The Gazette of India
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 22] NEW DELHI, TUESDAY, JANUARY 18, 1983/PAUSA 28, 1904
Separate paging is given to this Part in order that it may be filed as a separate
compilation
1 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i),MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health)
NOTIFICATIONV
New Delhi, the 18th January, 1983
G.S.R. 31(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 which the Central Government proposes to make in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, is hereby published, as required by the said sections, for the information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules will be taken into considera- tion on or after the expiry of a period of ninety days from the date on which copies of the official Gazette in which this notification is published are made available to the public.
Any objections or suggestions which may be received from any person with respect to the said draft, rules before the expiry of the aforesaid period of ninety days will be taken into consideration by the Central Government.
Objections or suggestions, if any, may be sent to the Secretary to the Government of India, Ministry of Health and Family Welfare, New Demi.
DRAFT RULES
1. These rules may be called the Drugs and Cosmetics (Amendment) Rules, 1983.
2. In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), In rule 61, sub-rule (2) for the proviso, the following proviso shall be substituted, namely :—
"Provided that a licence in Form 21-A shall not be granted for drugs specified in Schedule C and shall be valid for only such Schedule C ( l) drugs as are specified in the licence".
3. In rule 96 of the said rules, in sub-rule (1), in the proviso to clause (viii), for the words "provided that" the following shall be substituted, namely :—
"Provided that drugs in bulk form included in Schedule CXI) which are not ready for use need not bear pa the label the date of expiry of potency, fixed by the manufac- turer :
Provided further that"
4. In Schedule A of the said rules #
(i) In Form 19-A-l
(a) in paragraph 1, in sub-paragraph
(ii) for the words, letters, bracket* and figuioa; "drug* specified in Schedules C and C ( l )" in both the places where this occur, tho words, letters, brackets and figure 'drugs specified in Schcdulo C(i)" shall be substituted;
(b) In paragraph 4, for the words, letters, brackets and figures, "Schedules C and C<1)" the word, tetter, brackets and figure "Schedule C ( l )" shall be substituted;
(iii) In Form 21-A, for the words, letters, brackets and figure "Schedules C and C(l)" wherever they occur, the word, letter, brackets and figure "Sche- dule C ( l )" shall be substituted.
5. In Schedule C of the said rules, for serial number 11 and the entries relating thereto, the following serial number and entries ehall be substituted, namely :—
"11. Antibiotics and preparations, thereof in a form to be administered parenterally."
6. In Schedule CXI) of the said rules, for aerial number9 and the entries relatijig thereto, the following serial number and entries shall be* substituted, namely :—
"9. Antibiotics and preparations thereof not in a form to be administered parenterally.1*
INo. X. 11013/12/81-DMS&PFA]
R. K. SINGHAL, Jt. Secy.