Whether you are opening a new pharmacy, a wholesale distributorship, or a manufacturing unit, we'll get your pharmaceutical operations totally compliant with Indian drug laws.
Whether you are an aspiring businessman planning to open a pharmacy, wholesaler, distributor, medical device trading or a manufacturer aiming to set up a wholesale drug distribution network, the Drug Licence is your foundational document. It has become a necessity; it is the legal licence that allows you to handle and deal with life-saving substances (drugs & medicines).
We will describe all the requirements you need for a drug licence application, from the size requirements of your shop to the technicalities of pharmacy registration renewal online, ensuring you have an easy understanding of how to maintain the rules and regulations of Drugs and Cosmetics Act, 1940.
The Indian domestic pharmaceutical market is growing at an exponential rate, expected to reach 130 billion by 2030. However, with great volume comes the need for strict restrictions. The government, through the Central Drugs Standard Control Organization (CDSCO) and State Drug Control Departments, ensures that every pill sold in the country is safe, effective, and stored correctly. This is where the drug licence role comes.
A drug licence is a legal permission granted by the relevant State or Central authority under the Drugs and Cosmetics Act, 1940, allowing an entity to manufacture, import, sell, stock, or distribute drugs and cosmetics. Without this drug licence certificate, involvement in any kind of pharmaceutical trade is a serious, punishable offense, which can cause heavy fines and legal punishments.
Druglicense.in can help you to get Drug License in UP, Drug License in Delhi, and Drug License in Haryana
Complete assistance for the procurement of your Retail, Wholesale or Manufacturing Drug License under the Drugs & Cosmetics Act, 1940.
We ensure that your pharmacy or facility maintains complete compliance with all regulatory requirements related to storage, record-keeping and operations.
Our experts will assist in the preparation and verification of all the required affidavits, blueprints and personnel documents for a zero-error submission.
Get expert guidance through every step of pharmaceutical licensing. Our team ensures compliance and accelerates your approval timeline.
The primary objective of the drug licence is public safety. Medicines are chemical substances that require specific environmental conditions to remain effective. A slight change in temperature or humidity can turn a life-saving drug into a toxic chemical. Therefore, the government mandates a strict procedure for the RERA owners.
Obtaining a medical drug licence proves that your business meets all the safety, storage, infrastructure, and technical standards required to handle medication issued by the government. It ensures that a qualified professional—a registered pharmacist—is always present to interpret prescriptions and counsel patients.
Before you begin the drug licence apply process, it is critical to understand the specific category required for your business model. The Act classifies licences based on the nature of the activity. Applying for the wrong category is a common mistake that leads to immediate rejection.
This is the most sought-after license, required for general chemists, pharmacy shops, and standalone medical stores. If you are searching for a drug licence for a medical store, this is your category. It authorizes the sale of drugs to the end consumer. It strictly mandates the presence of a registered pharmacist during business hours.
This is for distributors. If you want to sell medicines to other retailers, hospitals, or clinics, you need to know how to apply wholesale drug licence. This does not necessarily require a pharmacist to be present at all times, but it does require a 'Competent Person' (a graduate with experience) to oversee operations.
This is often overlooked. A restricted license is issued to general stores or vendors in remote areas who wish to sell household remedies (like aspirin or cough syrup) but do not have a qualified pharmacist. It allows the sale of drugs that do not require expert supervision.
Issued to entities that produce allopathic, ayurvedic, homeopathic, or cosmetic drugs. This requires approval from both state and central authorities (CDSCO) depending on the drug schedule.
This is a strategic license for businesses that want to manufacture drugs but do not own a factory. They 'loan' the manufacturing facilities of another licensee. Prerequisites: Infrastructure and Personnel.
This license is issued to businesses that manufacture, sell, stock, exhibit, or distribute medical devices, including In-Vitro Diagnostic Devices. Such as Injections, medical scalpels, and scissors used by surgeons during surgeries. The Licensing Authority will not even consider your drug licence application if your foundation is weak. You must prepare your premises and team before logging into the portal.
For a pharmacy licence registration, the pharmacist is the backbone.
The individual must hold a Diploma in Pharmacy (D.Pharma) or a Bachelor in Pharmacy (B.Pharma).
They must be registered with the State Pharmacy Council.
They cannot be employed full-time elsewhere. Their certificate will be endorsed on your license.
Do you want a Drug licence Delhi? Contact us now!
The procedure to get a drug license in India involves several key steps. Most states now offer drug license registration online. Here is a step-by-step process on how to apply drug licence online:
Go to your State Drugs Control Department’s official website. Register your firm by creating a unique User ID and password. Ensure the mobile number used is permanent, as all OTPs for future drug licence renewal will go there.
Once logged in, look for the "New Application" section. You will see various forms. Select carefully:
Fill in the details of the proprietor/partners, the Competent Person/Pharmacist, and the exact address of the premises. This is the core drug licence apply phase where accuracy is paramount.
