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vicky ☆ 2012-02-29 09:45 (5233 d 22:23 ago) Posting: # 8185 Views: 5,723 |
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Does Clacitriol 0.5mg tablet require BE NOC approval from DCGI. |
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drgunasakaran1 ★★  2012-02-29 10:41 (5233 d 21:27 ago) @ vicky Posting: # 8186 Views: 5,162 |
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Dear Mr.Vicky, Calcitriol soft gelatin capsules was approved by CDSCO on Aug, 1993. Calcitriol was available only as 0.25 mcg strength in the Indian Market. I hope you are inquiring about Calcitriol 0.5 mcg tablet, not 0.5 mg tablet. Considering Calcitriol tablet 0.5 mcg as strength, you need to get BE NOC approval from DCGI before conducting BE study since the strength and the formulation is not approved by CDSCO for marketing in India. — 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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vicky ☆ 2012-02-29 10:47 (5233 d 21:22 ago) @ drgunasakaran1 Posting: # 8187 Views: 5,063 |
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Thanks Dr. I could find some reference about Calcitriol 0.5mcg capsule, being imported in India in the year April 2008. http://cdsco.nic.in/html/Registeredrecmain.html Could not find anything wrt tablet formulation. Kind Regards Vicky 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] |
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drgunasakaran1 ★★ 2012-02-29 11:18 (5233 d 20:51 ago) @ vicky Posting: # 8188 Views: 5,292 |
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Dear Mr.Vicky, Don't get confused with the Applications received by CDSCO for Registration to import drugs uploaded in the CDSCO website. It is meant to give details regarding the import of drugs into India (Should not be taken into consideration for BE NOC requirements). Roche Scientific co. submitted application to CDSCO to import Calcitriol 0.5 mcg into India on 02.04.2008. For BENOC requirement, check the Drugs approved for Marketing in India webpage. — 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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vicky ☆ 2012-03-01 08:54 (5232 d 23:14 ago) (edited on 2012-03-01 12:16) @ drgunasakaran1 Posting: # 8195 Views: 4,968 |
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thanks Dr. May I know if there is any approval required to ship plasma samples from US/ Europe to India. The studies are healthy volunteer Bioequivalence studies. 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 ★★ 2012-03-01 15:59 (5232 d 16:09 ago) @ vicky Posting: # 8200 Views: 5,053 |
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Dear Mr.Vivek, You need to obtain No Objection Certificate for importing and exporting biological samples in/out of India from Director General of Foreign Trade (DGFT). — 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 |
Ing. Helmut Schütz