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FORMS AND FEES

 

A : SALE APPLICATIONS, LICENSES, FEES AND PENALTY

 

B : MANUFACTURING APPLICATIONS, LICENCES, FEES AND PENALTY*

         I.     ALLOPATHIC DRUGS

         II.     HOMOEOPATHIC MEDICINES

         III.     COSMETICS

         IV.     APPROVAL OF PRIVATE TESTING LABORATORIES

 

 

 

A:  SALE APPLICATIONS, LICENSES, FEES AND PENALTY
S.No. Category Type Sale Application Form Licence Form Fees for Grant/ Renewal Renewal Certificate Form No. Penalty after expiry but within six months Fees for duplicate copy of Org. Lic.
1. Drugs other than those specified in Schedule C&C (1)&X Whole Sale 19 20-B ₹1500 Omitted ₹1500+
two per cent. of the licence fee for every month or part thereof
₹150
Retail Sale 19 20 ₹1500 Omitted ₹1500+
two per cent. of the licence fee for every month or part thereof
₹150
Restricted (Gen.Store) 19-A 20-A



R-61(1)
₹500



R-59(2)
Omitted ₹500+
two per cent. of the licence fee for every month or part thereof

R-59(4)
₹150



R-59(3)
2. Drugs specified in Schedule C&C (1) but excluding those specified in Schedule ‘X’ Whole Sale 19 21-B ₹1500 Omitted ₹1500+
two per cent. of the licence fee for every month or part thereof
₹150
Retail Sale 19 21 ₹1500 Omitted ₹1500+
two per cent. of the licence fee for every month or part thereof
₹150
Restricted (Gen.Store) 19-A 21-A



R-61(2)
₹500



R-59(2)
Omitted ₹500+
two per cent. of the licence fee for every month or part thereof

R-59(4)
₹150



R-59(3)
3. Drugs specified in Schedule ‘X’ Whole Sale 19-C 20-G ₹500 Omitted ₹500+
two per cent. of the licence fee for every month or part thereof
₹150
Retail Sale 19-C 20-F



R-61(1)
₹500



R-59(2)
Omitted ₹500+
two per cent. of the licence fee for every month or part thereof

R-59(4)
₹150



R-59(3)
4. Sale of Drugs from motor vehicles
(1) Drugs other than those specified in Schedule C&C (1)
Whole Sale 19-AA 21-BB ₹500 Omitted ₹500+
two per cent. of the licence fee for every month or part thereof
₹150
(2) Drugs specified in Schedule C&C (1) Retail Sale 19-AA 21-BB



R-62-D
₹500



R-62-C
Omitted ₹500+
two per cent. of the licence fee for every month or part thereof

R-62-C
₹150



R-62-C
5. Homoeopathic Medicines Whole Sale 19-B 20-D ₹250 20-E ₹250+
₹50p.m. or part thereof
₹150
Retail Sale 19-B 20-C



R-67-C
₹250



R-67-A(2)
20-E ₹250+
₹50p.m. or part thereof

R-67-A(2)
₹150



R-67-A(2)

* GSR No. 421 dated 24/08/2001

 

 

 

B:  MANUFACTURING APPLICATIONS, LICENCES, FEES AND PENALTY*
I. ALLOPATHIC DRUGS
S.No. Category of drugs Application Form Licence Form Fees for Grant/ Renewal Renewal Certificate Form No. Retention fee after expiry but within six months Fees for duplicate copy of Org. Lic. Fee for addl. item for more than 10 item for each category
I II III IV V VI VII VIII IX
1. Drugs other than those specified in Schedule C&C (1) & X

(i) Repacking of drugs




24-B upto 10 items for each category



R: 69(1)(a)




25-B






R: 70




Lic. fees of ₹ 500+ Insp. fee of ₹ 200 for every inspection

R: 69(2)(a)




Omitted






R: 73-B




₹500+retention fee at the rate of two per cent. of the licence fee for every month or part thereof up to six months in addition to an inspection fee of ₹200

R: 69(3)(i)




₹1000






R: 69(4)




