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DCGI gives approval to Pfizer and Moderna Corona Vaccine; No need of bridging trials
This move of DCGI has cleared the way for foreign vaccines like Pfizer and Moderna to come to India.
New Delhi: DCGI has further simplified the access of foreign vaccines like Moderna, Pfizer to increase the import of vaccine in the country. The Drug Controller General of India has said that companies will no longer need bridging trials in India in an effort to accelerate the import of vaccines approved by countries and WHO for emergency use.
Approval to foreign vaccines:
This move of DCGI has cleared the way for foreign vaccines like Pfizer and Moderna to come to India. Vaccine companies had requested the government for exemption from local trials. DGCI said that it has decided to exempt these companies from post-launch bridging trials. In a letter to DGCI, VG Somani said that this decision has been taken due to the need for vaccination in India.
No need of Bridging Trials:
Vaccines for COVID-19 vaccine in India will be approved for restricted use in emergency situations, which have already been approved for emergency use by US FDA, EMA, UK MHRA, PMDA Japan. Apart from this, the vaccines which are included in the WHO's Emergency Use List (EUL) and which have already been administered to millions of people.After approval of clinical trial requirement and Central Drugs Laboratory's requirement of testing each batch of vaccine (CDL), Kasauli can be exempted if the vaccine batch/lot is certified by the National Control Laboratory of the country of origin.
Sputnik light will come to India soon:
The single-dose corona vaccine Sputnik Light is likely to be launched in India soon. Sources said that applications seeking regulatory approval for the 'Jab' are expected to be filed soon. Dr. Reddy's is in talks with the Government of India to bring Russia's 'Sputnik Light Vaccine' to India. Sputnik Lite could become the first single-dose vaccine to be launched in India.
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