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REGISTERED NO. D. (D.N.)-72

The Gazette of India

EXTRAORDINARY

PART II—-Section 3—Sub-section (i)

PUBLISHED BY AUTHORITY

No. 154] NEW DELHI, TUESDAY, MAY 8, 1984 /VAISAKHA 18, 1906

Separate paging is given to this Part in order that it may be filed as a separate

compilation

(1)

172 GI/84

MINISTRY OF HEALTH AND

FAMILY WELFARE

NOTIFICATION

New Delhi, the 8th May, 1984

G.S.R. 331(E).—Whereas certain draft rules further to amend the Drugs and Cosmetics Rules, 1945, were published as required by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), at pages 1 to 3 of the Gazette of India, Extra- .ordinary Part-II, Section 3, Sub-Section (i), dated the 12th May, 1983, under the notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health) No. G.S.R. 385(E), dated the 12th May, 1983, inviting objections and suggestions from all persons likely to be affected thereby before the expiry of ninety 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 said Gazette^ were made

.available to the Public on the 27th May, 1983;

And whereas the objections and suggestions received from the public On the said draft have been considered toy the Central Government;

Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government after consultation with the Drugs Techni- cal Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely :—

1. (1) These rules may be called the Drugs and

Cosmetics (Second Amendment) Rules, 1984.

(2) They shall come into force on the date of

their publication in the Official Gazette.

2. In the Drugs and Cosmetics Rules, 1945 (here- inafter referred to as the said rules)., in rule 67G after clause (5^, the following clause shall be added, namely:—

"(6) The licensee shall maintain , an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed."

3. In rule 74-B of the said rules, after clause (5)

the following clause shall be added, namely:—

"(6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record hia impressions and the defects noticed."

3

record his impressions and the defects noticed."

5. In rule 138 of the said rules,—

(i) the provisions to sub-rules (1), (2) and (30

shall be omitted;

(ii) for sub-rule (4) the following sub-rule shaH

be substituted, namely :—

"(4) A fee of rupees fifty shall be paid for duplicate copy of a licence issued under sub-rule (1), if the original is defaced, damaged or lost.¹'

6. In rule 139 of the said rules, in sub-rule (1), the proviso to clause (c), and clause (d), shall be omitted.

7. In rule 158 of the said rules, after clause (b),

the following clause shall be added, namely :—

"(c) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed."

8. In rule 158-A of the said rules, after clause (d),

the following clause shall be added, namely :—

"(e) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed."

9. In Schedule A to the said rules, in Form 35, for the brackets, words, figures and letters, "(See rules 65, 74, 74-A, 78, 85-H, 142 and 142-A)" the brackets, words figures and letters, "(See rules 65, 67-G, 74, 74-A, 74-B, 78, 78-A, 85H, 142, 142A, 158 and 158-A)" shall be substituted.

10. Tn Schedule V to the said rules, after entry 2,

the following entry shall be added, namely :—

"3 Standards for patent or proprietary medicines

in capsule form :—

A patent or proprietary medicine in capsule form shaH comply with the 'disintegration test' specified in the monograph for 'Cap- sules' in the Indian Pharmacopoeia."

Note : The Drugs and Cosmetics Rules, 1945, as amended upto 1-5-1979, is contained in the publication of the Ministry of Health end Family Welfare (Department of Health) containing the Drugs and Ccsmetics Acts ml the Rules (PDGHS-61). Subsequently the said rules have been amended by the follow- ing notifications published in Part II, Section 3(i) of the Gazette of India, namely:—

7. G.S.R. 540CE) dated 22-9-1980.

15. G.S.R. 510(E) dated 26-7-1982.

8. G.S.R. 680(E) dated 5-12-1980.

16. G.S.R. 13 (E) dated 7-1-1983.

9. G.S.R. 681 (Ej dated 5-12-1980.

17. G.S.R. 318(E) dated 1-5-1984.

10. G.S.R. 682(E) dated 5-12-1980.

11. G.S.R. 27(E) dated 17-1-1981.

|No. X 11O12|4I82-DMS & PFA}

12. G.S.R. 478(E) dated 6-8-1981.

S. V. SUBRAMANIYAN, Jt Secjk

PKlNlfcD BY f kt MANAGbR, OOVT. OF INDIA TRESS, RING RUAO, NEW DELHI-110064

AND PUBLISHED BY THE CONTOOLLHR OF tUBLIClTIONS, b B U H - 1 1 0 0 5 4, 1 9 84