Preparing for CDSCO Inspection: Documentation, Site Readiness, and Common Reasons for Delay
A CDSCO inspection is one of the most consequential events in a Medical Device company’s regulatory journey in India. Whether you are a manufacturer or Importer, demonstrating compliance with the Medical Devices Rules (MDR), 2017 is essential for obtaining and maintaining regulatory approvals. For manufacturing license applicants, a successful inspection […]
Read MoreCommon Reasons for CDSCO Drug Import Application Rejections
CDSCO Drug Import applications are often rejected due to documentation errors, non-compliance, incorrect product classification, and delayed responses. Understanding these issues can improve approval of success and ensure smooth Regulatory Compliance. The increasing demand for Imported Pharmaceutical products has made Regulatory Approval a critical requirement. However, CDSCO Application Rejection remains […]
Read MoreISO 13485 for Indian Medical Device Manufacturers: What It Means for CDSCO Compliance
ISO 13485 is the internationally recognised standard for Quality Management Systems (QMS) in the Medical Device industry. For Indian manufacturers, it has become not just a global best-practice credential but an increasingly important element of CDSCO compliance under India’s Medical Devices Rules, 2017 (MDR 2017). Despite this, many manufacturers — […]
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Cosmetic Labelling in India: CDSCO, , and Legal Metrology — Three Bodies, One Label
Three Regulatory Bodies, One Physical Label A Cosmetic label entering India is reviewed — directly or through market surveillance — against the requirements of three separate regulatory frameworks: CDSCO’s Cosmetics Rules 2020 (governing Cosmetic-specific content and claims), BIS (informing ingredient and specification details), and the Legal Metrology (Packaged Commodities) Rules […]
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Form 10 vs Form 10A: Understanding Drug Import Licenses in India
Learn the difference between Form 10 Drug Import License and Form 10A License, their application process, eligibility, validity, and requirements for importing Schedule X Drugs into India. Importing Pharmaceutical products into India requires compliance with the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. A Form […]
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Importer vs Indian Manufacturer Pathways for Biologicals in India: Key Regulatory Differences
One of the most consequential strategic decisions for any global Biological product company entering India is whether to proceed as an importer or establish local manufacturing. This decision has profound implications for Regulatory timelines, clinical data requirements, dossier expectations, commercial positioning, and long-term market competitiveness. India’s Regulatory framework under the […]
Read MoreRegulation/Guidelines
New Medical Device in India: When MD-22, MD-23, MD-26, and MD-27 Apply
India’s Medical Devices Rules, 2017 (MDR 2017) has a distinct regulatory pathway for Devices classified as New Medical Devices — a category that carries additional scrutiny, documentation requirements, and in many cases, clinical data obligations. Navigating this pathway requires a clear understanding of four specific forms: MD-22, MD-23, MD-26, and […]
Regulation/Guidelines
How Global Biotech Companies Should Adapt Their CTD Dossiers for India
The Common Technical Document (CTD) is the universal language of Pharmaceutical and Biological registration. Most global regulatory agencies, including the USFDA, EMA and PMDA accept the ICH CTD format with regional Module 1 variations. India’s CDSCO also accepts the ICH CTD format for Biological product registrations, but a copy-paste submission […]
Regulation/Guidelines
Cosmetic Manufacturing License in India: The State Licensing Authority (SLA) Process Explained
The Most Common Misconception in Indian Cosmetic Manufacturing Many Cosmetic manufacturers, Importers, startups, and international brands entering the Indian market assume that the Central Drugs Standard Control Organisation (CDSCO) is responsible for granting Cosmetic manufacturing licences. However, under the Cosmetics Rules, 2020, this is not the case. If you are […]