Draft Drugs and Cosmetics (Amendment) Rules 2019

Aug 12, 2019 | by Avantis RegTech Legal Research Team

The Ministry of Health and Family Welfare (MoHFW) on August 08, 2019, in consultation with the Drugs Technical Advisory Board hereby published the draft Drugs and Cosmetics (Amendment) Rules, 2019 to further amend the Drugs and Cosmetics Rules, 1945. It will come into force on the date of its final publication in the Official Gazette that is August 09, 2019.

The amendments made in the Drugs and Cosmetics Rules, 1945 are:

 A new sub-rule Rule 96(5) has been inserted, which specifies that 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).

The objections and suggestions are invited from persons likely to be affected thereby, before the expiry of a period of 30 days from the date on which the copies of the Official Gazette containing the said Notification were made available to the public. The 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 [email protected]

[Notification No. G.S.R. 567(E)]


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