Question : New Drugs in NLEM

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?

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 anti-cancer, heart and lung medicines is as follows:

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

(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 31st 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 27th February, 2019 put a cap on Trade Margin of 42 select non-scheduled anti-cancer medicines under ‘Trade Margin Rationalisation’ 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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