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rave04 ● 2012-02-03 07:10 (5241 d 21:19 ago) Posting: # 8041 Views: 6,605 |
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Hi frnds, I need little help from u all I am applying to DCG India to get BE-NOC for products which we are selling for more than 4 years but still our two products are not found in the approved list of the DCGI. please help as we are going to conduct BE study in India. |
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drgunasakaran1 ★★  2012-02-03 07:45 (5241 d 20:44 ago) @ rave04 Posting: # 8044 Views: 5,978 |
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Dear Mr.Rave, Did you checked the DCGI approval status of the products in their online Approval checking page http://cdsco.nic.in/listofdrugapprovedmain.html DCGI updated the drugs which are approved for marketing in India from the year 1999 only. If the drugs are approved for marketing in India before 1999, it will not be available in the website. You can send an Email to DCGI for a PDF document which contains the CDSCO approved drugs from the year Jan 1988 - Jun 1999. I hope that the two products you are mentioning here is not a Fixed Dose Combination. If it is a FDC, the criteria to apply for BENOC will vary. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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rave04 ● 2012-02-03 08:23 (5241 d 20:06 ago) (edited on 2012-02-03 18:50) @ drgunasakaran1 Posting: # 8046 Views: 5,943 |
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Thank you very much Mr.Gunasakarn We are applying for four formulation out of which I got approval date for 2 but remaining two is not available. Two which are approved are in year 2007. So how to go about them for BE-NOC. Rest two are Levonorgestrel 0.15mg + Ethinylestradiol 0.03mg FDC & Levonorgestrel 0.75 mg but we are manufacturing them for more than 4 years. please help!!! Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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drgunasakaran1 ★★ 2012-02-03 14:19 (5241 d 14:10 ago) (edited on 2012-02-03 18:52) @ rave04 Posting: # 8050 Views: 5,927 |
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Dear Mr.Rave, If the drugs are approved in the 2007 and the drug is available in the Indian market for more than 04 years, then there is no need for BE NOC. However, you may need to apply for T License if your are planning to import the investigational product from foreign countries in case if your are planing to conduct the above two studies for USFDA/EMEA/other foreign regulatory bodies. ❝ Rest two are Levonorgestrel 0.15mg + Ethinylestradiol 0.03mg FDC & Levonorgestrel 0.75 mg but we are manufacturing them for more than 4 years. please help!!! Levonorgestrel 0.15mg + Ethinylestradiol 0.03mg FDC was approved by CDSCO on 13.10.10. Ref: http://cdsco.nic.in/LIST%20OF%20APPROVED%20DRUG%20FROM%2001.htm Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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Vardhan82 ☆ India, 2012-02-03 07:57 (5241 d 20:31 ago) @ rave04 Posting: # 8045 Views: 6,041 |
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Dear Rave04, ❝ I am applying to DCG India to get BE-NOC for products which we are selling for more than 4 years but still our two products are not found in the approved list of the DCGI. please help as we are going to conduct BE study in India. Regards, vardhan |
Ing. Helmut Schütz