Cipla Gets DCGI Approval to Import Moderna Vaccination for Emergency Use in India
NEW DELHI:
According to news agency PTI, Mumbai-based pharma company Cipla has got regulatory clearance to import Moderna's Covid-19 Vaccine for limited emergency usage in India.
Dr VK Paul, a member of the NITI Aayog's Health Committee, said on Tuesday that an application submitted from vaccine producer Moderna through an Indian partner has gained emergency use authorization, indicating that the vaccine may be imported soon.
"New drug permission has been granted to Moderna, the first internationally developed vaccine. This new drug permission is for restri cted use,"ANI reported Paul stating this during a news conference on the COVID-19 issue. Paul went on to say that only regulatory permission has been obtained, and that the subject of indemnification is being looked into.
Cipla has asked for compensation if the Moderna vaccine causes any negative side effects or problems.
"There are four vaccines (against COVID-19 ) now Covaxin, Covishield, Sputnik-V and Moderna. We will soon close the deal on Pfizer as well," ANI quotes Paul as saying.
Pfizer CEO Albert Bourla stated last week that the company is nearing final clearance in India for its COVID-19 vaccine. Bourla was reported by news agency ANI as stating, 'I hope very soon we will finalise an agreement with the government.' Pfizer is also seeking legal protection from any potential legal repercussions.
Paul said on Tuesday that the four vaccinations that have been authorised for usage in the country are safe for nursing moms. "Vaccines have no link to infertility," he said.
PTI had previously reported that India's drug regulator DCGI has granted Mumbai-based pharmaceutical giant Cipla permission to import Moderna's COVID-19 vaccine for limited emergency usage in the country, citing official sources.
"This permission is for restricted use in emergency situations in public interest. The firm has to submit 7 days safety assessment of the vaccine in first 100 beneficiaries before rolling out of vaccine for further immunisation programme, according to the approval order," an official said.
Cipla filed the application for permission to import Moderna's vaccine on Monday, citing DCGI notifications dated 15 April and 1 June, which state that if the vaccine is authorised by the US FDA for EUA, it can be awarded marketing authorization without a bridging research. Before the immunisation programme is launched, the first 100 vaccine recipients' safety data must be evaluated.
Furthermore, if the batch/lot is released by the CDL of the nation of origin, the need of testing by the Central Drugs Laboratory (CDL), Kasauli might be waived. However, the laboratory must conduct a summary lot protocol review and document scrutiny prior to batch release in accordance with normal protocols, according to Cipla, according to the DCGI's new amended guidelines.
Moreover, Moderna has informed the government of India via separate communication that the US government has consented to give a specific number of doses of the Moderna vaccine, mRNA-1273, via COVAX to the government of India for use in the country and has filed the dossiers by e-mail.
On June 1, the DCGI agreed to waive batch testing at CDL for foreign-manufactured vaccines that have been approved by international drug authorities such as the US FDA, the UK's MHRA, or the WHO in order to speed vaccine deployment.
In April, the Central Government released comprehensive instructions and aggressively facilitated entrance into India of foreign-made COVID-19 vaccines authorised by the US FDA, EMA, the UK's MHRA, and Japan's PMDA, as well as WHO's Emergency Use Listing.
These vaccinations will not require previous bridging investigations, according to the recommendations. The clause was further changed to exclude well-established vaccines made in other countries from the trial requirement entirely.
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