**Summary:**
The Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services, has issued a directive (File No. X110263192021BD) on December 23, 2021, to all State/UT Drug Controllers regarding vigilance over the distribution and sale of suspected spurious Tocilizumab 400mg/20ml injections in India. This action follows a complaint received from Roche Products India Private Limited, the import and marketing authorization holder for Tocilizumab injections (80mg/4ml, 200mg/10ml, and 400mg/20ml) under the brand name "Actemra," which are distributed and marketed by Cipla Ltd.
Roche's distribution partner, Cipla Ltd., received images of a suspected counterfeit pack, and preliminary technical investigation by Roche revealed that the imprinted batch details do not correspond to genuine Roche batches, indicating a spurious product. The sale of such products poses a significant public health hazard due to potential reduced efficacy, severe side effects, and the drug's use in COVID-19 management.
State/UT Drug Controllers are requested to maintain vigilance over the distribution and sale of suspected spurious Tocilizumab injections and report any action taken to the CDSCO.
The Drugs Controller General of India, Dr. V. G. Somani, issued the directive. Copies have been distributed to all Zonal/Sub-Zonal offices of CDSCO, the Indian Drug Pharmaceutical Association Forum, and the CDSCO website. The CDSCO Biological Division can be contacted at Tel No. 01123236965 and Fax No. 01123236973.
Key Entities Referenced
Central Drugs Standard Control Organisation: A central drug regulatory body in India that received a complaint.
Tocilizumab 400mg/20ml Injections: A drug product that is suspected to be spurious, which is the subject of the notification.
Roche Products India Private Limited: The company that filed the complaint with CDSCO regarding suspected spurious Tocilizumab Injections.
India: The country where the spurious drugs are being distributed and sold.
Cipla Ltd.: The distribution partner of Roche Products India Private Limited that received images of the suspected counterfeit pack.
Actemra: Brand name of Tocilizumab Injection 80mg/4m, 200mg/10ml and 400mg/20ml marketed in the country by Ms Cipla Ltd.
COVID19: The disease for the management of which Tocilizumab is being used.
Dr. V. G. Somani: Drugs Controller General India
File No. X-11026/319/2021-BD
Government of India
ae
Directorate General of Health Services
Central Drugs Standard Control Organisation
(Biological Division)
FDA Bhawan, Kotla Road,
New Delhi 110002
Tel No. 011-23236965
Fax No. 011-23236973
Dated: 23.12-2o2r1
To,
All State/UTs Drug Controller
Subject: Vigil on the activities of distribution & sale of suspected spurious
Tocilizumab 400mg/20ml Injections in India — reg
Sir,
CDSCO has received a complaint from M/s Roche Products (India) Private
Limited regarding distribution & sale of suspected spurious Tocilizumab Injections in
the country. The said firm is holder of import and marketing authorization for
Tocilizumab Injection 80mg/4m!, 200mg/10ml and 400mg/20mIi (Brand name -
"Actemra") in the country and the products are distributed and marketed in the
country by M/s Cipla Ltd.
In the complaint, firm has informed that their distribution partner M/s Cipla
Ltd., 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 prelirninary technical investigation performed by M/s 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. The drug (Tocilizumab which is imported by Roche) is currently
being used in COVID-19 management.
In view of above facts and ongoing COVID-19 pandemic situation in the
country, you are requested to keep a watch & vigil on the activities of
distribution/sale of suspected spurious Tocilizumab Injections in India. Action taken
may be informed to this office.
Yours faithfully,
\e
a
(Dr. V. G. Somani)
Drugs Controller General (India)
Copy to —
1) All Zonal/sub-Zonal offices of CDSCO
2) Indian Drug/Pharmaceutical Association Forum
3) Website of CDSCO