DRUGS AND COSMETICS (FIRST AMENDMENT) RULES, 2016

Preamble - DRUGS AND COSMETICS (FIRST AMENDMENT) RULES, 2016

DRUGS AND COSMETICS (FIRST AMENDMENT) RULES, 2016

PREAMBLE

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. 559(E), dated the 17th July, 2015, published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), dated the 17th July, 2015, 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 copies of the Gazette were made available to the public on 17th July, 2015;

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:-

Rule 1 - RULE 1

(1) These rules may be called the Drugs and Cosmetics (First Amendment) Rules, 2016.

(2) They shall come into force on the date of their publication in the Official Gazette.

Rule 2 - RULE 2

In the Drugs and Cosmetics Rules, 1945, in Schedule Y,-

(A) for paragraph "(2) Post Marketing Surveillance" and clause (i) relating thereto, as published in Part II, Section 3, Sub-section (i) of the Gazette of India, Notification G.S.R. 32 (E) dated 20th January, 2005, at page 63, the following shall be substituted, namely:-

"4. Post Marketing Surveillance.-

(i) The applicant shall have a pharmacovigilance system in place for collecting, processing and forwarding the report to the licensing authority for information on adverse drug reactions emerging from the use of the drug manufactured or marketed by the applicant in the country.

(ia) The system shall be managed by qualified and trained personnel and the officer in-charge of collection and processing of data shall be a medical officer or a pharmacist trained in collection and analysis of adverse drug reaction reports.

(ib) Subsequent to approval of the product, new drug shall be closely monitored for its clinical safety once it is marketed.

(ic) The applicant shall furnish Periodic Safety Update Reports (PSURs) in order to-

(a) report all relevant new information from appropriate sources;

(b) relate the data to patient exposure;

(c) summarise the market authorisation status in different countries and any significant variations related to safety; and

(d) indicate whether changes shall be made to product information in order to optimise the use of product.";

(B) in Appendix III, in paragraph 1.8, in the table,-

(i) under the heading 'Systemic Toxicity Studies', for sub-heading "Oral or Parenteral or Transdermal" and entries relating thereto, the following shall be substituted, namely:-

"Oral, or parentral or transdermal	Single dose or several doses in one day, Upto 1 wk	I, II, III	2sp, 2wks
	>1 wk but upto 2 wks	I, II, III	2sp; 2wks
	Upto 2 wks	Marketing permission	2 sp; 4 wks
	>2 wks but upto 4 wks	I, II, III	2 sp; equal to duration of human exposure
		Marketing permission	2 sp; 12 wks
	> 4 wks but upto 12 wks	I, II, III	2 sp; equal to duration of human exposure
		Marketing permission	2 sp; 24 wks
	> 12 wks but upto 24 wks	I, II, III	2 sp; equal to duration of human exposure
		Marketing permission	2 sp; Rodent 24 wks, non-rodent 36 wks
	> 24 wks	I, II, III	2 sp; Rodent 24 wks, non-rodent 36 wks
		Marketing permission	2 sp; Rodent 24 wks, non-rodent 36 wks";

(ii) under the heading "Male Fertility Study", for entries thereunder, the entries "Phase III in male volunteers/patients" shall be substituted.