DCGI directs strict vigil on spurious Tocilizumab Injs distribution in India

This alert came in line with the complaint received from Roche Products (India) Private Limited regarding the distribution and sale of suspected spurious Tocilizumab Injections in the country.

Roche Products (India) Private Limited is the holder of the import and marketing authorization for Tocilizumab Injection 80mg/4ml, 200mg/10ml and 400mg/20ml (Brand name - "Actemra") in the country, and the products are distributed and marketed in the country by Cipla Ltd.

Tocilizumab is an interleukin-6 (IL-6) receptor antagonist used to treat Cytokine Release Syndrome (CRS), Systemic Juvenile Idiopathic Arthritis (sJIA), Giant Cell Arteritis (GCA), and Rheumatoid Arthritis (RA). It is currently being investigated whether to treat severely ill patients with COVID-19.

In the complaint, Roche Products (India) Private Limited 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 a 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.

The sale of such bogus products can result in reduced or no efficacy in the patient, as well as severe side effects, posing a serious risk to public health.The drug (Tocilizumab, which is imported by Roche) is currently being used in COVID-19 management.

In view of the above facts and the ongoing COVID-19 pandemic situation in the country, through a recent notification, the DCG has asked all the State/UTs Drug Controllers to keep a watch and vigil on the activities of distribution and sale of suspected spurious Tocilizumab Injections in India.

To view the official notice, click the link below:

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODAyNQ==