Planning to start Ayurvedic medicine manufacturing? HERE IS A GUIDE FOR YOU

The use of Ayurvedic medicines in medical treatment is an ancient practice. Introduced in the natural life science medical system through Vedic scriptures and Vedas, Ayurvedic medicines are considered as a cure for longevity. Medicines made through ayurvedic science offer a complete system recovery of the natural human body with minimal chances of side effects. Ayurveda also offers treatment options for many long going diseases that require medication for a long duration and patience of the patient.

The use of Ayurvedic medicines is most preferred in Indian culture than modern treatment methods. Among the India folks use of Ayurvedic medicines is well trusted and has a great demand.

It is always advised to buy or consume medicines with prescriptions of professional medical personnel or a registered doctor in practice. Modern medicines with high acidic value or chemical composition rates are prone to ail side effects or long-lasting disease patterns if consumed without proper prescription. The resultant pattern of side effects can also be seen in a consumer of ayurvedic medicines, if no proper prescription is followed or if no proper standards are maintained by producer.

The impact of Ayurvedic medicine can also be disastrous if no proper standards or methods are followed during its production.

To regulate and restrict improper formation & transmission of Ayurvedic medicines in India, the Ministry of Health, Medical, and Family Welfare introduced the AYUSH licensing concept. The Ministry of AYUSH is a regulatory body for all doctors, medical professionals, and all related persons involved in manufacturing, wholesale, retail, or use of Ayurvedic, Unani, Siddha, Naturopathic or Homeopathic Medicines.

Entities all involved in the business of Ayurvedic medicines and natural utilities are required to obtain licenses from the Ministry of AYUSH to formerly initiate their business in the industry.

About Ayurvedic Medicine Manufacturing Business

Ayurvedic Medicine Manufacturing business is World’s oldest manufacturing business which also has it remains in India. In Ayurvedic Medicine manufacturing, extracts of nature (plants, herbs, minerals, metals, animal waste, compost, etc.) with the contrast of some artificial chemicals like mercury, lead or arsenic or in the absolutely pure form are processed and transmitted in different parts of the country for medication purposes. Ayurvedic medicine manufacturing requires expertise and knowledge of medical professionals proficient in disciplines of Ayurveda and medicinal practices.

Ayurvedic Medicines include all drugs and medicines intended for internal and external use for or in the diagnosis, treatment, prevention, mitigation of disease or disorder in human beings or animals. These include all drugs and medicines manufactured in accordance with formulas and prescriptions given in the authoritative books of Ayurvedic, Siddha, or the UNANI system of medicine.

In India, different State authorities issue license and regulatory guidelines to be followed for initiating an Ayurvedic Medicine business. However, some common initials for licensing of medicines and health care products made of Ayurveda have been provided in the Drugs and Cosmetics Act, 1945.

Essentials to Know for Ayurvedic Medicine Manufacturing Business

Regulations and requirements for setting up an Ayurvedic Medicine manufacturing plant can be different as per state requirements. Reference to Rules as applicable on certain category producers of Ayurveda medicines has been provided under Section 151 to 160 of the Drugs and Cosmetics Act, 1945.

While the minimum specifications to hold include:

For manufacturing unit –

  • Landholding or an Industrial establishment in a govt approved industrial area not less than 1300 sqft.
  • Registration of entity.
  • Certification of GMP(Good Manufacturing Practise) and CoPP (Certificate of Pharmaceutical Product) to the Industrial establishment
  • Minimum 2 Ayurvedic practitioners and 2 pharmacists
  • Machinery, Processing and Packaging units
  • Systemized flow of information and accessibility to records or production units for time-bound inspections.

For loan license manufacturer or distributor –

  • A land area or establishment with a minimum of three rooms each for storage of finished, semi-finished goods and one for office.
  • Record Accessibility for regular inspection.
  • Business Registration

Ayurvedic Medicine Manufacturing Business – License and Registrations 

 Licenses and Registrations

 

  Forms 

 

  1.  Application for license to manufacture Ayurvedic (including Siddha) or Unani drugs OR Renewal of Manufacture License
  Form 24-D

 

2.      Ayurveda Loan License (where the applicant has no manufacturing facility and outsource manufacturing work)

 

  Form 25-D

 

3.       Certificate of Good Manufacturing Practises (GMP)

 

4.      Registration for Testing of Raw Material and Medicines used in Manufacturing  Form 47

 

5.      FSSAI License (if dealing in food products or food products involved in production )

 

6.      GST Registration

 

 

Benefits of Initiating Ayurvedic Medicine Manufacturing Business

Opportunities to grow business in the Medicine world are ample. The government with its initiative of “go local” is also fostering entities and consumers to rely on home production than procuring artificially made foreign goods. Some beneficial points to discover in the Ayurvedic Medicine manufacturing business:

  • The Health system in the country and even in all big economies of the World has manifold due to the spread of COVID-19.
  • Medicines made of natural herbs and resources generally have a low risk of side effects and hence more trusted by users.
  • Manufacturing of Ayurvedic medicine can just be initiated by receiving approval from AYUSH Ministry and through state approvals by making payment of only nominal fees (differ state-wise).

How TaxReturnWala.com assist in establishing Ayurvedic Medicine Business?

TaxReturnWala.com is an outgoing venture dealing in all licensing and taxation compliances work on behalf of clients. With including services from small business incorporation to tax filling to brand registration to business structure development to business advisory to legal compliance services, TaxReturnWala provides all required help in giving the business a stable standing.

If you need help in initiating your own Ayurvedic Medicine Business, then our consultants are there to help you at each step.

Email us your queries at info@taxreturnwala.com