Hand sanitizer became one of the most commonly used healthcare products during the COVID-19 period. Many traders, pharmacies, supermarkets, general stores and online sellers started selling hand sanitizers.
A common question is:
“Is drug licence required for selling hand sanitizer in India?”
The simple answer is:
For stocking or selling hand sanitizer, sale licence was exempted by the Central Government through notification S.O. 2451(E), dated 27 July 2020, subject to the condition that expired or wrongly labelled products should not be sold.
However, this exemption should not be misunderstood.
Manufacturing hand sanitizer still requires the applicable manufacturing licence. Selling only properly manufactured; properly labelled and non-expired hand sanitizer is allowed under the exemption.
What Was the 27 July 2020 Notification?
The Ministry of Health and Family Welfare issued notification S.O. 2451(E) on 27 July 2020.
The purpose of the notification was to make hand sanitizers easily available to the public during the COVID-19 emergency.
The notification exempted hand sanitizer from the requirement of sale licence for stocking or sale under Chapter IV of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
This means ordinary sellers were allowed to stock and sell hand sanitizers without obtaining a separate drug sale licence, subject to the condition mentioned in the notification.
Does Hand Sanitizer Need Sale Licence?
For stocking or sale, hand sanitizer was exempted from sale licence requirement by the Central Government notification.
So, a person may sell hand sanitizer without wholesale or retail drug sale licence, provided:
Product is legally manufactured
Product is properly labelled
Product is not expired
Product is not sold against label directions
Product is sourced from a genuine manufacturer or supplier
GST and normal trade compliance are followed
Does Hand Sanitizer Need Manufacturing Licence?
Yes. Manufacturing is different from selling.
The exemption is for sale licence, not for manufacturing licence.
If you want to manufacture hand sanitizer, you need the applicable licence depending on the product category and formulation.
Manufacturing may fall under:
Allopathic drug manufacturing licence
Ayurvedic/Siddha/Unani manufacturing licence, if ASU category
Cosmetic manufacturing licence, if the product is truly cosmetic and does not make medicinal/disinfectant claims
Other applicable permission depending on formulation and claims
Before manufacturing, product classification should be confirmed from the State Drug Licensing Authority.
Difference Between Selling and Manufacturing
Activity
Licence Position
Selling hand sanitizer
Sale licence exemption available under S.O. 2451(E), subject to conditions
Stocking hand sanitizer
Sale licence exemption available, subject to conditions
Manufacturing hand sanitizer
Applicable manufacturing licence required
Marketing own brand sanitizer
Must get manufactured from licensed manufacturer or obtain own manufacturing licence
Importing sanitizer
Import compliance may apply
Selling expired sanitizer
Not allowed
Important Condition Under Rule 65(17)
The notification says the seller must comply with condition 17 of Rule 65.
In simple words, this means:
Do not sell expired sanitizer.
Do not stock expired sanitizer for sale.
Do not sell product in violation of label directions.
Follow storage and label instructions.
Keep expired stock separate and marked not for sale if kept for return/disposal.
This condition is very important for traders and retailers.
Can a General Store Sell Hand Sanitizer?
Yes, a general store may sell hand sanitizer without drug sale licence under the exemption, provided the product is legally manufactured and properly labelled.
But the seller should keep purchase bills and avoid selling expired, duplicate, unlabelled or poor-quality sanitizer.
Can a Pharmacy Sell Hand Sanitizer?
Yes. Pharmacies can sell hand sanitizer. Even though pharmacies already have drug licence, the specific notification exempted hand sanitizer from separate sale licence requirement for stocking or sale.
Can a Wholesaler Sell Hand Sanitizer Without Drug Licence?
As per the exemption, sale licence is not required for stocking or sale of hand sanitizer. But the wholesaler should still maintain proper purchase and sale records, GST invoices, batch details and expiry details.
Can I Launch My Own Hand Sanitizer Brand?
Yes, you can launch your own brand, but you should not manufacture it without proper licence.
You have two options:
Get it manufactured from a licensed manufacturer.
Obtain your own applicable manufacturing licence.
If you are only marketing your brand, take care of:
Trademark
Label approval/compliance
Manufacturer licence copy
Batch number
Mfg/Exp date
MRP
Composition
Storage condition
Warning
GST
Proper invoice and records
What Should Be Checked Before Buying Hand Sanitizer for Sale?
