Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das.
With Goods and Services Tax (GST) officers under pressure to exceed the Rs 1-trillion collection mark per month, industry has faced a barrage of recovery notices and summons issued over the last one month across sectors, according to company executives. Industry bodies have claimed harassment by field officers, blocking of input tax credit, cancellation of GST registration, threats of arrest and steep penalties, impacting their working capital and operations. Company executives pointed at an atmosphere of apprehension and fear due to such notices and summons.
The Centre is looking to procure around 1 billion syringes between September and December to support the COVID-19 vaccination drive.
Gennova has also got permission for phase-2 and 3 clinical trials for its lyophilised mRNA vaccine for injection from the subject expert committee advising the Central Drugs Standards Control Organisation, reports Sohini Das.
Government institutions and pharma industry are examining if a 'cocktail' approach to making a multi-variant Covid-19 vaccine works against multiple strains of the ever-mutating virus, reports Sohini Das.
The income tax (I-T) department on Tuesday extended the deadline for filing settlement applications for eligible taxpayers till September 30, as the income tax settlement commission (ITSC) ceased to exist from February 1. This comes amid interim relief provided by some high courts, directing acceptance of applications of settlement even after February 1. To dispose the pending settlement applications as on January 31, the central government has constituted Interim Board for Settlement.
'The kind of tax which will be generated from the second pillar may far outweigh what we may be losing in the first pillar.'
The health system is trying to ensure that it isn't caught by surprise -- the way it was last time. So, hectic preparations are on.
While Lupin is working on a Remdesivir powder for inhalation, Glenmark has tied up with a Canadian Biotech firm for nitric oxide nasal spray that reduces Sars-CoV-2 viral load and thus transmission.
If things go according to plan, the vaccine would be available in the market by the end of this year.
The Union government's offer of settling the retrospective taxation case with Cairn Energy may hinge on Vedanta withdrawing the ongoing arbitration from the Singapore Tribunal on the same issue. The government has offered to refund Cairn Energy Rs 7,900 crore that it had collected under the retrospective tax demand on fulfilment of certain conditions, including withdrawal of pending litigation and furnishing of an undertaking to the effect that no claim for cost, damages, interest, etc., would be filed. This condition is also part of the Taxation Laws (Amendment) Bill, 2021, passed by Parliament recently.
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.
India is not keen to 'bow down' to demands related to indemnity against legal liabilities in case any vaccine recipient develops severe adverse reactions post inoculation.
While Covishield supplies would meet the target of 500 mn doses between August and December, it looks like Covaxin would miss the target of 400 mn unless the partner sites of Bharat Biotech ramp up very rapidly, reports Sohini Das.
But no extra risk after second dose, shows study led and funded by drug maker, reports Sohini Das.
The government may look at areas around Thonnakkal, in Thiruvananthapuram district, for the facility. If successful, this would be one of the few sites of Sputnik V owned by Russian firms outside that country. Shine Jacob and Sohini Das report.
From Covid-19 essentials, such as Vitamin C supplements and thermometers, to bicycles, laptops, and personal weighing scales, demand for certain items galloped during last financial year as the pandemic altered what Indians used on a day-to-day basis. Imports of outdoor sports equipment, handbags for women, and dentures, among others, plummeted. With outdoor activities coming to a halt last year and schools functioning virtually, imports of sports goods witnessed a decline, while inbound shipments of laptops and battery chargers saw a sharp uptick, according to the import data for the financial year 2020-21.
'The Centre is planning to procure five million vials of Remdesivir ahead of the third wave. What's better is that this time, the government is paying us in advance,' said a senior executive of a Mumbai-based pharma player which makes Remdesivir. Sohini Das reports.
Amid economic uncertainties owing to the pandemic, the government's key revenue agency, the Income Tax Department, has close to 400 vacancies at commissioner level and above, affecting its functioning. Seventy-three of the 91 chief commissioner positions are lying vacant, with some for more than a year. Chief commissioner is the second-highest post in the department, below principal chief commissioner, which is at par with secretary in a ministry.
So far, no other vaccine has been approved globally for children below 12 years. Sohini Das reports.