Section 16 of the Act defines the standards of quality from drugs.

1 The Section 17 defines

“misbranding”.2 A drug is considered misbranded if it claims to be of more therapeutic value
than it actually is. The manufacturer of such a drug may be asked to suspend manufacture of the
drug under Section 18 and Section 27 of the Act that deals with fake and adulterated drugs. The
Act requires more of those ingredients of the drugs should be printed on the label. 34The Section
22 defines the powers of the drug inspectors 5 and Section 23 defines the strict procedure which
should be followed by the inspectors during any raids.6

Hence, from the above mentioned provisions of the Act, it is quite observant that the law creates
a web of regulatory authorities to govern the process at both the Central and State level. At the
Central level, the Drugs and Cosmetics Act, 1940 has created the Central Drugs Standard
Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is
the key regulatory authority, acting under the advice of the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committee (DCC). CDSCO operates through zonal offices
spread across the country, which have designated roles in drug regulation, such as inspections,
recalls, and market surveillance. CDSCO also has a role in overseeing the functioning of state
authorities involved in drug regulation.

1
Section 16, Drugs and Cosmetics Act, 1940 – Standards of quality.
2
Section 17, Drugs and Cosmetics Act, 1940 – Misbranded drugs.
3
Section 18, Drugs and Cosmetics Act, 1940 – Prohibition of manufacture and sale of certain drugs and cosmetics.
4
Section 27, Drugs and Cosmetics Act, 1940 – Penalty for manufacture, sale, etc., of drugs in contravention of this
Chapter.
5
Section 22, Drugs and Cosmetics Act, 1940 – Powers of Inspectors.
6
Section 23, Drugs and Cosmetics Act, 1940 – Procedure of Inspectors.
V

Section 16 of the Act defines the standards of quality from drugs. 7 The Section 17 defines
“misbranding”.8 A drug is considered misbranded if it claims to be of more therapeutic value
than it actually is. The manufacturer of such a drug may be asked to suspend manufacture of the
drug under Section 18 and Section 27 of the Act that deals with fake and adulterated drugs. The
Act requires more of those ingredients of the drugs should be printed on the label. 910The Section
22 defines the powers of the drug inspectors 11 and Section 23 defines the strict procedure which
should be followed by the inspectors during any raids.12

Hence, from the above mentioned provisions of the Act, it is quite observant that the law creates
a web of regulatory authorities to govern the process at both the Central and State level. At the
Central level, the Drugs and Cosmetics Act, 1940 has created the Central Drugs Standard
Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is
the key regulatory authority, acting under the advice of the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committee (DCC). CDSCO operates through zonal offices
spread across the country, which have designated roles in drug regulation, such as inspections,
recalls, and market surveillance. CDSCO also has a role in overseeing the functioning of state
authorities involved in drug regulation.

7
Section 16, Drugs and Cosmetics Act, 1940 – Standards of quality.
8
Section 17, Drugs and Cosmetics Act, 1940 – Misbranded drugs.
9
Section 18, Drugs and Cosmetics Act, 1940 – Prohibition of manufacture and sale of certain drugs and cosmetics.
10
Section 27, Drugs and Cosmetics Act, 1940 – Penalty for manufacture, sale, etc., of drugs in contravention of this
Chapter.
11
Section 22, Drugs and Cosmetics Act, 1940 – Powers of Inspectors.
12
Section 23, Drugs and Cosmetics Act, 1940 – Procedure of Inspectors.
Section 16 of the Act defines the standards of quality from drugs. 13 The Section 17 defines
“misbranding”.14 A drug is considered misbranded if it claims to be of more therapeutic value
than it actually is. The manufacturer of such a drug may be asked to suspend manufacture of the
drug under Section 18 and Section 27 of the Act that deals with fake and adulterated drugs. The
Act requires more of those ingredients of the drugs should be printed on the label. 1516The Section
22 defines the powers of the drug inspectors 17 and Section 23 defines the strict procedure which
should be followed by the inspectors during any raids.18

Hence, from the above mentioned provisions of the Act, it is quite observant that the law creates
a web of regulatory authorities to govern the process at both the Central and State level. At the
Central level, the Drugs and Cosmetics Act, 1940 has created the Central Drugs Standard
Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is
the key regulatory authority, acting under the advice of the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committee (DCC). CDSCO operates through zonal offices
spread across the country, which have designated roles in drug regulation, such as inspections,
recalls, and market surveillance. CDSCO also has a role in overseeing the functioning of state
authorities involved in drug regulation.

