Malegra DXT (a combination tablet with sildenafil and duloxetine, manufactured in India by Sunrise Remedies Pvt Ltd), the responsibility for safety testing and regulatory oversight depends on the country where it’s approved and sold. Here’s how it generally works:   Manufacturer (Sunrise Remedies) The pharmaceutical company that makes the drug is responsible for conducting pre‑market safety testing, quality control, and stability studies as part of the drug development process. They must follow good manufacturing practices (GMP) and conduct internal testing to ensure the product meets required standards before it’s sold. safegenericpharmacy.com  National Regulatory Authority (e.g., CDSCO in India) In India, the Central Drugs Standard Control Organization (CDSCO) is the national regulatory body that oversees the approval, safety, and quality of pharmaceutical products under the Drugs and Cosmetics Act. The Drugs Controller General of India (DCGI), who heads CDSCO, is responsible for approving new drugs, clinical trials, and ensuring ongoing safety monitoring of marketed products.