Hand sanitizers are becoming a necessary item for both public safety and hygiene. Getting the appropriate certifications is essential if you produce hand sanitizer in India or intend to launch a hand sanitizer manufacturing company.
Why Do You Need Hand Sanitizer Certification?
To make sure your product satisfies legal requirements and is safe for consumer usage, hand sanitizer certification is crucial. Having the appropriate certification as a hand sanitizer manufacturer offers numerous important advantages:
Legal Compliance: The Drugs and Cosmetics Act of 1940 requires certification, which guarantees that your hand sanitizer satisfies the necessary safety and quality requirements. Product recalls and legal repercussions may result from operating without certification.
Consumer Trust: Customers who purchase certified goods are more likely to trust your hand sanitizer's efficacy and safety, which increases brand recognition and patronage.
Market Access: If you intend to distribute your goods abroad, certification enables you to comply with export laws and sell it lawfully within India.
Competitive Advantage: Possessing reputable certifications like ISO and BIS improves your product's standing in the market and sets it apart from uncertified rivals.
Types of Certifications Required for Hand Sanitizer Manufacturing
Drug License (Manufacturing License)
Required under the Drugs and Cosmetics Act, 1940.
Applies to alcohol-based hand sanitizers as they are classified as a drug.
BIS Certification (Bureau of Indian Standards)
Mandatory for ensuring the product meets IS 4948:2022 standards for hygiene and safety.
ISO Certification
ISO 9001: For Quality Management Systems.
ISO 22716: For Good Manufacturing Practices (GMP) specific to cosmetics and personal care.
For small and medium-sized enterprises to receive government assistance.
GST Registration
Required to legally sell hand sanitizers and comply with taxation laws.
How to Manufacture Hand Sanitizer: Step-by-Step Process
Formulation Development
Follow WHO-recommended formulations:
Ethanol (80%) or Isopropyl Alcohol (75%)
Hydrogen Peroxide (0.125%)
Glycerol (1.45%)
Set Up Manufacturing Facility
Ensure the production facility meets GMP standards.
Apply for Necessary Certifications
Submit applications to relevant authorities (State Drug Controller, BIS, etc.).
Quality Testing & Inspection
Perform quality tests for alcohol content, pH balance, and microbial efficacy.
Product Labeling
Include essential details like ingredients, batch number, manufacturing date, and expiry date.
Documents Required for Hand Sanitizer Certification
Company registration certificate
Manufacturing site plan
Drug license application
Product formulation details
Quality testing reports
GST certificate
Director's PAN and Aadhaar
Timeline for Certification Approval
Drug License: 30-45 days
BIS Certification: 20-30 days (subject to inspection)
ISO Certification: 15-20 days
Final Thought
Obtaining certification for the production of hand sanitizer is crucial for both regulatory compliance and fostering customer confidence. Following legal regulations as an Indian sanitizer manufacturer not only improves product quality but also creates opportunities for expansion and exports. To successfully complete the hand sanitizer production process and obtain the required certifications, adhere to the specified procedures.
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