regulatoryaffairs

Punishment for Selling Medicines Without a Drug License

Punishment for Selling Medicines Without a Drug License

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 […]

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Cosmetics Labeling Requirements

Cosmetics Labeling Requirements / Labeling Requirements For Cosmetics In India

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

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Biological Registration Certificate

Biological Registration Certificate: Unveiling the Essential Need

What is the Need of Biological Registration Certificate? In a world dominated by innovation and scientific breakthroughs, the need for a Biological Registration Certificate has become paramount. This article delves into the intricacies of why this certification is more than just a regulatory requirement—it’s a crucial aspect of ensuring safety, quality, and accountability in the

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Navigating Non-Specified Food And Food Ingredients / Products: A brief overview

Summary – In the dynamic landscape of the food industry, securing FSSAI approval for non-specified food products and ingredients is paramount. CliniExperts, a seasoned team with a proven track record, stands ready to guide you through the seamless process of obtaining licenses through Form I and Form II. Explore the tailored assistance offered by our

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CPCB Alert EPR Compliance - Submit Your Annual Report on Time!

CPCB Alert : EPR Compliance – Submit Your Annual Report on Time!

On the 20th of November 2023, the Central Pollution Control Board (CPCB) issued a directive alert, extending the deadline for filing the Annual Report for FY 2022-23 on the Centralised Extended Producers Responsibility (EPR) Portal for Plastic Packaging. The new deadline for compliance is set on or before the 30th of November 2023. Understanding Plastic

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CDSCO Registration for Obstetrical and Gynaecological Medical Devices

CDSCO Registration for Obstetrical and Gynaecological Medical Devices

Introduction Obstetrics and Gynaecology, often referred to as OB-GYN, encompass medical care related to pregnancy, childbirth, and female reproductive health. The regulatory framework in India for medical devices in this field is overseen by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act of 1940. This article outlines the CDSCO registration

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BIS Certification for Fortified Rice Kernels

Unveiling the Power of BIS Certification: Fortified Rice Kernels and Your Health

In a world grappling with the relentless challenge of malnutrition, a beacon of hope emerges through the fortification of staple foods. Rice, a global dietary cornerstone, takes center stage in this nutritional revolution. Countries like India are championing the cause by implementing robust certification standards, such as the Bureau of Indian Standards (BIS) certification, to

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medical device classification in india

Classification of Medical Devices: Decoding CDSCO’s Medical Device Classification in India

Unraveling the Medical Device Classification Let’s dive into the intricacies of CDSCO medical device classification in India. The Central Government set the stage in 2017 with a set of rules outlining different classes for these devices. However, the clarity on which device fits where was as clear as mud. The term ‘Class’ became a crucial

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Rise of Decentralized Clinical Trials (DCTs) in India

The Rise of Decentralized Clinical Trials (DCTs) in India – DCT Opportunities and Challenges

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,

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Documents For Wholesale Drug License

Mandatory Documents For Wholesale Drug License | Necessary Documents For Wholesale License

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

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