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Penalty for Unauthorized Sale of Medications without a License Obtaining a drug license in India is straightforward but can be lengthy. Starting a pharmaceutical business requires strict adherence to the drug license process, which is the first step in obtaining permission from the relevant state authority to commence a pharmaceutical business and conduct activities within […]

Cosmetics Labeling Requirements for Import Registration Under Rule 21 of the Drugs and Cosmetics Act of India, stringent guidelines are established for overseas brands and importers concerning cosmetic labeling and packaging. Compliance involves submitting approved format labels or regulatory artworks to CDSCO as part of the application process for approval. This ensures adherence to regulatory

Decentralized Clinical Trials (DCTs), also known as virtual or remote clinical trials, are a modern approach to conducting clinical research that leverages digital technologies and remote processes to increase patient convenience, enhance data collection, and improve trial efficiency. In traditional clinical trials, participants are typically required to visit a physical study site for various activities,

Required Documents For Wholesale Drug License   Drug License  To start the wholesale Pharma business, a drug license is required. State Licensing Authority (SLA)  issue the drug license in India. Normally, the State Licensing Authority issues two types of Drug licenses – one is a Retail drug license which is issued to a person who runs

The Food Safety Standard and Authority of India (FSSAI) is India’s regulatory body regulating the rules and regulations of food business in India. The main objective of FSSAI is to regulate the food business from production, manufacturing, packaging, storing, transportation, to marketing and advertising. Food business owners must comply with FSSAI rules and regulations to

Summary about SUGAM Portal: What is SUGAM Portal? As digitization of Indian initiatives is on the rise, the CDSCO has also joined in this movement and launched an online e-Governance portal called SUGAM. The purpose of SUGAM is to facilitate drug licensing processes such as permissions, approvals, application tracking, registration certificate etc. SUGAM has a

Summary Of Proprietary Foods Food Safety and Standards Authority of India (FSSAI) defines Proprietary food as an article of food which are not standardized under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 regulations. Proprietary food shall contain only those ingredients other than additives which are either standardized or permitted

FSSAI Compliance Requirements – Summary: The Food Safety and Standards Act, 2006 has laid down certain provisions and consequences of FSSAI Compliance Requirements. It is essential as it not only ensures consumer safety but also enables the Authorities to oversee any misleading or compromises happening in the Food Business. In case the, Food Business Operators

About IVD Labeling Compliance Or In Vitro Diagnostic Device Labeling Requirements – Central Drug and Standard Control Organization (CDSCO) is the regulatory body of India that works under the control of the Ministry of Health and Family Welfare (MoHFW). CDSCO follows the Drug and Cosmetic Act 1940 and Rules 1945, along with Medical Device Regulation