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 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 8th August, 2019. G.S.R. 567(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to public; Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government; Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in. DRAFT RULES 1.            (1) These rules may be called the Drugs and Cosmetics (......Amendment) Rules, 2019.  (2) They shall come into force on the date of their final publication in the Official Gazette. 2.            In the Drugs and Cosmetics Rules, 1945, in rule 96, after sub-rule (4), following sub-rule shall be inserted, namely:- “(5) Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing. The stored data or information shall include the following minimum particulars, namely:- (i)Unique product identification code, (ii)Name of the API, (iii)Brand name (if any), (iv)Name and address of the manufacturer, (v) Batch no., (vi)Batch size, (vii)Date of manufacturing, (viii)Date of expiry or retesting, (ix)Serial shipping container code, (x)Manufacturing licence no. or import licence no. (xi)Special storage conditions required (if any).”. [F. No. X.11014/17/2019-DR] Dr. MANDEEP K BHANDARI, Jt. Secy.