₹ 100 for each addl.item




R: 69(5)
(ii) Drugs specified in Schedule X 24-F upto 10 items for each category



R: 69(1)(b)
25-B






R: 70
Lic. fees of ₹ 500+ Insp. fee of ₹ 200 for every inspection or for retention of licence

R: 69(2)(a)
Omitted






R: 73
₹6000+ retention fee at the rate of two per cent. of the licence fee for every month or part thereof up to six months in addition to insp. fee of ₹1000


R: 69(3)(ii)
₹1000






R: 69(4)
₹ 300 per item





R: 69(5)
(iii) Any other 24 upto 10 items for each category



R: 69(1)(c)
25






R: 70
Lic. fee of ₹ 6000+ Insp. fee of ₹ 1500 for every inspection or for retention of licence

R: 69(2)(c)
Omitted






R: 73
₹6000+retention fee at the rate of two per cent. of the licence fee for every month or part thereof up to six months in addition to insp. fee of ₹1500


R: 69-A(1)
₹1000






R: 69(4)
₹ 300 per item





R: 69(5)
(iv) Loan Licence 24-A upto 10 items for each category



R: 69-A(1)
25-A






R: 70-A
Lic. fee of ₹ 6000+ Insp. fee of ₹ 1500 for every inspection or for retention of licence

R: 69A(1)
Omitted






R: 73-A
₹6000+retention fee at the rate of two per cent. of the licence fee for every month or part thereof up to six months in addition to insp. fee of ₹1500


R: 69-A(1)
₹1000






R: 69-A(4)
₹ 300 per item





R: 69-A(3)
* GSR No. 421 dated 24/08/2001

2. Drugs specified in Schedule C&C(1) excluding those specified in Sch. X

(i) Own unit





27
up to 10 items for each category


R: 75(1)





28






R: 76





Lic. fee of ₹ 6000 + Insp. fee of ₹ 1500 for every inspection or for renewal of licence

R: 75(1)





Omitted






R: 77





₹6000+₹1000 p.m. or part thereof in addition to insp. fee of ₹1500


R: 75A(1)





₹1000






R: 75A(4)





₹ 300 per item





R: 75(5)
(ii) Loan Licence 27-A
up to 10 items for each category


R:75A(1)
28-A






R: 76A
Lic. fee of ₹ 6000 + Insp. fee of ₹ 1500 for every inspection or for renewal of licence

R: 75(2)
Omitted






R: 77
₹6000+₹ 1000 p.m. or part thereof in addition to insp. fee of ₹1500


R: 75(2)
₹1000






R: 75(4)
₹ 300 per item





R: 75(5)
(iii) Drugs specified in Schedule C&C (1) &X 27-B
up to 10 items for each category


R:75(2)
28-D






R: 76
Lic. fee of ₹ 6000 + Insp. fee of ₹ 1500 for every inspection or for renewal of licence

R: 75(2)
Omitted






R: 77
₹6000+₹ 1000 p.m. or part thereof in addition to insp. fee of ₹1500


R: 75(2)
₹1000






R: 75(4)
₹ 300 per item





R: 75(5)
(iv) Drugs specified in Sch. C, viz. LVP and Sera & Vaccines 27-D
up to 10 items for each category


R: 75(3)
28-D






R: 76
Lic. fee of ₹ 6000 + Insp. fee of ₹ 1500 for every inspection or for renewal of licence

R: 75(3)
Omitted






R: 77
₹6000+₹ 1000 p.m. or part thereof in addition to insp. fee of ₹1500


R: 75(3)
₹1000






R: 75(4)
₹ 300 per item





R: 75(5)
(v) Whole Human Blood & Components 27-C






R: 122F(1)
28-C






R: 122G
Lic. fee of ₹ 6000 + Insp. fee of ₹ 1500 for every inspection or for renewal of licence

R: 122F(1)
26-G






R: 122H
₹6000 + ₹ 1000 p.m. or part thereof in addition to insp. fee of ₹1500


R: 122F(1)
₹1000






R: 122F(2)
₹ 300 per item





R: 75(5)
3. Mfg. of drugs for purpose of examination, test / analysis 30


R: 90
29


R: 89
₹250


R: 90(2)
- - - -
Fee for further application after rejection ₹250 (R: 82)
Fee for further application after rejection ₹250 (R: 122K)

