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(1) (API) Active pharmaceutical ingredients or bulk drug: Any pharmaceutical, chemical, biological or plant product including its salts, esters, isomers, analogues and derivatives, conforming to standards specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and which is used as such or as an ingredient in any formulation.

(2) Brand: A name, term, design, symbol, trademark or any other feature that identifies one seller’s drug as distinct from those of other sellers.

(3) Ceiling price: A price fixed by the Government for Scheduled formulations in accordance with the provisions of THE DRUGS (PRICES CONTROL) ORDER, 2013.

(4) Dealer: A person carrying on the business of purchase or sale of drugs, whether as a wholesaler or retailer and includes his agent.

(5) Distributor:  A person engaged in the work of distribution of drugs and includes an agent or a stockist for stocking drugs for sale to a dealer.

(6) Existing manufacturer: means manufacturer existing on the date of publication of this order in the Official Gazette, THE DRUGS (PRICES CONTROL) ORDER, 2013.

(7) Formulation: A medicine processed out of or containing one or more drugs with or without use of any pharmaceutical aids, for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease and, but shall not include – (i) any medicine included in any bonafide Ayurvedic (including Sidha) or Unani (Tibb) systems of medicines; (ii) any medicine included in the Homeopathic system of medicine; and (iii) any substance to which the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) do not apply

(8) Generic version of a medicine: A formulation sold in pharmacopeial name or the name of the active pharmaceutical ingredient contained in the formulation, without any brand name.

(9) Government: means the Central Government.

(10) Import: with its grammatical variations and cognate expressions means bringing a drug into India from a place outside India for its sale.

(11) Local taxes: Any tax or levy (except excise or import duty included in retail price) paid or payable to the Government or the State Government or any local body under any law for the time being in force by the manufacturer or his agent or dealer.

(12) Manufacturer: Any person who manufactures or imports or markets drugs for distribution or sale in the country.

(13) Market share: The ratio of domestic sales value (on the basis of moving annual turnover) of a brand or a generic version of a medicine and the sum of total domestic sales value of the all brands and generic versions of that medicine sold in the domestic market having same strength and dosage form.

(14) Margin to retailer: Percentage of price to retailer like 15% of Price Rs. 100 = Rs. 15.

(15) Market based data: means the data of sales related to a drug collected or obtained by the Government as deemed fit, from time to time.

(16) Maximum retail price: The ceiling price or the retail price plus local taxes and duties as applicable, at which the drug shall be sold to the ultimate consumer and where such price is mentioned on the pack.

(17) Moving annual turnover: In a particular month means cumulative sales value for twelve months in domestic market, where the sales value of that month is added and the corresponding sales of the same month in the previous year are subtracted.

(18) National List of Essential Medicines (NLEM): National List of Essential Medicines, 2011 published by the Ministry of Health and Family Welfare as updated or revised from time to time and included in the first schedule of this order by the Government through a notification in the Official Gazette.

(19) New drug: A formulation launched by an existing manufacturer of a drug of specified dosages and strengths as listed in the National List of Essential Medicines by combining the drug with another drug either listed or not listed in the National List of Essential Medicines or a formulation launched by changing the strength or dosages or both of 1 Substituted vide GSR 1233 (E), w.e.f. 08-05-2015 the same drug of specified dosages and strengths as listed in the National List of Essential Medicines.

(20) Non-scheduled formulation: A formulation, which is not included in Schedule of THE DRUGS (PRICES CONTROL) ORDER, 2013.

(21) Pharmacoeconomics: A scientific discipline that compares the therapeutic value of one pharmaceutical drug or drug therapy to another.

(22) Price to retailer: The price of a drug at which it is sold to a retailer which includes duties and does not include local taxes.

(23) Retail price: The price fixed by the Government for a new drug.

(24) Retailer: A dealer carrying on the retail business of sale of drugs to customers

(25) Scheduled formulation: Any formulation, included in the First Schedule whether referred to by generic versions or brand name.

(26) Wholesaler: means a dealer or his agent or a stockist engaged in the sale of drugs to a retailer, hospital, dispensary, medical, educational or research institution or any other agency.

(27) Wholesale price index: means annual wholesale price index of all commodities as announced by the Department of Industrial Policy and Promotion, Government of India, from time to time.

 

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