Food and Drugs Administration (FDA) Nagpur division has received directives from Dr V G Somani, Drugs Controller General (India), to keep vigil on the activities of distribution and sale of suspected spurious Tocilizumab 400 mg/20ml injections in India. “Acting on the directives, Nagpur FDA has started monitoring the distribution and sale of Tocilizumab injection in the division. Inspections, visits and tracking of the stock have been started in the division,” said FDA Joint Commissioner, Dr P M Ballal, while talking to The Hitavada. Central Drugs Standard Control Organisation (CDSCO) has received a complaint from M/S Roche Products (India) Private Limited regarding distribution and sale of suspected spurious Tocilizumab Injections in the country.

 

The said firm is holder of import and marketing authorisation for Tocilizumab Injection 80 mg/4ml, 200mg/10ml and 400mg/20 ml (Brand Name Actemra) in the country and the products are distributed and marketed in the country by M/S Cipla Limited. Roche in its complaint has informed that their distribution partner Cipla, received images of the suspected counterfeit pack from a 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. Dr Ballal said, “Considering the seriousness of the issue, DCGI felt, sale of such spurious products can lead to reduced or no efficacy in the patient and it could cause severe side effects and thereby could cause a serious hazard in the public health.

 

The drug Tocilizumab which is imported by Roche is currently being used in COVID 19 management.” “In view of the fact and ongoing COVID 19 pandemic situation, Nagpur FDA has started keeping watch and vigil on the activities of distribution/sale of suspected spurious Tocilizumab Injections in the division and the report about action taken would be sent to DCGI,” Dr Ballal added. Like Nagpur FDA 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 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. What is Tocilizumab? 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.