Executive Summary:
This policy, dated September 13, 2023, announces the inclusion of three additional NABL-accredited private testing laboratories for cough syrup intended for export, supplementing the existing 14 government laboratories. It lists the laboratories and reiterates testing and documentation requirements for manufacturers/exporters to ensure product quality. State Licensing Authorities, CDSCO Zonal offices, and drug manufacturers associations are requested to note the information and requirements.
Key Points / Main Content:
* **Approval of Additional Laboratories:**
* Three private testing laboratories are approved for testing cough syrup for export, in addition to the existing 14 government labs.
* The newly approved laboratories are:
* Bee Pharmo Labs Pvt. Ltd (Thane, Maharashtra)
* Oasis Test House (Ahmedabad, Gujarat)
* Shriram Institute for Industrial Research (New Delhi)
* **Reference Documents:**
* This decision refers to Notification no: 06/2023 dated 22nd May 2023, Ministry of Commerce Industry,
* Govt. . of India No. X11035/4/2023-DRS dated 23.05.2023 JS (R), MoHFW, Govt. . of India
* Directorate Letter. No. DCGIMISC2023/09 dated 26.05.2023.
* **Testing and Documentation Requirements for Exporters:**
* Manufacturers/Exporters must submit the following for each batch of cough syrup:
* Certificate of Analysis of product composition including excipients.
* Product specification and method of analysis (Spec/STP).
* Reference working standard and Placebo (if applicable).
* Undertaking that the product meets specified requirements for export.
* Export is permitted only after complete analysis of the sample is completed.
* **Reference Laboratories:**
* Lists NABL accredited Central & State Drugs Testing Laboratories.
Impact Analysis:
* **Indian Drug Manufacturers/Exporters:**
* Impact: Expanded options for cough syrup testing, potentially streamlining the export process. Required to meet specific testing and documentation requirements.
* Action Required: Utilize approved laboratories for testing, ensure compliance with documentation requirements for each batch of exported cough syrup.
* **State Drug Controllers/UTs & CDSCO Zonal/Sub-Zonal/Port Offices:**
* Impact: Must be aware of the newly approved laboratories and the associated testing requirements.
* Action Required: Note the information and ensure that manufacturers/exporters comply with the policy requirements.
* **NABL Accredited Testing Laboratories (Government & Private):**
* Impact: Newly approved private labs can now offer cough syrup testing services for export purposes. All listed labs are expected to adhere to testing standards.
* Action Required: Provide testing services according to established standards and documentation requirements.
* **State Licensing Authorities**
* Impact: Need to ensure manufacturers are adhering to updated guidelines
* Action Required: Note the new approved labs and testing requirements.
Key Entities Referenced
Directorate General of Health Services: A government organization under the Government of India.
Central Drugs Standard Control Organization (CDSCO): National Regulatory Authority for Drugs, Cosmetics and Medical devices under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India
NABL Accredited Private Testing Laboratories: Private laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) for testing cough syrups intended for export.
Ministry of Health Family Welfare: A ministry of the Government of India.
Bee Pharmo Labs Pvt. Ltd Thane, Maharashtra: A private testing laboratory located in Thane, Maharashtra, India.
Oasis Test House, Ahmedabad, Gujarat: A private testing laboratory located in Ahmedabad, Gujarat, India.
Shriram Institute for Industrial Research, New Delhi: A research institute located in New Delhi, India.
Indian Pharmacopoeia Commission (IPC), Ghaziabad: An autonomous institution of the Ministry of Health & Family Welfare, Govt. of India
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
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.
Ref:- 1. Notification no: 06/2023 dated 22nd May 2023, Ministry of Commerce & Industry,
2.G o Dv .t O. . o Lf e I tn td ei ra . 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,
3. G Su hj ra ir ra at m. Institute for Industrial Research (A Unit of Shriram Scientific and Industrial
Research Foundation), 19-University Road, New Delhi-110007.
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Details of NABL Accredited State Drugs Testing
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Food and Drugs Laboratory, Near Polytechnic, Opp. M.S. University,
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Uttarakhand Hospital Campus, Near Indira Chowk, Kichha Road Rudrapur
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specification and method of analysis (Spec./STP). -
Page 2 of 3_ 8. Reference/working standard and Placebo as applicable.
In view of above, all State Licensing Authorities/CDSCO 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 fai.thfully,
Encl:
1. Directorate Lr. No. DCGI/MISC/2023/09 Quw a
dated 26.05.2023 (Dr. Rajeey Singh RaSttuvahshi)
General (India)&
Central Licensing Authority
Copy to:
1.
ir &
The Drugs Controller for the State of
Gujarat/Karnataka/Kerala/Madhya Pradesh/MaharashtraJammu & \
Kashmir and Uttarakhand,
. All Directors of NABL accredited State Laboratories of
Gujarat/Karnataka/Kerala/Madhya Pradesh/Maharashtra/Jammu
& Kashmir and Uttarakhand,
With a request to test
b3. Secretary-cum-Scientific Director, IPC, Ghaziabad,
DEG/EG in all
. Head of laboratories of CDL, Kolkata,
. Head of laboratories of CDTL, Chennai, Mumbai and samples even if it is
Hyderabad, not part of the mfr.
fot. Head of laboratories of RDTL, Guwahati, Chandigarh. specifications along
. Bee Pharmo Labs Pvt. Ltd Thane, C-2 Hatkesh Udyog Nagar, Mira
with other test
Bhayander Road, Mira Road (East), thane-401107, Maharashtra.
parameters and issue
. Oasis Test House, 24-A, B Sardar Patel, industrial Estate, Narol,
the test report as per
Ahmedabad-382407, Gujarat. the format enclosed.
. Shriram Institute for Industrial Research (A Unit of Shriram
NSceiewn tDieflich ia-n1d1 0I0n0du7s.t rial Research Foundation), 19-University Road, yy
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