The Ministry of Health and Family Welfare (MoHFW), on June 14, 2022, published the draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make. The 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 the 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.
the following sub-rule shall be inserted, namely: —
(5A) The manufacturers of drug formulation products as specified in the Schedule H2 of the said rule, shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in the primary package label, on the secondary package label that store data or information legible with the software application to facilitate authentication. The stored data or information shall include the following particulars, namely: —
(i)Unique product identification code,
(ii)Proper and generic name of the drug,
(iii)Brand name,
(iv)Name and address of the manufacturer,
(v)Batch number,
(vi)Date of manufacturing,
(vii)Date of expiry, Manufacturing license number
In the said rules, after schedule H1, schedule H2 shall be inserted.
They shall come into force on the First day of May 2023.
[G.S.R. 448(E)]
