Tocilizumab injections suspected spurious formulations: DCGI raises alarm
The Medicines Controller General of India (DCGI) has asked the State medicine regulators, zonal services of Central Medicines Standard Control Organisation (CDSCO), and the medicine manufacturers in the country to keep a watch and surveillance on the conditioning of distribution and trade of suspected spurious tocilizumab injections, one of the drugs used for operation of Covid-19, in the country.
The alarm has been sounded following a complaint from Roche Products (India) Pvt Ltd regarding distribution and trade of suspected spurious tocilizumab injections in the country. Roche owns the import and marketing authorisation for tocilizumab Injection 80mg/ 4 ml, 200mg/ 10 ml and 400mg/ 20 ml, under the brand name Actemra, in the country. The products are distributed and retailed by Cipla Ltd.
In the complaint, Roche has informed that their distribution mate Cipla Ltd entered images of the suspected fake pack from the plaintiff who had inquired the establishment to know whether the product offered for trade to him was genuine or not.
Upon primary specialized disquisition performed by Roche, it was revealed that the ingrained batch details don’t correspond to any genuine Roche batch in the Roche records and are spurious.
Trade of similar spurious products can lead to reduced or no efficacity in the case and it can beget severe side goods and thereby can beget a serious hazard in the public health, said the DCGI in a letter to the medicine regulators of all States and Union homes.
“ In view of above data and ongoing Covid-19 epidemic situation in the country, you’re requested to keep a watch and surveillance on the conditioning of distribution/ trade 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 surge of Covid-19, including the new variant of the epidemic named as Omicron.
Manufactured by Roche under the brand Actemra/ RoActemra, tocilizumab is a monoclonal antibody is claimed to play a crucial part in cranking the seditious pathway that contributes to the signs and symptoms of Rheumatoid arthritis, is approved in 116 countries. It has entered Emergency Use Authorisation from the US Food and Drug Administration (FDA) for treatment of Covid-19 in hospitalised grown-ups and children in June, 2021. It has also entered an extension of marketing authorisation from the European Commission in December, 2021, to include the treatment of Covid-19 in grown-ups who are entering systemic corticosteroids and bear supplemental oxygen or mechanical ventilation.
Tocilizumab has been advised by ICMR to manage cases with severe Covid-19 symptoms in India. It has time and again reviewed the substantiation of use of colorful medicines including tocilizumab for operation of Covid-19 in the country, through the National Task Force (NTF) on the epidemic. It has also bandied the price control mechanisms for high cost drugs similar as remdesivir and tocilizumab in the midst of 2020. While an NTF meeting in September 2020, witnessed suggestion on junking of tocilizumab from clinical operation protocol, the medicine has been used in operation of Covid-19.
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