Drugs and Cosmetics Act 1940 / Section 33

Section 33 of Drugs and Cosmetics Act 1940: Power of Central Government to Make Rules

Section 33 of the Drugs and Cosmetics Act, 1940 is the principal rule-making provision for Chapter IV of the Act. It authorises the Central Government to make rules, generally after consultation with or on the recommendation of the Drugs Technical Advisory Board and after previous publication in the Official Gazette.

In brief: Section 33 enables detailed subordinate legislation on matters such as laboratories, Government Analysts, Inspectors, testing standards, licences, records, packaging, labelling, prohibited claims, poisonous substances, exemptions and compounding amounts. The detailed regulatory framework is principally contained in rules made under the Act.

Meaning and scope of Section 33

The expression "make rules" means the statutory power delegated by Parliament to the Central Government to prescribe detailed requirements needed to implement Chapter IV. The rule-making power must remain within the scope of the Act and is exercised through notification in the Official Gazette, subject to the procedural requirements stated in Section 33.

The "Board" referred to in Section 33 is the Drugs Technical Advisory Board constituted under Section 5 of the Act. Section 33(1) contemplates consultation with, or a recommendation of, that Board. In urgent circumstances consultation may be dispensed with initially, but the Board must then be consulted within six months and its suggestions concerning amendment of the rules must be considered.

Text and subjects covered by Section 33

(1) The Central Government may, after consultation with, or on the recommendation of, the Board and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter.

Proviso: Consultation with the Board may be dispensed with where the Central Government considers circumstances to require rules without such consultation. In that event, the Board is to be consulted within six months and its suggestions regarding amendment of the rules are to be considered.

(2) Without prejudice to the general rule-making power, rules may address the following matters:

(a) establishment of laboratories for testing and analysing drugs or cosmetics;

(b) qualifications and duties of Government Analysts and qualifications of Inspectors;

(c) methods of test or analysis for determining whether a drug or cosmetic is of standard quality;

(d) units or methods of standardisation for biological and organometallic compounds;

(dd) colours which a drug may bear or contain for colouring purposes under Section 17A(d);

(dda) colours which a cosmetic may bear or contain for colouring purposes under Section 17E(d);

(e) forms of licences for manufacture for sale or distribution, sale and distribution of drugs or cosmetics; applications, licence conditions, licensing authority, qualifications, fees, cancellation and suspension;

(ee) records, registers and other documents required under Section 18B;

(eea) fees for inspection of premises for grant or renewal of manufacturing licences;

(eeb) manner of certification of copies under Section 22(2A);

(f) diseases or ailments for which a drug may not claim prevention, cure or mitigation and other effects a drug may not claim to have;

(g) conditions for manufacture of small quantities of drugs for examination, test or analysis;

(h) statement of date of manufacture and expiry of potency on specified drugs and restrictions on sale, stocking, exhibition for sale or distribution after the specified period;

(i) conditions for packing drugs or cosmetics, including packing material in direct contact with drugs, and prohibition of non-compliant packing;

(j) mode of labelling packed drugs or cosmetics and matters to be included or excluded from labels;

(k) maximum proportions of poisonous substances in drugs, related prohibitions and substances deemed poisonous;

(l) display of the accepted scientific name of a specified drug on the label or wrapper of a patent or proprietary medicine;

(m) omitted;

(n) powers and duties of Inspectors, qualifications of the authority to which they are subordinate, and the drugs or cosmetics and conditions to which those powers and duties relate;

(o) forms of Government Analyst reports, applications for test or analysis under Section 26 and applicable fees;

(p) offences under Chapter IV or rules for which an order of confiscation may be made under Section 31;

(q) conditional or other exemptions for specified drugs, classes of drugs, cosmetics or classes of cosmetics from provisions of Chapter IV or rules made under it;

(r) the sum that may be specified by the Central Government under Section 32B relating to compounding of certain offences.

Important provisions referred to in Section 33

Section 17A - Adulterated drugs

Section 17A specifies circumstances in which a drug is deemed to be adulterated. Section 33(2)(dd) supports prescription of permitted colours for the purpose referred to in Section 17A(d).

Section 17E - Adulterated cosmetics

Section 17E identifies when a cosmetic is deemed adulterated. Section 33(2)(dda) authorises rules prescribing colours a cosmetic may bear or contain for colouring purposes.

Section 18B - Maintenance of records and furnishing information

Section 18B requires prescribed records, registers and other documents to be maintained and information to be furnished by persons holding licences or otherwise covered by the provision. Section 33(2)(ee) supplies the rule-making authority for those prescribed records and documents.

Section 22 - Powers of Inspectors

Section 22 sets out statutory powers of Inspectors. Section 33(2)(eeb) permits rules on certification of copies under Section 22(2A), while clause (n) supports detailed rules governing Inspectors' powers and duties.

Section 26 - Test or analysis

Section 33(2)(o) permits prescription of Government Analyst report forms, the manner of applying for test or analysis under Section 26 and the fees payable.

Sections 31 and 32B - Confiscation and compounding

Section 33(2)(p) concerns identification by rules of offences for which confiscation may be ordered under Section 31. Section 33(2)(r) concerns the amount that may be specified for compounding under Section 32B.

Practical legal effect

Section 33 is an enabling provision. Many operational requirements governing manufacture, sale, distribution, testing, labelling, licensing and regulatory supervision are therefore found not only in the Act but also in subordinate rules and notifications made under the Act. For compliance or litigation, the relevant statutory section should be read together with the applicable rules and current notifications.

Current regulatory note: CDSCO continues to publish Acts, Rules, notifications, circulars and public notices relating to drugs and cosmetics. Users should verify the latest applicable rule or notification for the specific product and activity concerned before relying on a historical rule position.

Legislative history reflected in the provision

Section 33 has been amended over time, including by Act 11 of 1955, Act 35 of 1960, Act 21 of 1962, Act 13 of 1964, Act 68 of 1982 and Act 26 of 2008. The 2008 amendment, among other changes, inserted provisions connected with cosmetics and compounding. For authoritative wording and amendment notes, consult the current India Code text.