DCGI asks States to keep vigil on suspected spurious tocilizumab injections in India

New Delhi : The Drugs Controller General of India (DCGI) informed the State drug controllers, zonal offices of Central Drugs Standard Control Organisation (CDSCO), and the drug manufacturers in the country to keep a watch and vigil on the distribution and sale of suspected spurious tocilizumab injections, one of the medicines used for management of COVID-19.

Following a complaint from Roche Products (India) Pvt Ltd regarding distribution and sale of suspected spurious tocilizumab injections in the country. Roche owns the import and marketing authorisation for tocilizumab injection 80mg/4ml, 200mg/10 ml and 400mg/20ml, under the brand name Actemra, in the country. The products are distributed and marketed by Cipla Ltd.

“In view of above facts and ongoing COVID-19 pandemic situation in the country, you are (State drug controllers) are requested to keep a watch and vigil on the activities of distribution/sale of suspected spurious tocilizumab injections in India. Action taken may be informed to this office,” said the letter issued on December 28, 2021.

In the complaint to DGCI, Roche has informed that their distribution partner Cipla Ltd received images of the suspected counterfeit pack from the complainant who had inquired the firm to know whether the product offered for sale to him was genuine or not.

Upon preliminary technical investigation performed by Roche, it was revealed that the imprinted batch details do not correspond to any genuine batch in the Roche records and are spurious.

"Sale of such spurious products can lead to reduced or no efficacy in the patient and it can cause severe side effects and thereby can cause a serious hazard in the public health," said the DCGI in a letter to the drug controllers of all States and Union territories.

Manufactured by Roche under the brand Actemra/RoActemra, tocilizumab is a monoclonal antibody is claimed to play a key role in activating the inflammatory pathway that contributes to the signs and symptoms of rheumatoid arthritis, is approved in 116 countries. Tocilizumab has been advised by ICMR to manage patients with severe COVID-19 symptoms in India.

It has received Emergency Use Authorisation from the US Food and Drug Administration (FDA) for treatment of COVID-19 in hospitalised adults and children in June, 2021. It has also received an extension of marketing authorisation from the European Commission in December, 2021, to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.