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If you’re manufacturing Ayurveda, Yoga, Unani, Siddha, and Homeopathy (AYUSH) products, secure an Ayush License with Canjain experts today.
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Are you a manufacturer, retailer, or wholesaler dealing in Ayush products in India? If yes, you are at the right place. Our experts help entrepreneurs like you secure Ayush license effortlessly.
AYUSH, which stands for Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy, is a reflection of the ancient medical systems followed in India. These practices have been integral to the country’s healthcare for years. However, these products and practices were unregulated until the Ministry of AYUSH was formed in 2014. Since then, a robust legal and regulatory framework has boosted the manufacturing, sales, marketing, and export of these products in a big way.
Are your eyes all set on getting legal authority to manufacture and sell Ayush products? Get assistance from Canjain Ayush License consultants to secure an Ayush license with the promise of gaining customer trust and immense market opportunities.
The regulatory guidelines for issuance of Ayush License to manufacture Ayurvedic, Siddha, and Unani medicines are mentioned in Rule 158-B in the Drugs and Cosmetics Rules, 1945. Besides this, the regulatory guidelines for the issuance of license to manufacture Homoeopathic medicines are mentioned in Rule 85(A to I) in the Drugs and Cosmetics Rules, 1945.
An AYUSH license is important for businesses involved in manufacturing, retailing, and trading of Ayurvedic, Unani, Siddha, and Homeopathy products. An AYUSH manufacturing license or AYUSH retail license is essential to legally operate a business in India. Some key benefits of AYUSH license include the following:
1. Legal Authorization
AYUSH license grants legal authorization to manufacture and sell Ayurvedic, Siddha, Unani, and Homeopathy products in compliance with the required regulations and standards as per the Drugs and Cosmetics Act, 1940.
2. Enhanced Credibility
The AYUSH manufacturing license helps manufacturers boost their credibility, build consumer trust, draw customers, and collaborate with businesses. This license reflects the business’s commitment towards product quality, ensuring their genuineness.
3. Regulatory Compliance
Manufacturers that have obtained AYUSH license online are compliant, ensuring adherence to all the government standards for manufacturing, marketing, and exporting traditional medicine. Regulatory compliance ensures seamless and hassle-free business operations.
4. Global Market Access
AYUSH license is the gateway for businesses to enter global markets. Businesses that have obtained AYUSH license can legally export their products to international markets and capitalize on global demand for products manufactured under different Indian traditional medicine systems.
5. Consumer Trust
AYUSH license reflects the business’s commitment to deliver quality products to the customers and helps build trust. This license assures that products have undergone rigorous quality checks and are safe to use.
6. Business Expansion
Businesses that have obtained AYUSH license online can explore new markets to grow their business and expand into new territories to tap unique customers. AYUSH license ensures business expansion within the required legal and operational framework.
7. Tax Benefits
Businesses with AYUSH manufacturing license can avail of different government schemes and incentives, including tax benefits, which, in turn, help them reduce their operating expenses and boost profits.
8. Simplified Operations
AYUSH license online helps businesses streamline their operations and business processes, reducing the burden of heavy paperwork needed to physically apply for the permit. Overall, it allows quick turnaround time with faster approval rates.
9. Quality Assurance
An AYUSH license requires businesses to adhere to all the mandatory compliances, including Good Manufacturing Practices (GMP), to ensure the delivery of qualitative products and follow high standards in their manufacturing and distribution procedures.
10. Market Recognition
Any business that has obtained an AYUSH license, including an AYUSH retail license is considered legitimate by customers. Such businesses are trusted by consumers as well as professional associates. They earn the much-needed market credibility, giving them an edge over their competitors.
India is a country that recognizes various systems of medicine, enabling legitimate treatment under each system. However, anyone involved in either the treatment or manufacturing, retailing, wholesaling, exporting or introducing new products in Ayurvedic, Homeopathy, Siddha or Unani systems is mandated to apply for AYUSH license. This license helps businesses maintain compliance and operate legally. Let us explore different types of AYUSH licenses granted by the Ministry of AYUSH in India below:
1. AYUSH Manufacturing License
AYUSH manufacturing license is a mandatory requirement for businesses involved in the manufacturing of Ayurvedic, Unani, Siddha, or Homeopathy products. This license facilitates the business’s compliance with Good Manufacturing Practices (GMP) under the Drugs and Cosmetics Rules, 1945.
2. Unani Manufacturing License
The Unani Manufacturing License facilitates businesses manufacturing Unani medicines, focusing on holistic healing. Unani medical system underlines disease prevention and cure, and this license enables manufacturers to produce drugs within legal and compliance frameworks. The Unani medical system is considered an effective complementary medical system.
3. Siddha Manufacturing License
Siddha is a unique medical system that focuses on holistic healing by striking a balance between the mind, body, and soul. It concentrates on restoring harmony through treatments that combine yoga, meditation, diet, and lifestyle changes. A Siddha manufacturing license is required to produce Siddha medicines for holistic wellness.
4. AYUSH Retail License
Businesses that sell authentic AYUSH products require an AYUSH retail license to operate legally in India. This license ensures a business’s compliance with quality and safety standards for selling Ayurvedic, herbal, or homeopathy medicines and cosmetics.
5. AYUSH Wholesale License
The Ministry of AYUSH issues AYUSH wholesale license to wholesalers or distributors dealing with AYUSH products in bulk. This license is mandatory for such businesses to function legally and meet all regulatory compliance. It also ensures that storage and quality requirements have been fulfilled.
