DRUGS AND COSMETICS RULES 1988
Ministry of Health and Family Welfare (Department of Health)
New Delhi, the 21st September 1988
G.S.R.944 (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 (28 of 1940), under the
notification of the Government of India in the Ministry of Health and Family Welfare, No. GSR 602(E), dated
the 26th June, 1987, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), dated the 26th
June, 1987, inviting objections and suggestions from all persons likely to be effected 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 the said Gazette was made available to the public
on the 12th August, 1987. And whereas the objections and suggestions received from the public on the said draft
rules have been 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:
These rules may be called the Drugs and Cosmetics (Eight Amendment) Rules, 1988.
They shall come into force on the date of their publication in the Official Gazette.
In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), rules 30A, 69B and
75B shall be omitted.
After Part X of the said rules, the following new part XA shall be inserted, namely : Part - XA - Import
or manufacture of new drug for clinical trials or marketing. 122A. Application for permission to
import new Drug.
No new drug shall be imported except under and in accordance with the permis