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REGISTERED No. D-(D)-72

The Gazette of India

EXTRAORDINARY

PART II—Section 3—Sub-section (i)

PUBLISHED BY AUTHORITY

No. 27] NEW DELHI, THURSDAY, JANUARY 22, 1976/MAGHA 3, 1897

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

as a separate compilation

MINISTRY OF HEALTH AND FAMILY PLANNING

(Department of Health)

NOTIFICATION

New Delhi, the 8th January 1976

G.S.R. 33(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules. 1945, which the Central Government proposes to make, after consul- tation with the Drugs Technical Advisory Board, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is 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 rule will be taken into consideration after the expiry of the period of 90 days from the date on which the copies of the Official Gazette containing this notification are made available to the public.

Any objections or suggestions which may be received from any person with respect to the said draft rule before the expiry of the period so specified will be taken into consi- deration by the Central Government.

DRAFT RULES

1. These rules may be called the Drugs and Cosmetics (Amendment) Rules, 1975.

2. In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules.

In rule 70, the following words shall be inserted at the end, namely: "and every such licence shall be issued within three months of the receipt; of the application for the grant of licence provided that the application is complete in all respects and the applicant is otherwise eligible for the grant of the licence".

( 9 1)

3. In rule 70-A of the said rules, the following words shall be inserted at the end, namely:—•

"within three months of the receipt of the application for the grant of such licence provided that the application is complete in all respects and the applicant is otherwise- eligible for the grant of the licence".

namely:—

4. In rule 73 of the said rules, the following words shall be inserted at the end '

"within three months of the receipt of the application for renewal provided that the application is complete in all respects and the applicant is otherwise eligible for the grant of the licence".

5. In rule 73-A of the said rules, the following words shall be inserted at the and namely:—

"within three months of the receipt of the application for the renewal provided that the application is complete in all respects and the applicant is otherwise eligible for the grant of the licence".

6. In rule 73-B of the said rules, the following words shall be inserted at the end, namely:—

"within three months of the receipt of the application for the renewal of licence provided that the application is complete in all respects and the applicant is otherwise eligible for the grant of the licence"'.

namely:—

7. In rule 74 of the said rules, after clause (1), the following clauses shall he inserted, • "(m) the licensee shall • manufacture basic drugs and/or various categories of for- mulated drugs in quantities' not exceeding the capacity calculated on the basis of annual production capacity approved by the licensing authority.

Explanation.—For this purpose, the annual production capacity shall be fixed on the basis of production in a single shift of eight hours per day, unless otherwise indicated.

(n) The licensee shall inform the licensing authority in writing every six months giving the quantities of the basic drugs and/or various categories of for- mulated drugs manufactured during that period, alongwith the dites of manufacture of such drugs and the quantities thereof sold or distributed.

Where the licensee desires to manufacture basic drugs or their formulations in more than one shift per day or to manufacture drugs in each shift per day in excess of quantities approved by the licensing authority he shall inform the licensing authority of his intention to do so and shall obtain the neces- sary permission in writing before actually undertaking such manufacture'.

8. Hn rule 74-A of the said rules, after clause (h), the following clauses shall be inserted, namely:—-

"(i) the licensee shall repack basic drugs and/or various categories of formulated drugs in quantities not exceeding the capacity calculated on the basis of annual repacking capacity approved by the licensing authority.

Explanation.—-For this purpose the annual repacking capacity shall be fixed on the basis of repacking carried on in a single shift of eight hours per day, unless otherwise: indicated.

(j) The licensee shall inform the licensing authority in writing every six months giving the quantities of the basic drugs andVor various categories of for- mulated drugs repacked during that period along with the dates of repacking of such drugs and the quantities thereof sold or distributed.

Where the licensee desires to repack basic drugs or their formulations in more than one shift per day or to repack drugs in each shift per day in excess of the quantities approved by the licensing authority, he shall inform the licens- ing authority of his intention to do so and stnll obtain the necessary per- mission in writing before actually undertaking such repacking."

9. Tn rule 74-B of the said rules, after sub-rule (S). the following subfiles shall be

inserted, namely:—

"(6) The licensee shall manufacture basic drugs and/or various categories of foi- mulated drugs in quantities not exceeding the cipneity approved by the licensing authority.

