Drug License Registration in India - Process, Fees & Documents
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
- Form-20B
- Form-21B
Conditions for obtaining Drug License in India
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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- Minimum Area & Height of Premises: The minimum area of 10 square meters is required to start a medical shop, pharmacy, or wholesale outlet. If combining retail and wholesale, a minimum of 15 square meters is required. The clear height should follow the National Building Code of India, 2005, as amended.
- Storage Facility: Must have a refrigerator & air conditioner. Certain drugs like vaccines, sera, insulin injections, etc., must be stored in the refrigerator as per labeling specifications.
- Pharmacist / Competent / Technical Staffs:
- Manufacturing: Technical staff must be present at manufacturing and testing units.
- Wholesale: Sales must be made in the presence of a registered pharmacist or a competent person (graduate with 1 yr experience in drugs, or SSLC with 4 yrs experience), approved by the drug control department.
- Retail: Sales must be made in the presence of a registered pharmacist approved by the department, required throughout working hours.
- Commercial Premises: Licences for drug sale can only be granted at commercial premises or premises independent of residence. State drug office guidance can be referred to.
- Location Based License: If drugs are sold or stocked at more than one place, a separate license is needed for each location. Similarly, manufacturers require separate licenses for each manufacturing location.
- License for Each State: Businesses operating in more than one state must obtain a drug license in each state. Licenses are location-specific, so all sites within the state must be included in the application.
- Importer of Drugs or Cosmetics: Drugs or cosmetics must meet safety, effectiveness, and state quality standards. Schedule X drugs can be imported only after obtaining a license.
Documents for Drug License in India
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.
- Covering Letter stating purpose of the Application
- The firm's constitution
- Property Paper ( Registry Deed/ Lease Deed/ POA in case of owned Property)
- Board Resolution, List of Directors, Certificate of Incorporation ( in case of company)
- The key plan and the site plan of the premises ( Blue Print).
- One Invoice copy of Refrigerator/ Air conditioner purchased for use
- Copy of Rent agreement / Rent Recepits
- ID proof of Directors/ Partners/ Proprietor
- For Retail License: Registered Pharmacist's degree certificate, Registration certificate with State Pharmacy Council and Appointment Letter and Bio-data.
- For Wholesale License: Competent person's degree certificate, Experience Certificate in medicine job and Appointment Letter and Bio-data.
- For Manufacturing - List of Technical Staff and their proof of Education Qualification, Experience Certificate, Biodata, Appointment Letter, three photographs.
- For manufacturer - Affidavit of Non Conviction, List of Equipment and Machineries for manufacturing and List of Equipment Provided for Testing
Drug License Registration process in India
The drug license registration process in India involves online application submission, document upload, inspection, and final approval.
- Login ID and Password: The applicant must obtain a User ID and Password by submitting a request letter in person along with the firm’s details.
- Online Application: Ensure all information is filled accurately before e-submitting the application. In case of rejection due to incomplete details, the paid fees will be forfeited.
- Upload Documents: All documents must be scanned at 100 DPI in black and white and uploaded using the provided User ID and Password. The licensing authority may request additional documents if required.
- Physical Inspection: All original documents must be presented to the inspector at the time of inspection. Additional documents may be requested if deemed necessary.
- Approval / Rejection: After approval or rejection, the applicant will receive an SMS or email notification. In case of rejection, the applicant must respond to the queries raised on the portal within the given timeframe.
- Change in Constitution: Any change in proprietor or partners will be considered a change in constitution, and a fresh drug license must be obtained.
- Separate Password for Pharmacists: Registered pharmacists must update their details by obtaining a separate login password.
Drug License Registration Fees
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.
Our Service Package Inclusion in Drug License Registration
Here’s what’s included in our service package for drug license registration in India.
- Consultation : 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.
- Documentations : 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.
- Preparing Application : Once your documents is prepared, we starts preparing your application along.
- Application Submission : Once your application is completed in all respect, we proceed to file with state Drug Control Authority.
- Inspection assistance : 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.
- Registration Copy : The whole process of approval shall take upto 45 to 60 days by the Authority.
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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.
Frequently Asked Questions (FAQs)
Is it necessary to obtain drug license prior to commencement of the
drug business?
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
What are different types of Licenses Issued for the Pharmaceutical
Business?
Based on the requirement of the pharmaceutical business, an applicant must apply for issue of specific drug license. There are various licenses, for example,
- Drug Manufacturing License,
- Wholesale Drug License,
- Retail Drug License,
- Import of Drugs or Cosmetics,
- Import of Medical Equipment,
- Export of Medicines etc.
Do I have to apply and seek separate drug license for Branches of My
Pharmaceutical Business?
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.
How to import Drugs or Cosmetics?
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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