TN can procure, administer foreign vax without local trials

With the State government resolving to invite global tenders for vaccines to inoculate those aged between 18-44, health experts clarified that Tamil Nadu can import drugs and vaccines from other countries directly after obtaining the nod from the Central government.
TN can procure, administer foreign vax without local trials


According to the recent guidelines issued by the Union Health Ministry, vaccines approved by drug regulators from the US, UK, European Union and Japan only can be put to use without local trials.
Several vaccines including Johnson & Johnson, Moderna and Pfizer could not be launched in the country earlier as they sought exemption for local trials in the country, which was mandatory until recently as per the Indian Council for Medical Research (ICMR) guidelines, before they are administered to Indian citizens.
“According to latest Union Health Ministry guidelines, now, there is no mandatory local trial required for the vaccines to be procured and administered on people in India,” said Dr Prabhadeep Kaur, deputy director at National Institute of Epidemiology.
She added that the primary focus should be on vaccinating the people, mainly the ones above the age of 45 years and the more vulnerable to prevent COVID deaths as more cases are being reported.
“Drugs and vaccines can be imported from other countries after they are approved by the Central government.
The State Government will seek approval for the same from the Centre and procure the vaccines from other countries. Local trials for procured vaccines need not be done,” said State Drug Controller K Sivabalan.
Senior officials from the Tamil Nadu Medical Services Corporation say that global tenders towards procurement of the vaccines from other countries is in approval stage and vaccine distribution will be planned throughout the State through TNMSC.

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