Drug license is not required for those OTC products which don’t come under medicines/drugs/healthcare/pharma products. If a OTC products is manufactured under pharmaceutical product then you will require to have drug license to supply these preparations.
One of the main thing to identify whether it is pharmaceutical preparation or not. A pharmaceutical preparation composition section always contains I.P., B.P., U.S.P. just after active ingredient. This is most common identity of pharmaceutical preparation even it is not a prescription product (Rx).
Commonly used Over the counter (OTC) products in pharmaceutical sector are:
- Non prescription Pharmaceutical Preparations
- Food and Dietary Supplements
- Ayurvedic Preparations
For pharmaceutical products, you need drug license. For food and dietary supplements, you required FSSAI registration. For Cosmetic and ayurvedic preparations, no drug license is required, only TIN is enough.
Hope above information is helpful to you…