DRUG MANUFACTURING LICENCE FEES

Head of Account for Deposit of Fee for Licensing/Renewal, Registration/Renewal, Advertising, Import & Export and Appellate etc.


                           C-Non Tax Revenue
                           C02-Receipts from Civil Administration and other Functions.
                           C028-Social Services.
                           C02871-Health-Other Receipts

Head of Account for Deposit of Central Research Fund (CRF)

                           G-Liabilities.
                           G-12-Special Deposit-Fund.
                           G-127-Other Funds.
                           G-12745-Central Research Fund.

DRUG MANUFACTURING LICENCE

(A) For the grant of license:-

Type of license                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. 10,000/-

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

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

Type of license                    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 26(3B)]
(A) Site of inspection and verification- - - Rs. 1,000/-
(B) Approval of layout plan- - - - Rs. 1000/- per Section
(C) Revision or Extension of layout plan- - Rs. 500/-per Section

III REPAKING
[See Rule 17(3)]

Repacking of Drugs Rs. 500/- per drug Specified in
Schedule D.

(IV) DRUGE REGISTRAION 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/-


(B) For renewal of registration :

(i) If the application for renewal is made before theory of the period of validity of a certificate 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 renewals made after the expiry of the period of validity of certificate of registration but within sixty days after expiry of the period of validity.

Type of Drug                     Fee
For Import - - - - - - - - -Rs. 15,000/-
For local Manufacture - - Rs. 8,000/-
Including galenicals


(C) Variance to registration application i.e. Rs.1,000/-

 
REGULATIONS

  • Drug Act. 1976
  • Drug Rules
  • CONAPS Act. 1998
  • Pharmacy Act. 1967
  • Fee
  • Pricing
  • Credentials of the Manufacturer Abroad
  • Inspection Performa
  • Labeling Reqs. for Veterinary Drugs
  • Current Good Manufacturing Practices
  • © Copy Rights 2003. All Rights Reserved to Ministry of Health.