Home-made or Herbal Medicine Start-up : Legal Compliances

Remember that winter drink your grandmother made, to prevent cold and cough. Or that superfood that your grandfather used to alleviate all his aches and pains. Herbal medicines have been a part of our culture, and our everyday since time immemorial, but can we commercially profit from them on a small scale? In this article we explore the licensing requirements behind manufacture and commercial sale of herbal medicines.

What are Herbal medicines?

The Law does not define Herbal Medicines or Herbal Drugs per se. Section 3(b) of the Drugs and Cosmetics Act, 1940 (DC Act, 1940) defines drug as any substance for internal or external use of humans or animals, intended for medical purposes, or one that may affect the structure or function or human body, among other things, as can be seen below:

1. “all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;]

2. such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of 6 [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;

3. all substances intended for use as components of a drug including empty gelatin capsules; and

4. such devices* intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;”

Additionally, Section 3 (h) of the Act defines “patent or proprietary medicine” as specialised formulae that may be used to treat ailments in all forms of medicine as can be seen below:

1. “in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a);

2. in relation to any other systems of medicine, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorised in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board constituted under section 5;”

REGISTRATIONS

Below is the list of 3 licenses you might need:

1. CENTRAL DRUNG STANDARD CONTROL ORGANISATION

Home-made Herbal Remedies require permissions to be sold commercially. Section 153 of the DC Act, 1940 says that an application shall be made vide Form-24 to the Licensing Authority i.e. the Central Drug Standard Control Organisation (CDSCO) along other relevant documents.

Additionally, Section 33EEB of the Act specifically provides for registration of these remedies with the Ministry of AYUSH.

2. Ministry of AYUSH

Tasked with regulating and promoting Ayurveda, Yoga, Unani Tibb, Siddha and Homoeopathy (AYUSH), the ministry provides licenses for commercial operations around home-made medicines. Such license can be provided under three categories. They are:

1. Complete Manufacturing License: Such a license required for the manufacturing unit to be spread over an area of minimum 1200 sq.ft. and should be situated in an industrial area.

2. Loan License: Under this a manufacturer can finance a loan to the manufacturing unit of a third party to manufacture herbal, ayurvedic etc

3. Contract/Third Party Manufacturing: Wherein a license can be obtained to manufacture medicines in a contracted or a third-party manufacturing premises.

Thus, operations of scale and magnitude falling under any above category shall be required to be registered with Ministry of AYUSH as well.

3. FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA

Apart from the above, in order to commercialise a small-scale operation of Herbal Medicines, you may also be required to obtain an FSSAI license. Depending on if your raw ingredients are enlisted by the FSSAI as such as per the Food and Safety Act, 2006. For the list, please follow link: Click here.

CONCLUSION

In order to commercially manufacture herbal medicines, you require a license from the CDSCO if the product is being marketed as a medicine or a remedy. In addition you also need a license from the Ministry of AYUSH if manufacturing unit falls under any of the three categories as listed by the ministry. In addition, such a venture might also necessitate a license from FSSAI if the raw material used, mandates such compliance. And hence, the licensing requirements for manufacture of Home-made Herbal Medicines.

Reach out to our experts for more information!