13
Section 16, Drugs and Cosmetics Act, 1940 – Standards of quality.
14
Section 17, Drugs and Cosmetics Act, 1940 – Misbranded drugs.
15
Section 18, Drugs and Cosmetics Act, 1940 – Prohibition of manufacture and sale of certain drugs and cosmetics.
16
Section 27, Drugs and Cosmetics Act, 1940 – Penalty for manufacture, sale, etc., of drugs in contravention of this
Chapter.
17
Section 22, Drugs and Cosmetics Act, 1940 – Powers of Inspectors.
18
Section 23, Drugs and Cosmetics Act, 1940 – Procedure of Inspectors.
Section 16 of the Act defines the standards of quality from drugs. 19 The Section 17 defines
“misbranding”.20 A drug is considered misbranded if it claims to be of more therapeutic value
than it actually is. The manufacturer of such a drug may be asked to suspend manufacture of the
drug under Section 18 and Section 27 of the Act that deals with fake and adulterated drugs. The
Act requires more of those ingredients of the drugs should be printed on the label. 2122The Section
22 defines the powers of the drug inspectors 23 and Section 23 defines the strict procedure which
should be followed by the inspectors during any raids.24

Hence, from the above mentioned provisions of the Act, it is quite observant that the law creates
a web of regulatory authorities to govern the process at both the Central and State level. At the
Central level, the Drugs and Cosmetics Act, 1940 has created the Central Drugs Standard
Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is
the key regulatory authority, acting under the advice of the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committee (DCC). CDSCO operates through zonal offices
spread across the country, which have designated roles in drug regulation, such as inspections,
recalls, and market surveillance. CDSCO also has a role in overseeing the functioning of state
authorities involved in drug regulation.

19
Section 16, Drugs and Cosmetics Act, 1940 – Standards of quality.
20
Section 17, Drugs and Cosmetics Act, 1940 – Misbranded drugs.
21
Section 18, Drugs and Cosmetics Act, 1940 – Prohibition of manufacture and sale of certain drugs and cosmetics.
22
Section 27, Drugs and Cosmetics Act, 1940 – Penalty for manufacture, sale, etc., of drugs in contravention of this
Chapter.
23
Section 22, Drugs and Cosmetics Act, 1940 – Powers of Inspectors.
24
Section 23, Drugs and Cosmetics Act, 1940 – Procedure of Inspectors.
Section 16 of the Act defines the standards of quality from drugs. 25 The Section 17 defines
“misbranding”.26 A drug is considered misbranded if it claims to be of more therapeutic value
than it actually is. The manufacturer of such a drug may be asked to suspend manufacture of the
drug under Section 18 and Section 27 of the Act that deals with fake and adulterated drugs. The
Act requires more of those ingredients of the drugs should be printed on the label. 2728The Section
22 defines the powers of the drug inspectors 29 and Section 23 defines the strict procedure which
should be followed by the inspectors during any raids.30

Hence, from the above mentioned provisions of the Act, it is quite observant that the law creates
a web of regulatory authorities to govern the process at both the Central and State level. At the
Central level, the Drugs and Cosmetics Act, 1940 has created the Central Drugs Standard
Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is
the key regulatory authority, acting under the advice of the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committee (DCC). CDSCO operates through zonal offices
spread across the country, which have designated roles in drug regulation, such as inspections,
recalls, and market surveillance. CDSCO also has a role in overseeing the functioning of state
authorities involved in drug regulation.

25
Section 16, Drugs and Cosmetics Act, 1940 – Standards of quality.
26
Section 17, Drugs and Cosmetics Act, 1940 – Misbranded drugs.
27
Section 18, Drugs and Cosmetics Act, 1940 – Prohibition of manufacture and sale of certain drugs and cosmetics.
28
Section 27, Drugs and Cosmetics Act, 1940 – Penalty for manufacture, sale, etc., of drugs in contravention of this
Chapter.
29
Section 22, Drugs and Cosmetics Act, 1940 – Powers of Inspectors.
30
Section 23, Drugs and Cosmetics Act, 1940 – Procedure of Inspectors.
Section 16 of the Act defines the standards of quality from drugs. 31 The Section 17 defines
“misbranding”.32 A drug is considered misbranded if it claims to be of more therapeutic value
than it actually is. The manufacturer of such a drug may be asked to suspend manufacture of the
drug under Section 18 and Section 27 of the Act that deals with fake and adulterated drugs. The
Act requires more of those ingredients of the drugs should be printed on the label. 3334The Section
22 defines the powers of the drug inspectors 35 and Section 23 defines the strict procedure which
should be followed by the inspectors during any raids.36

