FORMS AND FEES
A : SALE APPLICATIONS, LICENSES, FEES AND PENALTY
B : MANUFACTURING APPLICATIONS, LICENCES, FEES AND PENALTY*
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 | Rs.1500 | 21-C | Rs.1500+ Rs.500 p.m. or part thereof |
Rs.150 |
Retail Sale | 19 | 20 | Rs.1500 | 21-C | Rs.1500+ Rs.500 p.m. or part thereof |
Rs.150 | ||
Restricted (Gen.Store) | 19-A | 20-A R-61(1) |
Rs.500 R-59(2) |
21-C | Rs.500+ Rs.250 p.m. or part thereof R-59(4) |
Rs.150 R-59(3) |
||
2. | Drugs specified in Schedule C&C (1) but excluding those specified in Schedule ‘X’ | Whole Sale | 19 | 21-B | Rs.1500 | 21-C | Rs.1500+ Rs.500 p.m. or part thereof |
Rs.150 |
Retail Sale | 19 | 21 | Rs.1500 | 21-C | Rs.1500+ Rs.500 p.m. or part thereof |
Rs.150 | ||
Restricted (Gen.Store) | 19-A | 21-A R-61(1) |
Rs.500 R-59(2) |
21-C | Rs.500+ Rs.250 p.m. or part thereof R-59(4) |
Rs.150 R-59(3) |
||
3. | Drugs specified in Schedule ‘X’ | Whole Sale | 19-C | 20-G | Rs.500 | 21-C | Rs.500+ Rs.250 p.m. or part thereof |
Rs.150 |
Retail Sale | 19-C | 20-F R-61(1) |
Rs.500 R-59(2) |
21-C | Rs.500+ Rs.250 p.m. or part thereof R-59(4) |
Rs.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 | Rs.500 | 21-CC | Rs.500+ Rs.250 p.m. or part thereof |
Rs.150 |
(2) Drugs specified in Schedule C&C (1) | Retail Sale | 19-AA | 21-BB R-62-D |
Rs.500 R-62-C |
21-CC | Rs.500+ Rs.250 p.m. or part thereof R-62-C |
Rs.150 R-62-C |
|
5. | Homoeopathic Medicines | Whole Sale | 19-B | 21-D | Rs.250 | 21-CC | Rs.250+ Rs.50p.m. or part thereof |
Rs.150 |
Retail Sale | 19-B | 21-C R-67-C |
Rs.250 R-67-A(2) |
21-E | Rs.250+ Rs.50p.m. or part thereof R-67-A(2) |
Rs.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. | 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 |
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 Rs. 500+ Insp. fee of Rs. 200 for every inspection or for renewal of licence R: 69(2)(a) |
26-B R: 73-B |
Rs.500+Rs.250 p.m. or part thereof in addition to an inspection fee of Rs.200 R: 69(3)(i) |
Rs.1000 R: 69(4) |
Rs. 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 Rs. 500+ Insp. fee of Rs. 200 for every inspection or for renewal of licence R: 69(2)(a) |
26-F R: 73 |
Rs.6000+ Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1000 R: 69(3)(ii) |
Rs.1000 R: 69(4) |
Rs. 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 Rs. 6000+ Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 69(2)(c) |
26 R: 73 |
Rs.6000+Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 69-A(1) |
Rs.1000 R: 69(4) |
Rs. 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 Rs. 6000+ Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 69A(1) |
26-A R: 73-A |
Rs.6000+Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 69-A(1) |
Rs.1000 R: 69-A(4) |
Rs. 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 Rs. 6000 + Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 75(1) |
26 R: 77 |
Rs.6000+Rs.1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 75A(1) |
Rs.1000 R: 75A(4) |
Rs. 300 per item R: 75(5) |
(ii) Loan Licence | 27-A up to 10 items for each category R:75A(1) |
28-B R: 76 |
Lic. fee of Rs. 6000 + Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 75(2) |
26-F R: 77 |
Rs.6000+Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 75(2) |
Rs.1000 R: 75(4) |
Rs. 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 Rs. 6000 + Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 75(2) |
26-F R: 77 |
Rs.6000+Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 75(2) |
Rs.1000 R: 75(4) |
Rs. 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 Rs. 6000 + Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 75(3) |
26-H R: 77 |
Rs.6000+Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 75(3) |
Rs.1000 R: 75(4) |
Rs. 300 per item R: 75(5) |
|
(v) Whole Human Blood & Components | 27-C R: 122F(1) |
28-C R: 122G |
Lic. fee of Rs. 6000 + Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 122F(1) |
26-G R: 122H |
Rs.6000 + Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 122F(1) |
Rs.1000 R: 122F(2) |
Rs. 300 per item R: 75(5) |
|
3. | Mfg. of drugs for purpose of examination, test / analysis | 30 R: 90 |
29 R: 89 |
Rs.250 R: 90(2) |
- | - | - | - |
Fee for further application after rejection Rs.250 (R: 82) Fee for further application after rejection Rs.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 |
Rs.200 + Rs.100 for 1st inspection or Rs.50 in case of inspection for renewal of licence R: 85-B(2)(a) |
26-C R: 85-G |
Rs.200 + Rs.100 p.m. or part thereof and inspection fee of Rs.50 R: 85-B(3)(a) |
Rs.50 R: 85-B(4) |
2. | Potentised Preparation | 24-C R: 85-B(2) |
25-C R: 85(b) |
Rs.200 + Rs.100 for 1st inspection or Rs.50 in case of inspection for renewal of licence R: 85-B(2)(b) |
26-C R: 85-G |
Rs.200 + Rs.100 p.m. or part thereof and inspection fee of Rs.50 R: 85-B(3)(b) |
Rs.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 |
Rs.200 + Rs.100 for 1st inspection or Rs.50 in case of inspection for renewal of licence R: 85-B(2)(c) |
26-C R: 85-G |
Rs.200 + Rs.100 p.m. or part thereof and inspection fee of Rs.50 R: 85-B(3)(c) |
Rs.50 R: 85-B(4) |
4. | Additional item | Rs. 50 for each additional Item R: 85-B(5) |
|||||
Note: Fee for further application after rejection Rs.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 Rs. 2500 + Insp. fee of Rs. 1000 for every inspection or for renewal of licence R: 138(2) |
33 R: 141 |
Rs.2500+Rs.400 p.m. or part thereof in addition to insp. fee of Rs.1000 R: 138(2) |
Rs.250 R: 138(4) |
Rs.100 for each additional item subject to a maximum of Rs.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 Rs. 2500 + Insp. fee of Rs. 1000 for every inspection or for renewal of licence R: 138-A(1) |
33-A R: 141-A |
Rs.2500+Rs.400 p.m. or part thereof in addition to insp. fee of Rs.1000 R: 138A(2) |
Rs.250 R: 138-A(6) |
Rs.100 for each additional item subject to a maximum of Rs.3000 R: 138-A(5) |
Note: Fee for further application after rejection Rs. 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 Rs.6000 R: 150-B(1) |
38 R: 150-J |
Rs.6000+Rs. 1000 p.m. or part thereof R: 150-B(1) |
- | Rs.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 Rs.1500 R: 150-B(1) |
38 R: 150-J |
Rs.1500+Rs. 1000 p.m. or part thereof R: 150-B(1) |
- | Rs.1000 per category R: 150-B(2) |
Note: Fee for further application after rejection Rs. 250 (R: 139 AD) |