Bioequivalence and Bioavailability Forum

Dear Dr. Deepak C Chilkoti
I guess it is not necessary to have such a license, since a bioequivalence study is an in vivo quality testing taking bioavailability as a surrogate parameter for efficacy. By this a BE study does not reflect the clinical use.
I hope this helps.
Kind regards
Dan

Dear Dr. Deepak,

As per the NDPS Act, for import of innovator from other countries a CRO shall obtain the import license from the DCGI as well as Central Bureau of Narcotics Gwalior before initiating the study.


Regards
Kiran

Dear Dr. Deepak,

There is no need to have separate license for a CRO to conduct BE studies with Psychotropic drugs such as Zolpidem which falls under the category of Narcotics.

However, you need to provide the following documents to DCGI/CBN to get BENOC & T License approval for conducting BE studies with narcotics such as Zolpidem.

1. Application form and the Background information in the prescribed format for import of Narcotics.
   
2. Licence Fee of Rs. 560/- in form of Demand Draft drawn in favour of Drawing and Disbursing Office,
   Central Bureau of Narcotics, Gwalior.
   
3. Copy of valid drug manufacturing licence possessed by the exporter (in case of manufacturer) and copy of valid drug licence for sale, distribution or exhibit (in case of merchant exporter).
   
4. Original Test Licence/Import Licence from Drug Controller General (India) for the proposed import.
   
5. Copy of import-export contract with the overseas supplier.

Sometimes, you may be requested to provide the additional documents mentioned below if your CRO is applying for the first time to import narcotics.

1. Complete postal address and telephone, fax no. of various factories of the company manufacturing Narcotic Drugs and Psychotropic Substances including Jurisdictional Central Excise division and Central Excise Commissionerate and Zonal office of Narcotics Control Bureau in respect of factories.
   
2. List of Narcotic drugs and Psychotropic Substances being manufactured by the company and details of manufacture of Narcotic drugs and Psychotropic Substances by the company in the last three calendar years (1st January to 31st December).
   
3. Details of export/import of Narcotic drugs and Psychotropic Substances by the company during the last three calendar years (1st January to 31st December).
   
4. Name, address, telephone Nos. and Fax No. of the Chairman, Managing Director and other Directors, proprietor/ partners, in charge of production and finance.
   
5. Sales Tax Registration No., Central Excise Registration No. and Company’s PAN No. (Attested copies of these documents shall also be submitted.)
   
6. Name of concerned Jurisdictional Commissionerate of Customs and Central Excise.
   
7. Balance Sheet of Company for last 3 years.
   
8. Amount of Excise Duties paid by company during last three years.
   
9. Profile of the company.