Section 3(b) of the Drugs and Cosmetics Act, 1940, defines the term “drug” to encompass all medicinal products and devices intended for internal or external use by humans or animals. It includes substances designated for diagnosis, treatment, mitigation, or prevention of diseases. Additionally, the definition covers preparations used on the human body to deter insects such as mosquitoes, substances intended for insect extermination, and essential drug components, including items like empty gelatin capsules. An amendment made in 1964 further extended the definition to include Ayurvedic and Unani medicines.
A drug license remains valid for five years unless it is revoked or suspended by the regulatory authority. Renewal must be completed prior to expiration by logging into the appropriate drug control portal. Upon approval, a renewed license is issued by the drugs controller.
All businesses involved in the manufacture, sale, or distribution of drugs or cosmetics must obtain a drug license under the Drugs and Cosmetics Act, 1940. This applies to enterprises dealing in allopathic, homoeopathic, ayurvedic, Siddha, and Unani products.
Yes. Drug licenses are location-specific. If a business operates in multiple states, a separate license must be secured for each state. Each premises used for selling or distributing drugs must be individually licensed, except in the case of permitted mobile vendors.
In the event of relocation, the drug license associated with the former premises must be surrendered. A new application must be submitted for the updated location, as licenses are issued in relation to a specific property and cannot be transferred between locations.