Drug Regulatory Affairs (DRA)

Introduction The regulatory climate in India has an important part to play in the quality, safety, and efficacy of goods and services within a variety of industries like cosmetics, food, pharmaceuticals, medical devices, and chemicals. Governed by various agencies such as Central Drugs Standard Control Organization (CDSCO), Food Safety and Standards Authority of India (FSSAI), […]

Introduction Regulatory affairs plays a pivotal role in industries such as pharmaceuticals, biotechnology, medical devices, cosmetics, and food and beverages. Professionals in this field ensure companies comply with national and international laws, regulations, and guidelines. They work closely with regulatory agencies like the FDA (USA), EMA (Europe), or CDSCO (India), handling everything from product approvals

Introduction Digital health products encompass a wide range of technology-driven solutions designed to enhance healthcare delivery, patient monitoring, and medical decision-making. These include mobile health apps for remote patient tracking, wearable health devices for fitness and chronic disease management, telemedicine platforms for virtual consultations, and AI-powered diagnostic tools that assist in early disease detection. The rapid advancement

Introduction to CDSCO Overview of the Central Drugs Standard Control Organization (CDSCO) The Central Drugs Standard Control Organization (CDSCO) is India’s apex drug regulatory authority operating under the Ministry of Health and Family Welfare. As the national regulatory body for pharmaceuticals and medical devices in India, CDSCO is responsible for approving new drugs, regulating clinical trials,

Introduction The drug discovery and development process is a complex and multi-stage journey that involves the identification of new potential therapeutic targets, the screening of compounds, preclinical testing, and extensive clinical trials before approval for public use. The process begins with basic research, where scientists identify molecular targets that may be responsible for diseases. After

Introduction The pharmaceutical industry is essential for global healthcare, yet its environmental impact has become a growing concern. From energy-intensive manufacturing processes to the disposal of pharmaceutical waste, drug development can contribute to pollution, water contamination, and high carbon emissions. In response, sustainability and green chemistry are emerging as transformative approaches to reduce the environmental footprint of

Introduction Drug Regulatory Affairs (DRA) plays a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products that reach consumers. As the global pharmaceutical industry continues to evolve, the field of DRA is experiencing significant transformations. With increasing complexities in drug development, regulatory requirements, and the impact of emerging technologies, DRA professionals must