Starting an Ayurveda Products Manufacturing Business in Kerala

Ayurvedic medicines, oils and wellness products from Kerala have a strong market in India and abroad. Manufacturing them is regulated under the Drugs and Cosmetics Act, 1940, which requires a licence for every unit that makes Ayurvedic, Siddha or Unani drugs, and good manufacturing practices for the premises and processes.

This article sets out the structure, licences and points that usually apply to an Ayurveda manufacturing business in Kerala.

Choosing the structure

A private limited company or an LLP is usually preferred, since manufacturing involves premises, machinery, staff and often bank finance. Family units sometimes start as partnerships and convert later. See company registration in Kerala and LLP registration in Kerala.

Manufacturing licence

1. A licence to manufacture Ayurvedic, Siddha or Unani drugs is issued by the State Licensing Authority for AYUSH drugs in Kerala.
2. The premises, equipment and processes must meet the Good Manufacturing Practices in Schedule T to the Drugs and Cosmetics Rules.
3. The unit must employ qualified technical staff, as prescribed, to supervise manufacture.
4. Each product is licensed by name and formulation; classical formulations and proprietary medicines have different requirements.
5. Labels must carry the details prescribed by the Rules, including the licence number.

Other registrations

• Local body licence and building approvals for the factory
• Consent from the Kerala State Pollution Control Board
• Fire safety approval, depending on the building
• FSSAI licence for products sold as foods or nutraceuticals, rather than as drugs
• Cosmetic manufacturing licence for products sold as cosmetics
• GST registration; see GST registration
• Import Export Code and export documentation for exports; see registering an exporting company

Brand and product protection

Brand names are valuable in this sector and are often copied. Registering the trademark early, and avoiding names similar to established brands, prevents disputes later. See trademark registration. Claims made in advertising must also stay within the limits of the law on drug advertisements.

Frequently asked questions

Can Ayurvedic products be made under loan licence?

Yes. A brand owner without a factory can arrange manufacture in a licensed unit under a loan licence, subject to the conditions in the Rules.

Is a licence needed for selling Ayurvedic medicines?

Retail and wholesale sale of Ayurvedic medicines is treated differently from allopathic drugs; the current requirements of the State Licensing Authority should be checked for the specific activity.

Can the products be exported?

Yes. Exports need an Import Export Code and documentation such as certificates of free sale or GMP, and must meet the importing country’s rules.

ചുരുക്കം (Summary in Malayalam)

ആയുർവേദ, സിദ്ധ, യൂനാനി മരുന്നുകൾ നിർമ്മിക്കാൻ ഡ്രഗ്സ് ആൻഡ് കോസ്മെറ്റിക്സ് ആക്ട്, 1940 പ്രകാരം കേരളത്തിലെ AYUSH സ്റ്റേറ്റ് ലൈസൻസിംഗ് അതോറിറ്റിയിൽ നിന്ന് നിർമ്മാണ ലൈസൻസ് വേണം. ഫാക്ടറി Schedule T-യിലെ ഗുഡ് മാനുഫാക്ചറിംഗ് പ്രാക്ടീസസ് പാലിക്കണം; യോഗ്യതയുള്ള സാങ്കേതിക ജീവനക്കാർ വേണം. തദ്ദേശ സ്ഥാപനത്തിന്റെ ലൈസൻസ്, മലിനീകരണ നിയന്ത്രണ ബോർഡിന്റെ അനുമതി, GST, കയറ്റുമതിക്ക് IEC എന്നിവയും വേണം. ബ്രാൻഡ് നാമം ട്രേഡ്മാർക്കായി രജിസ്റ്റർ ചെയ്യുന്നത് പ്രധാനമാണ്.

This article gives a general overview of licensing for Ayurvedic manufacturing. The Drugs and Cosmetics Rules and their schedules are revised from time to time; for accurate and current requirements, check with the State Licensing Authority for AYUSH drugs, Kerala. The article is not advice on any particular case.