93 Approval of NABL Accredited Private Testing Laboratory for Testing of Cough Syrup to be exported by the Manufacturer/Exporter 2023-Sep-13 2263 KB

Enfore-11017(11)/3/2023-eoffice Government of India Directorate General of Health Services Central Drugs Standard Control Organization . FDA Bhawan, Kotla Road, New Delhi-110002

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Date: 13" Sep, 2023

To, All State Drug Controllers/UTs All CDSCO Zonal, Sub-Zonal, Port offices, All Indian Drug manufacturers Associations

Subject: - Approval of NABL Accredited Private Testing Laboratory for Testing of Cough Syrup to be exported by the Manufacturer/Authorize person of Manufacturer/Exporter -reg.

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Ref:1. Notification no: 06/2023 dated 22nd May 2023, Ministry of Commerce & Industry, Govt. of India. 2. D.O. Letter No. X-11035/40/2023-DRS dated 23.05.2023 JS (R), MoHFW, Govt. of India ‘ 3. Directorate Letter. No. DCGI/MISC/2023/09 dated 26.05.2023. Sir, Further to this Directorates Letter vide File No. DCGI/MISC/2023/09 dated 26.05.2023, it has been decided with the approval of Ministry of Health & Family Welfare to include the following 03 NABL Accredited Private Testing Laboratories for Testing of Cough Syrup to be exported by the Manufacturers/Authorize person of Manufacturer/Exporter apart from 14 NABL Accredited Government Laboratories. The details of the 03 Laboratories are as follows:

1. Bee Pharmo Labs Pvt. Ltd Thane, C-2 Hatkesh Udyog Nagar, Mira Bhayander Road, Mira Road (East), thane-401107, Maharashtra.

2. Oasis Test House, 24-A, B Sardar Patel, industrial Estate, Narol, Ahmedabad-382407, Gujarat.

3. Shriram Institute for Industrial Research (A Unit of Shriram Scientific and Industrial Research Foundation), 19-University Road, New Delhi-110007.

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The List of NABL Accredited Central Drugs Testing Laboratories and State Drug Testing Laboratories which are involved in testing of cough syrup are listed below: petals of NABL Accredited Central Drugs Testing Laboraiiess ee indian Pharmacopoeia Commission (IPC), Raj Nagar, Ghaziabad Nene | Coie Drug Teseg taboo (COTE ew Ce eh Fol Drugs Testing Labsatory (RDIL), Cova —__

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Details of NABL Accredited State Drugs Testing Laboratories:

ee a a SeFood and Drugs Laboratory, Near Polytechnic, Opp. M.S. University, Karnataka Drug Testing Laboratory, Drug Control Department. Palace Road, ee oeDrug _‘Testing Laboratory, Red Cross Road, | Vanchiyoor, Pradesh East, Mumbai Uttarakhand STATE FOOD AND DRUG TESTING Laboratory OLD, J.L.N Govt. at] ca alge

• The pre-requisite/requirements for submission of samples by the manufacturer/exporter to one of the above mentioned laboratories remains same as mentioned in Directorate letter vide No. DCGI/MISC/2023/09 dated 76.05.2023 and the same is reproduced below. 1. Covering letter from the manufacturer/exporter on Jetter head addressed to concerned laboratory.

• 2. Manufacturing license of the product for export purpose. 3. Export order 4. Representative sample from the export consignment. 5. Thrice the quantity required for performing complete analysis of the sample as per their STP
• 6. Qualitative composition of product including excipients. 7. Certificate of analysis by the manufacturer of the particular batch, product specification and method of analysis (Spec./STP). -

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_ In8. viewReference/working of above, all State Licensingstandard and Authorities/CDSCOPlacebo as applicable.Zonal, Sub-Zonal Offices and . all Indian Drug Manufacturer Associations are once again requested to note the above information/requirements for export of cough syrup. . Yours faithfully, 1. Directorate Lr. No. DCGI/MISC/2023/09 Qu Encl: aa g dated 26.05.2023 Drugs(Dr.Controller] Rajee Generalingh Ragi(Indiah& i Central Licensing Authority

Copy to:

1. The Drugs Controller for the State of Gujarat/Karnataka/Kerala/Madhya Pradesh/MaharashtraJammu & Kashmir and Uttarakhand,

2. All Directors of NABL accredited State Laboratories of

• Gujarat/Karnataka/Kerala/Madhya Pradesh/Maharashtra/Jammu & Kashmir and Uttarakhand, .

3. Secretary-cum-Scientific Director, IPC, Ghaziabad, With a request to test 4. Head of laboratories of CDL, Kolkata, DEG/EG in all . 5. Head of laboratories of CDTL, Chennai, Mumbai and samples even if it is Hyderabad, not part of the mfr.

4. Head of laboratories of RDTL, Guwahati, Chandigarh. specifications along 7. Bee Pharmo Labs Pvt. Ltd Thane, C-2 Hatkesh Udyog Nagar, Mira sith other fest Bhayander Road, Mira Road (East), thane-401107, Maharashtra. parameters and issue

5. Oasis Test House, 24-A, B Sardar Patel, industrial Estate, Narol, the test report as per Ahmedabad-382407, Gujarat. the format enclosed.

6. Shriram Institute for Industrial Research (A Unit of Shriram Scientific and Industrial Research Foundation), 19-University Road, New Delhi-110007.

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