Section 3 of DCA : Section 3: Definitions

Explanation using Example

Imagine a company in India that produces a herbal ointment, claiming it can treat eczema. The ointment is made following traditional Ayurvedic formulas and is intended for external application to the skin. This product would be considered an "Ayurvedic drug" under the Drugs and Cosmetics Act, 1940.

Before the ointment can be sold, the company must ensure it complies with the Act. This means the product must be manufactured exclusively in accordance with the formulae described in the authoritative Ayurvedic texts listed in the First Schedule of the Act. Additionally, the company must abide by the regulations concerning the manufacture, labeling, and sale of such drugs, which may involve seeking approval from the "Board"—in this case, the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board.

If the government suspects the ointment is not in compliance, a "Government Analyst" may test it to ensure its safety and efficacy, and an "Inspector" may visit the manufacturing facility to ensure that the production processes meet the regulatory standards.