FAQs about New Drug, Banned drugs etc.

FAQs about New Drug, Banned drugs and stability data for drugs

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FAQs
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Lalit Kr. Goel
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Q1. What is a new drug?

Ans: Definition of new drug is given in Rule 122(E) of Drugs and Cosmetics Act, 1940. Click here for definition.

Q2. Where list of new drug is available?

Ans: New drug list is available on the website of CDSCO. To download the new drugs list, click here.

Q3. For how much time a new drug shall continue to be considered as new drug?

Ans: A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval.

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Q4. What is the status of a new drug after four year?

Ans: A new drug automatically comes out from the list of new drug after four years and State Licensing Authority gives approval for the drug.

Q5. Are drugs mentioned in IP 2014 and IP 2018 out of the new drug list?

Ans: No, because as per the amendment in the definition of new drug in the year 2013, where word “IP” has been deleted from the definition of new drug.

Q6. Has State Drugs Controller the power to ban any drug in their respective state?

Ans: No, the power to ban drug lies with central government under section 26 A of the drugs and cosmetics act, 1940.

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Q7. How many drugs are banned in India till date?

Ans: 513 drugs have been banned in India till date. Click here to download the list of banned drugs in India.

Q8: What is the status of 294 drugs stayed by Hon’ble Madras High Court?

Ans: The case was decided by the Hon’ble Supreme court of India dated 15.12.2017 in which approximately 83 drugs have been cleared as rational drugs.

Q9. Out of 294 drugs, for how many drugs and which data to be submitted to DCG(I), New Delhi?

Ans: Out of 294 drugs, only for 49 drugs, data for requirement of further generation in terms of safety and stability by conducting clinical trials, is to be submitted.

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Q10.  What about the notification about submission of stability data of drug while applying for approval?

Ans: Earlier stability data was to be submitted only for the Patent and Proprietary drugs. Now as per the notification GSR 360 (E) dated 10.04.2018 submission of stability data of every drug (including Patent and Proprietary and drugs mentioned in IP) is mandatory while applying for approval. Click here for above said notification.

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