DRUGS AND COSMETICS (EIGHTH AMENDMENT) RULES, 2019
PREAMBLE
Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published as required under sub-section(1) of section 12 and sub-section(1) of 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. 720(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 4th August, 2018;
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 - RULES 1
(1) These rules may be called the Drugs and Cosmetics (Eighth Amendment) Rules, 2019.
(2) They shall come into force on the date of their publication in the Official Gazette.
Rule 2 - RULES 2
In the Drugs and Cosmetics Rules, 1945 (hereinafter to be referred as said rules), in PART XV(A), in the heading, after the words, "MANUFACTURE FOR SALE OF DRUGS / COSMETICS", the words, "OR AN INDIVIDUAL OR ORGANISATION OR PROCUREMENT AGENCY" shall be inserted.
Rule 3 - RULES 3
In the said rules, in rule 150B, in sub-rule (1) for the words "for sale of drugs or cosmetics, shall be made in Form 36" the words "for sale of drugs and cosmetics or an individual or organisation or procurement agency shall be made in Form 36" shall be substituted.
Rule 4 - RULES 4
In the said rules, in rule 150C,-
(i) In heading, after the words, "for manufacture of drugs/cosmetics", the words "or for an individual or organisation or procurement agency" shall be inserted.
(ii) In sub-rule (1), after the words, "for manufacture of drugs or cosmetics", the words "or an individual or organisation or procurement agency" shall be inserted.
Rule 5 - RULES 5
In the said rules, in rule 150E, for clause (f) the following clause shall be substituted, namely:-
"(f) The approved institution shall furnish reports of the results of test or analysis on the samples received from manufacturer in Form 39 and from an individual or organisation or procurement agency in Form 39A."
Rule 6 - RULES 6
In the said rules, in Schedule A,-
(i) In Form 36 and Form 37, in the heading, after the words, "MANUFACTURE FOR SALE OF DRUGS/ COSMETICS", the words, "OR FOR AN INDIVIDUAL OR ORGANISATION OR PROCUREMENT AGENCY" shall be inserted.
(ii) In Form 36, in paragraph (1), after the words, "manufacture for sale of drugs/ cosmetics", the words, "or for an individual or organisation or procurement agency" shall be inserted.
(iii) after the Form 39, the following Form shall be inserted, namely:-
"Form 39A
[See sub-rule (f) of rule 150E]
Report of test or analysis by approved institution for an Individual or Organisation or Procurement agency
(1) Name of individual or organisation or procurement agency from whom sample is received............................
(2) Serial number and date of sender's memorandum................................
(3) Number of samples.........................................
(4) Date of receipt of the sample............................................................
(5) Name of drug or cosmetics or raw material purporting to be contained in the sample.....
(6) Details of raw material or final product in bulk or final product in finished pack* as obtained by sender:
(a) Name and address of the Manufacturer and Licence number mentioned on the label .............
(b) Name of original Manufacturer in the case of raw materials and re-packed drugs ............
(c) Batch number .........
(d) Date of manufacture, if any .......
(e) Date of expiry, if any ..........
(7) Results of test or analysis with protocols of test or analysis applied.
In the opinion of the undersigned, the sample referred to above is *of standard quality/is not of standard quality as defined in the Act and the rules made thereunder for the reasons given below.
Date.........................................................
Signature of Person-in-charge of testing
Note:- Final product includes repacked material.
*Delete whichever is not applicable."
