**Executive Summary:**
This notification announces amendments to the Drugs and Cosmetics Rules, 1945, as per the Drugs and Cosmetics Act, 1940. These amendments follow a draft publication on July 30, 2018, and consideration of public feedback. The amendments, called the Drugs and Cosmetics Ninth Amendment Rules, 2018, are effective from the date of their publication in the Official Gazette.
**Key Points / Main Content:**
* **Amendments:** The Drugs and Cosmetics Rules, 1945 are amended.
* **Rule 127 Amendment:** In rule 127, subrule 2, the following words are inserted at the end: "except gelatine capsules wherein approved or permitted colour shall be used."
* **Nomenclature:** These rules are called the Drugs and Cosmetics Ninth Amendment Rules, 2018.
* **Effective Date:** The rules come into force on the date of their publication in the Official Gazette.
**Impact Analysis:**
* **Drug Manufacturers (Gelatine Capsules):**
* *Impact:* Must comply with the amended rule regarding the use of approved or permitted colors in gelatine capsules.
* *Action Required:* Ensure only approved or permitted colors are used in gelatine capsules.
* **Regulatory Bodies (Central Government, Drugs Technical Advisory Board):**
* *Impact:* Responsible for enforcing the amended rules and providing guidance.
* *Action Required:* Implement and enforce the new regulations.
* **Public:**
* *Impact:* Benefits from regulated use of colors in gelatine capsules.
* *Action Required:* Be aware of the updated regulations.
Key Entities Referenced
New Delhi: The capital city of India, mentioned as the place of publication.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India, issuing the notification.
Department of Health and Family Welfare: A department within the Ministry of Health and Family Welfare.
Drugs and Cosmetics Rules, 1945: A set of rules pertaining to the regulation of drugs and cosmetics in India, being amended by this notification.
Drugs and Cosmetics Act, 1940: The act of the Indian Parliament which regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Central Government: The government of India, responsible for considering objections and suggestions and exercising powers under the Drugs and Cosmetics Act, 1940.
Drugs Technical Advisory Board: A board consulted by the Central Government in amending the Drugs and Cosmetics Rules, 1945.
Drugs and Cosmetics Ninth Amendment Rules, 2018: The title of the amendment rules being introduced by this notification.
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[एफ.सं. ए6स .11014/15/2018-डीआर]
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 7th December, 2018
G.S.R. 1186(E).—Whereas the draft of certain rules further to amend the Drugs and Cosmetics Rules,
1945 was published as required under section 12 and 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. 721(E), dated the 30th July, 2018, 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 forty-five 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 Gazette were made available to the public on the 3rd August, 2018;
And whereas, objections and suggestions received from the public on the said rules have been duly
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 and Cosmetics Rules, 1945,
namely:―
1. (1) These rules may be called the Drugs and Cosmetics (Ninth Amendment) Rules, 2018.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, in rule 127, in sub-rule (2), at the end, the following words
shall be inserted, namely:―
“except gelatine capsules wherein approved or permitted colour shall be used”.
[F. No. X.11014/15/2018 -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. 1161(E), dated the
3rd December, 2018.
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.