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.
If you're considering opening a business related to sale, distribution, or manufacturing medicine or cosmetics in India, the first step is to mandatorily obtain a Drug License. The Drug License is required for all premises under the Drugs and Cosmetics Act, 1940 which relates to pharmaceutical activities, including retail pharmacies, wholesale distributors, and manufacturing plants.
A Drug License is granted by the State Drug Control Department and serves as official proof that a premises and its business operations comply with all of the legal standards for safety, storage and personnel qualifications.
Obtaining a Drug License involves a thorough process that involves evaluating a business plan, personal qualifications of the staff (pharmacists or competent persons), and the business premises and its design and infrastructure including storage facilities such as refrigeration and air conditioning. Upon obtaining a Drug License, it is generally valid for up to 5 years before renewal is required. Operating without a valid Drug License can lead to severe legal penalties including fines, imprisonment and even potential suspension or closure of the business.
From application to inspection and beyond — our team provides end-to-end assistance to ensure your pharmaceutical business stays compliant and fully licensed.
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.
We coordinate with the State Drug Control Department to facilitate timely inspections and approvals for your license.
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.
Get expert guidance through every step of pharmaceutical licensing. Our team ensures compliance and accelerates your approval timeline.
Numbers that reflect our commitment to pharmaceutical excellence
Expert consultations provided to pharmaceutical businesses across India.
Ensuring every licensing process fully complies with Indian drug laws.
Successfully processed pharmaceutical licences for retail, wholesale, and manufacturing units.
A decade of excellence in simplifying drug licensing and compliance across India.
From document collection to final approval, our experts guide you through every stage of the drug license registration journey.
We assist you in gathering and preparing all necessary documents from property papers to pharmacist qualifications.
The application is submitted online through the official state drug control portal.
We ensure all forms (e.g., Form 19, 19A, 19C) are filled out correctly and then submitted online via the portal.
The appropriate government license fee is paid online through the portal.
A Drug Inspector visits your location for a physical inspection to verify all details.
Upon satisfactory verification, the Drug Controller issues the license.
Our comprehensive 8-step process ensures 100% compliance and faster approval times. Get started with India's most trusted pharmaceutical licensing experts.
A drug licence is not just a regulatory requirement—it's your gateway to legitimate pharmaceutical business operations, consumer trust, and sustainable growth in the healthcare industry.
Operate your pharmaceutical business legally under Indian regulations and avoid penalties or shutdowns.
Ensure your products meet GMP standards and safety protocols, building consumer confidence.
Prevent counterfeit and substandard medicines from entering the market, safeguarding public health.
Access government tenders, hospital contracts, and expand to new markets with licensed operations.
Build trust with customers, suppliers, and healthcare providers through regulatory compliance.
Meet WHO guidelines and international quality standards for global pharmaceutical trade.
Understanding the critical role of pharmaceutical regulation in India's healthcare ecosystem
Different licenses are required based on the type of pharmaceutical operation you plan to undertake
For businesses manufacturing drugs and cosmetics, including allopathic, homeopathic and ayurvedic medicines.
Required for pharmacies and chemist shops selling medicines directly to consumers.
Needed for distributors selling medication in bulk to retailers, hospitals or licensed institutions.
For businesses using another licensed manufacturer's facilities to produce drugs under their brand name.
Required for importing drugs or raw materials to manufacture drugs in India.
To operate pharmacies with the same brand name in more than one state.
Applicants must meet certain conditions regarding premises, storage and personnel
Documentation varies according to the type of license you're applying for
Government fees vary depending on the type of license
| License Type | Fee Amount |
|---|---|
| Retail or Wholesale License | ₹3,000 |
| Restricted License (general stores) | ₹1,000 |
| Schedule X Drugs (additional) | ₹500 |
| Manufacturing License | ₹7,500 + inspection fees |
| Renewal Fee | Same as original fee |
Different forms are required based on the type of drugs and license purpose
| License Purpose | Application Form |
|---|---|
| Retail/Wholesale of Allopathic drugs (not in Schedule C, C1, X) | Form 19 |
| Restricted license for Allopathic drugs (general stores) | Form 19A |
| Retail/Wholesale of Homeopathic medicines | Form 19B |
| Retail/Wholesale of drugs in Schedule X | Form 19C |
| Drugs in Schedule C & C1 (biological & special products) | Form 19 (License in Form 20B/21B) |
30 to 60 Days
It usually takes between 30 and 60 days to obtain a drug license after submitting an application, depending on documentation completion and the inspection schedule.
Serious penalties apply for non-compliance with the Drugs and Cosmetics Act, 1940
Punishable offense leading to:
Severe penalties for selling:
Caused by adulterated drugs:
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
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