Allahabad HC: MPs, Judges and Ministers May Use ‘Hon’ble’; Civil Servants are Not Entitled to it  ||  Calcutta HC: Salary Withholding and Harassment Claims are Not Defamation Without Reputational Harm  ||  Gauhati HC: Officer Resigning Without New Govt Appointment Cannot Claim Pension under Assam Service  ||  MP HC: Attachment & Auction are Quasi-Judicial Duties of Tehsildar; Action Invalid Without Mala Fide  ||  Supreme Court: Fence-Sitters Cannot Raise Seniority Disputes Once Third-Party Rights are Settled  ||  SC: Medical Negligence Claims Can be Filed Against Deceased Doctor’s Legal Heirs Who Inherit Estate  ||  Supreme Court: Bail Must Be Considered if Speedy Trial Rights are Violated, Regardless of Offence  ||  Supreme Court: Article 226 Cannot be Used to Seek FIR Registration Without Exhausting Remedies  ||  SC: Dowry Deaths Remain a Grave Social Issue, Especially in Uttar Pradesh, Bihar, and Karnataka  ||  Supreme Court Outlines Principles Governing Exercise of Jurisdiction under Article 227    

Drugs and Cosmetics (5th Amendment) Rules, 2017- (Ministry of Health and Family Welfare) (15 Mar 2017)

MANU/HFAM/0030/2017

Civil

Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published as required by 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. 44(E), dated the 17th January, 2017, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), dated the 17th January, 2017, 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 Gazette were made available to the public on 17th January, 2017;

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 section 12 and section 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 (5th Amendment) Rules, 2017.

(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 3A, in sub-rule (8), in clause (b), after item (5) and the entries relating thereto, the following shall be inserted, namely:-

"(6) Enzyme and Hormones such as-

(a) Streptokinase (Natural and Recombinant);

(b) Human Chorionic Gonadotropin (hCG);

(c) Human Menopausal Gonadotropin (hMG).

(7) Bacterial vaccine such as-

(a) Bacillus Calmette-Guerin (BCG) vaccine.

(8) Viral vaccines such as-

(a) Live attenuated Measles vaccine;

(b) Live attenuated Rubella vaccine;

(c) Cell culture Rabies vaccine"

Tags : RULES   AMENDMENT   DRUGS  

Share :        

Disclaimer | Copyright 2026 - All Rights Reserved