Explanation.— Foi this purpose the annual production capacity shall be fixed on the basis ot production in a single shift of eight hours per day, unless othciwisc indicated.

(7) The licensee shall inform the licensing authority in writing every six months giving the quantities of the basic drugs and/or various categories of for- niulaicd drugs manufactured during that period alongwith the dates of manufacture of such drugs and the quantities thereof sold or distributed.

Where the licensee desires to manufacture basic drugs and/or their formulations in more than one shift per day or to manufacture drugs in each shift per day in excess of the quantities approved by the licensing authority, ho ehall inform the licensing authority of his intention to do so and shall obtain the necessary permission in writing before actually undertaking such manufac- ture".

10. In rule 7f> of the said rules, in the opening paragraph, after, the words and figures "issued in Form 2H", the following words shall be inserted namely:—-

"within three months of the receipt of the application for the grant of licence pro- vided that the application is complete in all respects and the applicant is otherwise eligible for the grant of the licence".

11. In rule 76-A of the said rules, the following wards shall be inserted at the end, namely:—•

"within three months of the receipt of the application for the grant of licence pio- vided that the application is complete in all respects and the applicant \', otherwise eligible for the grant of the licence".

12. In rule 78 of the said rules, after clause (m), the following clauses shall be inserted, namely:—

"(n) the licensee shall manufacture basic drugs and/or various categories of for- mulated drugs in quantities not exceeding the capacity calculated on the basis of the annual production capacity approved by the licensing authority.

Expltmurion.—For this purpose the annual production capacity shall be ibted on the basis of production in a single shift of eight hours per day, unless otherwise indicated.

(o) The licensee shall inform the licensing authority in writing every six months giving the quantities of the basic drugs and/or various categories of for- mulated drugs manufactured during that period, along with the dales of manufacture of such drugs and the quantities thereof sold or distributed.

Where the licensee desires to manufacture basic drugs and/or their formulations in more than one shift per day or to manufacture drugs in each ^hift per day in excess of the quantities approved by the licensing authority, he sh'all inlonn the licensing authority of his intention to do so and shall obtain the necessary permission in writing before actually undertaking such manufacture."

13. In rule 78-A of the said rules, after sub-rule (6), the following sub-rules shall be inserted, namely :—

"(7) The licensee shall manufacture basic drugs and/or various categories of formulated drugs in quantities not exceeding the capacity calculated on the basis of the annual production capacity approved by the licensing authority.

Explanation.—For this purpose the annual production capacity shall be fixed on the basis of production in a single shift of eight hours per day, unless other- wise indicated,

(8) The licensee shall inform the licensing authority in writing every six months giving the quantities of the basic drugs and/or various categories of for- mulated drugs manufactured during that period, alongwith the date of manufacture of such drugs and the quantities thereof sold or distributed.

Where fnc licensee desires to manufacture basic drugs and/or their formulations in more than one shift per day or to manufacture drugs in each shift per day in excess of the quantities approved by the liccrising authority, he shall inform the licensing authority of his intention to do so and shall obtain the necessary permission in writing before actually undertaking such manufacture".

14. In rule 80 of the Said rules, after the words "Licensing authority", the words "or the controlling authority" shall be inserted.

15. In rule 83 of the said rules, the following words sh'all be inserted at the end, namely:—

"within three months of the receipt of application for the renewal of licence provided that the application is complete in all respect and the applicant is otherwise eligible for the grant of the licence".

16. In rule 83-A of the said rules, the following words shall be inserted at the end, namely:—•

"within three months of the receipt of toe application for the renewal of licence provided that the application is complete in all respects and the applicant is otherwise eligible for the grant of the licence".

17. In Schedule-A of the said rules,

(i) in Form 24, after entry 4, the following entry shall be inserted, namely;—

" j. I/We propose to manufacture the following basic drugs (shown item-wise) and/or for- mulations thereof (shown category-wise).

Naru^ of the basic drug(s) and/ Capacity of production per Capacity of annual production or category of formulations of shift of hours per (calculated on the basis of drug(s) day 300 working days in a year unless otherwise indicated below)",

(ii) in Form 24-A, after entry 4, the following entry shall be inserted namely :—

"5. I/We propose to manufacture the following basic drugs (shown item-wise) and/or formulations thereof (shown category-wise).

