Stopped manufacturing, supply of additional Covishield doses, disclosed all side effects: Serum Institute
AstraZeneca has voluntarily withdrawn the "marketing authorisation" of its Covid vaccine, sold as Covishield in India and Vaxzevria in Europe.
Serum Institute of India, Pune based company that manufactures Covidshield, has reportedly sought protection from liability, according to sources. They have sought the move based on the fact that the same rule should apply to everyone considering that the Centre is mulling granting indemnity against legal proceedings to foreign vaccine makers Pfizer and Moderna prior to their rollout in India.
“All vaccine makers, whether Indian or foreign, should be granted the same protection,” IANS quoted the company reportedly telling the government.
“Not just Serum Institute of India (SII), all the vaccine companies should get indemnity protection against liabilities if foreign companies are granted it,” It further added.
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It is to be noted that the government has not given indemnity to any vaccine companies from severe side effects as of now.
Apart from that, the SII has also applied to the Drug Controller General of India (DCGI) to manufacture the Russian ‘Sputnik V’ Covid-19 vaccine in India. ‘Sputnik V’ is currently being imported by Dr Reddy’s Laboratories.
Meanwhile, COVID-19 vaccines which are globally available can now be administered among the Indian populace without the post-approval clinical trials of every batch of vaccines.
In a notification, the Drugs Controller General of India has stated that vaccines which have been approved for restricted use by US FDA, EMA, UK MHRA and PMDA Japan and under the WHO Emergency Use Listing (EUL) and where millions of individuals have been vaccinated, the requirement of conducting post-approval clinical trials and the requirement of testing every batch of the vaccine by Central Drugs Laboratory (CDL), Kasauli can be exempted.
(With IANS inputs)
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