Cipla, which has been looking to commit USD 1 billion into bringing Moderna's single-dose mRNA booster vaccine to India, also requested an exemption.
In a big relief, the Drugs Controller General of India (DCGI) on Tuesday said that foreign COVID-19 vaccines approved by specific countries and World Health Organisation (WHO) for emergency use will not require bridging trials in India. Similar demands have been raised by foreign companies like Pfizer and Cipla for some time.
The move by DCGI will fast-track the import of doses needed to bolster vaccinations as well as clear the way for the entry of vaccines such as Pfizer and Moderna, who had requested the government for waivers like indemnity and post-approval local trials.
Cipla, which has been looking to commit USD 1 billion into bringing Moderna's single-dose mRNA booster vaccine to India, had also requested an exemption from bridging trials in India.
Earlier it required local clinical trials or bridging studies that involve testing the vaccine in Indian participants to assess the safety and immunogenicity in the local population for vaccines developed overseas. The exemptions were given based on the recommendation of the National Expert Group on Vaccine Administration for COVID-19, VG Somani, DCGI said.
DCGI's new exemption policy is limited to COVID-19 vaccines approved in India for restricted use in an emergency situation. Such vaccines have already been approved for restricted use by either USFDA, EMA, UK MHRA, PMDA Japan, or listed in WHO Emergency Use Listing (EUL).
These also include vaccines that are well-established from the standpoint that millions of individuals have already been vaccinated with the said vaccines.
Companies are also being exempted from the requirement that every batch of their vaccine be tested by the Central Drugs Laboratory (CDL) in Kasauli, India. However, that is if provided the vaccine batch has been certified and released by the National Control Laboratory of the country of origin.
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