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/ retention | 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 (R.61/63) |
₹1500 | Omitted | ₹1500+two per cent. of the licence fee for every month or part thereof | ₹150 |
| Retail Sale | 19 | 20 (R.61/63) |
₹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.61/63) |
₹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 (R.61/63) |
₹1500 | Omitted | ₹1500+two per cent. of the licence fee for every month or part thereof | ₹150 |
| Retail Sale | 19 | 21 (R.61/63) |
₹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.61/63) |
₹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 (R.61/63) |
₹500 | Omitted | ₹500+two per cent. of the licence fee for every month or part thereof | ₹150 |
| Retail Sale | 19-C | 20-F (R.61/63) |
₹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 | 20-BB (R.62D/63) |
₹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.62D/63) |
₹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 (R.67C/67EE) |
₹250 | 20-E | ₹250+₹50p.m. or part thereof | ₹150 |
| Retail Sale | 19-B | 20-C (R.67C/67EE) |
₹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/ Retention | 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.70/72) |
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.70/72) |
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.76/77) |
Lic. fee of ₹ 6000 + Insp. fee of ₹ 1500 for every inspection 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/83) |
Lic. fee of ₹ 6000 + Insp. fee of ₹ 1500 for every inspection 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.76/77) |
Lic. fee of ₹ 6000 + Insp. fee of ₹ 1500 for every inspection 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 [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 [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(2)] |
₹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/Retention | 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/ Retention | 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) | ||||||||