Expert Articles
Biologicals |
Clinical Trials
CDSCO Guidelines for Biological Clinical Trials in India (NDCT Rules 2019) define a structured regulatory pathway for evaluating biologics through phased human studies. The framework ensures safety, quality, and efficacy through strict documentation, ethical approval, GCP compliance, and scientific review. It supports safe development of vaccines, gene therapies, and other biologics before market authorization in
Medical Devices
WPC Import License for Wireless Devices in India
WPC import license India is a mandatory regulatory approval required for importing wireless and radio-frequency-enabled devices into the Indian market under the WPC framework. Understanding WPC Compliance in India The Wireless Planning and Coordination Wing (WPC) operates under the Department of Telecommunications in India. It regulates wireless communication equipment and radio frequency usage. Manufacturers and
Drug
Investigational New Drug (IND) Application in India: Requirements & Proces
The Investigational New Drug application process in India is a structured regulatory framework that enables safe initiation of human clinical trials. It requires submission of preclinical and supporting scientific data for a detailed review by authorities. The evaluation focuses on safety, quality, and ethical compliance under the Second Schedule of New Drugs and Clinical Trial
Drug
Subsequent New Drug (SND): Regulatory Pathway & Clinical Trial Requirements
A subsequent New Drug (SND) refers to an approved Drug that is modified and requires fresh regulatory approval before marketing. The process includes defined application cases, detailed evaluation, and sometimes clinical trial support. Regulatory authorities check safety, quality, and effectiveness at each step. Clinical trial guidelines ensure ethical conduct and reliable data generation, helping to