Question : Inclusion of Drugs in NLEM

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?

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:-
..2/-

-2-
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





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