Important Definitions

IMPORTANT DEFINITIONS

(i) Bulk Drug: It means any pharmaceutical, chemical, biological or plant product or medicinal gas conforming to Pharmacopoeal or other standard accepted under DCA, 1940 which is used in any formulations.

(ii) Formulation: It means a medicine processed out of or containing one or more of bulk drugs with or without the use of pharmaceutical aids for internal or external use for or in the diagnosis, treatment, mitigation, or prevention of disease in human beings or animals, but shall not include any bonafide Ayurvedic, Siddha, Unani, Tibbi and Homeopathic Systems of Medicine. It also does not include any substance to which provisions of DCA, 1940 do not apply

(iii) Ceiling Price : This is the price fixed by Government for Scheduled formulations in accordance with the provisions of the Order.

(iv) Drug It includes:

(a) all medicines for internal or external use of human beings or animals and all substances useful in diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals including insect repellent preparations,

(b) any substance capable of affecting any function of human or animal body or used for destruction of insect or vermin which cause disease in human beings or animals, and

(c) bulk drugs and their formulations.

(v) Manufacture:

In relation to any drug under DPCO includes any process or part of a process for making, altering, finishing, packing, labeling, breaking up or otherwise, treating, or adapting any drug with a view to its sale and distribution, but, doesn't include the compounding or dispensing or packing of any drug in the course ofretail business.

(vi) Scheduled Bulk Drug : It means the bulk drug specified in First schedule to the DPCO.

(vii) Non-Scheduled Bulk Drug: It means a bulk drug not specified in the First Schedule to DPCO.

(viii) Pre-tax Return: It means profits before payment of income tax and sur-tax and includes such other expenses as do not form part of the cost of the formulation.

(ix) Sale Turnover: It means the product of units of formulation sold by manufacturer or an importer, as the case may be, in one accounting year, multiplied by retail price inclusive of sales tax, if only.

(x) Retailer: It means a dealer carrying on the retail business of sale of drugs and cosmetics.

(xi) Wholesaler: It means a dealer or his agent or a stockist appointed by a manufacturer or an importer for the sale of his drugs to a retailer, hospital, dispensary, medical educational or research institution purchasing bulk quantities of drugs.