EMERGENCY USE APPROVAL FOR VIRAFIN

EMERGENCY USE APPROVAL FOR VIRAFIN

Subject : Science & tech

Context: Zydus Cadila on Friday announced that it has received restricted emergency use approval from the Indian drug regulator, Drug Controller General of India (DCGI), for the use of ‘Virafin’, Pegylated Interferon alpha-2b (PegIFN) in treating moderate coronavirus infection in adults.

Concept :

Emergency Use Approval

• There is nothing such as emergency use approval in Indian rules, however the 2019 rules provide for “Accelerated Approval Process” in several situations that would include the one like the current pandemic.
• In such situations, there is a provision for granting approval to a drug that is still in clinical trials provided the product is of meaningful therapeutic benefit.
• Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious, or life-threatening condition, or disease of special relevance to the country, and addresses unmet medical needs.
• A new drug, or a vaccine, can be considered for approval if remarkable effectiveness is reported even from phase-II trials.
• In such cases, additional post licensure studies may be required.
• The approval granted to drugs or vaccines that are still in clinical trials is temporary, and valid only for one year.

Drugs Controller General of India

• Drugs Controller General of India is the head of department of the Central Drugs Standard Control Organization of the Government of India.
• Responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
• DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
• Comes under the Ministry of Health & Family Welfare.
• DCGI lays down the standard and quality of manufacturing, selling, import and distribution of drugs in India.