You must scan your documents in high resolution (usually PDF format). Blurry or unreadable scans result in queries that delay the process by weeks. (We will list the exact documents in the next section.)
Pay the requisite government fees via the integrated payment gateway (Cyber Treasury or GRIPS). The drug licence online fee structure varies by state but generally ranges from ₹3,000 to ₹5,000 for a combined set of licenses (Biological and Non-Biological).
After payment, apply. The system will generate an acknowledgment receipt. Keep this safe; you will need it to track how to make drug licence inquiries later.
This is the "make or break" moment. After you submit the drug licence application, a Drug Inspector (DI) will be assigned to your file. They will visit your shop physically to verify:
If the DI is satisfied, they will forward a positive report to the Assistant Drug Controller (ADC). The Licensing Authority will then digitally sign and issue your drug licence certificate. You can download this from the portal.
Our comprehensive 7-step process ensures 100% compliance and faster approval times. Get started with India's most trusted pharmaceutical licensing experts.
To ensure a smooth approval without "queries raised," having a perfect dossier is helpful. Whether you are wondering how to get drug licence for medical store or for a wholesale unit, compile these documents:
| Category | Type Sale | Fees for Grant/ Retention | Penalty after expiry (6 months) | Duplicate License Fee |
|---|---|---|---|---|
| Drugs other than those specified in Schedule C&C (1)&X | Whole Sale | Rs.1500 | Rs 1500 + 2% per month or part thereof | Rs.150 |
| Retail Sale | Rs.1500 | Rs 1500 + 2% per month or part thereof | Rs.150 | |
| Restricted (Gen. Store) | Rs 500 R-59 (2) | Rs 500 + 2% per month or part thereof | Rs 150 R-59 (3) | |
| Drugs specified in Schedule C&C (1) but excluding those specified in Schedule 'X' | Whole Sale | Rs.1500 | Rs 1500 + 2% per month or part thereof | Rs.150 |
| Retail Sale | Rs.1500 | Rs 1500 + 2% per month or part thereof | Rs.150 | |
| Restricted (Gen. Store) | Rs 500 R-59 (2) | Rs 500 + 2% per month or part thereof | Rs 150 R-59 (3) | |
| Drugs specified in Schedule 'X' | Whole Sale | Rs.500 | Rs 500 + 2% per month or part thereof | Rs.150 |
| Retail Sale | Rs.500 R-59(2) | Rs 500 + 2% per month or part thereof | Rs 150 R- 59 (3) | |
| Homoeopathic Medicines | Whole Sale | Rs.250 | Rs 250+Rs. 50 p.m. or part thereof | Rs. 50 |
| Retail Sale | Rs. 250 R-67-A(2) | Rs.250+Rs.50p.m. or part thereof R-67-A(2) | Rs. 50 R-67-A(2) | |
| MD-42 License | Class A Medical Devices | ₹5,000 | ₹5,000 + 2% per month or part thereof | Rs. 500 |
| Class B Medical Devices | ₹5,000 | ₹5,000 + 2% per month or part thereof | Rs. 500 | |
| Class C Medical Devices | ₹50,000 | ₹50,000 + 2% per month or part thereof | ₹1,000 | |
| Class D Medical Devices | ₹50,000 | ₹50,000 + 2% per month or part thereof | ₹1,000 |
The retail/wholesale licence takes around 25 to 30 working days, depending on document readiness and government processing time.
The manufacturing licence takes around 150 to 180 working days, depending on document readiness and government processing time.
The timeline for obtaining an MD-42 License depends on the classification of the medical device (Class A, B, C, or D) and whether approval is handled at the State Licensing Authority (SLA) or Central Licensing Authority (CDSCO).
The MD-42 license typically takes 30 to 45 working days, subject to complete documentation and satisfactory inspection of premises.
The MD-42 license generally takes 60 to 90 working days, depending on device risk category, technical scrutiny, and inspection requirements.
Delays may occur if documents are incomplete or if inspection reports are unsatisfactory.
While the shop has a license, the professional running it (the pharmacist) also holds a license. These are two different entities.
Drug Licence: Belongs to the shop/business.
Pharmacy Registration: Belongs to the individual pharmacist.
If your pharmacist fails to renew their registration, they legally cease to be a pharmacist. Consequently, your shop's license becomes invalid immediately because you lack technical supervision.
Visit the Council Website: Go to your State Pharmacy Council portal.
Login: Access the pharmacist’s profile.
Update Details: If there is a change in address or additional qualifications.
Payment: Use the pharmacy registration renewal online facility to pay the annual fees.
Certificate: Download the renewed 'Green Card' or registration certificate.
Business owners must check the validity of their staff's registration annually. Searching for how to renew pharmacy registration online is a task for the pharmacist, but ensuring it is done is the duty of the shop owner.
Your drug licence is not a lifetime permit. Under the Drugs and Cosmetics Rules, a license is typically valid for 5 years (though this can vary by state amendments).
