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Grant of No Objection Certificate by DCGI for procuring Unapproved/Approved New Drug (Bulk) for R&D/Formulation Development / manufacture of Exhibit Batches for Overseas registration purpose - regarding
 

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Ref: PXL/H.O./CIR-097/2014-15                                              Date: 27.02.2015

 

To
All the Members of Council

Dear Sir/Madam,


Sub: Grant of No Objection Certificate by DCGI for procuring Unapproved/Approved New Drug (Bulk) for R&D/Formulation Development/manufacture of Exhibit Batches for Overseas registration purpose - regarding.

 

We are happy to inform our members that subsequent to strong representations and follow up by Pharmexcil to DCGI and Ministry of Health & Family Welfare, Government has considered and issued a notification (office memorandum) enabling exporters of new drug/unapproved drug formulations to procure the concerned bulk drug (APIs) from the domestic manufacturers also for purpose of R&D / formulation development / manufacture of exhibit batches for registration in overseas countries. So far, DCGI has been permitting procurement of unapproved/new drug (bulk drug) for such purpose through imports only.  The concerned NOC would be issued subject to compliance of prescribed conditions given in the notification.

 

Copy of the office memorandum issued by DCGI is enclosed for information.

 

We advise all our members to utilize the facility extended by Ministry of Health & Family Welfare / DCGI for growth of exports.

 

Thanks.

Dr P V Appaji

Director General

 

Encl: copy of memorandum (link)

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Tel: +91-40-23735462/66, Fax: +91-40-23735464
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