State FDA Hyderabad

Press Note – 23-04-2026 – Special Enforcement Drive – Weight Loss Drugs

Posted by: Prabhas Chakraborty April 29, 2026

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29th April, 2026

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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...

3rd July, 2026

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...

1st July, 2026

Regulation/Guidelines

Common 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...

30th June, 2026

Regulation/Guidelines

ISO 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...