Govt gives nod for Cipla to import Modern’a Vaccine

Govt gives nod for Cipla to import Modern’a Vaccine

Subject : Science & tech

Context : Mumbai-based pharma company Cipla has received regulator’s approval to import Moderna’s Covid-19 Vaccine for restricted emergency use in India, sources told news agency PTI.

Concept :

• Drugs Controller General of India (DCGI) has granted permission to Cipla to import Moderna’s COVID-19 vaccine for restricted emergency use in the country as per the provisions of the New Drugs and Clinical Trial Rules , 2019 under Drugs and Cosmetics Act, 1940
• This permission is for restricted use in emergency situations in public interest.
• The firm has to submit 7 days safety assessment of the vaccine in first 100 beneficiaries before rolling out of vaccine for further immunisationprogramme, according to the approval order.
• Moderna’s vaccine will be the fourth COVID-19 jab to be available in India after Covishield, Covaxin and Sputnik.

mRNA 1273 :

• mRNA-1273 is the working name of Moderna’s vaccine. It is currently under the aegis of the US National Institute of Allergy and Infectious Diseases (NIAID), a part of the US National Institutes of Health (NIH).
• The mRNA means the messenger RNA. This carries the carries the genetic formula for the coding of a specific protein.
• The mRNA is a molecule that genetically encodes a set of instructions, based on which cells make proteins and send them to various parts of the body.
• Vaccines based on mRNA technology take advantage of normal biological processes of the body to create the desired therapeutic effect.

Central Drugs Standard Control Organisation (CDSCO)

• The CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
• Major Functions:
• Regulatory control over the import of drugs, approval of new drugs and clinical trials.
• Approval of certain licences as Central Licence Approving Authority

Drug Controller General of India(DCGI)

• DCGI is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
• It comes under the Ministry of Health & Family Welfare.