Abstract

GUIDELINES ON FIXED DOSAGE COMBINATIONS (FDCS): A REVIEW

Hardik Kumar, Ranveer Singh, Sukhbir Singh Gill* and Pooja Luna

ABSTRACT

Combination products, also known as fixed dose drug combinations (FDCs), are a combination of two or more active pharmacological components. In the US, the Food and Drug Administration defines a "product" as "any combination of a drug and a tool or a biological product." Regulatory Bodies, such as CDSCO, have laid down various rules and regulations on FDCs and classify them into four different types based on their origin status. The US FDA has also enforces stringent regulations under 21CFR, which include pre-market, post market and jurisdictional data to protect public health and provide best medicine.

Keywords: Generic drugs, Pharmaceutical Industry, Regulatory, Guidelines, Fixed Dose Combinations, CDSCO, FDA Guidelines on FDCs.