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Draft of New Regulations for Clinical Trials in India Favours Drug Development in the Country

  The Ministry of Health and Family Welfare has come with new regulations regarding clinical trials of drugs in India called New Drugs and Clinical Trials Rules, 2019 with the objective to make the country more favourable for clinical research and drug development. These new rules will apply to all […]

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Insight

How Legal Metrology Affects the Market of Smart Watches – Part 1

Smart watches are gaining interest of consumers rapidly these days as they serve the standalone purpose and function of many gadgets.   A smart watch is a touchscreen operated wearable computer in the form of a wristwatch. While early models could perform basic tasks, such as calculations, digital time telling, […]

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Regulation/Guidelines

Licensing Process and Rules Related to Phytopharmaceutical Drugs in India

Now when you know about what is a new phytopharmaceutical drug, now you must be thinking about how and from where to obtain permission either for its import or manufacture? For importing or manufacturing a new phytopharmaceutical drug in India, one needs to apply for a license. For obtaining permission […]

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New Regulations of Government of India Considers 8 Medical Devices as Drugs

Medical devices market in India is booming now. There are lots of medical device innovation and import happening from all over the world. In order to maintain quality assurance and safety, Ministry of Health and Family Welfare bring new regulations for eight important and commonly used categories of medical devices. […]

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Regulation/Guidelines

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 […]

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Regulation/Guidelines

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 […]

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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 […]

Licenses Required For Operating a Smart Watch Business in India – Part 2

  With growing technology, smart watches have now become capable of aiding with measurements and calibrations. You can use a smartwatch to deduce temperature, blood pressure, heart rate, steps, humidity and many other such measurable factors. This has brought smart watches and their business under the observation and regulation of […]

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 […]

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