Wednesday, July 27, 2016
Vietnam - Ministry of Health recalls more Indian medicine
Two lots of antibiotics manufactured in India are being recalled for not meeting quality standards, according to documents recently issued by the Department of Drug Management under the Ministry of Health.
The two drugs are Ceferaxim 125 (Cefuroxime 125mg), lot no. 173316001, with the expiry date of January 5, 2018 and registration No.VN-11733-11, manufactured by Vintanova Pharma Pvt. Ltd., and imported by Dai Nam Pharmaceutical Co. Ltd., and Rom-150 tablets (Roxithromycin 150mg), lot No.ZET1709, manufacturing date July 22, 2014 and expiry date July 21, 2017 with registration No.VN-17178-13 manufactured by Zee Laboratories and imported by Codupha Central Pharmaceutical JSC.
A lot of antibiotics manufactured in Vietnam was also asked to be recalled, namely Philtadol (Cefpodoxim 100mg), lot No.15002, with the expiry date of November 3, 2017, registration No.VD-22044-14, produced by Korean company Phil Inter Pharma at its Vietnamese plant in Vietnam-Singapore industrial park in the southern province of Binh Duong.
The decision to recall these drugs was based on tests performed by the National Institute of Drug Quality Control.
India is one of the world’s major suppliers of pharmaceutical products and ingredients and the second largest supplier of these items in Vietnam, after France.
According to data released by the department, at the moment, there are 7,630 valid drug registration numbers in Vietnam, of which 2,814 were patented by Indian companies.
Besides, 200 of the 718 foreign manufacturers of drugs and drug ingredients licensed to operate in Vietnam are Indian.
The preferential tariffs stipulated by a free trade agreement signed by India with the ASEAN, of which Vietnam is a member, have facilitated the import of Indian medicines to the country.
However, despite making up for a significant share of the market, drugs imported from India have a bad track record. In the recalls ordered by the department from 2011 to now, the majority of the drugs in question were manufactured in India.
Last November, the Ministry of Health requested to get rid of all Cefpodoxime Proxetil Tablets USP manufactured by Indian Syncom Formulation due to low quality.
Last month, the department recalled Efixime 100DT, lot No.FNB-07, manufacturing date September 26, 2014, expiry date September 25, 2017, and registration No.VN-4941-10, manufactured by Indian All Serve Healthcare Pvt., Ltd., and imported by Sohaco Trading and Pharmaceutical Group JSC, also due to low quality.