The Indian healing systems of Ayurveda, Yoga, Unani, Siddha, and Homeopathy have been gaining popularity worldwide due to their holistic approach to health and wellness. However, anyone looking to manufacture or trade in these products in India must obtain an AYUSH license issued by the Ministry of AYUSH. This license ensures compliance with the necessary regulations and guidelines to provide trust and safety to users. In this article, we will delve into the different types of AYUSH licenses available and their benefits, as well as the process of obtaining them.
I. Introduction to Ayush License in India
Definition and purpose of Ayush License ;
Anush License is a legal document that is required for operating a business dealing with Ayurveda, Yoga, Unani, Siddha, and Homeopathy (AYUSH) products. It is granted by the Ministry of Ayurveda, Yoga, Naturopathy, Homoeopathy, and Unani (AYUSH). The purpose of the license is to regulate the manufacturing, distribution, and sale of AYUSH products to ensure that they are safe and effective for public use. Obtaining an Ayush License is a lengthy process that involves the submission of several documents and compliance with specific requirements. The license is necessary for entities that wish to market and distribute Ayurvedic or other traditional medicines. By acquiring an Ayush License, businesses can operate across multiple states and benefit from increased consumer trust and Health Insurance Policy coverage. The license also ensures that the business follows regulatory compliance, resulting in a reduction in the misuse of Ayurvedic products.
A brief history of the Ministry of Ayush :
The Ministry of Ayush has an interesting history dating back to 1995 when it was first established as the Department of Indian Systems of Medicine and Homeopathy (ISM&H). It was initially created to improve traditional systems of Indian medicine and promote better healthcare access in rural areas. Throughout the years, several committees and five-year plans lent considerable emphasis on the mainstreaming of Ayush. Eventually, the ministry assumed the name Ayush in 2003. The National Rural Health Mission placed mainstreaming of Ayush as one of its priorities. Upon the administration of Narendra Modi in 2014, the Ministry of Ayush was elevated to a standing ministry. The ministry budget for Ayush increased significantly and has since developed various healthcare programs with the primary aim of serving the rural population. With the growth of Ayurvedic medicine manufacturing units in India, the demand for Ayurvedic medicine is expected to rise even more.
II. Importance of Ayush License
Requirements for starting a drug or cosmetic business in India :
To start a drug or cosmetic business in India certain requirements needed to be met. First and foremost, it is crucial to obtain an applicable license for the specific type of business you intend to run. The Ministry of AYUSH provides licenses for those involved in the manufacturing and trade of Ayurvedic, Yoga, Unani, Siddha, and Homeopathy products. In addition to obtaining a license, the manufacturing unit needs to be in an industrial area that meets the minimum size requirements of 1200 sqft for producing one drug. It is also necessary to have access to all the required manufacturing and packaging machinery and be certified by GMP. Additionally, two Ayurvedic experts and two pharmacies need to be onboard. The drug inspector oversees regular inspections of the manufacturing unit. Finally, it is essential to ensurcompliancees with the AYUSH Act and maintain regular records and SOPs. Meeting these requirements will facilitate the smooth operation of the drug or cosmetic business in India.The necessity of obtaining a license from the Ministry of Ayush :
If’re planning to start a business that deals with herbal or Ayurvedic products in India, you need to obtain a license from the Ministry of Ayush. It is mandatory to have an Ayush license before launching a product in the market. The ministry, formed on 9th November 2014, manages the regulation of Ayush in India. The license ensures that the product you are selling is safe and reliable. Moreover, it helps to protect the customers from counterfeit or substandard products, providing them with quality herbal healthcare products. The manufacturing facility must comply with state government regulations and meet the minimum size of manufacturing land of at least 1200 square feet. The availability of certified Ayurvedic experts and the presence of manufacturing and packaging machinery are also important factors. The license issuance is followed by regular inspections by drug inspectors, and yearly compliance is required. To ensure smooth licensing processes, it is recommended to comply with AYUSH Act, maintain records of rejected recovered reprocessed and reworked materials, and standard operating procedures (SOPs), and obtain a WHO GMP certificate for the standard mark. Overall, an Ayush license is a crucial element and a legal requirement for starting a drug or cosmetic business in India.
