kerala-gets-nod-for-trial-of-plasma-therapy-summary

Context: Kerala has gone a step ahead and won Indian Council of Medical Research’s (ICMR) approval for the clinical protocol exploring the feasibility of an experimental therapy, convalescent plasma transfusion, which may be administered to severe COVID-19 patients.

Background:

The expert committee which is guiding the State’s containment and mitigation strategies against COVID-19 had recommended exploring the plasma therapy following the report in JAMA [Journal of American Medical Association] of a pilot study done by doctors in China.

What is Convalescent Plasma Therapy?

Image source: The Hindu

Importance of the therapy:

  • At present there are no specific antiviral agents which have been found to be effective in the treatment of COVID-19. 
  • Convalescent plasma therapy is not new and has been used by doctors to treat critically ill patients during H1N1, SARS and Ebola. 
  • Strengthening preparedness for next wave: Though, except for a few, most COVID-19 patients in Kerala have not even required ventilatory support, the clinical protocol for administering plasma therapy will strengthen preparedness to treat severe COVID-19 patients during the second or third wave.

The approval of the Drugs Controller General of India and institutional ethics committee would have to be there before the treatment can be administered.

 

Drugs Controller General of India (DCGI) 

  • It is a department of the Central Drugs Standard Control Organization of the Government of India. 
  • It is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India. 
  • Drug Controller General of India, comes under the Ministry of Health & Family Welfare.
  • DCGI sets standards for manufacturing, sales, import, and distribution of drugs in India.

The Central Drugs Standard Control Organisation(CDSCO)

  • CDSCO under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
  • Under the Drugs and Cosmetics Act, 1940, CDSCO is responsible for 
    • approval of Drugs, 
    • conduct of Clinical Trials, 
    • laying down the standards for Drugs, 
    • control over the quality of imported Drugs in the country and 
    • coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.


Source: https://www.thehindu.com/news/national/kerala/covid-19-kerala-gets-nod-for-trial-of-plasma-therapy/article31303701.ece