Section 33EEC of the Drugs and Cosmetics Act, 1940: Prohibition of Manufacture and Sale of Certain Ayurvedic, Siddha and Unani Drugs

Section 33EEC forms part of Chapter IVA of the Drugs and Cosmetics Act, 1940. It prohibits specified manufacture, sale, stocking, exhibition, offering for sale and distribution of Ayurvedic, Siddha and Unani drugs, and requires manufacture for sale or distribution to be carried out under a valid licence, subject to statutory exceptions.

What Section 33EEC regulates

The provision becomes operative from the date specified by the State Government by notification in the Official Gazette. From that date, a person cannot carry out the prohibited activities personally or through another person on his or her behalf.

Section 33EEC - statutory requirements

Manufacture for sale or distribution is prohibited where the product is:

  1. a misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drug;
  2. a patent or proprietary medicine that does not display, in the prescribed manner on its label or container, the true list of all ingredients contained in it; or
  3. an Ayurvedic, Siddha or Unani drug manufactured in contravention of Chapter IVA or the rules made under it.

Sale and distribution: A person must not sell, stock, exhibit or offer for sale, or distribute an Ayurvedic, Siddha or Unani drug manufactured in contravention of the Act or the rules.

Licence: Manufacture for sale or distribution must be under, and in accordance with the conditions of, a licence issued by the prescribed authority under Chapter IVA.

Meaning of key terms

Ayurvedic, Siddha or Unani drug: Section 3(a) covers medicines intended for internal or external use, or for diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, when manufactured exclusively in accordance with formulae described in the authoritative books of the relevant systems specified in the First Schedule.

Patent or proprietary medicine: For these traditional systems, Section 3(h) covers qualifying formulations containing ingredients mentioned in the formulae described in the authoritative books specified in the First Schedule, subject to the statutory exclusions and conditions.

The expressions misbranded, adulterated and spurious Ayurvedic, Siddha or Unani drugs are addressed respectively by Sections 33E, 33EE and 33EEA. Those provisions should be read with Section 33EEC when determining whether manufacture or sale is prohibited.

Manufacturing licence and applicable Rules

Part XVI of the Drugs Rules, 1945 regulates manufacture for sale of Ayurvedic, Siddha or Unani drugs. Rule 152 concerns State licensing authorities, while Rule 153 deals with applications for manufacturing licences. Manufacturers should also comply with the conditions attached to the applicable licence and other relevant requirements under the Act and Rules.

Practical effect: Section 33EEC is not limited to manufacturing. It also reaches downstream sale, stocking, exhibition, offering for sale and distribution where the drug was manufactured contrary to the Act or Rules.

Exceptions under Section 33EEC

The first proviso excludes Vaidyas and Hakims who manufacture an Ayurvedic, Siddha or Unani drug for use by their own patients. The second proviso excludes, subject to prescribed conditions, manufacture of small quantities for examination, test or analysis.

Related penalty provision

Contravention of Chapter IVA should be read with Section 33I, which contains the penalty provision for manufacture, sale and related activities involving Ayurvedic, Siddha or Unani drugs in contravention of the Chapter.

Official regulatory resources

For current regulatory material, consult the Central Drugs Standard Control Organization pages for the Drugs and Cosmetics Act and Rules, the Drugs Rules, 1945 and traditional drugs. Regulatory requirements can be amended by notification, so the latest official text and applicable State licensing requirements should be checked for compliance.