DCGI Eases Clearance Norms For Foreign Made COVID-19 Vaccine/Drugs In India

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The Drugs Controller General of India (DCGI) announced a relaxation in the testing requirements for the Wuhan virus vaccines.  The decision came at a time when Pfizer and Cipla, two pharmaceutical companies which make COVID-19 vaccines, negotiated in terms of clearance to provide vaccines in India. 

With this, the requirement of testing every batch of foreign made COVID-19 vaccines by the Central Drugs Laboratory (CDL,) Kasauli would be easier.

The decision to ease strict guidelines of testing of the COVID-19 vaccines (made abroad) was taken considering the heavy demand of vaccines in India.

Amid the surge of the Novel Coronavirus (COVID-19) in the second wave,  a huge number of people are infected by the Wuhan virus.  The number of deceased cases also increased, taking the total to more than 3.5 lakh cases.  Besides this, the Nation is also reporting cases of Black Fungus, White Fungus and Yellow Fungus, post the treatment of the Wuhan virus, as side effects. 

Considering all these current issues, the DCGI made certain exemptions in COVID-19 vaccine testing.   The DCGI said, “It has been decided that for approval of COVID-19 vaccines in India for restricted use in emergency situation which are already approved for restricted use by the United States (U.S.,) Food And Drug Administration (FDA,) the United Kingdom (U.K.,) Medicines and Healthcare products Regulatory Agency (MHRA,) the Pharmaceuticals and Medical Devices Agency (PMDA) Japan or which are listed in WHO Emergency Use Listing and which are well established vaccines from the standpoint that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post approval bridging clinical trials and of testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of country of origin (sic.)”

However, scrutiny of their summary lot protocol and certificate of analysis of batch would be undertaken by the CDL, Kasauli.  In addition, before the nationwide roll out, the vaccine would be given to 100 beneficiaries in 7 days, starting soon. 


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