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Know More About Drug Licence Registration
Introduction and Its Compliance
In India, selling, stocking, exhibiting or distributing drugs without a valid drug licence is a punishable offence under the Drugs and Cosmetics Act, 1940. Whether you are a pharmaceutical company, chemist or a healthcare startup dealing with allopathic, ayurvedic or homeopathic drugs, obtaining a drug licence is mandatory. The Central Drugs Standard Control Organization (CDSCO) and respective State Drug Authorities regulate and issue these licences. Lawfinity India Private Limited ensures complete end-to-end assistance for securing the appropriate drug licence—whether it's a retail, wholesale or manufacturing licence—by complying with the latest regulatory guidelines issued under the amended Drugs Rules, 2023.
Why It Is Needed
A drug licence is legally required to engage in any kind of drug-related business in India. It ensures that the sale, distribution or manufacture of drugs is done under ethical and safe conditions as per government regulations. Obtaining a valid drug licence through Lawfinity prevents legal penalties and guarantees public health protection by allowing only certified professionals to deal with medicines.
Benefits and Advantages
- Legal Authorization A drug licence grants your business the legal right to manufacture, sell or distribute drugs, ensuring you operate within the law and avoid criminal prosecution under the Drugs and Cosmetics Act, 1940 and related regulatory frameworks.
- Consumer Trust Holding a valid drug licence builds customer confidence, showing that your business complies with safety and quality standards. It enhances your credibility in the pharmaceutical and healthcare sector, attracting more loyal and informed consumers to your brand.
- Market Access With a drug licence, your business gains entry into formal and regulated markets such as hospitals, pharmacies and institutional buyers. It allows participation in tenders, supply chains and contracts requiring legal certification for dealing in drugs.
- Business Expansion A valid drug licence makes it easier to expand operations across different cities or states. It enables faster registration for new branches, partnerships or franchises while maintaining compliance with central and state drug authorities.
- Avoid Regulatory Penalties Compliance through a drug licence protects your business from heavy fines, inspections and sudden closures. It ensures smooth operations by preventing legal complications or punitive actions from drug inspectors and state regulatory bodies.
Eligibility Criteria
To apply for a drug licence in India, the following conditions must be met:
- The applicant must have a suitable premise (minimum 10 sq. meters for retail/wholesale and 15 sq. meters for both).
- The premise must have proper storage facilities like refrigeration and ventilation.
- A registered pharmacist (for retail) or a competent person with relevant experience (for wholesale) must be appointed.
- The applicant must comply with the zoning regulations of the local municipal authority.
- The business entity must be registered (as a proprietorship, partnership, LLP or private limited company).
Documents Required
Here’s a list of essential documents needed to apply for a drug licence with Lawfinity’s assistance:
- System generated application form for relevant drug sale (19/19A/19B/19C as applicable)
- Site plan and key plan of the premise
- Constitution of the firm
- In case of company: MOA, AOA and Copy of resolution Passed;
- In case of partnership firm: partnership deed, duly attested by Notary Public;
- In case of trust / society: Trust deed;
- Photo ID proof of the director / partner / proprietor of the firm.
- Affidavit regarding non-conviction of Property/Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.
- Affidavit regarding compliance of MPD 2021, if the premises are located on DDA residential flat / plot /building.
- Online fee deposit receipts.
- System generated affidavit from the registered pharmacist/competent person.
- For Wholesale License Competent person:
- Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets
- Experience Certificate
- Appointment Letter and Bio-data.
- Premises:
- If Owned: Registered Sale Deed / Regd. GPA / Conveyance Deed in the name of owner or Unregistered Sale Deed / unregistered GPA supported with Electricity Bill / Water Bill / property tax receipt.
- If Rented: Rent receipt, registered rent agreement, unregistered rent agreement along with ownership documents of property owner.
- In case of village, Khasra Khatauni documents will be considered
Steps for Applying
- Consultation & Eligibility Check: Lawfinity experts assess your business model and determine the type of licence required.
- Document Collection & Verification: Our team compiles and verifies all documents for accuracy.
- Online Application Filing: We file your application through the State Drug Control Department's online portal.
- Fee Payment: Government fees are paid online and confirmation is submitted.
- Site Inspection: Drug Inspector visits the premises to verify the setup, storage and compliance.
- Grant of Licence: Upon approval, the licence is issued electronically.
- We at Lawfinity also handle follow-ups and corrections (if required) to ensure fast approval.:
Penalties
- Imprisonment of up to 5 years
- Fines which may extend up to ₹5 lakhs or more depending on the offence
- Sealing of Premises
- Cancellation/Suspension of the existing drug licence
- Criminal records and blacklisting for repeated violations
Timelines
Retail/Wholesale Licence
The retail/wholesale licence takes around 25 to 30 working days, depending on document readiness and government processing time.
Manufacturing Licence
The manufacturing licence takes around 150 to 180 working days, depending on document readiness and government processing time.
*Delays may occur if documents are incomplete or if inspection reports are unsatisfactory.
Timelines may vary depending on document verification and government approvals.
Fee
Frequently Asked Questions
Because every great business starts with the right answers.
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.
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.
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.
Most drug licences are valid for five years. Renewal should be done before expiry to ensure uninterrupted operations and avoid penalties from the drug control department.
Yes, businesses involved in the trade or sale of medicines must have GST registration as it’s a mandatory document for applying for any drug-related licence.
No. Each location or branch dealing in drugs requires a separate drug licence. You must apply individually for every premise involved in sale, storage or distribution.
Lawfinity offers complete support including document preparation, online filing, communication with authorities, inspection scheduling and compliance assistance to ensure you get your drug licence without hassle.
Yes, but the process is complex, involving multiple technical documents, regulatory criteria and inspections. Lawfinity simplifies this with expert handling from start to finish for faster approval.
Yes, especially for medicines that require controlled temperatures. A refrigerator with a thermostat is mandatory to maintain proper storage and comply with inspection requirements.
Voices of Success
Hear from those who have thrived with us and discover how businesses have transformed and grown with our expert guidance and support.
Anil Yadav
Shaperz India Grain Private Limited
“From FSSAI to Trade License, Lawfinity handled all our approvals efficiently. One-stop solution for all licensing needs.”
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