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Regulation/Guidelines

Legal Metrology – Importer, Manufacturer and Packaging Registration

The Directorate of Legal Metrology is a separate government wing under the Ministry of Consumer Affairs, Food and Public Distribution. The Legal Metrology department looks after the norms and regulations related to the measurements and weights of measuring devices and other products imported/manufactured or sold in the Indian market. According […]

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Regulation/Guidelines

Principles for Safety & Performance of Medical Devices

The new ‘Medical Devices Rules, 2017’ have already been published and will commence w.e.f January 1st, 2018. A guidance document has been issued by the Ministry of Health & Family Welfare (MoH&FW) for the said rules under the ‘Rule 6’ after consulting medical devices & in-vitro diagnostic devices (IVD) industry […]

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Insight

Kokate Committee

Constitution: The Kokate Committee was constituted by Ministry Of Health And Family Welfare, Government of India, under the chairmanship of Prok. C.K. Kokate, VC, KLE University, Belgaum, Karnataka.(1) The need to constitute the Kokate Committee: Drug Controller General India (DCGI) had issued a letter dated 15.01.2013 to all the State […]

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Regulation/Guidelines

Expected Changes in FSSAI Labeling Regulations and Gazetted Alcoholic Beverage Regulations

The Food Safety and Standards Authority of India on April 5, 2018, published a gazette notification of Food Safety and Standards (Alcoholic Beverages) Regulations 2018 and on April 11, 2018, it published the Draft Food Safety and Standards (Labelling and Display) Regulations, 2018.

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News

New Medical Device Rules To Be Rolled Out In 2018

The Drugs and Cosmetics Act, 1940, has been governing drugs and medical devices since 1940 and has received multiple iterations each year. Owing to the significant changes that have occurred in the healthcare and pharmaceutical industry and constant requests from leaders in these industries, an overhaul was long overdue. In […]

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Insight

FSSAI Regulations for Caffeinated Beverages

FSSAI has added standards for caffeinated beverages and use of blue tint in the plastic bottles related to beverages non-alcoholic carbonated food products

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Regulation/Guidelines

Comparison of Initial Draft and Final Gazette Regulations for Alcoholic Beverages

FSSAI has framed regulations specifying the standards for the production and packaging of alcoholic beverages, the draft of which was released in September 2016. With Amendments, these regulations i.e. Food Safety and Standards (Alcoholic Beverages Standards) Regulations, 2018, specify the standards for manufacturing Alcoholic beverages and their packaging which include: […]

Regulation/Guidelines

New Regulations for Medical Devices Industry by CDSCO

Nowadays, therapeutic treatment based on medical devices is providing technologically advanced solutions for the management, diagnosis, treatment,mitigation or prevention of several diseases. Thus, the demand continues to grow in the market at a tremendous rate leading to a renewed interest in the scientific development and research in the field of […]

News

Self-Assessment/Audit of Unit for GMP/GLP Compliance

The Indian government has brought about some major changes with regards to the rules and regulations governing the manufacturing to enhance the quality of products used in the healthcare industry. As India being a major market for the healthcare-related products and its services, these modifications to the existing regulations are […]

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