REGULATORY REQUIREMENTS OF OVER THE COUNTER (OTC)DRUGS IN INDIA AS PER CDSCO IN COMPARISION WITH UNITED STATES OF AMERICA

Ashok Kumar P.*, Divyashree, Manasa Shetty, Renuka V., Sudeep Gowda K. and Yashaswini

ABSTRACT

The article outlines the principal distinctions in the regulatory regimes in the US and India for the production,
importation, and export of over-the-counter (OTC) drugs. The Drugs and Cosmetics Act of 1940 governs OTC
drug regulation in India, and the Central Drugs Standard Control Organization (CDSCO) is in charge of its
enforcement. Regulating, however, is not always followed, especially in rural areas. On the other hand, the FDA in
the United States has a strong regulatory framework that consists of production standards, import limitations, and
severe export laws. Safe over-the-counter medications can be approved by the FDA more quickly thanks to the
monograph system, but innovative formulations must pass stringent testing before being approved as NDAs. The
study also examines post-market surveillance systems. The FDA actively monitors adverse drug reactions to ensure
ongoing safety, whereas India's post-market surveillance is hindered by resource limitations. Ultimately, the
comparative analysis emphasizes the need for India to enhance its enforcement mechanisms and establish clearer
regulations, particularly in manufacturing and rural distribution. By aligning more closely with U.S. standards,
India can improve the safety and efficacy of OTC medications, thereby enhancing public health outcomes and
ensuring higher quality within the pharmaceutical sector.

Keywords: OTC Drugs, CDSCO, FDA, Regulatory framework.