Hand sanitizer was treated as an optional medicinal and cosmetic product in the pre-Covid era. But the demand for hand sanitizer in India has been surging ever since the Covid 19 virus hit this country. Owing to the skyrocketing demand, existing manufacturers are finding it hard to attain the desired production level. Given this pressing issue, the government has took several decisions to boost the production of hand sanitizer such as exempting alcohol makers to produce sanitizer via ethyl alcohol and enforcing state authorities to speed up the licensing process. In this write-up we will talk about the legalities that start-ups need to address for the establishment of Hand Sanitizer Manufacturing Unit in India.
An overview on Hand Sanitizers
Hand Sanitizers typically fall under three important categories:
- Pharmaceutical Hand Sanitizer
- Cosmetic Hand Sanitizer
- Ayurvedic Hand Sanitizer
As implied by their types, hand sanitizers might be produced under these industries.
The type of license required for Hand sanitizer manufacturing will differ in accordance with the classification of the hand sanitizer. For instance, if you intend to produce pharma-based hand sanitizer, then you will require availing drug manufacturing license.
Likewise, if you wish to engage with the manufacturing of cosmetic-based hand sanitizer, then you will require obtaining an ayurvedic manufacturing license.
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Ayurvedic manufacturing license for Hand sanitizer manufacturing unit
A manufacturing facility dealing with herbal/ayurvedic products is mandated to avail registration from the Ministry of Ayush[1]. Ministry of Ayush has underpinned some fundamental prerequisites for availing the aforesaid registration:
Your manufacturing facility ought to be of a minimum size of 1200 sqft and it should be located industrial area.
- There is a compulsion of appointing 2 Ayurvedic experts and 2 Pharmacists.
- The manufacturing facility should have GMP certification in place.
- The manufacturing facility should be outfitted with the required machinery and equipment.
- The place of manufacturing will be subjected to periodic inspection, which will be done by the official appointed by the Drug controller.
- The manufacturing unit should have the required paperwork in place.
How to apply for an Ayush license?
- Visit the respective state portal of AYUSH.
- Download the required e-form, attachments, documents, including affidavits & other licenses such as CoPP & GMP, as the case may be.
- Apply for CoPP & GMP if applicable.
- Submit the aforesaid documents and e-form before the Directorate of the AYUSH, located in the respective jurisdiction
Drug manufacturing license for Hand sanitizer manufacturing unit
Steps to avail Drug Manufacturing License (Fresh)
Stage 1: The Applicant has to make an online application to the State Drugs Controller. The documentation has to be submitted and to be handed over to the Drug Control Officer during the verification. The applicant is required to apply in the prescribed form. The details of application forms & standard fees are mention below:
- Application on form 24 related to Non-biological drugs manufacturing license with a standard fee of INR 7500 for 10 items/category & INR 300/item for more than ten items/category. Application on Form 27 related to the manufacturing of Biological drugs with a standard fee of INR 7500 for 10 products/category and INR 300/product for a product more than 10 products/category.
- Application on Form 24A relating to the manufacturing license for Non-biological drugs as per norms cited and application for loan license relating to bio-logical drugs is to be furnished on Form 27A.
- Application on Form 24 for drug repacking with a fee of INR 700 up to products/category & INR 100/product if the products are more than 10 products.
- Application on Form 24C relating to Homeopathic manufacturing license with a standard fee of INR 300 for mother tincture INR 300 for potential preparations and INR 300 for potentized and INR 50 for additional products if the products are more than 10.
Users can pay the requested fee via an online portal by way of Net Banking/Debit Card/Credit Card.
Stage 2: The applicant shall furnish an application via an online portal after rendering requested documents to the State Drugs Controller.
The applicationform undergoes a rigorous verification process, & then makes its way to the Senior Drugs Control Officer of the respective region for the on-site inspection of the firm.
During the on-site inspection, the Senior Drugs Control Officer jot down his findings and then create a report, which further makes its way to the Senior Drugs Control Officer
Stage 3: Issuance of manufacturing drug license: if all norms as cited by the Act have been met, the license is bestowed byState Drugs Controller and the applicant gets informed via SMS/email.
Documents to be arranged for Drug Manufacturing License
- Schematic of the premises. It must enclose the signature of the firm’s partner/owner/director.
- Lease deed or rent receipt of the manufacturing facility (original or attested photocopies)
- Certified copy of the partnership deed (applicable for partnership firm), MOA, and AOA (applicable for private and public limited companies). These documents must entail the Director’s signature.
- List of existing directors manifesting their entire details such as name and address.
- If there is a change in Directors (addition, registration, replacement) as original with their certified Xerox of Form 32 in respect of such outgoing or incoming director.
- Complete detail related to staff/registered individuals along with the photocopies of the academic and professional education, experience, and registration certificates.
- Non-conviction affidavit of approved staff as needed with academic approval and qualification.
- Certified copies of academic & professional qualification and the approval of staff as per norms cited in Drugs and Cosmetics Act, 1940 and Rules, 1945
- List of machinery and lab equipment available at the premises.
- Purchase bills of the equipment and machinery (attest copy)
- No objection certificate from the fire department and SPCB.
- Proof of load approved
- Certified Xerox of occupation certificate form
- Affidavit pertaining to the partner/Director accountable for managing the daily operation.
- Affidavit manifesting director’s and partner’s non-association with any felony under Drugs and Cosmetics Act, 1940 and Rules, 1945.
- Resolution of BODs manifesting the appointment of an authorized signatory.
- Non-conviction affidavit by an authorised signatory,
Conclusion
Setting up a Hand Sanitizer manufacturing unit in India attracts a tedious licensing process. Keep in mind that the likelihood of cancellation of application is considerably higher in this case since it is a matter of public health. Therefore, you need to remain cautious while handling the paperwork or meeting compliances. If possible, do prefer the availing service of a professional firm like CorpBiz if you wish to skip the trouble of being rejected by the authority.
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