 

 

 

II. HOMOEOPATHIC MEDICINES
S.No. Category of drugs Application Form No. Licence Form No. Fees for Grant / Renewal Renewal Certificate Form No. Fee+Penalty after expiry but within six months Fees for duplicate copy of Org. Lic.
1. Mother Tinctures & Potentised Preparations 24-C





R: 85-B(2)
25-C





R: 85-D
₹200 + ₹100 for 1st inspection or ₹50 in case of inspection for renewal of licence

R: 85-B(2)(a)
26-C





R: 85-G
₹200 + ₹100 p.m. or part thereof and inspection fee of ₹50


R: 85-B(3)(a)
₹50





R: 85-B(4)
2. Potentised Preparation 24-C





R: 85-B(2)
25-C





R: 85(b)
₹200 + ₹100 for 1st inspection or ₹50 in case of inspection for renewal of licence

R: 85-B(2)(b)
26-C





R: 85-G
₹200 + ₹100 p.m. or part thereof and inspection fee of ₹50


R: 85-B(3)(b)
₹50





R: 85-B(4)
3. Potentised Preparations from back potencies by Pharmacy which are licensed to sell Homoeopathic Medicines by retail 24-C





R: 85-B(2)
25-C





R: 85-D
₹200 + ₹100 for 1st inspection or ₹50 in case of inspection for renewal of licence

R: 85-B(2)(c)
26-C





R: 85-G
₹200 + ₹100 p.m. or part thereof and inspection fee of ₹50


R: 85-B(3)(c)
₹50





R: 85-B(4)
4. Additional item ₹ 50 for each additional Item

R: 85-B(5)
Note: Fee for further application after rejection ₹250 (R- 85 ED)

 

 

 

III. COSMETICS
S.No. Category of drugs Application Form Licence Form Fees for Grant/ Renewal Renewal Certificate Form No. Penalty after expiry but within six months Fees for duplicate copy of Org. Lic. Fee for addl. item for more than 10 item for each category
1. Own manufacturing 31
up to 10 items for each category


R: 138(1)
32






R: 139-A
Lic. fee of ₹ 2500 + Insp. fee of ₹ 1000 for every inspection

R: 138(2)
Omitted






R: 141
₹2500+two per cent. of the licence fee for every month or part thereof up to six months in addition to insp. fee of ₹1000


R: 138(2)
₹250






R: 138(4)
₹100 for each additional item subject to a maximum of ₹3000


R: 138(3)
2. Loan Licence 31-A
up to 10 items for each category


R: 138-A(1)
32-A






R: 139-B
Lic. fee of ₹ 2500 + Insp. fee of ₹ 1000 for every inspection

R: 138-A(1)
Omitted






R: 141-A
₹2500+two per cent. of the licence fee for every month or part thereof up to six months in addition to insp. fee of ₹1000


R: 138A(2)
₹250






R: 138-A(6)
₹100 for each additional item subject to a maximum of ₹3000


R: 138-A(5)
Note: Fee for further application after rejection ₹ 250 (R: 139 AD)

 

 

 

IV. APPROVAL OF PRIVATE TESTING LABORATORIES
S.No. Category of drugs Application Form Licence Form Fees for Grant/ Renewal Renewal Certificate Form No. Penalty after expiry but within six months Fees for duplicate copy of Org. Lic. Fee for addl. item for more than 10 item for each category
1. Testing of drugs specified in Sch.C & C (1) 36



R: 150-B
37



R: 150-C
Inspection fee of ₹6000


R: 150-B(1)
Omitted



R: 150-J
₹6000+two per cent. of the licence fee for every month or part thereof up to six months

R: 150-B(1)
- ₹1500 per category


R: 150-B(2)
2. Testing of drugs other than those specified in Sch.C & C(1)& Homoeopathic Medicines & Cosmetics 36






R: 150-B
37






R: 150-C
Inspection fee of ₹1500





R: 150-B(1)
omitted






R: 150-J
₹1500+two per cent. of the licence fee for every month or part thereof up to six months




R: 150-B(1)
- ₹1000 per category





R: 150-B(2)
Note: Fee for further application after rejection ₹ 250 (R: 139 AD)