Name of the basic drug(s) and/ Capacity of production per Capacity of annual production or category of formulations shift of hours per (calculated or the basis on 300 of drug(s) day working days in a year unless otherwise indicated below)",

(iii) in Form 24-B, after entry 4, the following entry shall be inserted, namely :—

"5. I/We propose to repack the following basic drugs (shown item-wise) and/or formulations thereof (shown category-wise).

Name of the basic drug(s) and/ Capacity of repacking per Capacity of annual repacking or category of formulations of shift of hours per (calculated on the basis of drug(s) day 300 working days in a year unless otherwise indicated below)",

(iv) in Form 25, after entry 4, the following entry shall be inserted, namely :—•

"5. The licence authorises manufacture of the following basic drugs and/or categories of formulations of drugs in quantities to be manufactured in 300 working days in a year calculated on the basis of production capacity of each drug in a single shift of eight hours a day, unless otherwise indicated below :—

Name of the basic drug(s) and/ Capacity of production per Capacity of annual produc- or category of formulations of shift of hours per tion (calculated on the basis drug(sj day of 300 working days in a year unless otherwise indi- cated below)",

(v) in Form 25-AJ after entry 5, the following entry shall be inserted, namely :—

"6. The licence authorises the manufacture of the following basic drugs and/or categories of formulations of drugs in quantities to be manufactured in 300 woiking days in a

year, calculated on the basis of production capacity of each drug in a single shift of eight hours a day, unless otherwise indicated below: —

Name of the basic drug^s) and/ Capacity of production per Capacity of annual production or category of formulations of shift of hours per (calculated on the basis of drug(s) day 300 working days in a year unless otherwise indicated below)",

(vi) in Form 25-B, after entry 4, the following shall be inserted, namely :—

"5. The licence authorises the repacking of the following basic drugs and/or categories of formulations of drugs in quantities to be repacked in 300 working days in a year, calculated on the basis of repacking capacity of each drug in a Single shift of eight hours a dayj unless otherwise indicated below :—

Name of the basic drug(s) and/ Capacity of repacking per Capacity of annual repacking or category of formulations of shift of hours per (calculated on the basis of 300 drug(s) day working days in a year unless otherwise indicated below)",

(vii) in Form 27, after entry 4, the following entry shall be inserted, namely :—

"5. I/We propose to manufacture the following basic drugs (shown ilem-wise) and/or formulations thereof (shown category-wise).

Name of the basic drug(s) and/ Capacity of production per Capacity of annual production or category of formulations of Shift of hours per (calculated on the basis of drug(s) day 300 working days in a year unless otherwise indicated below)",

(viii) in Form 27-A, after entry 4, the following entry shall be inserted, namely :—

"5. I/We propose to manufacture the following basic drugs (shown item-wise) and/or formulations (shown category-wise).

Name of the basic drug(s) and/ Capacity of production per Capacity or annual production or category of formulations of shift of hours per (calculated on the basis of day 300 working days in a year 4rug(s) unless otherwise indicated below)",

(ix) in Form 28, after entry 5, the following entry shall be inserted, namely :—

"6. The licence authorises the manufacture of the following basic drugs and/or categoriee of formulations of drugs in quantities to be manufactured in 300 working days in a year, calculated on the basis of production capacity of each drug in a single shift of eight hours a day, unless, otherwise indicated below :—

Name of the basic drug(s) and/ Capacity of production per Capacity of annual production or category of formulations of shift of hours per (calculated on the basis of drug(s) day 300 working days in a year unless otherwise indicated below)",

(x) in Form 28-A, after entry 5, the following entry shall be inserted, namely :

"6. The licence authorises the manufacture of the following basic drugs and/or categories of formulations of drugs in quantities to be manufactured in 300 working days in a year, calculated on the basis of production capacity of each drug in a single shift of eight hours a day, unless otherwise indicated below :—

Name of the basic drug(s) and/ Capacity of production per Capacity of annual production or category of formulations of shift of hours per (calculated on the basis of drug(s) day 300 working days in a year unless otherwise indicated below)".

[No. X. UO14/8/73-D&MS]

SHRAVAN KUMAR, Jt. Secy.

PRINTED BY THE GENERAL MANAGER, GOVERNMENT OF INDIA PRESS, M^NTO ROAD, NEW DELHI AND PUBLISHED BY THE CONTROLLER OF PUBLICATIONS, DELHI, 1 9 76