Ayush Third Party Manufacturing

The AYUSH sector in India refers to traditional medicine systems, which consist of Ayurveda, Yoga, Unani, Siddha, and Homeopathy. As the demand for herbal and traditional products continues to rise, businesses want to manufacture and market such products. Thus, an AYUSH Third-Party Manufacturing License has become essential. 

What is AYUSH Third-Party Manufacturing License?

An AYUSH Third-Party Manufacturing License allows a company (the license holder) to manufacture its products by another licensed manufacturer (the third party). This arrangement benefits businesses that want to market their products without investing in their manufacturing facilities.

• Compliance with Law: It will ensure that the process of manufacturing complies with the norms as prescribed by the Ministry of AYUSH.
• Quality Guarantee: It ensures products manufactured follow standard quality levels so they can be ensured to be safe and effective.
• Access to Market: Businesses will be able to widen the scope of their product and market presence without huge capital costs involved.

Before proceeding with the application process, it is important to know the types of licenses available under the AYUSH framework:

• Complete Manufacturing License: This license is required when a manufacturer intends to produce and market their own products. It necessitates setting up a manufacturing unit compliant with AYUSH regulations.
• Loan License: A loan license is issued if a manufacturer does not have his manufacturing facility but intends to get their products manufactured by a licensed third-party manufacturer. A loan license holder shall also seek permission for their products from the relevant authorities.
• Contract Manufacturing License: This license enables a marketing company to have its products produced by a licensed manufacturer but does not have a manufacturing setup. The contract manufacturer will manufacture the products, and the marketing company will handle the branding and sales.

An applicant must fulfill certain criteria to apply for an AYUSH third-party manufacturing license:

• Business Registration: Applicant should be a registered business entity, such as a sole proprietorship, partnership, or company.
• AYUSH Regulations: The applicant should adhere to all regulations put forth by the Ministry of AYUSH.
• GMP Certification: The manufacturing facility must be GMP certified.
• Qualification: The applicant must have qualified personnel, which may include Ayurvedic experts and pharmacists.

• Incorporation / Proprietary / Other form of business
• Area of the manufacturing unit should be not less than 1285 sq. ft.
• DMR [The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954]
• (DMR Act compliances must be followed for manufacturing)
• Technical Officer (BMS doctor)
• Technical Officer (BSC with Bio.)
• Product information (what are the product going to be manufacture)
• Form of product [in what form (tablets/liquid/powder) product going to be manufacturing)
• Directors (related to the herbal domain) will be more preferable

To apply for the license, one requires the following documents:

• Application Form: The prescribed application form can be downloaded from the website of the Ministry of AYUSH.
• Identity Proof: The applicant's Aadhar card or PAN card.
• Business Registration Documents: Proof of registration of your business entity.
• GMP Certificate: Copy of GMP certification of the manufacturing facility.
• Product Details: Any details pertaining to the formulations and specifications of products that you are looking to manufacture.
• Agreement with Manufacturer: A legal contract between yourself and the third-party manufacturer stating the conditions and agreements.
• List of Equipment: Machine and Equipment used for Production.

Making an Online Application Submission

• Log in through the Official website: Ministry of AYUSH or at your respective State's website of AYUSH dept.
• Registration on the Portal: If you are a new user, register with the portal and provide relevant details.
• Login: Use your credential to log in to your account.
• Fill Application Form for Third-Part Manufacturing: Locate and fill out the application form for third-party manufacturing.
• Upload Necessary Documents: Attach all documents as mentioned in the guidelines.
• Pay the Application Fee: Pay whatever fees are applicable along with the application.
• Application Submission: Ensure that all information is correct and submit your application.

Post Submission Process for AYUSH Third Party Manufacturing License

After submitting your application:

• Acknowledgment Receipt: You will receive an acknowledgment receipt with a unique application number.
• Review by Authorities: The relevant authorities will review your application and documents.
• Inspection (if required): An inspection may be conducted at your proposed manufacturing facility to ensure compliance with safety standards.
• Grant or Rejection: Based on the scrutiny of your application and inspection report (if any), the authorities would either approve or reject your license.

If you already possess an AYUSH third-party manufacturing license that is about to expire, you need to apply for renewal before it expires:

Online Renewal Application

• Access your account on the AYUSH portal.
• Click on the renewal application option.
• Fill out the renewal form with new information if available.
• Attach or upload all necessary documents dealing with compliance in your previous tenure.
• Pay whichever renewal fees apply.
• Submit your renewal request.

Review for AYUSH Third-Party Manufacturing License

Renewal may be subject to review wherein:

• The compliance against the existing conditions set at the time of issuance as stated in your original license,
• Possible inspections by a regulatory officer.

Benefits of Having an AYUSH Third-Party Manufacturing License

There are numerous benefits associated with holding an AYUSH third-party manufacturing license. They include:

• Legitimacy of Operations: Legitimate operation without any threats of penalties or closure from regulatory authorities is achieved.
• Higher Credibility: Clients tend to trust the operator, who is licensed, and adheres to the standards of safety.
• Access to Government Contracts: Obtaining a license opens doors for bidding on government contracts concerning public health and safety.
• Enhanced Customer Confidence: This can lead to increased customer retention and referrals.

Problems in the Issuance of an AYUSH Third-Party Manufacturing License

Obtaining an AYUSH third-party manufacturing license is essential; however, the process might involve several problems for a business entity:

• Documentation Complexity: Such a complex requirement requires a lot of effort.
• Regulatory Updates: Changes in licensing requirements may require more training or documentation.
• Time Consumption: Time consumption may result from waiting for inspection or processing.

Corpseed offers end-to-end assistance for obtaining an Ayush third-party manufacturing license by helping you with documentation, regulatory compliance, and application submission. We also provide support during inspections and ensure ongoing compliance with AYUSH standards.