Section 18A of the Drugs and Cosmetics Act 1940: Disclosure of the Name of the Manufacturer
Section 18A creates a traceability obligation in the drug and cosmetics supply chain. A person who is not the manufacturer, or the manufacturer's distribution agent, must disclose the source from whom the drug or cosmetic was acquired when an Inspector requires that information.
Text of Section 18A
Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the drug or cosmetic.
Section 18A was inserted by section 14 of the Drugs and Cosmetics (Amendment) Act, 1964 (Act 13 of 1964) and came into force on 15 September 1964. It forms part of Chapter IV of the Drugs and Cosmetics Act, 1940, which regulates the manufacture, sale and distribution of drugs and cosmetics.
Meaning and Scope of Section 18A
The provision enables a Drug Inspector to trace the source of a drug or cosmetic through the distribution chain. It applies to a person dealing with a drug or cosmetic who is neither its manufacturer nor the manufacturer's agent for distribution.
- Who must disclose: A person other than the manufacturer or the manufacturer's distribution agent.
- When disclosure is required: When an Inspector requires the information in exercise of regulatory functions under the Act.
- What must be disclosed: The name, address and other particulars of the person from whom the drug or cosmetic was acquired.
- Purpose: The provision supports regulatory traceability by allowing the source of a drug or cosmetic to be identified.
Who is an Inspector under the Act?
Section 21 of the Drugs and Cosmetics Act, 1940 provides for the appointment of Inspectors by the Central Government or a State Government for specified areas and purposes. Section 22 sets out the statutory powers of Inspectors, while Section 23 prescribes procedure for certain actions taken by them. Section 18A should therefore be read with these inspection and enforcement provisions.
Penalty for Contravention
Section 28 of the Drugs and Cosmetics Act provides the penalty for contravention of Section 18A or Section 24. Under the law presently in force, contravention may be punished with imprisonment for a term extending to one year, or with a fine of not less than twenty thousand rupees, or with both.
Related Provisions
Section 18A is closely connected with Section 18B, which concerns maintenance of records and furnishing of information, and Section 24, which requires specified persons to disclose the place where drugs or cosmetics are manufactured or kept. Section 28 specifically links non-disclosure under Sections 18A and 24 with penal consequences.
Practical Compliance
Dealers, retailers, wholesalers and other persons in the distribution chain should preserve reliable supplier and purchase records so that the source of a drug or cosmetic can be identified if an Inspector lawfully requires disclosure. The exact records required in a particular case may also depend on the licensing and record-maintenance provisions applicable to the business and product concerned.
Official Legal Sources
For the authoritative statutory text and regulatory material, refer to the official Government sources below.