IV. Requirements for Obtaining Ayush Manufacturing License
Minimum size of manufacturing land :
In to obtain an AYUSH manufacturing license certain requirements need to be fulfilled. One of the most important requirements is related to the minimum size of manufacturing land. For producing a single drug, the minimum size of the manufacturing land should be 1200 sqft. However, if you plan to manufacture more than one drug, then you would need more space manufacturing unit must be located in an industrial area and certified by GMP. Additionally, you need to have two certified Ayurvedic experts and two pharmacies on board. It’s also important to have all the required machinery for manufacturing and packaging. Regular inspections of your manufacturing unit will be conducted by the drug inspector. Compliance with the AYUSH Act is necessary to get the AYUSH license. You also need to fulfill other requirements specified by the State Authority of AYUSH. The minimum size of manufacturing land is important to ensure a suitable atmosphere for the proper production of AYUSH medicines.
Compliance with AYUSH Act :
Com with the AYUSH Act is crucial when it comes to obtaining an Ayush License in India. The AYUSH Act was established to regulate the manufacturing, sale, and distribution of Ayurvedic, Unani, Siddha, and Homeopathy medicine to comply with the AYUSH Act, certain requirements must be met such as having a minimum size of manufacturing land, being certified by the GMP, having certified Ayurvedic experts, having nd access to all manufacturing and packaging machinery. It is also compulsory to have standard operating procedures and maintain records of rejected, recovered, reprocessed, and reworked materials. Moreover, regular inspections by a drug inspector should be conducted to ensure compliance. By complying with the AYUSH Act, you can ensure that your business is operatinbyth the regulations and standards set by the Ministry of AYUSH. This will enhance the trust of your consumers, and in turn, increase the demand for your products.
Availability of manufacturing and packaging machinery :
When comes to obtaining an Ayush License in India, one crucial aspect to consider is the availability of manufacturing and packaging machinery. Manufacturing and packaging are the key components of the Ayush industry, and the right machinery is needed to ensure the production of high-quality products that meet all the regulatory requirements. The Ministry of Ayush has set specific criteria for the machinery to be used in the manufacturing process, and businesses must ensure compliance with these guidelines to obtain the necessary licenses. The manufacturing unit must have access to all the required machinery, including equipment for extraction, distillation, pulverization, and granulation. Additionally, the packaging machinery must be of high quality to ensure that the products are packaged safely and accurately. Companies must also ensure that their machinery is correctly calibrated and maintained to ensure the quality of their products. By following the guidelines set by the Ministry of Ayush, companies can ensure that they have access to the appropriate machinery for manufacturing and packaging their Ayurvedic products effectively and safely.
Presence of certified Ayurvedic experts :
Manufacturing Ayurvedic or Herbal products in India requires obtaining an Ayush License from the Ministry of AYUSH. To acquire this license the manufacturer must have certified Ayurvedic experts present in their manufacturing process. The Ayurvedic experts must possess knowledge of the Science of Life and its principles of Ayurveda, as well as have comprehensive knowledge of the herbs used in the manufacturing process. They must also be well-versed in the preparation methods of Ayurvedic medicines, including their dosage and usage. Without the presence of certified Ayurvedic experts, the manufacturing process may not be compliant with the AYUSH Act, which has strict regulations for manufacturing Ayurvedic medicines. Furthermore, regular inspections by drug inspectors ensure that the manufacturing process follows the required standards and minimum size of manufacturing land is met. Overall, the presence of certified Ayurvedic experts is a fundamental requirement for obtaining the Ayush License and complying with the AYUSH Act.
Regular inspections by drug inspector :
Regular inspections are an important aspect of obtaining an AYUSH License in India. The drug inspector appointed by the Ministry of AYUSH conducts regular inspections of the manufacturing units to ensure compliance with the AYUSH Act and GMP standards. These inspections serve as a means of monitoring the quality of products being manufactured and ensuring that they meet the necessary standards. The drug inspector checks for adherence to regulations, quality control measures, record keeping, and the use of certified machinery. Any deviations or non-compliance can result in penalties or suspension of the license. Manufacturers must be aware of the inspection schedules and be prepared for them in advance. Maintaining accurate records, strict adherence to SOPs, and following GMP standards are essential for successfully passing inspections. The inspections are essential in ensuring that the products manufactured are of high quality and free from any harmful substances. Regular inspections conducted by the drug inspector promote public health and safety and are an important factor in obtaining and maintaining an AYUSH License.
