FORMS AND FEES A: SALE APPLICATIONS, LICENSES, FEES AND PENALTY

B: MANUFACTURING APPLICATIONS, LICENCES, FEES AND PENALTY* o I. ALLOPATHIC DRUGS o II. HOMOEOPATHIC MEDICINES o III. COSMETICS o IV. APPROVAL OF PRIVATE TESTING LABORATORIES

A: SALE APPLICATIONS, LICENSES, FEES AND PENALTY S.No. Category Type Sale Application Form 19 Licence Form 20-B Fees for Grant/ Renewal Penalty after Fees for Renewal Certificate expiry but within duplicate copy Form No. six months of Org. Lic. Rs.1500 21-C Rs.1500+ Rs.500 p.m. or part thereof Rs.1500+ Rs.500 p.m. or part thereof Rs.500+ Rs.250 p.m. or part thereof R-59(4) 21-C Rs.1500+ Rs.500 p.m. or part thereof Rs.1500+ Rs.500 p.m. or part thereof Rs.500+ Rs.250 p.m. or part thereof Rs.150

1.

Drugs other than those specified in Schedule C&C (1)&X

Whole Sale

Retail Sale

19

20

Rs.1500

21-C

Rs.150

Restricted (Gen.Store)

19-A

20

Rs.1500

21-C

Rs.150

R-61(1) 2. Drugs specified in Schedule C&C (1) but excluding those specified in Schedule X Whole Sale 19 21-B

R-59(2) Rs.1500

R-59(3) Rs.150

Retail Sale

19

21

Rs.1500

21-C

Rs.150

Restricted (Gen.Store)

19-A

21-A

Rs.1500

21-C

Rs.150

R-61(1) 3. Drugs specified in Schedule X Whole Sale 19-C 20-G

R-59(2) Rs.1500 21-C

R-59(4) Rs.500+ Rs.250 p.m. or part thereof Rs.500+ Rs.250 p.m. or part thereof R-59(4) 21-CC Rs.500+ Rs.250 p.m. or part thereof

R-59(3) Rs.150

Retail Sale

19-C

20-F

Rs.1500

21-C

Rs.150

R-61(1) 4. Sale of Drugs from motor vehicles (1) Drugs other than those specified in Schedule C&C (1) (2) Drugs specified in Schedule C&C (1) Whole Sale 19-AA 21-BB

R-59(2) Rs.500

R-59(3) Rs.150

Retail Sale

19-AA

21-BB

Rs.500

21-CC

Rs.500+ Rs.250 p.m. or part thereof R-62-C

Rs.150

R-62-D 5. Homoeopathic Medicines Whole Sale 19-B 21-D

R-62-C Rs.250 21-CC

R-62-C Rs.150

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

Retail Sale

19-B

21-C

Rs.250

21-E

Rs.150

R-67-C * GSR No. 421 dated 24/08/2001

R-67-A(2)

R-67-A(2)

A: MANUFACTURING APPLICATIONS, LICENCES, FEES AND PENALTY* I. ALLOPATHIC DRUGS

S.No. Category of drugs

Application Licence Form Form

Fees for Grant/ Renewal

Renewal Penalty after expiry Fees for Fee for addl. Certificate but within six duplicate item for more Form No. months copy of Org. than 10 item Lic. for each category VI VII VIII IX

I 1.

II Drugs other than those specified in Schedule C&C (1) & X (i) Repacking of drugs

III

IV

24-B upto 10 items for each category

25-B

Lic. fees of Rs. 500+ Insp. fee of Rs. 200 for every inspection or for renewal of licence R: 69(2)(a)

26-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

Rs. 100 for each addl.item

R: 69(5) R: 69(4) Rs.1000 Rs. 300 per item

R: 69(1)(a) (ii) Drugs specified in Schedule X 24-F upto 10 items for each category

R: 70 25-B Lic. fees of Rs. 500+ Insp. fee of Rs. 200 for every inspection or for renewal of licence R: 69(2)(a)

R: 73-B 26-F Rs.6000+ Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1000 R: 69(3)(ii) R: 73 Lic. fee of Rs. 6000+ Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 69(2)(c) 26 Rs.6000+Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 69-A(1) R: 73 Lic. fee of Rs. 6000+ Insp. fee of Rs. 1500 26-A Rs.6000+Rs. 1000 p.m. or part thereof in

R: 69(1)(b) (iii) Any other 24 upto 10 items for each category

R: 70 25

R: 69(4) Rs.1000

R: 69(5) Rs. 300 per item

R: 69(1)(c) (iv) Loan Licence 24-A upto 10 items for

R: 70 25-A

R: 69(4) Rs.1000

R: 69(5) Rs. 300 per item

each category

for every inspection or for renewal of licence R: 69A(1) R: 70-A R: 73-A * GSR No. 421 dated 24/08/2001

addition to insp. fee of Rs.1500 R: 69-A(1) R: 69-A(4) R: 69-A(3)

R: 69-A(1)

