Drug Act & Rules 1976 - PakSearch.com

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1.DRUG MANUFACTURING LICENCE FEE
{SEE RULE 5(2)

(A) For the grant of licence :-

Type of licence	Fee
By way of basic	Rs 10,000
By way of semi -basic	Rs 10,000
By way of formulation	Rs 35,000
By way of repacking	Rs 20,000
(B) For renewal of licence:- (i)If the application for renewal is made before the expiry of the period of validity of license:
Type of licence	Fee
By way of basic	Rs 5,000
By way of semi -basic	Rs 5,000
By way of formulation	Rs 17,500
By way of repacking	Rs 10,000
(ii) Omitted by SRO No. 285 (I)/2002 Dated 22nd May 2002
Type of licence	Fee
By way of basic	Rs 10,000
By way of semi -basic	Rs 10,000
By way of formulation	Rs 35,000
By way of repacking	Rs 20,000

II. SITE VERIFICATION AND LAYOUT PLAN
[See rule 16(f)]

(schedule "B"paragraph1.2 of section -1)

(A) Site inspection and verification	Rs 1,000
(B) Approval of layout plan	Rs 1,000 per section
(C)Revision or Extension of layout plan	Rs 500 per section

III. REPAKING [see rule17(3B)]
Repacking of drugs	Rs 500 per drug specified in schedule D.

IV. DRUG REGISTRATION FEE [See rule 26(3B)] (A) For the grant of registration:
Type of drug	Fee
New drug molecule	Rs 15,000
Any other drug for import	Rs 15,000
Any other drug for local manufacture	Rs 8,000
including galenicals

(B) For renewal of registration: (i) If the application for renewel is made before the expiry of the period of validity of a certificate of registration:
Type of drug	fee
For import	Rs 7,500
For local manufacture	Rs 4,000

(ii)If the application for the renewel is made after the expiry of the period of validity of certificate of registrationbut within sixty
days after expiry of the period of validity :

Type of drug	Fee
For import	Rs 15,000
For local manufacture including galenicals	Rs 8,000

(C) Variance to registration application i.e
changes in inactive raw material , method of
manufacture,testing methods/quality specfications Rs 1,000
,product specification,packing materials including
change of labelling specifications,etc.

NOTE:
An application for :-
(i)Transfer of registration from one importer to 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 a grant of a new registration and shell be made as per rule 26(1)

V.FEE FOR ADVERTISEMENT
[SEE RULE 31(1B)]

Application for advertisement                                                          (i) Rs 2,033 per advertisement for print media
                                                                                                      (ii)Rs 3,000 per advertisement for Radio/Audio .
                                                                                                      (iii)Rs 5,000 per advertisement for T.V/Cinema.

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