Section 33EED of the Drugs and Cosmetics Act 1940: Power to Prohibit Ayurvedic, Siddha or Unani Drugs in Public Interest
Section 33EED empowers the Central Government to prohibit the manufacture, sale or distribution of an Ayurvedic, Siddha or Unani drug when the statutory conditions concerning safety, therapeutic value and public interest are satisfied.
What Section 33EED provides
Without prejudice to the other provisions of Chapter IVA, the Central Government may act when, on the basis of evidence or other material available to it, it is satisfied that use of an Ayurvedic, Siddha or Unani drug is likely to involve a risk to human beings or animals, or that the drug does not possess the therapeutic value claimed or purported to be claimed for it. The Government must also be satisfied that prohibition is necessary or expedient in the public interest. The prohibition is made by notification in the Official Gazette and may cover manufacture, sale or distribution of the drug.
Meaning and scope of Section 33EED
The provision is a public-interest safety power in Chapter IVA of the Drugs and Cosmetics Act, 1940, the chapter dealing specifically with Ayurvedic, Siddha and Unani drugs. It operates in addition to the other provisions of that Chapter.
Conditions for exercise of the power
The statutory power is linked to evidence or other material available to the Central Government. The relevant grounds are: a likely risk to human beings or animals, or absence of the therapeutic value claimed for the drug. In addition, the Central Government must consider prohibition necessary or expedient in the public interest.
How a prohibition takes effect
Section 33EED requires a notification in the Official Gazette. The notification can prohibit the manufacture, sale or distribution of the drug concerned. Accordingly, the legal effect depends on the terms and scope of the particular Gazette notification issued under the section.
Relationship with nearby provisions
Section 33EEC regulates and prohibits specified manufacture and sale activities involving Ayurvedic, Siddha and Unani drugs. Section 33EED separately gives the Central Government a notification-based public-interest power where the statutory safety or therapeutic-value grounds exist.
A contravention of a notification issued under Section 33EED is addressed by Section 33I. Under the current text of Section 33I(1)(c), such contravention may attract imprisonment extending to three years and a fine extending to fifty thousand rupees or three times the value of the drugs confiscated, whichever is more.
Practical legal significance
Manufacturers, sellers and distributors of Ayurvedic, Siddha and Unani drugs should check applicable Official Gazette notifications in addition to the Act and Rules. A Section 33EED notification can directly affect whether a particular drug may continue to be manufactured, sold or distributed.