In 2009, Ranbaxy had to recall about 4,000 cartons of Sotret Isotretinoin through its US-based subsidiary.
According to officials, an additional dose of vaccine is different from a booster dose.
Indian drug firms get a shot in the arm in the $12 bn Australian drug market as the Therapeutic Goods Administration (TGA), Australia agrees to accelerate the drug approval process in that country for Indian players who already have an approved plant and product from one of the stringent regulatory authorities like US, EU or Canada. From current sales of $340 mn, the Indian firms can see a significant upside in sales; felt Dinesh Dua, former chairman of the Pharmaceutical Exports Promotion Council of India (Pharmexcil), and the MD of Nectar Lifesciences. He highlighted that only 12 percent of the Australian drug market is generic, as against 80-90 per cent in the US or EU. Of this $1.5 bn generic drug market in India, Indian companies have a small share.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available in India.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
Sputnik V is the third vaccine India has given the go-ahead to after 'Covishield', developed by Oxford University and AstraZeneca and 'Covaxin', the indigenous vaccine manufactured by Bharat Biotech. Covishield is manufactured by the Serum Institute of India.
"Vaccination is our big weapon in the fight against COVID-19," he said. He added that India is the fastest country globally to reach the landmark of 17 crore doses in 114 days and thanked all the states and UTs for their contribution in achieving this feat.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
Senior Congress leader Anand Sharma on Sunday raised concerns over India's drugs regulator granting permission for restricted use of Bharat Biotech's COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.
The expert committee sought more information from Serum Institute regarding the Oxford-AstraZeneca vaccine.