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.