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Know More About DRUG & COSMETIC LICENCE
Introduction and Its Compliance
The Drug & Cosmetic Licence is a mandatory requirement under the Drugs and Cosmetics Act, 1940, for those business involved in manufacturing, distribution, sale or import of drugs or cosmetic products in India. This licence is regulated by the Central Drugs Standard Control Organization (CDSCO) and respective State Drug Authorities. It ensures that the pharmaceutical and cosmetic products sold in India meet required safety, efficacy and quality standards. Lawfinity assists clients in securing the correct type of licence whether for retail, wholesale or manufacturing by ensuring complete regulatory compliance and seamless documentation.
Why It Is Needed
Obtaining a Drug & Cosmetic Licence is a legal requirement before commencing any business activity related to drugs or cosmetics. It protects public health by ensuring that only the tested and approved products are circulated in the market. The licence also builds trust among the consumers and regulatory authorities and is also essential for participating in tenders, exporting products outside India or collaborating with other bigger pharmaceutical companies.
Benefits and Advantages
- Legal Authorization A Drug & Cosmetic Licence allows a business to legally sell, stock, exhibit or distribute drugs and cosmetics in India, avoiding penalties and shutdowns.
- Enhanced Market Credibility Businesses with this licence are seen as credible and trustworthy, attracting better collaborations and retail opportunities.
- Consumer Trust and Safety Licensing ensures product quality, which builds consumer confidence and reduces health risks from unsafe products.
- Business Expansion With a valid licence, businesses can expand their operations across multiple states, import/export products and engage in B2B transactions.
- Access to Government Contracts It is a prerequisite for bidding in government tenders or supply contracts related to pharmaceuticals and healthcare.
Eligibility Criteria
- The business must operate from a registered premise with proper storage and refrigeration facilities.
- A qualified pharmacist (for retail licence) or a competent person with relevant experience (for wholesale licence) must be appointed.
- The premise should comply with the space requirements as specified by the Drug Control Authority.
- For manufacturing licences, proper plant layout, equipment and technical staff are mandatory.
- Businesses must not have any criminal history related to drug violations.
Documents Required
- 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 Getting Registration
- Determine the Type of Licence: Retail, wholesale or manufacturing based on the nature of business.
- Prepare Documents: Collect all required documents, including educational and professional certificates of the pharmacist or competent person.
- Application Filing: Submit the application online through the respective state drug authority’s portal (or CDSCO for central licences).
- Inspection of Premises: A Drug Inspector will inspect the premises to ensure compliance with infrastructure and manpower norms.
- Verification & Approval: After successful inspection and document verification, the authority issues the Drug & Cosmetic Licence.
Penalties
- Operating without a valid licence is a criminal offense under the Drugs and Cosmetics Act. Penalties include:
- Fines up to ₹5,000 to ₹1,00,000 depending on the severity of the offense.
- Imprisonment ranging from six months to ten years.
- Cancellation of licence and blacklisting of the business.
- Seizure of goods and shutdown of operations by authorities.
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.
Timelines may vary depending on document verification and government approvals.
Fee
Frequently Asked Questions
Because every great business starts with the right answers.
It is a legal permit issued by drug authorities for manufacturing, selling, stocking or distributing drugs and cosmetic products.
Any individual, company or organization involved in the business of drugs or cosmetics must obtain this licence.
Yes, a qualified pharmacist with registration in the State Pharmacy Council is mandatory.
No. Selling or distributing drugs without a valid licence is illegal and punishable.
Most licences are valid for 5 years and must be renewed before expiry.
No. The licence is non-transferable and issued specifically for the premises and individual or entity named.
Yes, a licence is required if you are dealing with products falling under the Drugs and Cosmetics Act.
Retail licences are for businesses selling directly to consumers, while wholesale licences are for distributors and suppliers.
Absolutely. Lawfinity provides complete support for licence renewals, changes in ownership, additions of products or address modifications.
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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