Công văn 4336/QLD-CL của Cục Quản lý Dược về việc xử lý thành phẩm và nguyên liệu làm thuốc của Công ty Ranbaxy

THE MINISTRY OF HEALTH
THE DRUG ADMINISTRATION OF VIETNAM

Official Dispatch No.4336/QLD-CL dated March 24, 2014 of the Drug Administration of Vietnam on handling the finished medicine products and raw materials for medicine production of Ranbaxy Company

- Pursuant to current pharmaceutical regulations of Vietnam;

- Pursuant to notices of Food and Drug Administration of United States (US-FDA) forbidding several establishments of Ranbaxy Laboratories Ltd from producing and distributing medicines and raw materials for medicine production on American market:

+ Factory in Toansa, India – address:Village Toansa, P.O Rail Majra, Nawanshahar District - 144533 Punjab, India;

+ Factory in Mohali, India – address:Plot No. A-41 Industrial Area, Phase VIII-A,S.A.S Nagar, Mohali - 160071 Pujab, India;

+ Factory in Paonta Sahib, India – address:Village Ganguwala, Tehsil Paonta Sahib, Sirmour - 173025, Himachal Pradesh, India;

+ Factory in Batamandi, India – address:Village Batamandi, Tehsil Paonta Sahib-173025, Himachal Pradesh, India;

+ Factory in Dewas, India – address:Industrial Area 3, A B Road, Dewas - 455001 Madhya Pradesh, India;

+ Ohm Laboratories in Gloversville , USA;

- According to the report dated 13/3/2013 of representative office of Ranbaxy Laboratories Ltd., in Vietnam;

To ensure the safety for users, the Drug Administration of Vietnam notifies that:

1. The import of raw materials for medicine production which are produced by factory of Ranbaxy Laboratories Ltd., in Toansa (at theaddress mentioned above) and the finished medicines which are made of these raw materials will be suspended.

2.The receipt and processing of applications for new registration and re-registration of medicine imports shall be suspended in the following cases:

- Medicines produced by Ranbaxy Laboratories Ltd., in 06 factories mentioned above;

- Finished medicines which are made of raw materials produced by factory of Ranbaxy Laboratories Ltd., in Toansa (at the address mentioned above).

3. Medicine producers and importers must review, recheck the import of finished medicines and raw materials for medicine production (including raw materials in form of grain, semi-finished products, etc…) if these finished medicines and raw materials are produced by Ranbaxy Laboratories Ltd., and send reports to the Drug Administration of Vietnam:

- Fully inspecting the quality of raw materials according to quality standard (including additional criteria such as impurity, residual solvent, etc) before putting them into production.

- Fully inspecting 100% of imported batches of medicine produced by Ranbaxy Laboratories Ltd., as prescribed at official dispatch No. 13719/QLD-CL dated 23/8/2013 of the Drug Administration of Vietnam, on inspecting the quality of imported medicine, from the day of issuing this official dispatch. 

- Strictly monitoring the quality of medicines circulating on market; promptly handling and making reports on cases of bad-quality medicines and adverse reaction to the Drug Administration of Vietnam and the relevant agencies.

4. The National Institute of Drug Quality Control; Institute of Drug Quality Control of Ho Chi Minh city are requested to direct the quality control system to enhance the sampling for checking quality of medicines produced by Ranbaxy Laboratories Ltd., and send reports to the Drug Administration of Vietnam.

5. Services of Health of provinces and central-affiliated cities and the Health sectors must notify medicine producers, medicine importers, sellers and users to strictly implement the requirements stated in this official dispatch, enhance the inspection and control of medicine quality, promptly handle cases of adverse reactions due to medicines, send reports to the Drug Administration of Vietnam in order to have grounds for further handling.

The Drug Administration of Vietnam hereby notifies the units for information and implementation.

For the Director of Drug Administration of Vietnam
The Deputy Director
Do Van Dong