28 May 2012, BioSpectrum Bureau , BioSpectrum
Singapore: The Cosmetics Devices and Drugs Regulatory Authority (CDDRA), which is the drug regulator in Sri Lanka, suspended the registration of several biosimilar drugs belonging to Dr Reddy's, Biocon, Wockhardt and Intas Biopharma with immediate effect. The regulator revealed that these companies failed to furnish the documents that have been mandated by the World Health Organisation.
The products that have been suspended, include cancer drug Reditux and an anti-infective used in cancer patients, Grastim, from Dr Reddy's; Biocon's head and neck cancer drug Biomab Egfr and cancer drug Nufil-Safe; Wosulin 30/70, Wosulin R, Wosulin N, cancer drug Wepox-30,000, Wepox 2000 and Wepox 4000, from Wockhardt; Intas biopharma's Neukine, an anti-infective used for cancer patients, an immunological chemotherapy drug, Neupeg, and antiviral used in cancer patient, Intalfa.
Additionally, the Sri Lankan drug regulator also suspended two batches of disposable syringes from Nirma, which is better known for its FMCG products such as detergents.
The regulator said that, "The CDDRA decided to suspend the registration of these similar bio-therapeutic products with immediate effect. The products will be re-evaluated by the committee on similar bio- therapeutic products when the required documents are submitted."
Furthermore, the drug regulator also told the local partners of the companies that they are, "totally responsible for the consequences of use of these products after this notice; therefore, you must ensure that the product is withheld from use immediately, in the entire private sector."