Manufacturer of a very popular Menstrual Pain Patch with herbal ingredients wanted to introduce the product in USA. The product had herbal constituents sourced from India. With very strict US FDA requirements for importing and selling medicinal products in USA, the company wanted to have the right regulatory strategy, as the business opportunity was big. The patch manufacturing company approached DDReg for regulatory strategy.

Introducing such single or multi-ingredient herbal formulations without a large body of clinical efficacy and safety data in the US was almost an impossible task. Challenge was to identify products of similar nature available in pharmacies within the US, do thorough research on each. Using the past experience of handling OTC products for the US market, the DDReg team deep dived into formulation details, understood various herbal components and their role. At the same time, another group researched the FDA site as well as CFR to understand the OTC requirements; analyzed the historical situations to identify the basis of grant of OTC status.

With our expert regulatory advisory and strategy, the pain patch could qualify the requirements for the OTC product with minimal administrative requirements complied; the product was good to export to the US.

This was a big upside for the customer organization as it achieved

1) Speed/Rapid access to the US market for the customer.

2) Massive cost benefit – as regulatory strategy did not recommend any clinical or further development studies

3) a template for other similar herbal products for introduction in the US.