The Gazette of India
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 9] NEW DELHI, FRIDAY, JANUARY 7, 1983/PAUSA 17, 1904 Separate paging is given to this part in order that it may be filed as a separate compilation
2. THE GAZETTE OF INDIA : EXTRAORDINARY [PART II-SEC. 3(i)J(23 of 1940), the Central Government, alter consultation with the Drugs Technical Advisory Board, hereby mates tlie following rules further to amend t/ie Drugs and Cosmetic* Rules, 194?, namely:—
1. These rules irniy be called the Drugs jnd Cosmetic*
(First Amendment) Rules, 1983.
MINISTRY OF HEALTH AND FAMILY WELFARE
NOTIFICATION
New-Delhi, the 7th January, 1983
G.S.R. 13(E)—Whereas a draft of certain rule:, further U> amend the Drugs and Cosmetics Rules, 1945 was published, as required by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), under the notification of the Govern- ment of India, in the Ministry of Health and Family Welfare (Department of Health), No. G.S.R. 242 (E), dated the 5th March, J9S2, at pages 293 and 294 of the Gazette of indiu. Extraordinary, . Part-U, Section 3, Sub-S;ction (i), dated the 5th March, 1982, inviting objections and riiggestion;* from all persons likely to be affected thereby befoie the expiry of ninoty days from die date of publication of the draft noti- fication in the Official G.i5L=tfc;
And whereas the said Gazette was made available to the public on the 20th March, 1982;
And whereas no objection or suggestion has been received from public on the said draft rules;
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940, 2. (n iht; Dings ;md Cosmetics Kales, 194f.--
(I) in rule 85-B, after sub-rule (4), the following; sub- rule shall be inserted, namely:--
"(5) Applications by licensee to manufacture addi- tional items of Homoeopathic medicines shall bo made to the licensing authority and such appli- cations shall be accompanied by a fee of rupee* five for each additional item",
OT) In rule 85-H,—
(i) in clause (e), in sub-vhuisc; (i), (ii) and (Hi), the following words shall be added at the end, respectively, namely:—
"for a period of five years";
(ii) in clause (f), the following shall be added at the end, namely:— "such records shall be maintained for .i period of1 five years.";
( i n) In Schedule A,
(1) in Foim 24-C, for entry-I, the following shall be substituted, namely:—
"1. I/we————uf—•—holder of licence No.- —
in form 20-C hereby apply for grant/renewal of licence to manufacture the undermentioned Homoeopathic Mother Tincture uotentised and other preparations on the premises situated at—-——.
Names of the Homoeopathic preparations—
(Each item to be separately specified),"
ii) In Form 25-C, for entry-), the following shall bo substituted, namely:——
"lt. .. -—-—-—of—— •—who holds i licence in From 20-C is hereby licensed to mnnu- iacture the uuder mentione.il Homoeopathic Mpther Tincturelpotenthed und other preparations on the premises situated at ————under the. di- rection and supervision of following technical sioll. Names of the Homoeopathic preparations.
(Each item to be separately specified)
Names of the Technical Staff ——".
[No. X-11013/1O/81-DMS&PFA1
R. K. SINGHAL, Jt Secy.