Section 8 of the Drugs and Cosmetics Act 1940 - Standards of Quality

Section 8 defines when a drug or cosmetic is regarded as being of "standard quality" for the purposes of Chapter III of the Drugs and Cosmetics Act, 1940, which deals with import of drugs and cosmetics.

Current regulatory context: For drugs, Section 8 links standard quality to the standards set out in the Second Schedule to the Act. For cosmetics, the Act refers to standards prescribed under the applicable rules. The Cosmetics Rules, 2020 now contain the principal regulatory framework for cosmetics, including quality and safety requirements.

Text of Section 8 - Standards of quality

(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 the Second Schedule; and

(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.

(2) The 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 to do so, may by a like notification add to or otherwise amend the Second Schedule for the purposes of this Chapter, and the Second Schedule shall thereupon be deemed to be amended accordingly.

Meaning and scope of Section 8

Section 8 is a quality-control provision in Chapter III. It supplies the statutory benchmark for deciding whether an imported drug or cosmetic meets the quality standard required under the Act. It should therefore be read with the other provisions of Chapter III, including the restrictions on import under Section 10 and the Central Government's rule-making power under Section 12.

Standard quality of a drug

Under Section 8(1)(a), a drug is of standard quality for Chapter III when it complies with the standard specified in the Second Schedule. The Second Schedule identifies recognised standards applicable to different classes of drugs and is therefore central to the statutory quality test.

Standard quality of a cosmetic

Section 8(1)(b) uses the standards prescribed by rules for cosmetics. Under the current Cosmetics Rules, 2020, Rule 39 provides that a cosmetic must comply with the specifications prescribed in the Ninth Schedule or other applicable standards of quality and safety. Where a cosmetic is not included in the Ninth Schedule, the rule provides for compliance with the requirements of the Cosmetics Rules and the applicable specifications and standards in the country of origin.

Power to amend the Second Schedule

Section 8(2) authorises the Central Government to add to or otherwise amend the Second Schedule. The statutory process requires consultation with the Drugs Technical Advisory Board and at least three months' prior notice of the proposed change through a notification in the Official Gazette, followed by a further notification making the amendment.

Relevant definitions

Drug: Section 3(b) of the Act gives "drug" an extended statutory meaning covering medicines and specified substances used for diagnosis, treatment, mitigation or prevention of disease or disorder, and other categories brought within the definition by the Act.

Cosmetic: Section 3(aaa) broadly covers an article intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any part of it for cleansing, beautifying, promoting attractiveness or altering appearance, and includes an article intended for use as a component of a cosmetic.

For the complete statutory wording and related definitions, see Section 3 - Definitions.

Why Section 8 matters

It establishes the quality benchmark for drugs imported under Chapter III.
It connects drug quality directly with the Second Schedule.
It connects cosmetic quality with standards prescribed under the applicable rules.
It provides a statutory procedure for amendment of the Second Schedule.
It operates alongside the prohibitions and regulatory powers contained in the succeeding provisions of Chapter III.

Legislative notes

The heading under Chapter III was substituted with effect from 1 February 1983. Sub-section (1) was substituted by Act 21 of 1962 with effect from 27 July 1964. The reference to the "Second Schedule" was substituted for the earlier reference to "the Schedule" by Act 13 of 1964 with effect from 15 September 1964.

Updated: 25 September 2026. This page is an informational presentation of the statutory provision. For regulatory compliance, always check the latest Gazette notifications, amendments and applicable rules.