Phytopharmaceutical Drugs and Their Related Regulations in India
Phytopharmaceutical Drugs and Their Licensing Process in India Before putting the light on the phytopharmaceutical drugs in India, we would like to clarify, that this is the newest division declared by Indian FDA (CDSCO) after AYUSH, & the division is still getting evolved in terms of setting up standards & guidance […]
Read MoreNew 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 […]
Read MoreExpected 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.
Read MorePrinciples 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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Legal Metrology – Importer Registration, Dealer License, Repair License, Manufacturing License
The Legal Metrology Department of the Ministry of Consumer Affairs, is responsible for looking after the rules and regulations related to weights and measures in the country. This wing keeps an eye on the manufacturing, import, sale and repair of weights and measures instruments, devices and equipments. Devices such as […]
Coronary Stents are Now Included in the National List of Essential Medicines: Its Impact on Prices, Availability, and Healthcare
National List of Essential Medicines The National List of Essential Medicines (NLEM), 2011, has been reviewed and revised by the Core-Committee constituted by the Ministry of Health & Family Welfare (MOHFW), Government of India. The committee has formulated a new list as per the inclusion and exclusion criteria. The […]
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Update on Food Safety and Standards (Labelling and Display) Regulations Draft, 2018
The Food Safety and Standards Authority of India on April 11, 2018 has published the Draft for Food Safety and Standards (Labelling and Display) Regulations, 2018. These regulations propose to prescribe the labelling requirements of pre-packaged foods and display of essential information on premises where food is manufactured, processed, served […]
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
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 […]