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) (ii) Loan Licence 27-A up to 10 items for each category R:75A(1) (iii) Drugs specified in Schedule C&C (1) &X 27-B up to 10 items for each category 28 Lic. fee of Rs. 6000 + Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 75(1) R: 76 28-B Lic. fee of Rs. 6000 + Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 75(2) R: 76 28-D Lic. fee of Rs. 6000 + Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 77 26-F Rs.6000+Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 77 26-F Rs.6000+Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 75(2) R: 75(4) Rs.1000 R: 75(5) Rs. 300 per item 26 Rs.6000+Rs.1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 75A(1) R: 75A(4) Rs.1000 R: 75(5) Rs. 300 per item Rs.1000 Rs. 300 per item

R: 75(2) R:75(2) (iv)Drugs specified in Sch. C, viz. LVP and Sera & Vaccines 27-D up to 10 items for each category R: 75(3) (v)Whole Human Blood & Components 27-C R: 76 28-D Lic. fee of Rs. 6000 + Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 75(3) R: 76 28-C Lic. fee of Rs. 6000 + Insp. fee of Rs. 1500 for every inspection or for renewal of licence R: 122F(1) R: 122F(1) R: 122G 3. Mfg. of drugs for purpose of examination, test / analysis 30 R: 90 29 R: 89 Rs.250 R: 90(2) R: 122H R: 77 26-G R: 77 26-H

R: 75(2) R: 75(4) Rs.6000+Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 75(3) R: 75(4) Rs.6000 + Rs. 1000 p.m. or part thereof in addition to insp. fee of Rs.1500 R: 122F(1) R: 122F(2) R: 75(5) Rs.1000 R: 75(5) Rs. 300 per item Rs.1000 R: 75(5) Rs. 300 per item

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. 24-C Licence Form No. 25-C Fees for Grant / Renewal Rs.200 + Rs.100 for 1st Renewal Certificate Form No. 26-C Fee+Penalty after expiry but within six months Rs.200 + Rs.100 p.m. or Fees for duplicate copy of Org. Lic. Rs.50

1.

Mother Tinctures &

Potentised Preparations

inspection or Rs.50 in case of inspection for renewal of licence R: 85-B(2)(a) R: 85-B(2) R: 85-D 25-C Rs.200 + Rs.100 for 1st inspection or Rs.50 in case of inspection for renewal of licence R: 85-B(2)(b) R: 85-B(2) R: 85(b) 25-C Rs.200 + Rs.100 for 1st inspection or Rs.50 in case of inspection for renewal of licence R: 85-B(2)(c) R: 85-B(2) R: 85-D Rs. 50 for each additional Item R: 85-B(5) R: 85-G R: 85-G 26-C R: 85-G 26-C

part thereof and inspection fee of Rs.50 R: 85-B(3)(a) R: 85-B(4) Rs.200 + Rs.100 p.m. or part thereof and inspection fee of Rs.50 R: 85-B(3)(b) R: 85-B(4) Rs.200 + Rs.100 p.m. or part thereof and inspection fee of Rs.50 R: 85-B(3)(c) R: 85-B(4) Rs.50 Rs.50

2.

Potentised Preparation

24-C

3.

Potentised Preparations from back potencies by Pharmacy which are licensed to sell Homoeopathic Medicines by retail Additional item

24-C

4.

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 Penalty after expiry Fees for Certificate but within six duplicate copy Form No. months of Org. Lic. 33 Rs.2500+Rs.400 p.m. Rs.250 Fee for addl. item for more than 10 item for each category Rs.100 for each

1.

Own

31

32

Lic. fee of Rs. 2500 +

manufacturing

up to 10 items for each category R: 138(1) R: 139-A 32-A

Insp. fee of Rs. 1000 for every inspection or for renewal of licence R: 138(2) R: 141 Lic. fee of Rs. 2500 + Insp. fee of Rs. 1000 for every inspection or for renewal of licence R: 138-A(1) 33-A

or part thereof in addition to insp. fee of Rs.1000 R: 138(2) R: 138(4) Rs.2500+Rs.400 p.m. or part thereof in addition to insp. fee of Rs.1000 R: 138A(2) R: 141-A R: 138-A(6) Rs.250

additional item subject to a maximum of Rs.3000 R: 138(3) Rs.100 for each additional item subject to a maximum of Rs.3000 R: 138-A(5)

2.

Loan Licence

31-A up to 10 items for each category R: 138-A(1)

R: 139-B

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 Penalty after expiry Fees for Certificate but within six duplicate copy Form No. months of Org. Lic. 38 Rs.6000+Rs. 1000 p.m. or part thereof R: 150-B(1) R: 150-B 2. Testing of drugs other than those specified in Sch.C & C(1)& Homoeopathic 36 R: 150-C 37 R: 150-B(1) Inspection fee of Rs.1500 R: 150-J 38 Rs.1500+Rs. 1000 p.m. or part thereof Rs.1000 per category Fee for addl. item for more than 10 item for each category Rs.1500 per category R: 150-B(2)

1.

Testing of drugs specified in Sch.C & C (1)

36

37

Inspection fee of Rs.6000

Medicines & Cosmetics R: 150-B R: 150-C R: 150-B(1) R: 150-J

R: 150-B(1) Note: Fee for further application after rejection Rs. 250 (R: 139 AD)

R: 150-B(2)