Drug License

Any government’s top priority should guarantee access to drugs and medical care. The authority to produce and market drugs and medicines must be granted with caution. The 1940 Drugs and Cosmetics Act is the legislation that controls the entire pharmaceutical supply chain in India.

Access to medications and pharmaceuticals must be controlled and restricted to prevent persons from abusing or misusing such products. As a result, the Drugs and Cosmetics Act of 1940 makes it mandatory for all pharmacists, wholesalers, retailers, manufacturers, sellers, dealers, and importers of drugs, cosmetics, and ayurvedic, Siddha, and Unani drugs to obtain drug licence.

The goal of a drug licence is to give organisations or individuals permission to operate businesses that deal with pharmaceuticals and cosmetics. In India, no company or individual may run a business selling drugs, medicines, or cosmetics without obtaining a drug licence.

Requirement 

• Give the legal justification for carrying out drug-related activities

The nation does not permit unregistered entities to engage in drug-related operations. The Drugs and Cosmetics Act of 1940 includes rigorous restrictions enacted by CDSCO. The registered entities must constantly be vigilant to ensure their code of conduct complies with current laws. This might sound like a burden for some businesses, but it also benefits.

• Increase the business’s credibility and transparency

Ensuring Drugs and Cosmetic Act compliance over a sustained long period of time may assist the wholesalers in gaining a crucial market reputation. Such a licence may provide the foundation for success and offer countless prospects that guarantee long-term expansion. One of the most notable advantages of a wholesale drug licence is this.

• Ensure improved management and effectiveness

Assuring compliance with CDSCO requirements may initially cause problems, but over time, if the owner is willing to adhere to the Act, it can improve the effectiveness of the business.

Eligibility 

• Pharmacist/Competent Individual: In the event of a retail firm, the pharmacist must be qualified. A graduate with one year of experience or an undergraduate with four years of experience is required for a wholesale business.
• The drugstore/unit must be sufficient; this is the second criterion. The pharmacy/unit must be 15 square metres to qualify for wholesale and retail licences. It should be 10 square metres for a retail and medical store. The National Building Code of India, 2005, specifies the height of the sale.
• Storage Facility: Since some medications must be kept at low temperatures, a storage facility with refrigerators and air conditioners is also a requirement.
• Technical Staff: Qualified professionals with extensive knowledge must work in the retail pharmacy. The staff of the wholesale pharmacy must be either undergraduate with four years of experience or graduates with a minimum of one year of experience.