In view of the excessive demand for sanitizers, the Government has introduced relaxations for the sanitizer industry vides order on March 19, 2020. The Central Government by way of this order has directed the State Governments to carry out the following actions.
- Permission on account of licensing and storage of Ethyl alcohol may be granted to the existing sanitizer industry without any quota restriction on supply of Ethyl alcohol. Ethyl alcohol is one of the major components in manufacturing of sanitizer.
- Ensuring easy procurement of Ethyl alcohol so that sanitizers can be obtained by producers at reasonable prices.
- Sanitizer industry to be motivated to increase working capacity for enabling enhanced production.
- As distillery members can also produce sanitizers in bulk, they are to be accorded with necessary permissions on priority basis.
Requirement for License:
- Documents:
- Form 24
- Fee challan of Rs. 7500.
- Map of premises
- NOC of pollution and Fire department/Undertaking of compliance of
Provisions of Pollution and Fire.
- Water test report, (may be submitted before start of production)
- List of machinery and equipment’s
- Proof of building ownership
- Rent agreement, if applicable
- Constitution of the firm.
- Affidavit of responsible/authorized person.
- Health fitness certificate of workers.
- Consent of outside laboratory for testing, if applicable.
- Building:
- Change room
- Solution preparation room – air conditioned with controlled environment.
- Filling and packing room.
- Store room – raw material, packing material and finished goods
- Quarantine area.
- Machinery of production area:
- Hand Sanitizer Mixer
This is the equipment used for mixing the ingredients. This can be a Vacuum Emulsifier, High Shear Mixer or a Powder-liquid Disperser Mixer which can make small to large batches of hand sanitizer solution.
This is a machine used for accurately filling container bottles for hand sanitizers. You have several options such as Liquid Filling Machines and Viscous Liquid Filling Machines.
- Hand Sanitizer Capping Machine
An automated machine, capping machines can automatically cap bulk hand sanitizer containers in a matter of an hour. You may have several options such as Screw Capping Machines, Rotary Vacuum Screw Capping Machine
- Hand Sanitizer Labeling Machine
Labeling machines can accurately put a brand or emboss a name on your containers. A variety of options include Pressure Sensitive Labeler, Optical Laser Printing Machine, Inject Printing Machine.
- Technical Person:
- Manufacturing chemist – B.Sc with experience in manufacturing
- Analytical chemist – B.Sc. with experience in analysis
- Laboratory for the testing of raw material and finished products.
Hand sanitizers can be manufactured on Form 25 of Drugs and Cosmetics Rules and under Pharma License. This factory can manufacture following chemical based hand sanitizers are:
- Ethyl Alcohol, Glycerine & Hydrogen Peroxide sanitizer
- Isoproyl Alcohol, n-Propanol, Ethyl-Hexadecyl-Dimethyl Ammonium-Ethyl Sulphate
- Chlohexidine Gluconate, Cetrimide & Ethanol Solution for Hand Rub.
As sanitizers fall within the definition of “Drugs” under the Drugs and Cosmetics Act, 1940, the license to sell/ manufacture/ distribute the sanitizers has to be obtained from the Licensing Authority as prescribed by the Government under the Drugs and Cosmetic Rules, 1945.
The application for manufacturing has to be submitted in accordance with the prescribed Form under the 1945 Rules along with the required documents including but not limited to plan of premises. As many entrepreneurs, who aren’t having manufacturing facility of their own, can obtain a loan license to manufacture the drug for sale. In this regard, they would have to provide a consent letter from the premises where such manufacturing is being carried out.
