The Covid-19 vaccine, which has been approved by the World Health Organization (WHO) and some special countries, no longer has to go through the bridging trial phase in India. This was informed by the Drug Controller General of India (DCGI) today. It is said that this decision of DCGI in the wake of reports of shortage of vaccines will help in improving the supply of vaccines from abroad. Many vaccine makers, such as Pfizer and Moderna, put conditions against the government.
NEWS INSIDE BREAKING
Covid-19 Vaccine: Foreign Corona Vaccine Entry in India Now Easier! DCGI granted this exemption. NEWS INSIDE
Which organizations will get the exempted vaccine?
Emergency use listings from USFDA, EMA, UK MHRA, PMDA Japan or WHO i.e. vaccines included in EUL do not require bridging trial. It will also include vaccines that people have already taken doses of. DCGI’s VG Somani said the exemption was based on the recommendations of the National Expert Group of Vaccine Administration (NEGVAC). It is pertinent to mention here that earlier vaccine candidates had to undergo local clinical trials or bridging trials. Under which Indians were vaccinated and many things including security were checked. Notably, the government was accused of delaying the announcement of vaccine orders. “We have been in touch with Pfizer, Johnson & Johnson and Modern since mid-2020,” the government said in defense of its policy. It was reported that the government had exempted well-known foreign vaccine manufacturers from local trials. State governments also accused the government of not supplying adequate vaccines. On which it was said that the Center is delivering sufficient res to the states in a transparent manner as per the prescribed guidelines. Sputnik V is currently being used in India at the Serum Institute’s Covishield, Bharat Biotech’s Covacin and the Doctor Reddy’s Lab.