V. Process of Obtaining Ayush License
Requirements for application file :
To apply for an AYUSH License in India, individuals or entities must gather all the necessary details and documents. The AYUSH License Application Form must be submitted, with the necessary certifications and approvals, before being sent to the Ministry of AYUSH. The application file must contain documents such as the manufacturing unit’s blueprint, fire safety certificate, and proof of GMP certification. Other necessary documents include a list of product details, a list of machinery, and a list of medicines that the unit will manufacture. The applicant must also specify the type of AYUSH License he/she requires, as per the requirement. The application must also ensure that it complies with AYUSH Act requirements and guidelines. The application process requires liaison with the department and regular inspections by the drug inspector. The application may require additional information or inspections before the license is issued. The renewal process is as simple as the application process after that, with yearly compliance necessary if applicable. Obtaining an AYUSH License requires careful planning and compliance with all the necessary regulations for the manufacturing and marketing of Ayurvedic/Unani/Siddha or any similar products.
Inspection by department (if required) :
After submitting the application file for the Ayush License, the department’s inspection is required. It is essential to ensure compliance with all thy requirements for obtaining the license. The inspection is conducted by the drug inspector to evaluate the quality and safety of the manufacturing process. The inspector checks the manufacturing facility, machinery, the presence of certified Ayurvedic experts, and adherence to the SOPs. All the records of raw materials, finished products, and rejected materials are verified. The inspector also checks the availability of the WHO GMP certificate and Standard Mark. In case of any shortcomings or discrepancies, the manufacturer is given a chance to rectify and comply with the regulations. It is crucial to maintain transparency and honesty during the inspection to avoid any legal issues. A successful inspection ensures the issuance of the Ayush License, which is necessary for running a legitimate Ayurvedic medicine business in India.
Liaison with the department :
After the application file for an Ayush License, the liaison between the applicant and the department becomes crucial. The additional documents or information requested by the department should be provided to prevent delays in the process. During the process, approach the department politely and keep communication lines open. If the applicant has any queries or doubts, contact the liaison officer for clarification. The department will conduct routine inspections of the applicant’s manufacturing facility. During the inspection, the applicant should ensure that all records are in order and the facility complies with AYUSH Act regulations. Keep the department informed if any changes occur in the manufacturing process or changes in the management structure of the business. Additionally, a good working relationship with the department can make the renewal process smoother. Keep in mind that non-compliance with regulations can lead to revocation of the license. To avoid issues, applicants should maintain good communication with the department while following the required guidelines.
License issuance :
Obtaining a license from the Ministry of AYUSH is essential for individuals and entities looking to start a business in manufacturing Ayurvedic medicines or cosmetics in India. The license application process involves the s preparation of documents, inspection by the department if required, and liaison with the department. Once the license is issued, yearly compliance may be required depending on the situation, with renewal being necessary when due. The Ministry of AYUSH is responsible for issuing the license, and individuals or entities producing Ayurvedic, herbal, drug, or cosmetic products are eligible to obtain it. The license is necessary to comply with the Drug & Cosmetic Act t 1940 which covers all forms of drug businesses. Personal hygiene records, FDA licenscopiespy, quality controrecordsrd, finished producrecordsrd, and batch processing records are some of the essential documents that need to be submitted for the license application process. Compliance with AYUSH Act is essential, and regular inspections by drug inspectors are carried out to ensure compliance with manufacturing and packaging machinery, certified Ayurvedic experts, and the minimum size of manufacturing land requirements.
VI. Yearly compliance (if applicable)
After obtaining an AYUSH license, the license holder must adhere to the regulatory requirements of the Ministry of AYUSH every year if applicable. This compliance is essential to maintain the standard of the products manufactured and ensure the safety of the consumers. The yearly compliance involves submitting reports and maintaining records of the product’s quality control, purchase of materials, packaging labeling, and stability studies. The quality control records should include rejected materials anthe d recovery process. It’s also crucial to maintain the record of recalled and reference products, alongside other standards that must be adhered to under the AYUSH Act. Failure to maintain this annual compliance may lead to revocation of the license and legal issues. Therefore, it’s vital to comply with the Ministry of AYUSH regulatory requirements yearly to ensure the business remains valid and the products remain safe for consumers.
