DCGI Guidelines on Covid-19 vaccine: The Drugs Controller General of India (DCGI) has released new guidelines for pharma companies preparing the COVID-19 vaccine.
DCGI Guidelines on Covid-19 vaccine
The Drugs Controller General of India (DCGI) has released new guidelines for pharma companies preparing COVID-19 vaccine. DCGI has clearly stated that a company producing a COVID-19 vaccine should have at least 50 percent efficiency of the vaccine for the third phase trial, so that it can be widely deployed. This guideline has been issued keeping in mind the safety of patients. Let us know that among the increasing cases of COVID 19 worldwide, more than 150 domestic and foreign companies are working on the vaccine.
According to the new guidelines, pharma companies developing the Corona vaccine will have to provide sufficient data to inform the potential risk of Vaccine-associated Augmented Respiratory Disease (ERD). DCGI has also highlighted in the new guidelines that the corona vaccine should be used in pregnancy and in women with childbearing ability according to vaccination programs.
What is important for vaccine makers
According to the new guidelines for COVID-19 vaccine, the vaccine developers will have to ensure that this well is corrected and continues to be made. Guidelines suggest that a safe and effective vaccine is urgently needed for the prevention of COVID-19. Based on this, the clinical development program for COVID-19 vaccine should be pursued through an adaptive and intuitive approach. At the same time, the potential risk of vaccine-associated ERD should also be taken into consideration.
100 percent efficiency is not possible
ICMR Director-General Dr. Balaram Bhargava said that three things are important for a vaccine – (i) safety, (ii) immunogenicity, and (iii) efficacy. Even, the WHO says that if we can get more than 50 percent efficiency, then it will be an approved vaccine. We never get 100 percent efficiency for respiratory virus. We are aiming for 100 percent efficiency but can achieve 50-100 percent.
Work on 30 vaccines in the country
Health Minister Harsh Vardhan said that work is being done on 30 corona vaccines in the country. Three of these vaccines are in various stages of clinical trials, while four vaccines are in pre-clinical trials. Harshvardhan had said in the Rajya Sabha that India, like other countries, is making all efforts to make vaccines. We hope the vaccine will be available in India early next year.