPCO-2013) includes various  medicines  under  Anti-Cancer  (72  formulations),  Cardio  Vascular  (65 formulations), Anti-TB (Lung)(28 formulations) and Anti-Viral (HIV) (41 formulations) in Schedule-1 for price control.
- (b): No such report has been received in the Department.
- (c): National  Pharmaceutical  Pricing  Authority  has  fixed  the  ceiling  prices  of medicines appearing in various strength / dosages form in Schedule-I of DPCO, 2013 which also includes medicines used for cancer, lung and heart ailments. Further, the DPCO, 2013 has provisions under which the Government can fix the ceiling price of any drug in public interest. Till December 2017, the government has fixed the ceiling prices of 851 medicines under revised Schedule - I based on National List of Essential Medicines, 2015 (NLEM, 2015) which also includes drugs used for cancer, heart and lung ailments. The Government by implementing the provisions of DPCO, 2013 has helped the consumers make the following savings:-

| Particulars                              | Saving to Consumers in Rs. Crores   |
|------------------------------------------|-------------------------------------|
| NLEM 2011                                | 2,422.24                            |
| NLEM 2015                                | 2,643.37                            |
| NLEM 2015 - Coronary Stents              | 4,450.00                            |
| Para 19 - Knee Implants                  | 1,500.00                            |
| Para 19 - Cardio and Anti Diabetic drugs | 350.00                              |
| Grand Total                              | 11,365.61                           |

Further,  the  Government  had  issued  a  compulsory  license  for  a  drug 'NEXAVAR' used for the treatment of cancer. The patent is held by M/s Bayer Corporation. After the issue of the compulsory license, the Indian company M/s Natco Pharma Ltd. has been able to sell the medicine at a much lower.

(d): No such data is maintained in the Department. However, 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 during the period 2014 to 2017 (till date) is as under:

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

| Year           |   Quantity (Kg) |   Value (Rs. in crore) |
|----------------|-----------------|------------------------|
| 2014           |           15269 |                   29.2 |
| 2015           |           69628 |                   28.4 |
| 2016           |          141828 |                   58.5 |
| 2017 till date |          356387 |                   57.1 |

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

| Year           | Quantity (Nos.)      |   Value (Rs. in crore) |
|----------------|----------------------|------------------------|
| 2014           | 805189               |                    424 |
| 2015           | 1364869 +0.01kg      |                    855 |
| 2016           | 2153573              |                    915 |
| 2017 till date | 1532974 + 0.16005 kg |                    808 |

xxxxx