The AYUSH license is a governmental ordination of the Ministry of AYUSH in India for products based on traditional systems of medicine, which include Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homeopathy. This license was evolved through the Drugs and Cosmetics Act of 1940 in order to ensure quality within these products and make them safe and efficacious. With the increasing acceptance of traditional medicine worldwide, the AYUSH license will become an essential tool to make these practices official and safe from any kind of tampering and safeguard public health.
It is mandatory for all the firms that produce, supply or trade to other countries AYUSH medicines and methods to have this license. This license, as far as old methods go, will also cover proprietary preparations on which new drugs are manufactured so that along with classical medicines the old texts refer to, there comes this extension under a registered number to ensure proper following of the Good Manufacturing Practice under Schedule T of the Drugs and Cosmetics Act mainly for hygienic production, record keeping and quality control.
Being equipped with an AYUSH license would mean manufacturers and dealers would be committed to ensuring a safe and authentic product that would curb the proliferation of low-quality or spurious products through the regulatory architecture, thereby protecting consumer confidence and, in turn, opening up markets to traditional medicines in India.
Types of AYUSH License in India
AYUSH licenses issued in India categorise different licensing types in the huge space of regularisation for the manufacture, marketing, sale, distribution and export of any Ayurveda, Yoga and Naturopathy, Unani, Siddha or Homoeopathy medicines or products. Licenses are procured because they play individualistic roles in living up to the stipulated norms of quality and safety defined under the Drugs and Cosmetics Act of 1940. They foster an environment wherein, on the one side, the operations of AYUSH Sector promote the ideals of quality, safety and consumer trust, but, on the other, support the development of business through the traditional medicines of India.
1. Manufacturer’s License
This is provided to the AYUSH medicines producers. It also encompasses:
Classical Medicines: Based on texts of ancient time and their formulations, they are categorised by old texts and traditional formulations.
Proprietary Medicines: New formulations developed based on traditional methods.
Good manufacturing practices under Schedule T are ensured in the license, as well as adherence to sanitary practices, the quality of raw materials, and jurisdiction of storage.
2. Loan License
This license is available to persons or to corporate bodies who are using another licensed manufacturer’s facility for the manufacturing of their saleable AYUSH products instead of having their own ability to manufacture.
3. Retail License
It is one of the important licenses that is granted to businesses or pharmacies that sell AYUSH products directly to consumers. It allows only authorised retailers to sell these products to the public.
4. Wholesaler License
Once a business sells AYUSH products in bulk to its buyers, such as retailers, hospitals, or other wholesalers, the business requires a wholesale license, which is essential for its supply chain management.
5. Export License
For any business with an intention to market AYUSH products outside its territory, the export license forms the primary requirement. This normally follows a schedule of additional requirements like GMP and Certificate of Pharmaceutical Product.
6. Approval of AYUSH Product
Approval is the requirement for manufacturers of proprietary or new formulations so they can verify their safety and efficacy before the manufacturing and marketing processes commence.
Who Needs an AYUSH License in India?
Entities or persons in India engaged in the manufacture, trade, stocking or export of products related to Ayurveda, Yoga and Naturopathy, Unani, Siddha or Homeopathy shall be required to have an AYUSH license. Both classical AYUSH and proprietary manufacturers shall be required to hold Good Manufacturing Practices (GMP) standards. This license will also include a retailer or wholesaler selling or distributing the AYUSH products and an exporter to set up the AYUSH medicines or health products abroad. The loan licence holders who produce goods from other manufacturers’ premises shall come under this licence. Licenses shall also be there for new product formulation and, in order to get clearances, approval of novel or proprietary formulation shall be sought through the AYUSH framework.
Such licenses ensure that their AYUSH products meet the standard set under the Drugs and Cosmetics Act of 1940 in respect of safety and efficacy. Any business that deals with AYUSH medicines needs to have the right license to operate legally and therefore to gain consumer trust.
How to Obtain an AYUSH License? – Documents And Application Procedure
Obtaining a license from AYUSH in India also comes with the necessary documents; it actually depends on what kind of information one wants to attain the birth certificates for. These documents confirm all the legal and quality assurance setups needed for the functioning of AYUSH.
A full list of requirements will be as follows:
- Filled out an application form signed along with rules and regulations followed by the State AYUSH Authority.
- Company Documents: Certificate of Incorporation or GST Registration Drafted Memorandum of Association (MOA) and Articles of Association (AOA) for the entity.
