Updated on January 30, 2026 07:27:47 AM
Drug license registration is a legal permission required to sell, distribute, or manufacture medicines in India. If you want to start a pharmacy, open a medical store, or run a pharmaceutical business, you must get a drug license. This license is issued by the Central Drugs Standard Control Organization (CDSCO) and the State Drug Authority under the Drugs and Cosmetics Act, 1940. Having a valid drug license helps ensure that only safe and approved medicines are sold in the market. It also shows that your business follows all government rules related to health and safety.
To get a Drug License in India, businesses have to meet the required criteria such as having a minimum area of premises, proper storage facilities like air conditioning and refrigeration, and qualified technical staff such as a registered pharmacist or competent person. Furthermore, businesses have to apply for separate drug licenses to operate in multiple states or at different locations. Importers of drugs and cosmetics are also required to get specific approval prior to importing such products into the country.
The process for Drug License Registration includes filling out an application form online, submitting required documents, undergoing an inspection by the licensing authority, and complying with regulatory requirements. The following article entails complete information about the Drug License registration process, required documents, eligibility criteria, fees, and benefits that businesses need to learn to meet all legal requirements for compliance and smooth operations.
Drug License Certificate Sample
In India, obtaining a drug license is essential for businesses involved in the sale, manufacture, or import of drugs and cosmetics, ensuring compliance with the Drugs and Cosmetics Act to maintain safety, quality, and effectiveness standards. Here are the key conditions to obtain a drug license in India.
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In India, obtaining a drug license requires submitting specific documents to ensure compliance with the Drugs and Cosmetics Act. Below are the key documents required for obtaining a drug license in India.
The drug license registration process in India involves online application submission, document upload, inspection, and final approval.
The government fees for drug license registration vary in each state. If you apply offline, you must pay the fees to the government treasury. If you apply online, you can use the available payment options in your state. The table below shows the standard government fees for obtaining a drug license.
| Types of Drug License | Govt. Fees |
|---|---|
| Wholesale License Fees | Rs. 3000/- |
| Retail License Fees | Rs. 3000/- |
| Restricted License Fees | Rs. 1000/- |
| Schedule-X Drugs (Wholesale Fee) | Rs. 500/- |
| Schedule-X Drugs (Retail Fee) | Rs. 500/- |
Note: Professional Fees for Drug License Registration in India is ₹19,999 for Wholesale, ₹24,999 for Retail, and ₹49,999 for Manufacturing licenses.
Note: The aforementioned Fees is exclusive of GST.
Here’s what’s included in our service package for drug license registration in India.
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Conclusion
Businesses must get Drug License Registration in India to meet the legal requirement for sale, manufacture, and import of drugs and cosmetics. It proves compliance with the safety, quality, and regulatory standards set by the Drugs and Cosmetics Act, 1940. Businesses can apply for Drug License Registration in India by meeting the required criteria, submitting documents, and undergoing inspections to complete the application procedure. Drug License in India helps businesses avoid legal penalties and actions, build credibility and ensure consumer safety. With expert consultation and guidance from Professional Utilities, applicants can streamline the Drug License Registration process and obtain the required license for their operations seamlessly.
Professional Utilities simplify registrations, licenses, and compliances for your business. With experienced guidance and nationwide support, we help you complete every requirement efficiently and effectively.
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Yes, before you start any business dealing in drugs, whether it is Allopathic Drugs, Ayurvedic Medicine, Homeopathy or Unani, to manufacture, distribute or sell the drugs It is mandatory to obtain a license as per the nature of business by applying to the controller of the drugs and cosmetics
Based on the requirement of the pharmaceutical business, an applicant must apply for issue of specific drug license. There are various licenses, for example,
In case a business is operating in more than two states, it has to obtain drug license in every state in which business is being carried on. Drug licence is location specific, and hence within state application, all site must be included.
Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License
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