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

DRUGS AND COSMETICS (SECOND 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 read with 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. 11(E), dated the 6th January, 2016, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), dated the 6th January, 2016, 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 06.01.2016;

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 read with 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 (Second 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, (hereinafter referred to as the said rules), in rule 122 DA, after sub-rule (3), before the Explanation, the following shall be inserted, namely:-

"(4) No permission for conduct of clinical trial intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form where,-

(a) the trial is approved by the Ethics Committee; and

(b) subject to the provisions of sub-rule 5, the data generated is not intended for submission to licensing authority.

"(5) The Ethics Committee shall however inform the licensing authority about the cases approved by it and also about cases where there could be an overlap between the clinical trial for academic and regulatory purposes and where the said authority does not convey its comments to the Ethics Committee within a period of thirty days from the date of receipt of communication from the Ethics Committee, it shall be presumed that no permission from the licensing authority is required.".

Rule 3 - RULE 3

In Schedule Y to the said rules, in Appendix I, in item 4, after sub-item 4.8, the following note shall be inserted, namely:-

"Note.- Where the data on animal toxicity as per the specifications of Appendix III has been submitted and the same has been considered by the regulatory authority of the country which had earlier approved the drug, the animal toxicity studies shall not be required to be conducted in India except in cases where there are specific concerns recorded in writing.".