- Premises Documents: Ownership proof or a rental agreement for the place. Layout plan for manufacturing space or retail space.
- Technical Personnel Documents: Qualifications and Experience Certificates of the appointed technical staff, for example, AYUSH specialists or pharmacists.
- Product Information: List of AYUSH products or medicines comprising formulations and labels. Submission of stability test result if applicable.
- Good Manufacturing Practices (GMP): Commitment to comply with Schedule T of the Drugs and Cosmetics Act embracing quality control procedures.
- Identity Proof: Any identification like a PAN card or Aadhaar.
In essence, it is a systematic process for getting an AYUSH license in India, as defined under the Ministry of AYUSH following the Drugs and Cosmetics Act of 1940. The system ensures all quality, safety and regulatory norms for products and operations. It is important to consider that contacting professional consultants will ease the way for applications, as applications get delayed or even rejected due to failures regarding the requirements or documents and periodic updating as per the guidelines by the Ministry of AYUSH.
With such a comprehensive process, businesses are bound to operate legitimately within the AYUSH sector without compromising on the quality of their products or their safety for the consumer. Below is a complete step-by-step guide towards the process of obtaining an AYUSH license:
1. Identify the Type of License
Find out the exact category of AYUSH license which is required for your business:
- Manufacturing License to manufacture AYUSH medicines.
- Loan License to make use of another manufacturer’s facility.
- Retail or Wholesale License for selling AYUSH products.
- Export License for the export of AYUSH products.
- Product Approval for proprietary formulation.
2. Office Setup
Ensure that the office environment will meet hygiene and other infrastructural criteria. For manufacturing sites, Schedule T will have to comply with the established Good Manufacturing Practices of the Drugs and Cosmetics Act. Adequate space should be maintained for storage, production and quality control. Establish necessary facilities and equipment for the testing and manufacturing process.
3. Competent Human Resource
Hire technical personnel who are qualified to handle the manufacturing operations, including AYUSH experts with education qualifications in Ayurveda, Siddha, Unani or Homeopathy. Trained persons in retail and wholesale selling, such as licensed chemists, among others.
4. Documentation
Collect and put together all required documents like GST registration or a certificate of company registration. Evidence of ownership of the property or a lease agreement. A layout plan of the facility. Qualifications and experience certificates for the technical staff. Product formulations, labelling and testing reports. Proof of identity and address of the applicant.
5. Application Submission
The process of submitting applications to the Drug Control Department or the relevant state AYUSH licensing authority includes:
- Filing the relevant application form for the license desired.
- Including all relevant documents.
- Paying for the relevant procedure.
6. Authority Inspection
The licensing authority checks the facility for compliance with GMP regulations, which includes checking whether qualified technical personnel and equipment are available and checking cleanliness and storage conditions.
7. Approval of Product Formulations (if applicable)
For proprietary AYUSH products, the formulation details have to be submitted for approval. The authorities would render the safety, efficacy and conformity assessment of the products against AYUSH standards.
8. Licenses Issued
After the satisfactory inspection and verification, the AYUSH license will be issued. The process may take a few weeks, depending on the state and complexity of the application.
9. Post-license Grant Compliance
The rules and regulations need to be renewed regularly to abide by the continuous post-licensure requirements. There must be a continuous quality check of products, along with adherence to norms related to labelling and advertising.
Conclusion
Having an AYUSH license means it is mandatory for Indian people and companies that manufacture, sell or distribute Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy product-related products. This license only ensures that the norms of the Drugs and Cosmetics Act of 1940 are fully met in enacting the framework by which the AYUSH medicines and products are to be ensured.
The issuance of an AYUSH license puts forward the accountability of the manufacturers and distributors to furnish the consumers with products which are pure and safe for use. Hence, it will play a crucial role in minimising the trade in low-quality or fake products and increasing consumer confidence in traditional medicines. Lastly, the license shall be of immense help in forwarding the globalisation of old Indian medical practices in accordance with the emerging trend for whole-natural treatment.
In fact, a license is issued only on fulfilment of conditions as stipulated under Good Manufacturing Practices (GMP), employment of qualified persons, maintenance of proper clinical documentation and inspections. Then, with adequate support from the state AYUSH, they can start their business and operate entirely smoothly and legally.
In conclusion, the AYUSH license is indeed much more than a regulatory license; it is truly an important breakthrough in the growth and acceptance in the sector of Indian traditional medicine, thereby affiliated with the business practice and the larger society looking for alternative healthcare solutions.
