Updated on May 29, 2025 01:31:57 PM
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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The minimum area of 10 square meter is required to start a medical shop or pharmacy or wholesale outlet. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meter is required.
The clear height of the premises should be in accordance with the National Building Code of India, 2005 as amended from Time to Time.
Must have refrigerator & air conditioner in the premises. According to the labeling specifications certain drugs like vaccines, Sera, Insulin Injections etc., are required to be stored in the refrigerator.
Manufacturing : For an Drug manufacturing unit there must be Technical Staff at manufacturing and Technical Staff for testing as well.
Wholesale : The sale of drug by wholesale shall be made either in the presence of registered pharmacist or in the presence of a competent person who shall be a graduate with 1 yr experience in dealing in drugs or a person who has passed S.S.L.C with 4 years experience in dealing in drugs, specially approved by the department of drug control for the purpose.
Retail : The sale of drug by retail must be made in the presence of registered pharmacist approved by the department, Registered pharmacist is required throughout the working hours.
Licences for the sale of drugs can be granted only at premises that is commercial premises or premises independent of residence. For this purpose state drug office issues guidance which may be referred to.
If drugs are sold or stocked for sale at more than one place, a separate license is needed in respect of each such place. Similarly, in case of manufacturer, a separate license is required to manufacture same or different drugs but at different location
In case a business is operating in more than two states, it has to obtain drug licence 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
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 is a crucial step for businesses involved in the sale, manufacture, or import of drugs and cosmetics. To ensure compliance with the Drugs and Cosmetics Act, here are the general instructions for the drug license registration process in India.
Applicant has to obtain user ID and Password by giving request letter in person with the details of the firm.
Please be sure that, all the information is filled precisely for respective application mentioned below and only then e-send the application. In case of rejection of your application for incomplete information, the fees once paid will be forfeited.
All the documents should be scanned in 100 dpi & black and white, and then should be uploaded using the said ID and Password at space provided for the purpose. The licensing authority may ask for any other specific documents if required.
Show all the original documents to the inspector at the time of inspection. Inspector may ask you any further documents relevant to your application.
After grant or rejection of your application, you will receive an SMS about the same. Take a print out of the approval/rejection from ‘Print License’ option for fresh license and renewal and click ‘MISC approvals’ for other approvals within 3 days. You will receive licenses/approvals with the valid e-signature and official seal.
If the proprietor/ partner are changed, it will be treated as ‘change in constitution’ and applicant will have to obtain a fresh license.
Registered Pharmacists are also required to update their details by obtaining separate password.
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.
First, Get Consultation from our Drug License Consultant to know the Drug License Rule, Documents Requirements, License Expenses, Renewal , Types of License applicability as per your business nature, etc.
Drug License registration need various documents in support of application filing. Documents varies Region wise as well as business to business and type of Drug License. We prepare all required documents first.
Once your documents is prepared, we starts preparing your application along.
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Once your application is completed in all respect, we proceed to file with state Drug Control Authority.
We Assist client at the time of Inspection of premises by the Drug Inspector appointed by the Authority to check the Documents in Original and inspection of premises to ensure the particulars as mentioned in the applications is correct and premises fit for the drug business as per guidelines.
The whole process of approval shall take upto 45 to 60 days by the Authority.
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.
At Professional Utilities, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
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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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