New Regulatory Guidance to Facilitate Drug & Vaccine Approval for COVID-19
The SARS-CoV-2 virus started in December 2019 and then spread at an alarming rate, mainly to China, Italy, the USA, Iran, Japan, and South Korea and even India. There is no drug or vaccine yet approved by the FDA for COVID-19. Presently, there is not any evidence from randomized clinical […]
Read MoreAddressing Regulatory Compliance of Cosmetics Manufacturing & Sales in India
India is an emerging economy with high GDP growth rate and extremely lucrative market for consumer goods manufacturers like cosmetics. A report by TechSci Research states that the Indian cosmetics market is expected to grow at a CAGR of 6% in the period from 2019 to 2024. The demand is […]
Read MoreHow recent Regulatory changes will impact Cosmetics Registration in India?
Cosmetic items fall under the purview of the Ministry of Health and Family Welfare in India. The overarching Drug and Cosmetics Act 1940 and the Rules 1945 (last amended on 01.12.2016) regulate the drug and cosmetic industry. Who regulates the cosmetic segment? Cosmetics specifically are regulated by the Central Drug […]
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CDSCO Releases Frequently Asked Questions on Import and Registration of Drugs in India
The Central Authority, Central Drugs Standard Control Organisation (CDSCO) came out with Frequently Asked Questions (FAQs) on the Import and Registration of Drugs in India. Let’s take a look at the FAQs: How is drug import regulated in India? Chapter III of Drugs and Cosmetic Act, 1940, and Part […]
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NEW NOTICE BY DCGI FOR MEDICAL DEVICES
The Government of India is revamping the existing regulations on medical devices to be at par with the global norms and standards, to have a better control over their manufacture, import and sale. A new notification was released by the Drugs Controller General of India (DCGI) in Nov 2018 regarding […]
Marketing Authorization of Biological Products in India
What are Biological Products? Biological products are used for diagnosis, prevention, treatment and cure of diseases and certain medical conditions and are regulated by the Food and Drug Administration of India. They can be classified in varied categories and consist of complex molecules that are produced through biotechnological techniques in […]
Read MoreRegulation/Guidelines
New Regulation Introduced in Cosmetics Industry
Internet has led to an exponential growth in awareness. You are more tuned to “Googling” for information and clearing your doubts. There is a growing tribe of consumers who are alert, informed and take data-driven information. These developments are having far-reaching impact, which were earlier disjointed. This has prompted […]
Regulation/Guidelines
Regulatory Changes in India – Be in Control of Compliance
Imagine this scenario You have researched the market and identified certain needs You have mapped it to your core competency, strengths, resources You have invested money and taken risk You have identified a segment in the market You have setup a business and serving the chosen segment well with your […]
Regulation/Guidelines
Consumer Safety through Cosmetics Labeling Regulation – What’s New?
A report by TechSci Research states that the Indian cosmetics market is expected to grow at a CAGR of 6% in the period from 2019 to 2024. There is growing demand for cosmetics from people of all walks of life, belonging to either gender. The demand is equally strong […]