Data fraud by Ranbaxy Laboratories Ltd

12 November 2013

Question No. 1371

Name of Person:  Ms Sylvia Lim

Question

To ask the Minister for Health in view of a subsidiary of the multinational pharmaceutical company Ranbaxy Laboratories Ltd being found guilty of data fraud by the US Food and Drug Administration in May 2013 (a) whether the Health Sciences Authority (HSA) has done a review of all data submitted to it by Ranbaxy; and (b) how HSA ensures Singapore's supply of generic drugs from overseas is safe for use.

Answer

1        Prior to authorisation by HSA for supply in Singapore, generic drugs are subject to a peer review of scientific data by a team of regulatory scientists, including manufacturing and clinical data, to ensure that the drug meets the required standards for quality, safety and efficacy. The drugs have to be manufactured according to international Good Manufacturing Practice (GMP) standards.

2        With regard to the data submitted by Ranbaxy for registration of their products, all data submitted was reviewed by HSA.    

3        HSA takes a two-pronged approach in ensuring that medicinal products meet the required standards: pre-market review based on data submitted by the company and post-market sampling and testing to ensure compliance. All drugs are subject to post-market surveillance checks to ensure continued compliance with the required standards of quality, safety and efficacy. Such checks include targeted sampling and testing, in conjunction with a safety monitoring system, which enable HSA to detect local and global signals related to drugs safety.

4        In the case of Ranbaxy’s products, US FDA’s ruling in 2013 originated from the findings of the audit that FDA conducted at two of Ranbaxy’s manufacturing sites in 2008, which raised concerns that the manufacturing processes deviated from US manufacturing standards at those two sites.  In November 2008, these two sites were jointly audited by the World Health Organisation and five other international regulatory agencies. HSA participated in one of the two joint site audits. Findings observed during the joint audits were addressed by Ranbaxy and the two audit teams concluded subsequently that the two sites were in compliance with international GMP standards. GMP certificates were then issued by WHO and EMA to these two sites in 2009. Since then, the various regulatory authorities have conducted regular audits at these sites. HSA has maintained close communication with these agencies to track closely the results of these audit findings of the Ranbaxy sites concerned.  

5        Currently, there are 15 products manufactured by the 2 reported Ranbaxy sites marketed in Singapore. HSA has been conducting regular targeted sampling and testing of these products under the Product Quality Sampling programme, and the test results have confirmed that the products comply with approved quality specifications. To date, our adverse events database has also not indicated any safety signals associated with Ranbaxy’s products.

6        HSA will continue to monitor Ranbaxy products to ensure they meet safety, quality and efficacy requirements.