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Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
The Food Safety and Standards Authority of India (FSSAI) released a Draft Notification on September 14, 2022, amending the Food Safety and Standards (Labeling & Display) Regulations, 2020. These regulations may be called the Food Safety and Standards (Labeling & Display) Amendment Regulations, 2022.
The emergence of digital health technologies has fast-tracked the evolution of the healthcare sector. New-age healthcare products like wearables, telemedicine, and clinical decision-making tools use Artificial Intelligence (AI) and Machine Learning (ML) algorithms. Global Health Agencies, including CDSCO, are gearing up and devising new regulations to address the transformation.
India has a rich tradition of sweets, snacks and savories with a difference in taste, texture and ingredients. Traditional milk-based sweets are mostly prepared from Khoya, Chhena, sugar and other ingredients such as maida, flavors and colors, e.g., Peda, Barfi, Milk Cake, Gulab Jamun, Rasgulla, Rasmalai, etc.
Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.
Imported Cosmetic products are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. For importing Cosmetics in India, the products are required to be registered with the Central Drugs Standards Control Organization (CDSCO) by giving an application in Form 42 to obtain the Registration certificate in Form 43.
To strengthen the regulations of medical devices in India, the Central Drugs Standard Control Organization (CDSCO) has released two final amendments to the Medical Device Rule 2017. The amendments are expected to provide more clarity on the scope of medical devices and establish an expedited registration route for certain devices.
The Food Safety and Standards Authority of India (FSSAI) has published a guidance document announcing the re-categorization of all the health supplements for sports use as Food for Special Dietary Uses (FSDU). The guidance states that going forward health supplement manufacturers in India will have to comply with the Food Safety and Standards Act, established in the year 2016.
The Food Safety and Standards Authority of India (FSSAI) has issued a draft regulation pertaining to the safety standards of infant nutrition. In India, most of the nutritional products for infants with Inborn Errors of Metabolism (IEM) are imported from foreign countries. With the FSSAI’s new proposal for regulations, companies in India are expected to be able to manufacture IEMs locally.
Labeling, perhaps the most looked-after section of any product; either a medicinal product, medical device or a cosmetics product. As it furnishes the first-hand information about the product to the outside world, Life Sciences manufacturers across the globe are obliged to manage this piece of information as accurately as possible to win the end-user’s trust.
On May 15, 2019, Central Drugs Standard Control Organization (CDSCO) of India has published a notification regarding the classification of new devices, which are notified for regulation. As per the notification, the newly regulated medical and in vitro diagnostic (IVD) devices will be classified as per the provisions of Medical Device Rules – 2017.
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