DRUG LICENCE IN INDIA – AN OVERVIEW

A Drug Licence is a mandatory legal authorization issued by the Central Drugs Standard Control Organization (CDSCO) or State Drug Authorities in India to manufacture, distribute, or sell pharmaceutical products and medicines. It ensures that the drug-related business complies with the provisions of the Drugs and Cosmetics Act, 1940.

Businesses dealing in drugs, whether allopathic, homeopathic, ayurvedic, or cosmetic products, must acquire the appropriate Drug Licence before starting operations. The type of licence depends on the nature of the business, such as retail, wholesale, or manufacturing.

blog__img

What is a Drug Licence?

A Drug Licence is a legal permit that authorizes a person or company to engage in the manufacture, sale, stock, exhibit, or distribution of pharmaceutical products in India. It is governed under the Drugs and Cosmetics Act and ensures public health and safety by regulating the quality and legitimacy of drug transactions.

Who Needs It?

The Drug Licence is required by:

  • Retailers and wholesalers of pharmaceutical and cosmetic products.
  • Pharmaceutical manufacturers and repackers.
  • Importers and exporters dealing in drugs and medicines.
  • Online pharmacies and e-commerce platforms dealing with medications.

Key Requirements

To obtain a Drug Licence in India, applicants must:

  • Have a qualified pharmacist or competent person on staff.
  • Maintain a clean, compliant premises with proper storage facilities.
  • Register the business under appropriate legal entity (e.g., proprietorship, LLP, company).
  • Comply with guidelines set by the Drugs and Cosmetics Act and Rules.
  • Submit all required documentation including ID proofs, ownership/lease deed, and qualification certificates.

Licence Types

  • Retail Drug Licence (RDL): For retailers and pharmacy stores.
  • Wholesale Drug Licence (WDL): For businesses selling drugs in bulk to retailers.
  • Manufacturing Licence: For manufacturers of allopathic, ayurvedic, or cosmetic products.
  • Import Licence: For entities importing drugs or cosmetics into India.

Application Process Overview

  • Prepare all necessary documents and apply via the online SUGAM portal or State Drug Control office.
  • Inspection of premises by Drug Inspector for compliance.
  • Verification of qualifications and infrastructure.
  • Grant of licence after successful verification and fee submission.