Call us now for renewing of Drug Licence Haryana.
If you miss the expiry date, you have to pay a late fee. If you delay too long (usually 6 months post-expiry), the license is cancelled, and you have to apply for a fresh one—a nightmare scenario involving fresh inspections.
Login to the Portal
Use the same credentials from your original application.
Select Renewal
Click on the link for drug licence renewal online against your license number.
No-Change Affidavit
You generally need to upload an affidavit stating there has been no change in the constitution, premises, or staff during the tenure.
Pay Retention Fee
The fee is usually equivalent to the fresh license fee.
Validity Extension
Upon payment and verification, the validity of your drug licence certificate is extended in the database. You might not get a new physical paper; the receipt acts as proof of renewal.
Knowing how to renew drug licence online saves you from the panic of last-minute expiries.
You can hire us for the entire process of submitting documents, verifying, and renewing the Drug licence registration can be very hectic and annoying for you. By hiring us for your Drug licence registration, you will secure your precious time and mental health, stress-free. DrugLicense.in will do all the necessary activities by your side, from running to different departments for the approval of your licence.
Drug License Application: Complete assistance for the procurement of your Retail, Wholesale, or Manufacturing Drug License under the Drugs & Cosmetics Act, 1940.
Regulatory Compliance: We ensure that your pharmacy or facility maintains complete compliance with all regulatory requirements related to storage, record-keeping, and operations.
Documentation Support: Our experts will assist in the preparation and verification of all the required affidavits, blueprints, and personnel documents for a zero-error submission.
Liaison with Government Depts: We coordinate with the State Drug Control Department to facilitate timely inspections and approvals for your license.
Renewals & Audit Support: Feel empowered knowing you are receiving timely assistance for all your renewals and support during regulatory audit processes to ensure your business remains compliant year-round.
From initial documentation to ongoing compliance, we're your trusted partner in every aspect of pharmaceutical licensing and regulatory management.
100% accuracy in pharmaceutical paperwork to avoid delays, rejections, or regulatory penalties. Our expert team ensures every document meets CDSCO standards.
We don't stop at licences — we help you maintain year-round regulatory compliance with continuous monitoring and expert guidance.
Round-the-clock assistance for all your pharmaceutical licensing needs. Get instant access to our regulatory experts whenever you need guidance.
"Druglicense.in truly exceeded our expectations in handling our drug license in Delhi. Their team is knowledgeable and very cooperative and guided us through all the compliance requirement with clarity. All the documentation were prepared flawlessly and submitted well within the timeline. We are extremely satisfied with their professionalism and dedication."
Pharmaceutical Entrepreneur, Delhi
Get answers to the most common questions about Drug Licensing
Ans. To get a drug license in India, register on your state's Online Drugs Licensing System (ONDLS), prepare documents like proof of premises, identity/qualifications of proprietor/pharmacist, and pay fees, then submit online and await physical inspection by a Drug Inspector for final approval. The process involves online application, document submission, and a mandatory physical inspection to verify premises and compliance before issuance.
Ans. To get a drug license for a medical store in India, you must apply online via your State Drug Control Dept website, prepare documents like your premise plan, proprietor ID/qualifications, and a registered pharmacist's details, pay fees, and then undergo a physical inspection by a drug inspector who verifies your setup before the license is issued.
Check Eligibility & Premises: Ensure your shop meets space (e.g., 15 sq. meters) and layout requirements (with separate entry/exit, fridge).
Hire a Registered Pharmacist: Secure a qualified pharmacist with a valid registration and appointment letter.
Gather Documents: Prepare digital copies (PDFs) of:
Apply Online: Register on your State's Drug Control Portal, fill the form, upload documents, and pay fees.
Physical inspection: A drug inspector visits your premises for verification.
License Issuance: After successful verification, the license is issued.
Ans. To renew your drug license online, visit your State's Drug Control Department website, log in or create an account, select the renewal option (usually 2 months before expiry), fill the form, upload required documents, make an online payment, and submit for approval.
Find Your State Portal (e.g., drugs.delhi.gov.in for Delhi).
Login/Register with existing or new credentials.
Start Renewal: Select "Apply Retention/Renewal" option.
Followed by document upload (Pharmacist proofs, Old license, Fee receipts) and payment completion.
There are several types of drug licenses in India:
Ans. Drug licences are issued by the respective State Drug Control Authority, operating under the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
Ans. No. Operating a pharmacy or selling drugs without a valid drug licence is illegal in India and may lead to severe penalties, including fines, imprisonment, or closure of your business.
Ans. Yes. You must appoint a registered pharmacist with a diploma or degree in pharmacy, approved by the Pharmacy Council, to qualify for a retail drug licence in India.
Ans. Yes, especially for medicines that require controlled temperatures. A refrigerator with a thermostat is mandatory to maintain proper storage and comply with inspection requirements.