FDA

Biotechnological products have transformed modern medicine by providing targeted and innovative therapies, including recombinant proteins, monoclonal antibodies, gene therapies, and vaccines, forming the foundation of precision medicine. However, their biological complexity and structural variability necessitate stringent regulatory oversight to ensure safety, efficacy, and quality. This study presents a comparative analysis of regulatory frameworks governing biotechnological products in India and the United States. In India, the Central Drugs Standard Control Organization (CDSCO) serves as the apex regulatory authority, implementing guidelines under the Drugs and Cosmetics Act of 1940. It mandates rigorous preclinical evaluations, phased clinical trials, adherence to Good Manufacturing Practices (GMP), and robust post-marketing surveillance to ensure product safety and therapeutic benefit. Conversely, the United States Food and Drug Administration (US FDA) regulates biotechnological products under the Public Health Service (PHS) Act and the Food, Drug, and Cosmetic (FD&C) Act. A distinctive feature of the US system is the Biologics License Application (BLA), which requires extensive clinical trials, comprehensive pharmacovigilance, and stringent GMP compliance, reflecting a strong emphasis on scientific validation and patient safety. The comparative analysis highlights key differences in approval timelines, regulatory pathways, clinical data requirements, and pharmacovigilance mechanisms. While CDSCO focuses on accessibility and affordability within India, the US FDA prioritizes exhaustive scientific evaluation and global standardization. Understanding these regulatory nuances is essential for pharmaceutical companies to streamline product development, ensure compliance, and foster public trust. This study underscores the need for harmonization and mutual recognition of standards to accelerate global patient access to life-saving biotechnological therapies.

Paediatric oncology requires regulatory approaches that balance timely access with child-specific safety. This abstract equates the laws and rules for medicines used to treat childhood cancers in the India and United states. It reviews the regulations created by the Food and Drug Administration (FDA) in the US and the Central Drugs Standard Control Organization (CDSCO) in India focusing on trial design, approval pathways, incentives, ethics, and post-marketing safety. Paediatric oncology is a medical field that deals with diagnosing and treating cancers in children, from babies to teenagers. Children's medicine is different from adult medicine in various ways, such as how medicines are administrated, how metabolism takes place in children body and the way the body functions.  Many medicines given to children are made for adults, so the doses need to be changed to be safe for them. The USA demonstrates structured paediatric mandates (PREA, BPCA, RACE Act) and robust post-marketing mechanisms, while India operates through NDCTR 2019 and ethics-based oversight with fewer formal incentives. Differences exist in trial networks, orphan incentives, and pharmacovigilance capacity.  The article looks at the current state of laws for children's medicines worldwide to show important efforts, difficulties, and progress in this area. These regulations require that medicines are drugged properly for a child's age, tested well in clinical trials, and labelled clearly to avoid misuse. Harmonization, strengthened paediatric trial infrastructure, and targeted incentives in India could accelerate paediatric oncology drug availability while maintaining safety. Cross-border collaboration is recommended. Keywords; Regulatory requirements, Paediatric Oncology, CDSCO, FDA, Pharmacovigilance

With India and the United States having the highest rates of the disease, diabetes mellitus is becoming a global public health concern. In India, which is expected to have the world's biggest diabetic population (more than 101 million by 2023), accessibility and price are major concerns. A significant component of the antidiabetic medication market, which is projected to reach a valuation of USD 1.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 3.5% to reach USD 2.01 billion by 2029[1]. The primary treatment for Type 2 Diabetes (T2DM) is still metformin, which is augmented by sulfonylureas, DPP-4 inhibitors, and more recently, SGLT2 inhibitors. With new limitations on illogical fixed-dose combinations, regulatory bodies such as the CDSCO are actively trying to guarantee the safety and effectiveness of pharmaceuticals [2]. Diabetes is a chronic, metabolic disease characterized by elevated blood glucose levels or hyperglycaemia, which results from abnormalities in either insulin secretion or insulin action, or both. According to the report from CDC’s National Diabetes Statistics Report, there are about 37.3 million cases of diabetes in the US which is 11.3% of the US population. The kind of drug most frequently used to treat type 1 diabetes Insulin. Insulin, alpha-glucosidase inhibitors, biguanides, dopamine-2 agonists, DPP-4 inhibitors, GLP-1 receptor agonists, meglitinides and SGLT2 inhibitors, sulfonylureas, thiazolidinediones, and other drugs are commonly used orally to treat type 2 diabetes [3]. Keywords: Antidiabetics, Diabetes Mellitus, Regulatory Bodies, CDSCO, FDA, United States

Abuse, misuse and diversion of drug substance are one of the most growing problems of United States and all over the world. The most critical challenge in combating the problem of drug abuse is to balance the control of prescription drugs along with continued access for legitimate use. To overcome the increasing problem of drug abuse, development of abuse deterrent formulation can prove an effective tool. This review provides an overview of abuse, modes of abuse, drugs with abuse potential, and different approaches for development of abuse deterrent formulations. Due to high mortality and morbidity, Opioids are the drug of choice for development abuse deterrent formulation. Hence draft guidance of US F.D.A. (US Food and Drug administration) for evaluation and labeling of abuse deterrent Opioid formulations are also under the scope of this review.