Executive Summary:
This notification from the Ministry of Health and Family Welfare publishes draft rules to further amend the Drugs and Cosmetics Rules, 1945. It proposes that all active pharmaceutical ingredients (API) or bulk drugs manufactured or imported in India should bear a Quick Response (QR) code on their label at each level of packaging. The draft rules will be considered after 30 days from the date the notification is available to the public, and objections or suggestions can be sent to the Under Secretary Drugs.
Key Points / Main Content:
* **Purpose:** To amend the Drugs and Cosmetics Rules, 1945.
* **Effective Date:** The rules will come into force upon final publication in the Official Gazette.
* **Amendment to Rule 96:** After sub-rule 4, a new sub-rule will be inserted.
* **QR Code Requirement:** Every active pharmaceutical ingredient (API) or bulk drug manufactured or imported in India must have a Quick Response (QR) code on its label at each level of packaging.
* **QR Code Information:** The QR code must store data or information readable with a software application to facilitate tracking and tracing.
* **Minimum Particulars for QR Code:**
* Unique product identification code
* Name of the API
* Brand name (if any)
* Name and address of the manufacturer
* Batch no.
* Batch size
* Date of manufacturing
* Date of expiry or retesting
* Serial shipping container code
* Manufacturing licence no. or import licence no.
* Special storage conditions required (if any)
Impact Analysis:
**Manufacturers of Active Pharmaceutical Ingredients (APIs) / Bulk Drugs:**
* Impact: Must implement QR codes on all levels of packaging for APIs/bulk drugs manufactured in India, including specific data points in the code.
* Action Required: Update packaging processes to include QR codes with the required information, ensuring readability with software applications.
**Importers of Active Pharmaceutical Ingredients (APIs) / Bulk Drugs:**
* Impact: Imported APIs/bulk drugs must have QR codes on all levels of packaging.
* Action Required: Ensure that APIs/bulk drugs imported into India have QR codes meeting the specified requirements.
**Central Government:**
* Impact: Will consider objections and suggestions to the draft rules.
* Action Required: Review and address any objections or suggestions received within the specified period. Finalize and publish the amended rules in the Official Gazette.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: The principal act under which the Drugs and Cosmetics Rules are framed.
Central Government: The governing body responsible for making the amendments to the Drugs and Cosmetics Rules.
Drugs Technical Advisory Board: An advisory board consulted by the Central Government regarding the Drugs and Cosmetics Rules.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare in India, which includes the Department of Health and Family Welfare.
Active Pharmaceutical Ingredient: Bulk drug manufactured or imported in India.
Quick Response code: A machine-readable code containing data about the Active Pharmaceutical Ingredient (API).
New Delhi: The location where the notification was issued.
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[फा. सं. एbस .11014/17/2019–डीआर]
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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.¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
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.
Note: The principal rules were published in the Gazette of India vide notification number F. 28-10/45-H (1),
dated the 21st December, 1945 and last amended vide notification number G.S.R. ……(E),
dated …….
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.