Before purchasing sanitizer for resale, check:
Manufacturer name and address
Manufacturing licence number
Batch number
Manufacturing date
Expiry date
MRP
Composition
Alcohol percentage, if alcohol-based
Net quantity
Storage instructions
Warning and usage direction
GST invoice
Product quality and packaging condition
Avoid unlabelled or locally refilled sanitizer without proper details.
Can Expired Hand Sanitizer Be Sold?
No. Expired hand sanitizer should not be sold.
Expired stock should be separated from saleable stock and should be returned, disposed of or handled as per proper procedure.
Can Hand Sanitizer Be Sold Online?
Hand sanitizer may be sold online if the product is legally manufactured, properly labelled, non-expired and sold as per e-commerce, GST, consumer protection, transport and storage rules.
If the sanitizer is alcohol-based, also check transport and storage safety requirements.
Common Mistakes to Avoid
Avoid these mistakes:
Thinking sale exemption means manufacturing licence is not required
Buying sanitizer from unlicensed manufacturers
Selling expired sanitizer
Selling unlabelled sanitizer
Repacking sanitizer without licence
Making exaggerated germ-kill or disease-prevention claims
Selling duplicate or substandard products
Not maintaining purchase invoices
Ignoring alcohol storage and transport safety
Final Answer
For selling or stocking hand sanitizer, drug sale licence was exempted through the Central Government notification dated 27 July 2020.
But this exemption is limited to sale and stocking. It does not remove the requirement of manufacturing licence for manufacturers.
If you want to sell sanitizer, buy it only from a licensed and genuine manufacturer or supplier, keep proper invoices, check expiry, and follow label directions.
If you want to manufacture sanitizer, apply for the applicable manufacturing licence or work with a licensed third-party manufacturer.
Frequently Asked Questions
1. Is drug licence required for selling hand sanitizer?
As per S.O. 2451(E), hand sanitizer was exempted from sale licence requirement for stocking or sale, subject to Rule 65(17) condition.
2. Is licence required for manufacturing hand sanitizer?
Yes. Manufacturing requires the applicable manufacturing licence depending on formulation and category.
3. Can a general store sell hand sanitizer?
Yes, if the sanitizer is legally manufactured, properly labelled and not expired.
4. Can I sell hand sanitizer with only GST?
For sale/stocking, sale licence exemption is available, but GST and normal business compliance should be followed. Buy only from genuine licensed sources.
5. Can I make sanitizer at home and sell it?
No. Commercial manufacturing should not be done without the applicable manufacturing licence.
6. Can I sell expired sanitizer?
No. Expired sanitizer should not be sold or stocked for sale.
7. Can I market sanitizer under my own brand?
Yes, but get it manufactured from a licensed manufacturer or obtain your own manufacturing licence.
8. Is sanitizer a drug or cosmetic?
It depends on formulation and claims. The 2020 notification refers to hand sanitizer as a drug for the purpose of sale-licence exemption. Some hand hygiene products may be cosmetic depending on composition and claims, but classification should be confirmed before launch.
9. What records should a sanitizer seller maintain?
Maintain purchase invoices, sale invoices, batch details, expiry details, supplier details and GST records.
10. What is the safest way to start sanitizer business?
Start as a trader or marketer by purchasing from a licensed manufacturer, keeping proper bills and selling only non-expired, properly labelled products.
Looking for Ayurvedic Franchise or Distribution Opportunities?
Looking to start an Ayurvedic franchise, become a distributor, or launch your own herbal product range?
Elzac Herbal India offers:
Ayurvedic & Herbal Product Range
Franchise & Distribution Opportunities
Third-Party Manufacturing
Product Development Support
Marketing Guidance
PAN India Business Opportunities
Whether you are an entrepreneur, retailer, distributor, or healthcare professional, our team can help you explore the right business opportunity in the growing Ayurvedic sector.
Ajay Kamboj is an entrepreneur and business owners associated with many Ayurvedic and Pharmaceutical start-ups. With years of experience in Ayurvedic product marketing, pharmaceutical distribution, franchise development, and client relationship management, he regularly shares practical business insights based on real-world experiences. His articles focus on business growth, entrepreneurship, customer management, and lessons learned from the healthcare and wellness industry.
