Date: 2014-08-07Category: Extra OrdinaryState: Union GovernmentCountry: India
The Central Govt, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, These rules may be called the Drugs and Cosmetics (3rd Amendment) Rules, 2014.
Executive Summary:
This notification announces the Drugs and Cosmetics 3rd Amendment Rules, 2014, which further amend the Drugs and Cosmetics Rules, 1945. The amendment mandates that applications for licenses for drug formulations containing a single active ingredient must be made using the proper name. These rules come into force on the date of publication in the Official Gazette. Licensees manufacturing single active ingredient drug formulations at the time of commencement of these rules have one year to apply for a license using the proper name.
Key Points / Main Content:
General:
* These rules are called the Drugs and Cosmetics 3rd Amendment Rules, 2014.
* The rules take effect on the date of their publication in the Official Gazette.
* Manufacturers of single active ingredient drug formulations at the commencement of the rules have one year to apply for a license using the proper name.
Amendments to the Drugs and Cosmetics Rules, 1945:
* Rule 71: After subrule 7, subrule 8 is inserted, stating applicants must apply for a license for single active ingredient drug formulations using the proper name.
* Rule 71A: After subrule 3, subrule 4 is inserted, stating applications for single active ingredient drug formulations must be made using the proper name.
* Rule 71B: After clause iv, a proviso is inserted, stating applications for single active ingredient drug formulations must be made using the proper name.
* Rule 76: After subrule 8, subrule 9 is inserted, stating applicants must apply for a license for single active ingredient drug formulations using the proper name.
* Rule 76A: A proviso is inserted, stating applications for single active ingredient drug formulations must be made using the proper name.
Impact Analysis:
Licensees Manufacturing Single Active Ingredient Drug Formulations:
Impact:
These licensees are affected by the new requirement to apply for licenses using the proper name for drug formulations containing a single active ingredient.
Action Required:
They must apply for a license for drug formulations containing single active ingredient in proper name within one year of the commencement of these rules.
Applicants for Drug Licenses:
Impact:
Applicants are affected by the new requirement to apply for licenses using the proper name for single-ingredient drug formulations
Action Required:
Applicants must adhere to the new regulation when applying for licenses for single active ingredient drug formulations.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics in India, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament regulating the import, manufacture, distribution and sale of drugs and cosmetics. Sections 12 and 33 of the act are mentioned in the notification.
Drugs Technical Advisory Board: A board consulted by the Central Government in making amendments to the Drugs and Cosmetics Rules, 1945.
Central Government: The governing authority responsible for making and implementing the rules.
Drugs and Cosmetics 3rd Amendment Rules, 2014: The title of the new rules that amend the Drugs and Cosmetics Rules, 1945.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India. The Department of Health and Family Welfare is a department within this ministry.
New Delhi: The location where the notification was issued. New Delhi is the capital of India.
Official Gazette: A public journal, and statutory instrument of the government in India
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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33 (cid:20)ारा (cid:11)द? शि$य(cid:28) का (cid:11)योग करते @ए, औषिध तकनीक(cid:19) सलाहकार बोड 6 स े परामश6 करने के पAच ात् , औषिध और
(cid:11)साधन साम(cid:17)ी िनयम, 1945 का और संशोधन करने के िलए िनCिलिखत िनयम बनाती ह,ै अथा6त ्:—
3129 GI/2014 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
1. (1) इन िनयम(cid:28) का संि(cid:27): नाम औषिध और (cid:11)साधन साम(cid:17)ी (तृतीय संशोधन) िनयम, 2014 ह ै।
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कर(गे ।
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"(8) आवेदक एकल सK(cid:19)य संघटक अंतGवH करने वाली औषिध िविनGमित क(cid:19) अनुIि: (cid:11)दान करने के िलए
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जाएगा, अथा6त ्:—
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[फा. सं. ए1स-11014/5/2011-डीएफ1यूसी]
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 7th August, 2014
G.S.R. 570(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,
1945, was published, as required by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940),
vide the notification of the Government of India in the Ministry of Health and Family Welfare (Department of
Health), published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number
G.S.R. 748(E), dated the 5th October, 2012, inviting objections and suggestions from all 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 the copies of the Gazette in which the said notification was published were made
available to the public on the 5th October, 2012;
And whereas, the Drugs Technical Advisory Board has been consulted in the matter;
And whereas, the objections and suggestions received from the public on the said draft rules were
considered by the Central Government;
Now, therefore, in exercise of the powers conferred by 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 (3rd Amendment) Rules, 2014.
(2) They shall come into force on the date of their publication in the Official Gazette.
(3) Notwithstanding anything contained in sub-rule (2), the licensees who are manufacturing single
active ingredient drug formulation on the commencement of these rules shall make application
for grant of licence for the drug formulation containing single active ingredient in proper name
within one year of the commencement of these rules.
2. In the Drugs and Cosmetics Rules, 1945,—
(a) in rule 71, after sub-rule (7), the following sub-rule shall be inserted, namely:—
“(8) The applicant shall make application for grant of licence for a drug formulation
containing single active ingredient only in proper name.”;
(b) in rule 71A, after sub-rule (3), and before the proviso, the following sub-rule shall be
inserted, namely:—
“(4) The application for grant of licence for a drug formulation containing single active
ingredient shall be made only in proper name.”;
(c) in rule 71B, after clause (iv), the following proviso shall be inserted, namely:—4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
“Provided that the application for grant of a licence for a drug formulation containing single
active ingredient shall be made only in proper name.”;
(d) in rule 76, after sub-rule (8), the following sub-rule shall be inserted, namely:—
“(9) The applicant shall make application for grant of licence for a drug formulation
containing single active ingredient only in proper name.”;
(e) in rule 76A, the following proviso shall be inserted, namely:—
“Provided that the application for grant of a licence for a drug formulation containing single
active ingredient shall be made only in proper name.”
[F. No. X.-11014/5/2011-DFQC]
K. L. SHARMA, Jt. Secy.
Note : The principal rules were published in the Gazette of India, vide notification No. F. 28-10/45-H (1), dated
the 21st December, 1945 and last amended by notification published in the Gazette of India,
Extraordinary, Part II, Section 3, sub-section (i), vide number G.S.R. 346(E), dated the 21st May, 2014.
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.