DCGI raises alarm over suspected spurious tocilizumab injections in India

New Delhi, January 11, 2022:

The Drugs Controller General of India (DCGI) has asked 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 activities of distribution and sale of suspected spurious tocilizumab injections, one of the medicines used for management of Covid-19, in the country.

The alarm has been sounded 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 the complaint, 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 Roche 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.

“In view of above facts and ongoing Covid-19 pandemic situation in the country, you 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.

The letter comes at a time when the entire healthcare system is combating the new wave of Covid-19, including the new variant of the pandemic named as Omicron.

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. 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.

Tocilizumab has been advised by ICMR to manage patients with severe Covid-19 symptoms in India. It has time and again reviewed the evidence of use of various drugs including tocilizumab for management of Covid-19 in the country, through the National Task Force (NTF) on the pandemic. It has also discussed the price control mechanisms for high cost medicines such as remdesivir and tocilizumab in the midst of 2020. While an NTF meeting in September 2020, witnessed suggestion on removal of tocilizumab from clinical management protocol, the drug has been used in management of Covid-19.  Pharmabiz