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Topic: Drug Quality

Provisions relating to quality standards, substandard drugs, testing and regulatory quality control.

Section 16 of Drugs and Cosmetics Act, 1940 – Standards of Quality

Section 16 of the Drugs and Cosmetics Act, 1940 deals with Standards of Quality.

Bare Text

16. Standards of quality. —4
[(1) For the purposes of this Chapter, the expression “standard quality”
means—
(a) in relation to a drug, that the drug complies with the standard set out in 5
[the Second
Schedule], and
(b) in relation to a cosmetic, that the cosmetic complies with such standard as may
be prescribed.]
(2) The 6
[Central Government], after consultation with the Board and after giving by
notification in the Official Gazette not less than three months’ notice of its intention so to do,
may by a like notification add to or otherwise amend 5
[the Second Schedule] for the purposes
of this Chapter, and thereupon 5
[the Second Schedule] shall be deemed to be amended
accordingly.

Simple Meaning

Section 16 defines what “standard quality” means for the purposes of Chapter IV of the Drugs and Cosmetics Act, 1940. A drug is of standard quality when it complies with the standard set out in the Second Schedule. A cosmetic is of standard quality when it complies with the prescribed standard. This section is therefore the statutory foundation for deciding whether a drug or cosmetic passes the legal quality requirement.

Compliance Relevance

For manufacturers, distributors, pharmacists and lawyers, Section 16 is important because many enforcement actions begin with the allegation that a product is not of standard quality. It connects laboratory testing, official standards, Government Analyst reports and penalty provisions. In sample-failure matters, Section 16 should be read with Sections 18, 23, 25 and 27.

Related Provisions

Section 17, Section 17A, Section 17B, Section 18, Section 23, Section 25, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.

Section 17B of Drugs and Cosmetics Act, 1940 – Spurious Drugs

Section 17B of the Drugs and Cosmetics Act, 1940 deals with Spurious Drugs.

Bare Text

17B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be
spurious,—
(a) if it is manufactured under a name which belongs to another drug; or
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug
in a manner likely to deceive or bears upon it or upon its label or container the name of
another drug unless it is plainly and conspicuously marked so as to reveal its true character
and its lack of identity with such other drug; or
(c) if the label or container bears the name of an individual or company purporting to be the
manufacturer of the drug, which individual or company is fictitious or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

Simple Meaning

Section 17B states when a drug is deemed to be spurious. It includes drugs manufactured under the name of another drug, imitations or substitutes likely to deceive, drugs bearing a fictitious manufacturer’s name, substituted products, and products falsely purporting to be made by a manufacturer.

Compliance Relevance

Section 17B is central to anti-counterfeit and supply-chain compliance. Pharmacies, wholesalers and manufacturers must purchase and supply medicines only through reliable and authorised channels, maintain invoices and verify product identity. This provision is closely connected with Section 18 prohibitions and Section 27 penalties.

Related Provisions

Section 16, Section 17, Section 17A, Section 18, Section 22, Section 25, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.

Section 17A of Drugs and Cosmetics Act, 1940 – Adulterated Drugs

Section 17A of the Drugs and Cosmetics Act, 1940 deals with Adulterated Drugs.

Bare Text

17A. Adulterated drugs.— For the purposes of this Chapter, a drug shall be deemed to be
adulterated,—
(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or
(b) if it has been prepared, packed or stored under insanitary conditions whereby it
may have been contaminated with filth or whereby it may have been rendered injurious to
health; or
(c) if its container is composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or
(d) if it bears or contains, for purposes of colouring only, a colour other than one which is
prescribed; or
(e) if it contains any harmful or toxic substance which may render it injurious to
health; or
(f) if any substance has been mixed therewith so as to reduce its quality or strength.

Simple Meaning

Section 17A states when a drug is deemed to be adulterated. It covers filthy, putrid or decomposed substances, insanitary preparation, packing or storage, injurious containers, prohibited colouring, harmful or toxic substances and mixing of any substance that reduces quality or strength.

Compliance Relevance

This provision is important for manufacturing hygiene, storage conditions, container safety, quality assurance and supply-chain control. It is relevant where a sample failure involves contamination, harmful substances, insanitary conditions or reduced quality or strength. It should be read with Sections 16, 18, 25 and 27.

Related Provisions

Section 16, Section 17, Section 17B, Section 18, Section 25, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.

Section 17 of Drugs and Cosmetics Act, 1940 – Misbranded Drugs

Section 17 of the Drugs and Cosmetics Act, 1940 deals with Misbranded Drugs.

Bare Text

[17. Misbranded drugs.—For the purposes of this Chapter, a drug shall be deemed to be
misbranded,—

(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it
is made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement,
design or device which makes any false claim for the drug or which is false or misleading in
any particular.

1. Ins. by Act 21 of 1962, s. 11 (w.e.f. 27-7-1964).

Simple Meaning

Section 17 states when a drug is deemed to be misbranded. It covers situations where damage is concealed, where the drug is made to appear to have better or greater therapeutic value than it really has, where it is not labelled in the prescribed manner, or where the label, container or accompanying material contains a false or misleading claim.

Compliance Relevance

This section is crucial for labelling, packaging, product presentation and promotional claims. Manufacturers, marketers, distributors and pharmacies must ensure that the label and accompanying material do not create a false or misleading impression. Section 17 is directly connected with the prohibition in Section 18 and the penalty consequences under Section 27.

Related Provisions

Section 16, Section 17A, Section 17B, Section 18, Section 27

Official Source

Verified from the official India Code PDF of the Drugs and Cosmetics Act, 1940. Readers should re-check the latest official text before professional reliance.