6. AYUSH Export License
Any business exporting different AYUSH products must obtain the AYUSH export license to operate legally in global markets. This license ensures the fulfilment of international standards and facilitates hassle-free operations to expand and grow in new global territories.
7. AYUSH Product Approval License
Businesses require an AYUSH product approval license to launch new Ayurvedic, Unani, Siddha, or Homeopathy products. This license ensures the consumers that the new product is safe to use as it fulfils all the compliance requirements mandated by the Drugs and Cosmetics Act, 1940.
8. AYUSH Clinic License
It is mandatory for individuals and organizations offering Ayurveda, Unani, Siddha, or Homeopathy treatment to obtain an AYUSH clinic license to operate legally in India. This license ensures compliance with the required standards for hiring qualified professionals, safeguarding the patients and providing quality care.
9. AYUSH Loan License
An AYUSH loan license is mandatory for those businesses that do not manufacture AYUSH products independently but outsource the manufacturing process to third parties. In such a case, AYUSH loan license holders collaborate with GMP-certified manufacturers to make products on their behalf. However, obtaining product approvals from relevant AYUSH authorities before launching the products is necessary.
Any business that wants to venture into drug or cosmetic manufacturing must obtain the required licenses as mandated under the Drugs and Cosmetics Act, 1940. It includes different types of drugs manufactured under allopathic, homoeopathic, ayurvedic, herbal, and Unani medical systems.
However, ayurvedic medicine manufacturers must obtain AYUSH license from the Ministry of AYUSH to ensure regulatory compliance and encourage quality-driven practices. Let us explore the eligibility criteria for obtaining an AYUSH manufacturing license online given below:
1. Business Type
Businesses involved in the manufacturing, trading or marketing of Ayurvedic, Homeopathy, Siddha, or Unani are eligible to apply for an AYUSH license online.
2. Premises
Any business engaged in manufacturing, trading, or marketing different types of drugs and cosmetics and following Good Manufacturing Practices (GMP) under the Drugs and Cosmetics Rules, 1945, is eligible to apply for AYUSH drug license.
3. Qualified Personnel
Any business that complies with regulations and employs qualified technical staff, including experienced pharmacists or Ayurvedic practitioners, as mandated by the Ministry of AYUSH.
4. Equipment & Infrastructure
The manufacturing unit that wants to apply for AYUSH manufacturing license must have the required machinery and infrastructure appropriate for AYUSH product manufacturing.
5. Documentation
Businesses keen to apply for AYUSH License must furnish all the necessary documents, including proof of premises ownership/lease, site layout, GMP certification, product details, and staff credentials.
6. Compliance
Businesses that have applied for AYUSH license online must adhere to all the legal and regulatory standards issued by the Ministry of AYUSH. They must also comply with all the applicable laws of the respective state where they are operating.
Individuals and businesses applying for an AYUSH drug license, including an AYUSH retail license, must submit various documents as eligibility criteria. Documents must be submitted via the AYUSH license online portal or through AYUSH license consultants to meet compliance and obtain the permit required to commence manufacturing and selling AYUSH products. These documents include the following:
Businesses involved in manufacturing or trading Ayurvedic, Unani, Homeopathy or Siddha products must obtain an AYUSH license, including an AYUSH manufacturing license or AYUSH retail license, to conduct their operations legally and hassle-free in India. Every Indian state has its own dedicated AYUSH license apply online portal, which facilitates online application for a quick turnaround time. However, applicants must follow the below-given steps to ensure smooth processing of their application:
1. Visit the AYUSH Website
Applicants must visit the AYUSH license apply portal for the state they want to set up their business. Next, they must download the specific application form for the license required and submit the affidavit for Good Manufacturing Practices (GMP) and Certificate of Pharmaceutical Product (COPP).
2. Submit the Application
The next step involves an applicant filling out the downloaded form and attaching the necessary documents, such as identity proof, proof of business, and product details, before submitting it.
3. Approval by the Commissioner
The submitted application form is then reviewed by the officials at the AYUSH department to verify its correctness and validate the attached documents. The commissioner reviews the form to ascertain compliance and, if satisfied, approves the AYUSH license within 15 days.
4. Receive the AYUSH License
Once the application is reviewed and the AYUSH license for manufacturing or retailing is granted, the department sends the license to the applicant by post.
5. Loan License Provision
Loan license holders may provide the raw materials and packaging supplies to the manufacture new AYUSH manufacturing license with GMP-certified manufacturers.
Loan license holders need to know that manufacturers charge conversion fees to manufacture products at their facilities on their behalf. The conversion fees cover the costs incurred on manufacturing the specific products at their units. Besides, loan license holders must also pay the approval fees mandated by the regulatory authorities.
Loan license holders must sign a legal agreement with the manufacturer of their AYUSH products to safeguard their rights. The agreement should mention that ownership rights of the manufactured products lie with the loan license holder irrespective of who/where the products are manufactured or the circumstances. The agreement should include stringent clauses to protect the license holder’s interest in case of a dispute, assuring legal safety for all the parties involved.
The time it takes to get an Ayush license in India is 20-30 days. However, it may extend up to 60 days in case of regulatory delay. Besides this, it depends upon the workload of the Ministry of Ayush.
Given below are the reasons why manufacturers, wholesalers, and retailers of Ayush products prefer Ayush License Consultants at Canjain –
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