000927

S.R.O. 719(I)/2000.-- The following draft of certain further amendments in the Drugs (Licensing, Registering and Advertising) Rules, 1976 which are proposed to be made, in exercise of the powers conferred by section 43 of the Drugs Act, 1976 (XXXI of 1976), are hereby published, as required by sub-section (3) of the said section, for the information of all persons likely to be affected thereby and notice is hereby given that the draft will be taken into consideration after fifteen days of its publication in the official Gazette.

2. Any objection or suggestion which may be received from any person in respect of the said draft before the expiry of the said period will be considered by the Federal Government.

In the aforesaid Rules,--

(1) in rule 5, in sub-rule (4), for the word "hundred the word "thousand" shall be substituted;

(2) in rule 16, after clause (e) of the following new clause shall be added, namely:-
"(f) An application for site verification or approval of the layout plan or an application for extension or revision of layout plant, as the case may be shall be accompanied with a fee as prescribed under Schedule F.";

(3) in rule 17, after sub-rule (2), the following new sub-rule shall be added, namely:-
"(3) An application for repacking of a drug specified in Schedule D shall be accompanied with a fee as prescribed under Schedule F and such permission shall be valid for a period of five years only.";

(4) in rule 19, after sub-rule (5), the following new sub-rule shall be inserted, namely:-

"(5A) A fee of one thousand rupees shall be paid for a duplicate inspection book if the original is deface, damaged or lost. Such book shall bear the word 'duplicate' and shall be issued after passing the copies of the last three inspection reports available on record.";

(5) in rule 26, in sub-rule (5), for the word 'fifty' and the word 'thousand' shall be substituted;

(6) in rule 30, after sub-rule (9), the following new sub-rule shall be added, namely:--
"(10) The application for conducting clinical trials shall be made to the Registration Board addressed to its Secretary and shall be accompanied with a fee of five thousand rupees."; and

(7) for the Schedule F the following shall be substituted, namely:-

"SCHEDULE F
1. DRUG MANUFACTURING LICENCE FEE
[See rule 5 (2)]

(A) For the grant of license:-

(B) For renewal of license:-
(i) If the application for renewal is made before the expiry of the period of validity of license:

(ii) If the application for renewal is made after the expiry of the period of validity of license but within sixty days after expiry of the period of validity:

II. SITE VERIFICATION AND LAYOUT PLAN
[See rule 16(f)]
(Schedule "B" paragraph 1.2 of Section-I)

III. REPACKING
[See rule 17(3)]

IV. DRUG REGISTRATION FEE
[See rule 26 (3B)]

(A) For the grant of registration:

(B) For renewal of registration:
(i) if the application for renewal is made before the expiry of the period of validity of a certificate of registration:

(ii) If the application for renewal is made after the expiry of the period of validity of certificate of registration but within sixty days after expiry of the period of validity:

(D) Note:
An application for -1--
(i) Transfer of registration from one importer or manufacturer to another;
(ii) transfer from import to local manufacture;
(iii) import in bulk and repacking locally; and
(iv) change of name of registered drug, shall be considered as for grant of a new registration and shall be made as per rule (26) 91).

V. FEE FOR ADVERTISEMENT
[See rule 31 (1B)]

[No. F. 8-1/98-AU (Pt).]

S.R.O. 720 (I)/2000.-- The following draft of certain further amendments in the Drugs (Import and Export) Rules, 1976, which are proposed to made, in exercise of the powers conferred by section 43 of the Drugs Act, 1976 (XXXI of 1976), are hereby published, as required by sub-section (3) of the said section, for the information of all persons likely to be affected thereby and notice is hereby given that the draft will be taken into consideration after fifteen days of its publication in the official Gazette.

2. Any objection or suggestions which may be received from any person in respect of the said draft before the expiry of the said period will be considered by the Federal Government.

In the aforesaid Rules, in rule 6,--
(i) in sub-rule (1), for the word "fifty" the words "two hundred and fifty" shall be substituted;
(ii) in the proviso to sub-rule (1), for the words, "twenty-five" "the words" one hundred and twenty-five" shall be substituted; and
(iii) in sub-rule (2), for the words "twenty-five" the words "one hundred and twenty-five" shall be substituted.

[No. F.8-1/98-AU (Pt).]

S.R.O. 721 (I)/2000.-- The following draft of certain further amendment in the Drugs (Appellate Board) Rules, 1976, which are proposed to be made, in exercise of the powers conferred by section 43 of the Drugs Act, 1976 (XXXI of 1976), are hereby published, as required by sub-section (3) of the said section, for the information of all persons likely to be affected thereby and notice is hereby given that the drat will be taken into consideration after fifteen days of its publication in the official Gazette.

2. Any objection or suggestion which may be received from any person in respect of the said draft before the expiry of the said period will be considered by the Federal Government.

In the aforesaid rules, in rule 4, in sub-rule (2), after the word "appellant" the following words shall be inserted, namely:-
"and a fee of one thousand rupees for each application."?

[No. F.8-1/98-AU (Pt).]

Sd/-
DR. FARZANA CHOWDHARY
Drugs Controller