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From Startup Specialist
Ayurveda, a natural system of medicine, originated in India more than 3,000 years ago. The term Ayurveda is derived from the Sanskrit words ayur (life) and Veda (science or knowledge). Thus, Ayurveda translates to knowledge of life. Based on the idea that disease is due to an imbalance or stress in a person’s life. Ayurveda treatment starts with an internal purification process, followed by a special diet, herbal remedies, massage therapy, yoga, and meditation, so those who wish to start a business in Ayurvedic/Unani/Siddha, or any similar products must obtain AYUSH LICENSE or AYUSH CERTIFICATE means the authorization that’s given by the government.
TYPES OF AYUSH LICENSE
- The Drugs and Cosmetics Act, 1940 (Amendment 2005)
- Biological Diversity Act, 2002 & Related Regulations
- The Scheduled Tribes and Other Traditional Forest Dwellers (Recognition of Forest Rights) Act 2006
There are various advantages a person can have if they obtain AYUSH License –
- The individual or entity, after obtaining the AYUSH License, can function in any state regardless of the location of the manufacturing company.
- The individual or entity who has applied for the AYUSH License only looks after the marketing part of the product; the rest of all the compliance necessary for the product is being taken care of by the manufacturing company.
- AYUSH License benefits under the Health Insurance Policy as Benefits cover.
- The use of Ayurvedic and herbal medicine is most preferred in Indian culture, and to regulate and restrict the improper use of Ayurvedic medicine, one must get the AYUSH License.
- The government, with its approach of “go local”, is also encouraging entities and consumers to rely on home production, i.e., Ayurvedic and herbal medicines.
- The medicines produced by natural herbs and ayurvedic resources have a low risk of side effects, and the AYUSH license helps in enhancing the trust of the users.
In case you wish to take AYUSH Manufacturing license following is the requirement to be obtained under AYUSH Act:
- The manufacturing unit should be an industrial area.
- The minimum size of 1200 sqft. should be there, for one category of the drug only.
- In case more than one drug is required, and add more categories, you need to add more space.
- The manufacturing unit is mandatorily required to be GMP certified.
- 2 Ayurvedic experts and 2 Pharmacies must form the part of your team.
- All the manufacturing and packaging machinery should be available with you.
- Regular inspection of the premise shall be done by the Drug Inspectors.
- Details of the applicant. (PAN, Aadhar etc.)
- Details of company (MOA or AOA). If applicable.
- Manufacturing License copy as issued by the state government.
- List of products applied for.
- Issuance of Certificate of a Pharmaceutical Product (COPP)
- COPP composition.
- Site Plan Master file.
- Master manufacturing formula and the manufacturing process.
- List of approved products.
- Stability study evaluation batch wise, along with the Date of manufacturing, Date of Expiry, stability study condition, the name of Drug etc
- Process validation report for 3 batches. (Herbal Products)
- Validation report of the analytical method.
- List of technical staff along with their qualification, experience and approval status.
- List of equipment.
- Manufacturing Plant layout.
- Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.
- Any other rules prescribed for a particular product.