PSUR India, CDSCO’s Online Submission Requirement
PSUR – Periodic Safety Update Reports The Central Drugs Standard Control Organization (CDSCO) issued a new circular, File No.: PSUR-13011(15)/1/2024-eoffice, on March 9, 2024, which specifies that submissions of PSUR’s (Periodic Safety Update Reports) must now be made through the […]
Read MoreUniform Code for Pharmaceuticals Marketing Practices, 2024
On December 12, 2014, the central government released the Uniform Code for Pharmaceuticals Marketing Practices to be voluntarily complied by pharma industries with respect to marketing practices. It was mentioned in the code that if the code is not implemented […]
Read MoreGood Manufacturing Practices (GMP) – Pharmaceutical Sector
Good Manufacturing Practices (GMP) in Pharmaceutical Sector: On December 28, 2023, the Ministry of Health and Family Welfare, Government of India, revised the Drugs Rules, 1945, under Gazette Notification Number G.S.R. 922(E), introducing updated Good Manufacturing Practices (GMP) and requirements […]
Read MoreIndia’s Medical Device Grouping Structure
This article gives a brief on India’s Medical Device Grouping Structure – The regulatory landscape for medical device importation and registration in India has undergone significant changes, particularly since an important update in 2020 by the Central Drugs Standard Control […]
Read MoreMedical Device Industry in India: Growth Strategies
Introduction on India’s Medical Device Industry: The Ministry Of Chemicals And Fertilizers (Department Of Pharmaceuticals) For The Promotion Of Medical Device Industry Published Its 50th Report in February 2024. This blog covers some of the key highlights from the report […]
Read MoreRecall System for Drugs, India Guidelines
This article referring to CDSCO/RRAS Ver.:00 dated 23/11/2012, talks about the essential components of an effective recall system with the procedure to be followed in India and how Morulaa can help manufacturers and importers manage these challenges in case of […]
Read MoreDisinfection and Antiseptic Practices, India
This article gives a detailed overview on Disinfection and Antiseptic Practices to be included in the Indian Pharmacopoeia to be included in Chapter IP 2026. It will be published officially from July 2024. A comprehensive cleaning and sanitization program is […]
Read MorePeriodic Safety Update Reports: CDSCO’s New Update
Periodic Safety Update Reports (PSURs) submission process has significantly undergone a transformation by the CDSCO, marking a pivotal shift in regulatory submissions in India. From 26th February 2024, the process for submitting Periodic Safety Update Reports (PSURs) transitions to a […]
Read MoreDrugs & Cosmetics Act and PWM: Effects on Medical Devices
The Drugs & Cosmetics Act of 1940, underpinning the regulatory framework for healthcare in India, has paved the way for remarkable advancements in medical diagnostics and treatment through the innovation and implementation of medical devices. India’s healthcare sector, expected to […]
Read MoreFAQs by CDSCO: Key Highlights and Updates
This article talks about the recently published FAQs by CDSCO and is structured under clear headings for better readability and understanding. In the dynamic landscape of medical device registration in India, the Central Drugs Standard Control Organization (CDSCO) plays a […]
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