Is there any need of Drug License for OTC products supply?

Query:  

I saw your pharma blog website. I have gone through details. I have question. I want to start dealing in OTC Products as a supplier in Hospital. I have GST. I have registered as a proprietor. Some one told me , for OTC Products I don’t need any drug license. May I start dealing in OTC Products on the basis of GST number? Looking forward to hear from you.  

Response:

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
• Cosmetics
• 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 GST is enough.

Hope above information is helpful to you…  
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