Here's a summary of the provided policy text:
**Executive Summary:**
This order announces the cancellation of Registration Certificate No. SVH9 and Import License SVH9131, both related to Varicella vaccine Live I.P., Freeze dried manufactured by Ms Changchun Changsheng Life Sciences Ltd., China. The cancellation is due to the manufacturer's involvement in falsification of production records and violations of good manufacturing practices. The order is effective immediately, dating back to August 30, 2019 and August 12, 2019.
**Key Points / Main Content:**
* **Cancellation of Registration Certificate and Import License:**
* Registration Certificate No. SVH9 and Import License SVH9131 for Varicella vaccine Live I.P. have been cancelled.
* **Manufacturer Details:**
* The vaccine was manufactured by Ms Changchun Changsheng Life Sciences Ltd., China.
* **Reason for Cancellation:**
* The manufacturer was found to be involved in falsification of production records for its Vero cell-based Rabies Vaccine.
* Violations of relevant requirements of good manufacturing practices by the said manufacturer.
* **Background Information:**
* Ms Wockhardt Limited, Mumbai, was the Authorized Indian Agent and held the Registration Certificate.
* Ms Wockhardt Limited, Mumbai, held the Import License.
* A previous cancellation of registration certificate and Import license of Vero cell based Rabies vaccine issued to importer Ms. Synergy Diagnostics Pvt Ltd. due to violations of relevant requirements of good manufacturing practices by the said manufacturer.
* **Effective Date:**
* The cancellation is effective immediately, dating back to August 30, 2019 and August 12, 2019.
**Impact Analysis:**
* **Ms Wockhardt Limited, Mumbai (Authorized Indian Agent/Importer):**
* Impact: Can no longer import or distribute Varicella vaccine Live I.P., Freeze dried manufactured by Ms Changchun Changsheng Life Sciences Ltd. under Registration Certificate No. SVH9 and Import License SVH9131.
* Action Required: Cease all import and distribution activities related to the specified vaccine from the specified manufacturer under the cancelled Registration Certificate and Import License. Recall of available stock in the market to prevent any potential risk to patients.
* **Ms Changchun Changsheng Life Sciences Ltd., China (Registered Manufacturer):**
* Impact: Products are no longer permitted for import into India
* Action Required: Should cease exporting Varicella vaccine Live I.P., Freeze dried to India under the cancelled Registration Certificate and Import License.
* **Central Drugs Standard Control Organization (CDSCO):**
* Impact: Responsible for enforcing the cancellation order and ensuring compliance.
* Action Required: Ensure the cancellation is effectively implemented and monitor the market to prevent further distribution of the affected vaccine from the specified manufacturer.
* **State Licensing Authorities:**
* Impact: Accountable for ensuring implementation of the recall.
* Action Required: Direct Zonal and Sub Zonal officers to keep strict vigil on the movement, sale, distribution and stock of the drug product in the market.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the approval of drugs, cosmetics, and medical devices.
Drugs and Cosmetics Rules, 1945: A set of rules in India that regulate the import, manufacture, distribution, and sale of drugs and cosmetics.
Wockhardt limited, Mumbai, Maharashtra: An Indian pharmaceutical and biotechnology company, referred to as the Authorized Indian Agent in the document.
Changchun Changsheng Life Sciences Ltd., Changchun, China: A Chinese manufacturer of vaccines, referred to as the Registered manufacturer in the document.
Varicella vaccine Live I.P.: A vaccine against chickenpox, the specific drug for which the Registration Certificate and Import License are being cancelled.
Synergy Diagnostics Pvt Ltd., Thane West, Maharashtra: Importer whose registration certificate and Import license of Vero cell based Rabies vaccine was cancelled.
China’s State Drugs Administration: The drug regulatory authority in China that inspected Changchun Changsheng Life Sciences and found falsification of production records.
Vero cell based Rabies Vaccine: Vaccine, production of which was stopped due to falsification of production records.
F.No. X-11026/186/2018-BD
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
O/o Licensing Authority cum Drugs Controller General India
Kotla Road, Near Bal Bhawan,
ITO, New Delhi-110002
cae
et.
1
on
ORDER
Subject: Cancellation of Registration Certificate No. SVH-9 and Import License
SVH-9-1 31-regarding
WHEREAS, in terms of sub clause (i) of clause (b) of section 3 of the Drugs
va in ed
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m aa nn du f qa uac lt iu tyr .e and sale of drugs is regulated with a
AND WHEREAS, Rules 23 to 27 A of the Drugs and Cosmetics Rules, 1945
specify the provisions for grant of Registration Certificate and Import License for
import of Drugs.
AND WHEREAS, M/s Wockhardt limited, Plot no. C-2, Wockhardt Towers,
Bandra Kurla complex, Bandra (East) Mumbai 400051, India (herein after to referred
as Authorized Indian Agent) was granted Registration Certificate No. SVH-9 dated 05
Apr 2017 having validity upto 27/07/2020 for the drug Varicella vaccine (Live) |.P.,
Freeze dried along with sterile water for injection (as diluent) manufactured by M/s
Changchun Changsheng Life Sciences Ltd.,1615,Yueda Road, Changchun, China
(herein after to referred as Registered manufacturer) under the Rule 27A of Drugs and
Cosmetics Rules 1945.
AND WHEREAS, M/s Wockhardt limited, Plot no. C-2, Wockharat Towers,
Bandra Kurla complex, Bandra (East) Mumbai 400051, India was granted Import
License No. SVH-9-131 dated 09 Oct 2017 having validity upto 27/07/2020 for the
drug Varicella vaccine (Live) I.P., Freeze dried along with sterile water for injection (as
diluent) manufactured by M/s Changchun Changsheng Life Sciences Ltd.,
1615, Yueda Road, Changchun, China under the Rule 27 of Drugs and Cosmetics
Rules 1945.
AND WHEREAS, It has come to the notice of this office that during its
- inspection, China’s State Drugs Administration have observed that the manufacturer,
M/s Changchun Changsheng Life Sciences limited, 1615, Yueda road, Changchun,
China was involved in falsification of production records for its Vero cell based Rabies
Vaccine and has taken regulatory actions including order to stop production of the
vaccine. Further, this office has cancelled the registration certificate and Import license
of Vero cell based Rabies vaccine issued to importer M/s. Synergy Diagnostics Pvt
Ltd., 127-128, Laxmi Commecial Complex (Laxmi Market), Vartak Nagar, Thane
ce (West)-400 606, India vide letter even number dated 18 Oct 2018 due to violations of
relevant requirements of good manufacturing practices by the said manufacturer.AND WHEREAS, it has come to the notice of this Office vide letter reference
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