Question : PRICES OF LIFE SAVING MEDICINES

(a) the steps taken by the Government to reduce the prices of life saving medicines including those medicines for cancer, heart and kidney patients;

(b) whether the Government has noticed that some drug manufacturers are introducing in the markets, combinations of chemicals for treatment of various diseases thereby trying to defeat the move of the Government to reduce prices of a particular drug;

(c) if so, the reaction of the Government thereto;

(d) whether the Government proposes to issue licence to a particular drug for treatment of a particular disease and indicate the chemical name of the drugs on the cover of the medicine; and

(e) if so, the details thereof ?

MINISTER OF STATE (INDEPENDENT CHARGE) IN THE MINISTRY OF CHEMICALS AND FERTILIZERS AND MINISTER OF STATE (INDEPENDENT CHARGE) IN THE MINISTRY OF STATISTICS AND PROGRAMME IMPLEMENTATION (SHRI SRIKANT KUMAR JENA)

(a): The Government notified Drugs Prices Control Order,2013 vide which all the medicines specified in the National List of Essential Medicines 2011 (NLEM) have been brought under price control. There are 614 formulations specified in the first schedule of DPCO,2013 covering 27 therapeutic groups including medicines used in the treatment of cancer, Heart and kidney.

(b) and (c): The drugs are permitted to be manufactured only after the grant of manufacturing license for the drug product by the State Drugs Control Authorities appointed by the State Government. The fixed dose combination of two or more drugs, individually approved earlier for certain claims, which is now proposed to be combined for the first time in a fixed ratio, is considered as a new drug under the Drugs and Cosmetics Rules, 1945 and is permitted to be manufactured in the country only after it is duly approved by the office of DCG(I) for marketing in the country after examination of its safety and efficacy.

(d) and (e): Rule 96 of Drugs and Cosmetics Rules, 1945 prescribes the manner of labelling and provides that the proper name of the drug shall be printed or written in a more conspicuous manner than the trade name on the label of the drug. There is no proposal under consideration to amend the said rules.