DCGI Gives Nod for Restricted Emergency Use to Itolizumab for moderate to severe COVID-19 patients

February 23, 2021, 3:58:23 AM

DCGI Gives Nod for Restricted Emergency Use to Itolizumab for moderate to severe COVID-19 patients
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Image inside Biocon Park with PPE KIT. Credit: Namkeen ninja

Itolizumab (rDNA origin), a monoclonal antibody which was already approved for severe chronic plaque psoriasis, has now been granted Restricted Emergency Use authorisation by the Drugs Controller General of India (DCGI) based on clinical trials data.

M/s Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under brand name Alzumab. This indigenous drug has now been repurposed for COVID-19.

M/s Biocon has presented the Phase II clinical trial results generated in COVID-19 patients to DCGI. The results of these trials were deliberated in the Subject Expert Committee of DCGI’s office.

Details of the primary endpoint of mortality, other key endpoints of lung function such as improvement in PaO2 and O2 saturation were presented. Key inflammatory markers IL-6, TNFα etc., were presented to have reduced significantly with the drug thereby preventing hyper- inflammation in COVID-19 patients.

After detailed deliberation and taking into account the recommendations of the Committee, DCGI has decided to grant permission to market the drug under Restricted Emergency Use of the drug for the treatment of Cytokine Release Syndrome (CRS) in moderate to Severe Acute Respiratory Distress Syndrome (ARDS) patients due to COVID-19, subject to some conditions like informed consent of patients, a risk management plan, to be used in a hospital set up only etc.

The average cost of treatment with this indigenous drug i.e Itolizumab is also lesser than comparable drugs which are part of the “Investigational Therapies” indicated in the Clinical Management Protocol for COVID-19 of the Ministry of Health and Family Welfare.

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A search and seizure operation conducted by the Income Tax Department in Kolkata

March 11, 2021, 7:31:22 AM

A search and seizure operation conducted by the Income Tax Department in Kolkata

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Kolkata: The Income Tax Department carried out a search and seizure operation on 10.03.2021 on two separate persons based in Kolkata, who are engaged in the handling of cash of others on a commission basis.

Income Tax Department, India, Kolkata

India cabinet approves Pradhan Mantri Swasthya Suraksha Nidhi as a single non-lapsable reserve fund

March 10, 2021, 9:22:05 AM

India cabinet approves Pradhan Mantri Swasthya Suraksha Nidhi as a single non-lapsable reserve fund

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Delhi: Union Cabinet, chaired by the Prime Minister, Narendra Modi has approved the Pradhan Mantri Swasthya Suraksha Nidhi (PMSSN) as a single non-lapsable reserve fund for share of Health from the proceeds of Health and Education Cess levied under Section 136-b of Finance Act, 2007.

India, Finance, India Cabinet

Gurugram DGGI officials arrest 2 men for defrauding exchequer of over Rs 690 crore

March 10, 2021, 7:08:55 AM

Gurugram DGGI officials arrest 2 men for defrauding exchequer of over Rs 690 crore

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Delhi: The ongoing investigation of the Directorate General of GST Intelligence, Gurugram Zonal Unit, were able to arrest two gang members of a fake invoicing syndicate, namely Vikas and Manish, who were involved in GST fraud by way of issuance of fake GST invoices in excess of Rs 4,800 crore which defrauded the exchequer of more than Rs 690 crore.

India, Income Tax Department

The Government takes steps to deal with Casteism and Communalism in the country

March 10, 2021, 6:50:50 AM

The Government takes steps to deal with Casteism and Communalism in the country

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Delhi: The Central Government provides assistance to State Governments/ Union Territory Administrations towards incentive for inter-caste marriages, where one of the spouses is a member of a Scheduled Caste.

India

MCA strikes off 10,113 companies from April to Feb in 2020-2021

March 8, 2021, 1:49:31 PM

MCA strikes off 10,113 companies from April to Feb in 2020-2021

Rep. image, Office

Delhi: Ministry of Corporate Affairs (MCA) administers the Companies Act, 2013 (the Act), Limited Liability Partnership Act, 2008 and Insolvency and Bankruptcy Code, 2016. There is no provision for weeding out the Companies in the Act.

India

Railway Minister Piyush Goyal flags off Tanakpur-Delhi Jan Shatabdi Express special train

February 26, 2021, 11:22:48 AM

Railway Minister Piyush Goyal flags off Tanakpur-Delhi Jan Shatabdi Express special train

Rep. image, Train

Delhi: Minister Piyush Goyal said that the introduction of a new modern, safe, LHB coach Purnagiri Janshatabdi train, will boost tourism and connectivity in the region. The Minister also informed that electrification of Pilibhit- Delhi route was already complete, Tanakpur- Pilibhit route is also complete, only CRS inspection is awaited, soon the entire route (Tanakpur- Delhi) will be fully electrified.

INDIA RAILWAYS, Piyush Goyal

MHA extends guidelines for surveillance, containment and caution states/ UT to strictly enforce SOPs

February 26, 2021, 11:05:15 AM

MHA extends guidelines for surveillance, containment and caution states/ UT to strictly enforce SOPs

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Delhi: Ministry of Home Affairs (MHA) issued an Order today to extend the existing Guidelines for Surveillance, Containment and Caution to remain in force upto 31.03.2021.

Minister of Home Affairs (MHA), India

MoU sign by MCA & CBIC for exchange of data for enhancing the ease of doing business in India

February 25, 2021, 6:07:10 PM

MoU sign by MCA & CBIC for exchange of data for enhancing the ease of doing business in India

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Delhi: Ministry of Corporate Affairs (MCA) and Central Board of Indirect Taxes and Customs (CBIC), Ministry of Finance, signed a Memorandum of Understanding (MOU) for data exchange between the two organisations. The MoU was signed by Manoj Pandey, Joint Secretary, MCA, and B. B. Gupta, ADG, CBIC, in the presence of Rajesh Verma, Secretary, MCA and M. Ajit Kumar, Chairman, CBIC.

MoU, India, MCA, CBIC

India and Pakistan's joint statement on the situation along the Line of Control (LAC)

February 25, 2021, 2:03:51 PM

India and Pakistan's  joint statement on the situation along the Line of Control (LAC)

Delhi: The Director Generals of Military Operations of India and Pakistan held discussions over the established mechanism of hotline contact. The two sides reviewed the situation along the Line of Control and all other sectors in a free, frank and cordial atmosphere.

Line Of Control, LAC, India, Pakistan, Indian Armed Forces

Govt notifies IT (Intermediary Guidelines and Digital Media Ethics Code) Rules 2021

February 25, 2021, 1:44:00 PM

Govt notifies IT (Intermediary Guidelines and Digital Media Ethics Code) Rules 2021

Delhi: Amidst growing concerns around lack of transparency, accountability and rights of users related to digital media and after elaborate consultation with the public and stakeholders, the Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules 2021 has been framed in exercise of powers under section 87 (2) of the Information Technology Act, 2000 and in supersession of the earlier Information Technology (Intermediary Guidelines) Rules 2011.

Digital Media, India