Hence, from the above mentioned provisions of the Act, it is quite observant that the law creates
a web of regulatory authorities to govern the process at both the Central and State level. At the
Central level, the Drugs and Cosmetics Act, 1940 has created the Central Drugs Standard
Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is
the key regulatory authority, acting under the advice of the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committee (DCC). CDSCO operates through zonal offices
spread across the country, which have designated roles in drug regulation, such as inspections,
recalls, and market surveillance. CDSCO also has a role in overseeing the functioning of state
authorities involved in drug regulation.

31
Section 16, Drugs and Cosmetics Act, 1940 – Standards of quality.
32
Section 17, Drugs and Cosmetics Act, 1940 – Misbranded drugs.
33
Section 18, Drugs and Cosmetics Act, 1940 – Prohibition of manufacture and sale of certain drugs and cosmetics.
34
Section 27, Drugs and Cosmetics Act, 1940 – Penalty for manufacture, sale, etc., of drugs in contravention of this
Chapter.
35
Section 22, Drugs and Cosmetics Act, 1940 – Powers of Inspectors.
36
Section 23, Drugs and Cosmetics Act, 1940 – Procedure of Inspectors.
Section 16 of the Act defines the standards of quality from drugs. 37 The Section 17 defines
“misbranding”.38 A drug is considered misbranded if it claims to be of more therapeutic value
than it actually is. The manufacturer of such a drug may be asked to suspend manufacture of the
drug under Section 18 and Section 27 of the Act that deals with fake and adulterated drugs. The
Act requires more of those ingredients of the drugs should be printed on the label. 3940The Section
22 defines the powers of the drug inspectors 41 and Section 23 defines the strict procedure which
should be followed by the inspectors during any raids.42

Hence, from the above mentioned provisions of the Act, it is quite observant that the law creates
a web of regulatory authorities to govern the process at both the Central and State level. At the
Central level, the Drugs and Cosmetics Act, 1940 has created the Central Drugs Standard
Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is
the key regulatory authority, acting under the advice of the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committee (DCC). CDSCO operates through zonal offices
spread across the country, which have designated roles in drug regulation, such as inspections,
recalls, and market surveillance. CDSCO also has a role in overseeing the functioning of state
authorities involved in drug regulation.

37
Section 16, Drugs and Cosmetics Act, 1940 – Standards of quality.
38
Section 17, Drugs and Cosmetics Act, 1940 – Misbranded drugs.
39
Section 18, Drugs and Cosmetics Act, 1940 – Prohibition of manufacture and sale of certain drugs and cosmetics.
40
Section 27, Drugs and Cosmetics Act, 1940 – Penalty for manufacture, sale, etc., of drugs in contravention of this
Chapter.
41
Section 22, Drugs and Cosmetics Act, 1940 – Powers of Inspectors.
42
Section 23, Drugs and Cosmetics Act, 1940 – Procedure of Inspectors.
Section 16 of the Act defines the standards of quality from drugs. 43 The Section 17 defines
“misbranding”.44 A drug is considered misbranded if it claims to be of more therapeutic value
than it actually is. The manufacturer of such a drug may be asked to suspend manufacture of the
drug under Section 18 and Section 27 of the Act that deals with fake and adulterated drugs. The
Act requires more of those ingredients of the drugs should be printed on the label. 4546The Section
22 defines the powers of the drug inspectors 47 and Section 23 defines the strict procedure which
should be followed by the inspectors during any raids.48

Hence, from the above mentioned provisions of the Act, it is quite observant that the law creates
a web of regulatory authorities to govern the process at both the Central and State level. At the
Central level, the Drugs and Cosmetics Act, 1940 has created the Central Drugs Standard
Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is
the key regulatory authority, acting under the advice of the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committee (DCC). CDSCO operates through zonal offices
spread across the country, which have designated roles in drug regulation, such as inspections,
recalls, and market surveillance. CDSCO also has a role in overseeing the functioning of state
authorities involved in drug regulation.

