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August 18, 2021
PHARMACEUTICAL JURISPRUDENCE*
Drugs & Cosmetic Act: The Drugs & Cosmetic Act was passed in 1940 (10th April), with the main
object to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
FORMS FOR MANUFACTURE, SALE, REPACKAGEING AND IMPORT OF DRUGS
Sr.
No.
Purpose Drugs Application
made in
Form No.
License granted in Form
No.
I Manufacture 1. Homeopathic drugs 24C 25C
2. i. Cosmetics 31 32
ii. Loan manufacture of Cosmetics 31A 32A
3. i. Ayurvedic and Unani drugs. 24D 25D
ii. Loan manufacturing of A and U drugs 24E 25E
4. i Drugs specified in Schedule C, C1 and X 27B 28B
ii. Drugs specified in Schedule C and C1, excluding
those specified in Schedule X
27 28
iii. Drugs other than those specified in Schedule C, C1
and X
24 25
iv. Drugs specified in Schedule X 24F 25F
5. Manufacture for examination test or analysis. 29
II Sale of drugs
A. Wholesale
i. Homeopathic drugs 20D
ii. Drugs other than those specified in Schedule C, C1
and X
20B
iii. Drugs other than those specified in Schedule C,
C1 and X from a motor vehicle.
20BB
iv. Drugs specified in Schedule X 19B 20G
v. Drugs specified in Schedule C andC1 but not
included in Schedule X
19 21B
vi. Drugs specified in Schedule C and C1 but not
included in Schedule X from a
21BB
motor vehicle.
B. Retail Sale i. Homeopathic drugs 19B 20C
ii. Drugs other than those specified in Schedule C, C1
and X
19 20
iii. Drugs specified in Schedule C and C1 excluding
Schedule X
21
iv. Drugs specified in Schedule X 20F
2
August 18, 2021
(C)
Restricted
i. Drugs other than those specified in
Schedule
C, C1 and X
20A
ii. Drugs specified in Schedule C, C1 but not in
Schedule X
21A
III Repackaging Drugs specified in Schedule C and C1 24B 25B
IV Import i. Drugs specified in Schedule C and C1 8 10
ii. Drugs specified in Schedule X 8a 10a
iii. Import of drugs for testing 11
iv. Small quantity of drugs for personal use 12 12B
PHARMACYACT*
The Pharmacy Council of India is made up of the following members:
A. Elected members:
i. Six members, among whom at least one is a teacher of Pharmaceutical Chemistry, Pharmacy,
Pharmacology and Pharmacognosy of an Indian University, or a college affiliated thereto, which
grants a degree or diploma in Pharmacy, elected by the University Grants Commission.
ii. One member elected from amongst themselves by the Members of the Medical Council of India.
iii. One member to represent each State, nominated by State Government, who shall be a
Registered Pharmacist.
B. Nominated members:
i. Six members, four of whom are persons possessing a degree or diploma in, and practicing,
pharmacy or pharmaceutical chemistry, nominated by the Central Government.
ii. A representative of the University Grants Commission and a representative of the All-India
Council for Technical Education.
iii. One member to represent each State elected [from amongst themselves] by the members of each
State Council, who shall be a Registered Pharmacist.
C. Ex-officio members
i. Director General of Health Services, or a person authorized by him.
ii. Drugs Controller of India or a person authorized by him.
iii. Director of Central Drugs Laboratory.
3
August 18, 2021
STATE PHARMACY COUNCIL
State Pharmacy Council and Joint State Pharmacy Council are also constituted by State Governments.
Two or more states may also agree that the State Council of one state shall serve the, needs of the other
participating States. Two or more States may also enter into agreement (inter-state agreement) for definite
specified period, to form Joint State Council.
Pharmacy Council and Joint State Pharmacy Council, as follows-
State Council Joint Council
1. Six Registered Pharmacists elected from amongst
themselves.
2. One member elected from amongst
themselves by the Members of the Medical Council
of the State.
Nominated Members
1. Five members, of whom at least three shall possess a
degree or diploma in Pharmacy or Pharmaceutical
Chemistry, or be Registered Pharmacists, nominated by
the State Government.
Ex-officio Members:
1. Chief of Administrative Medical Officer of the state.
2. Officer–in-charge of Drugs and
Cosmetics Act, 1940.
3. Government Analyst under the Drugs and Cosmetics
Act, or where there is more than one, such as the State
Government may appoint in this behalf.
1. 3-5 Registered Pharmacists of each of
participating State, elected from amongst
themselves. However, if agreed, the number of
members elected by each of the participating state
may not be the same, but shall vary from 3-5.
2. One member elected by Medical Council of
each State from amongst its members.
1. 2-4 members nominated by each participating
State of whom more than half shall possess a degree
or diploma in Pharmacy or Pharmaceutical
Chemistry, or be Registered Pharmacists. However,
if agreed, the number of members nominated by each
of the participating State may not be the same, but
shall be 2-4 only.
1. Chief of Administrative Medical Officer of
each of the participating states.
2. Officer–in-charge of the Drugs Control
Organization of each participating state.
3. Government Analyst of each participating state
under the Drugs and Cosmetics Act, or where there is
more than one in each state, such one as the State
Government may appoint in his behalf.

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  • 1. 1 August 18, 2021 PHARMACEUTICAL JURISPRUDENCE* Drugs & Cosmetic Act: The Drugs & Cosmetic Act was passed in 1940 (10th April), with the main object to regulate the import, manufacture, distribution and sale of drugs and cosmetics. FORMS FOR MANUFACTURE, SALE, REPACKAGEING AND IMPORT OF DRUGS Sr. No. Purpose Drugs Application made in Form No. License granted in Form No. I Manufacture 1. Homeopathic drugs 24C 25C 2. i. Cosmetics 31 32 ii. Loan manufacture of Cosmetics 31A 32A 3. i. Ayurvedic and Unani drugs. 24D 25D ii. Loan manufacturing of A and U drugs 24E 25E 4. i Drugs specified in Schedule C, C1 and X 27B 28B ii. Drugs specified in Schedule C and C1, excluding those specified in Schedule X 27 28 iii. Drugs other than those specified in Schedule C, C1 and X 24 25 iv. Drugs specified in Schedule X 24F 25F 5. Manufacture for examination test or analysis. 29 II Sale of drugs A. Wholesale i. Homeopathic drugs 20D ii. Drugs other than those specified in Schedule C, C1 and X 20B iii. Drugs other than those specified in Schedule C, C1 and X from a motor vehicle. 20BB iv. Drugs specified in Schedule X 19B 20G v. Drugs specified in Schedule C andC1 but not included in Schedule X 19 21B vi. Drugs specified in Schedule C and C1 but not included in Schedule X from a 21BB motor vehicle. B. Retail Sale i. Homeopathic drugs 19B 20C ii. Drugs other than those specified in Schedule C, C1 and X 19 20 iii. Drugs specified in Schedule C and C1 excluding Schedule X 21 iv. Drugs specified in Schedule X 20F
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