Drug License Registration

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Overview

✔ A drug license—also referred to as a pharmaceutical or drug manufacturing license—is a mandatory legal authorization for individuals or entities engaged in the manufacture, distribution, sale, or storage of pharmaceutical drugs and medicines.

✔ In India, drug licensing is governed by the Central Drugs Standard Control Organization (CDSCO) under the provisions of the Drugs and Cosmetics Act, 1940, along with its related rules and regulations.

✔ Drug licenses are usually issued for a fixed duration, typically ranging from one to five years, and must be renewed before the expiry date to ensure continued legal operation.

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Types of ISO Registrations

Manufacturing License

Required for companies involved in the manufacturing of drugs and pharmaceutical products.

Retail License

Required for operating retail pharmacies, chemist shops, or medical stores that sell drugs to consumers.

Loan License

Issued to entities that do not have their own manufacturing facilities but use a third-party manufacturer holding a valid license.

Import License

Required for businesses importing pharmaceutical products and drugs into India.

Export License

Required for businesses engaged in the export of drugs and pharmaceutical products.

Activities that require a drug license

Wholesale Distributors

Businesses involved in the wholesale distribution of drugs, including wholesalers, stockists, and distributors, are required to have a Drug Wholesale License.

Drug Manufacturers

Any entity involved in the manufacturing or processing of pharmaceutical drugs—whether allopathic or alternative medicine—must obtain a Drug Manufacturing License.

Retail Pharmacies

Operating a retail pharmacy or chemist shop necessitates a Drug Retail License to legally sell medicines to consumers.

Handlers of Controlled Substances

Special licenses are mandatory for dealing with controlled substances such as narcotics, psychotropic drugs, or other regulated pharmaceuticals.

Importers and Exporters

ISO systems help organizations proactively identify risks, comply with regulations, and minimize the chances of legal or operational issues.

Advantages

Assured Quality Standards

Obtaining a drug license requires adherence to standards like Good Manufacturing Practices (GMP), ensuring the safety, efficacy, and consistency of your products.

Legal Compliance

A drug license ensures that your business operates within the legal framework, helping you avoid penalties, regulatory action, or forced closure due to non-compliance.

Market Access

Holding a valid license is often mandatory to enter and operate in the pharmaceutical market, unlocking business opportunities in retail, wholesale, manufacturing, and exports.

Enhanced Credibility and Trust

A licensed status strengthens your reputation and instills confidence among customers, suppliers, regulatory bodies, and business partners.

Competitive Edge

Demonstrating compliance with regulatory and quality standards highlights your commitment to ethical practices, giving your business a distinct advantage over unlicensed competitors.

Consumer Protection

Drug licensing plays a vital role in safeguarding public health by ensuring that only quality-tested and approved pharmaceutical products are distributed or sold.