Thursday 23 February 2012

Schedule - F : ( Fee for Manufacturing and Registration License) :The Drugs (Licensing, Registring and Advertising) Rules, 1976



SCHEDULE F
See rule 5 (2)]


1. DRUG MANUFACTURING LICENCE FEE
(a) For the grant of licence:
Type of licenceFee
By way of basicRs.10,000
By way of semi-basicRs.10,000
By way of formulationRs.25,000
By way of repackingRs.15,000
(b) For the renewal of licence

(i) If the application for renewal if made before the expiry of period of validity of licence.

Type of licenceFee
By way of basicRs. 5000
By way of semi-basicRs. 5,000
By way of formulationRs.12,500
By way of repackingRs. 7,500
(ii) If the application for renewal is made after the expiry of the period of validity of licence but within sixty days after expiry of the period validity:
Type of licenceFee
By way of basicRs.10,000
By way of semi-basicRs.10,000
By way of formulationRs.25,000
By way of repackingRs.15,000

II. DRUG REGISTRATION FEE
[See rule 26 (3)]
(A) For the grant of RegistrationRs. 5,000
(B) For the renewal of Registration
(i) if the application for renewal is made before the expiry of the validity of a certificateRs. 2,500
(ii) if the application for renewal is made within thirty days after the expiry of the period of validity of a certificate
 Rs. 5,000

III. FEE FOR ADVERTISEMENT
[See rule 31 (1A) and (1B)]
Application fee for Advertisement.Rs. 1,000 per advertisement


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