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Union of India - Section

Section 161A in The Drugs and Cosmetics Rules, 1945

161A. [ Exemption in labelling and packing provisions for export of Ayurvedic (including Siddha) and Unani drugs. [Inserted by G.S.R. 787(E), dated 17.10.2000 (w.e.f. 17.10.2000).]

(1)Labels and packages or containers of Ayurvedic, Siddha and Unani Drugs for export may be adapted to meet the specific requirements of the law of the country to which the said drug is to be exported, but the following particulars shall appear in conspicuous position on the container in which drug is packed and on every other covering in which that container is packed, namely:-
(a)name of the Ayurvedic, Siddha and Unani drug (single or compound formulations);
(b)the name, address of the manufacturer and the number of license under which the drug has been manufactured;
(c)batch or lot number;
(d)date of manufacture, alongwith date for "Best for use before".
(e)main ingredients, if required by the importing country;
(f)for export:
Provided that where Ayurvedic, Siddha and Unani single or compound drug not classified under the First Schedule or Schedule E(1), is required by the consignee to be not labelled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the licensing authority mentioned in rule 152.
(2)The provisions of rule 161 shall not apply to a medicine made up "ready for treatment," whether after, or without, alteration, which is supplied on the prescription of a registered medical practitioner, if the medicine is labelled with the following particulars, namely:-
(a)the name and address of the suppliers;
(b)the words "For external use only", if the medicine is for external application.]