Section 33N of the Drugs and Cosmetics Act 1940 - Power of Central Government to Make Rules
Section 33N authorises the Central Government to make rules for carrying out Chapter IVA of the Drugs and Cosmetics Act, 1940, which deals with Ayurvedic, Siddha and Unani drugs. The provision sets the rule-making procedure and identifies important subjects that may be regulated by rules.
Meaning and scope of Section 33N
The expression Ayurvedic, Siddha or Unani drug is defined in Section 3 of the Act. In relation to such drugs, the Board refers to the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board constituted under Section 33C. Section 33N is an enabling provision: it gives the Central Government statutory authority to prescribe detailed regulatory requirements needed to implement Chapter IVA.
Section 33N - statutory provision
(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 giving effect to the provisions of this Chapter.
The proviso permits consultation with the Board to be dispensed with where circumstances make immediate rule-making necessary. In that situation, the Board must be consulted within six months and its suggestions regarding amendment of the rules must be considered.
(2) Without limiting the general rule-making power, rules may deal with matters including:
- establishment of laboratories for testing and analysing Ayurvedic, Siddha or Unani drugs;
- qualifications and duties of Government Analysts and qualifications of Inspectors;
- methods of test or analysis for determining whether a drug is labelled with the true list of ingredients it purports to contain;
- specification of substances as poisonous substances;
- licence forms, applications, conditions, licensing authorities and fees for manufacture for sale and sale of processed Ayurvedic, Siddha or Unani drugs, including cancellation or suspension where applicable requirements are contravened;
- packing conditions, packing material in direct contact with drugs, labelling requirements and matters permitted or prohibited on labels;
- conditions for manufacture of small quantities for examination, test or analysis;
- colours that may be borne or contained by an Ayurvedic, Siddha or Unani drug for colouring purposes under Section 33EE(d);
- standards for Ayurvedic, Siddha or Unani drugs under Section 33EB;
- records, registers and documents to be kept and maintained under Section 33KB; and
- other matters that are required or permitted to be prescribed under Chapter IVA.
How the rule-making power operates
Consultation or recommendation of the Board
The normal statutory process involves consultation with, or a recommendation from, the Board. The proviso creates an exception for circumstances requiring rules to be made without prior consultation, while preserving later consultation within six months.
Previous publication and Official Gazette notification
Section 33N expressly requires previous publication and notification in the Official Gazette. This makes the provision the legislative basis for subordinate rules governing the subjects listed in subsection (2), subject to the Act and other applicable statutory requirements.
Illustrative matters covered
The listed matters show the breadth of the power: testing laboratories, analysts and inspectors, testing methods, poisonous substances, licences, packaging, labelling, small test quantities, permitted colouring, drug standards and statutory records. The words "without prejudice to the generality" mean that subsection (2) illustrates the rule-making power rather than limiting it only to those listed subjects.
Related provisions
Section 33N should be read with other provisions of Chapter IVA, including Section 33C on the Technical Advisory Board, Section 33EE on adulterated drugs, Section 33KB on records and information, and Section 33O concerning amendment of the First Schedule.
Legislative notes
The provision reflects amendments made by Act 68 of 1982, including the formulation concerning consultation with or recommendation of the Board and amendments to specific rule-making subjects. Clause (ggb), concerning records, registers and documents under Section 33KB, was inserted by Act 26 of 2008.