Drugs (Amendment) Rules, 2022

[18 January 2022]

G.S.R. 20(E).- Whereas a draft of certain rules further to amend the Drugs Rules, 1945, was published as required under sub-section(1) of section 12 and sub-section(1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 567(E), dated the 8th August, 2019, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And whereas, copies of the said Official Gazette were made available to the public on the 10th August, 2019;

And whereas, objections and suggestions received from the public on the said rules have been considered by the Central Government;

Now, therefore, in exercise of the powers conferred under sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:-

Rule 1. :-

(1)     These rules may be called the Drugs (Amendment) Rules, 2022.

(2)     They shall come into force on the first day of January, 2023.

Rule 2. :-

In the Drugs 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).".