43
Section 16, Drugs and Cosmetics Act, 1940 – Standards of quality.
44
Section 17, Drugs and Cosmetics Act, 1940 – Misbranded drugs.
45
Section 18, Drugs and Cosmetics Act, 1940 – Prohibition of manufacture and sale of certain drugs and cosmetics.
46
Section 27, Drugs and Cosmetics Act, 1940 – Penalty for manufacture, sale, etc., of drugs in contravention of this
Chapter.
47
Section 22, Drugs and Cosmetics Act, 1940 – Powers of Inspectors.
48
Section 23, Drugs and Cosmetics Act, 1940 – Procedure of Inspectors.
Section 16 of the Act defines the standards of quality from drugs. 49 The Section 17 defines
“misbranding”.50 A drug is considered misbranded if it claims to be of more therapeutic value
than it actually is. The manufacturer of such a drug may be asked to suspend manufacture of the
drug under Section 18 and Section 27 of the Act that deals with fake and adulterated drugs. The
Act requires more of those ingredients of the drugs should be printed on the label. 5152The Section
22 defines the powers of the drug inspectors 53 and Section 23 defines the strict procedure which
should be followed by the inspectors during any raids.54

Hence, from the above mentioned provisions of the Act, it is quite observant that the law creates
a web of regulatory authorities to govern the process at both the Central and State level. At the
Central level, the Drugs and Cosmetics Act, 1940 has created the Central Drugs Standard
Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is
the key regulatory authority, acting under the advice of the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committee (DCC). CDSCO operates through zonal offices
spread across the country, which have designated roles in drug regulation, such as inspections,
recalls, and market surveillance. CDSCO also has a role in overseeing the functioning of state
authorities involved in drug regulation.

49
Section 16, Drugs and Cosmetics Act, 1940 – Standards of quality.
50
Section 17, Drugs and Cosmetics Act, 1940 – Misbranded drugs.
51
Section 18, Drugs and Cosmetics Act, 1940 – Prohibition of manufacture and sale of certain drugs and cosmetics.
52
Section 27, Drugs and Cosmetics Act, 1940 – Penalty for manufacture, sale, etc., of drugs in contravention of this
Chapter.
53
Section 22, Drugs and Cosmetics Act, 1940 – Powers of Inspectors.
54
Section 23, Drugs and Cosmetics Act, 1940 – Procedure of Inspectors.
Section 16 of the Act defines the standards of quality from drugs. 55 The Section 17 defines
“misbranding”.56 A drug is considered misbranded if it claims to be of more therapeutic value
than it actually is. The manufacturer of such a drug may be asked to suspend manufacture of the
drug under Section 18 and Section 27 of the Act that deals with fake and adulterated drugs. The
Act requires more of those ingredients of the drugs should be printed on the label. 5758The Section
22 defines the powers of the drug inspectors 59 and Section 23 defines the strict procedure which
should be followed by the inspectors during any raids.60

Hence, from the above mentioned provisions of the Act, it is quite observant that the law creates
a web of regulatory authorities to govern the process at both the Central and State level. At the
Central level, the Drugs and Cosmetics Act, 1940 has created the Central Drugs Standard
Control Organisation (CDSCO), within which the Drugs Controller General of India (DCGI) is
the key regulatory authority, acting under the advice of the Drug Technical Advisory Board
(DTAB) and the Drug Consultative Committee (DCC). CDSCO operates through zonal offices
spread across the country, which have designated roles in drug regulation, such as inspections,
recalls, and market surveillance. CDSCO also has a role in overseeing the functioning of state
authorities involved in drug regulation.

55
Section 16, Drugs and Cosmetics Act, 1940 – Standards of quality.
56
Section 17, Drugs and Cosmetics Act, 1940 – Misbranded drugs.
57
Section 18, Drugs and Cosmetics Act, 1940 – Prohibition of manufacture and sale of certain drugs and cosmetics.
58
Section 27, Drugs and Cosmetics Act, 1940 – Penalty for manufacture, sale, etc., of drugs in contravention of this
Chapter.
59
Section 22, Drugs and Cosmetics Act, 1940 – Powers of Inspectors.
60
Section 23, Drugs and Cosmetics Act, 1940 – Procedure of Inspectors.