VII. Renewal process
Renewing an AYUSH license is vital for those who wish to continue manufacturing or dealing with Ayurvedic, Yoga, Unani, Siddha, and Homeopathy-related productsThe renewal process of the f AYUSH license in India is straightforward and must be initiated before the expiry of the current license. Moreover, the renewal process involves the submission of certain documents assessee.
Here are the steps to renew the AYUSH license in India:
1. First and foremost, initiate the renewal process by applying along with the required documents and the fee.
2. Once the application is submitted, an inspection of the manufacturing premises is carried out by the department to ensure compliance with the AYAct act.
3. After the inspection, if there are no discrepancies, the license is renewed for a further period of one or two years, depending on the type of license.
4. The renewed license is delivered by post to the registered address of the applicant.
It is essential to keep in mind that the renewal process of the f AYUSH license must be initiated before the current license expiry to avoid any possible legal implications. Failure to renew the license might lead to strict penalties.
VIII. Documents required for AYUSH License in India
The documents required for obtaining an AYUSH License in India vary depending on the type of license. However, the following documents are commonly required:
1. Identity proof
2. Address proof
3. Educational qualification certificates
4. Registration certificates from the respective AYUSH council
5. Affidavits stating no convictions or criminal records
6. Proof of ownership or lease agreement of the premises where the practice is proposed
7. Drug license
8. GST registration certificate
9. Medical certificates for the practitioner and staff members
10. NOC from the local municipal corporation.
IX. Advantages of AYUISH License in India
1. Greater recognition and credibility: Obtaining an AYUSH license is a significant achievement, and it elevates the professional status of the practitioner. It adds credibility to the system of AYUSH medicine, which is often dismissed as quackery by skeptics.
2. Increased scope of practice: With an AYUSH license, practitioners can expand their scope of practice since it encompasses various medical systems like Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy.
3. Growing demand: AYUSH medicine is gaining popularity worldwide, and the demand for qualified practitioners is increasing, which makes it a lucrative field to be in.
4. Access to government schemes and subsidies: AYUSH practitioners with a valid license can avail themselves of various government schemes and subsidies designed for AYUSH practitioners, which could potentially reduce their operating costs.
X. Disadvantages of AYUSH LIceense in India
1. Stringent regulatory framework: Obtaining an AYUSH license in India requires the individual to fulfill various criteria and comply with a strict regulatory framework, which can be overwhelming for some.
2. Limited scientific evidence: There is limited scientific evidence to support the efficacy of AYUSH medicine, and it is often criticized as being pseudoscientific.
3. Limited acceptance: Despite the growing demand for AYUSH practitioners, the system is yet to gain widespread acceptance and recognition in India and globally.
XI. Process getting AYUSH License in India
The process of obtaining an AYUSH License in India involves the following steps:
1. Choose the type of license: Depending on the medical system you wish to practice, you need to select the type of license.
2. Check the eligibility criteria: Ensure you meet the educational and professional qualification requirements set by the respective AYUSH council.
3. Prepare the required documents: Gather all the necessary documents mentioned in the application form.
4. Submit the application form: Submit the application form, along with the necessary documents, to the respective AYUSH council.
5. Wait for verification and approval: The AYUSH council will verify your application and documents, and if everything is in order, grant you the license.
XII. Types of AYUSH Licenses in India
The various types of AYUSH licenses in India are:
1. Ayurvedic Practitioner License
2. Yoga Instructor License
3. Naturopathy Practitioner License
4. Unani Practitioner License
5. Siddha Practitioner License
6. Homeopathy Practitioner License
7. Ayush Drug License
XIII. Frequently Asked Questions about AYUSH License in India
1. What is an AYUSH License?
Answer: An AYUSH license is a certificate issued by the respective AYUSH council that authorizes the practice of various medical systems like Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy.
2. How do I obtain an AYUSH License?
Answer: To obtain an AYUSH license, you need to fulfill the eligibility criteria set by the respective AYUSH council, submit the required documents, and await verification and approval.
3. What are the benefits of an AYUSH License?
Answer: The benefits of an AYUSH license include greater recognition, increased scope of practice, growing demand, and access to government schemes and subsidies.
4. What are the disadvantages of an AYUSH License?
Answer: The disadvantages of an AYUSH license include a stringent regulatory framework, limited scientific evidence, and limited acceptance of the system in India and globally.