CDSCO grants approval for making RT-PCR testing kits to detect Mpox in India

Context: The
Central Drugs Standard Control Organisation has granted approval to Siemens
Healthineers for the manufacture of RT-PCR testing kits for detection of Mpox,
a senior Health Ministry official said on Tuesday. The kits will be
manufactured by the company’s molecular diagnostics manufacturing unit in Vadodara,
with a production capacity of one million a year.

Central
Drugs Standard Control Organisation (CDSCO)

·      
About: It is the mso-hansi-theme-font:minor-latin;mso-bidi-font-family:"Times New Roman";
mso-bidi-theme-font:minor-bidi;font-weight:normal;mso-bidi-font-weight:bold">National
Regulatory Authority mso-ascii-theme-font:minor-latin;mso-hansi-theme-font:minor-latin;mso-bidi-font-family:
"Times New Roman";mso-bidi-theme-font:minor-bidi"> (NRA) of
India minor-latin;mso-hansi-theme-font:minor-latin;mso-bidi-font-family:"Times New Roman";
mso-bidi-theme-font:minor-bidi;font-weight:normal;mso-bidi-font-weight:bold">for
the medical devices industry under the provisions of the mso-hansi-theme-font:minor-latin;mso-bidi-font-family:"Times New Roman";
mso-bidi-theme-font:minor-bidi;font-weight:normal;mso-bidi-font-weight:bold">Drugs
and Cosmetics Act. It
works under the mso-ascii-theme-font:minor-latin;mso-hansi-theme-font:minor-latin;mso-bidi-font-family:
"Times New Roman";mso-bidi-theme-font:minor-bidi">Directorate General of Health
Services, mso-ascii-theme-font:minor-latin;mso-hansi-theme-font:minor-latin;mso-bidi-font-family:
"Times New Roman";mso-bidi-theme-font:minor-bidi">Ministry of Health &
Family Welfare, and Government of India.

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Significance: It is responsible for minor-latin;mso-bidi-font-family:"Times New Roman";mso-bidi-theme-font:minor-bidi;
font-weight:normal;mso-bidi-font-weight:bold">overseeing the import, minor-latin;mso-bidi-font-family:"Times New Roman";mso-bidi-theme-font:minor-bidi;
font-weight:normal;mso-bidi-font-weight:bold">manufacture, minor-latin;mso-bidi-font-family:"Times New Roman";mso-bidi-theme-font:minor-bidi;
font-weight:normal;mso-bidi-font-weight:bold">sale, and minor-latin;mso-bidi-font-family:"Times New Roman";mso-bidi-theme-font:minor-bidi;
font-weight:normal;mso-bidi-font-weight:bold">distribution of medical device
in the country. The CDSCO ensures that medical devices comply with safety,
quality, and efficacy standards.

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Objective: Approval
of new drugs, conduct of clinical trials, laying down the standards for drugs,
control over the quality of imported drugs in the country, coordination of the
activities of State Drug Control Organizations.

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Features: mso-hansi-theme-font:minor-latin;mso-bidi-font-family:"Times New Roman";
mso-bidi-theme-font:minor-bidi;font-weight:normal;mso-bidi-font-weight:bold">CDSCO,
along with state regulators, is minor-latin;mso-bidi-font-family:"Times New Roman";mso-bidi-theme-font:minor-bidi;
font-weight:normal;mso-bidi-font-weight:bold">jointly responsible for
the minor-latin;mso-hansi-theme-font:minor-latin;mso-bidi-font-family:"Times New Roman";
mso-bidi-theme-font:minor-bidi;font-weight:normal;mso-bidi-font-weight:bold">grant
of licenses mso-ascii-theme-font:minor-latin;mso-hansi-theme-font:minor-latin;mso-bidi-font-family:
"Times New Roman";mso-bidi-theme-font:minor-bidi"> for certain mso-hansi-theme-font:minor-latin;mso-bidi-font-family:"Times New Roman";
mso-bidi-theme-font:minor-bidi"> mso-hansi-theme-font:minor-latin;mso-bidi-font-family:"Times New Roman";
mso-bidi-theme-font:minor-bidi;font-weight:normal;mso-bidi-font-weight:bold">specialized
categories of critical Drugs such as blood and blood products,
I. V. Fluids, Vaccine, and Sera. The CDSCO minor-latin;mso-bidi-font-family:"Times New Roman";mso-bidi-theme-font:minor-bidi;
font-weight:normal;mso-bidi-font-weight:bold">conducts inspections and audits
to ensure that medical device companies are complying with regulations related
to safety, quality, and efficacy.

Key
points

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Overview: With the
RT-PCR kits, the test results will be available in 40 minutes, which is
significantly faster than traditional methods. This will help reduce the
turnaround time for reporting, leading to quicker responses.

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Reliability
of the test: The IMDX Monkeypox Detection RT-PCR Assay is a
molecular diagnostic test that targets two distinct regions in the viral
genome, spanning both clade I and clade II variants of the virus. This ensures
thorough detection across various viral strains, providing comprehensive
results. This assay is platform-agnostic and seamlessly fits into existing lab
workflows with standard PCR setups, eliminating the need for new instruments.

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Availability
in India: By providing India with advanced assay kits tailored to combat
Mpox, is a proactive stance in battling this disease and prioritising prompt
and precise detection that can truly make a difference in saving lives.