India’s central drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has issued a clear advisory stating that cosmetic products supplied in injectable form do not fall within the legal definition of cosmetics and are not permitted for use by consumers, professionals, or aesthetic clinics. The clarification comes amid the rising popularity of non-surgical aesthetic procedures promoted as cosmetic treatments in clinics and wellness centres.&nbsp;According to the regulator, cosmetics are legally defined under the Drugs and Cosmetics Act, 1940 as substances intended to be “rubbed, poured, sprinkled or sprayed” on the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.&nbsp;<h2>Injectables Excluded Under Drugs and Cosmetics Act</h2><h2>&nbsp;</h2>The CDSCO notice, issued on May 18, explicitly states: “Products supplied in form of injectable preparation do not fall under the definition of cosmetics. No cosmetic is permitted to be used as injection by consumer/ professionals/ aesthetic clinics.”It further reinforces that cosmetics are strictly intended for external application and cannot be used for treatment purposes. “Cosmetics are only intended to be rubbed, poured, sprinkled or sprayed to human body,” the notice added, emphasising that injectable use falls outside the legal framework governing cosmetics.&nbsp;ALSO READ: <a href="https://www.wionews.com/photos/pakistan-angle-to-cockroach-janta-party-netizens-flag-large-number-of-pak-bangladesh-and-turkey-based-followers-1779363695816">Pakistan angle to ‘Cockroach Janta Party’? Netizens flag large number of Pak, Bangladesh and Turkey-based followers</a>&nbsp;The regulator also warned that misleading labelling, false claims, and the use of prohibited ingredients violate the Drugs and Cosmetics Act and Cosmetics Rules, 2020.&nbsp;

What the law defines as cosmetics

&nbsp;<h2>Misleading Claims and Safety Concerns Flagged</h2>

CDSCO highlighted concerns over misleading advertising and unauthorised cosmetic practices, noting that such violations attract legal action under existing regulations. It also referred to the Bureau of Indian Standards (BIS) list of “generally not recognised as safe (GNRAS)” and restricted ingredients used in cosmetic formulations. The notice states: “As per the provisions of labelling, no cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user of cosmetics.”&nbsp;READ MORE: <a href="https://www.wionews.com/world/elon-musk-s-spacex-plans-10-000-launches-annually-in-5-years-faa-says-more-reliability-is-required-1779353115294">Elon Musk’s SpaceX plans 10,000 launches annually in 5 years; FAA says more reliability is required!</a>&nbsp;It further added that cosmetics cannot be used for treatment purposes by professionals or individuals, reinforcing that their function is limited to “cleansing, beautifying, promoting attractiveness, or altering the appearance” of the human body.&nbsp;<h2>Enforcement and Public Advisory</h2><h2>&nbsp;</h2>The regulator has urged manufacturers, importers, professionals, and consumers to comply with the law and avoid unauthorised use of cosmetic products in injectable form. It warned that violations involving injectable use, prohibited ingredients, or misleading claims would be treated as offences under the Act and Rules. The Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, issued the notice to all stakeholders, including state licensing authorities, and encouraged the public to report violations via official channels. The advisory aims to curb the growing misuse of cosmetic products in aesthetic procedures and ensure consumer safety amid increasing demand for cosmetic enhancements.&nbsp;

According to the regulator, cosmetics are legally defined under the Drugs and Cosmetics Act, 1940 as substances intended to be “rubbed, poured, sprinkled or sprayed” on the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.

India’s central drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has issued a clear advisory stating that cosmetic products supplied in injectable form do not fall within the legal definition of cosmetics and are not permitted for use by consumers, professionals, or aesthetic clinics. The clarification comes amid the rising popularity of non-surgical aesthetic procedures promoted as cosmetic treatments in clinics and wellness centres. According to the regulator, cosmetics are legally defined under the Drugs and Cosmetics Act, 1940 as substances intended to be “rubbed, poured, sprinkled or sprayed” on the human body for cleansing, beautifying, promoting attractiveness, or altering appearance. Injectables Excluded Under Drugs and Cosmetics Act The CDSCO notice, issued on May 18, explicitly states: “Products supplied in form of injectable preparation do not fall under the definition of cosmetics. No cosmetic is permitted to be used as injection by consumer/ professionals/ aesthetic clinics.” It further reinforces that cosmetics are strictly intended for external application and cannot be used for treatment purposes. “Cosmetics are only intended to be rubbed, poured, sprinkled or sprayed to human body,” the notice added, emphasising that injectable use falls outside the legal framework governing cosmetics. ALSO READ: Pakistan angle to ‘Cockroach Janta Party’? Netizens flag large number of Pak, Bangladesh and Turkey-based followers The regulator also warned that misleading labelling, false claims, and the use of prohibited ingredients violate the Drugs and Cosmetics Act and Cosmetics Rules, 2020.

According to the regulator, cosmetics are legally defined under the Drugs and Cosmetics Act, 1940 as substances intended to be 'rubbed, poured, sprinkled or sprayed' on the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.

'No cosmetic permitted as injection under law': India drug regulator CDSCO issues strict warning

The Drugs Controller General of India (DCGI) has approved the restricted emergency use authorisation to the Pune-based Serum Institute of India's coronavirus (COVID-19) vaccine 'Covovax' for children aged between 7 to 12 years, India-based news agencies reported on Tuesday (June 28) citing sources.&nbsp;

Sources said that DCGI also approved India's first indigenously developed mRNA vaccine against COVID-19 manufactured by Gennova Biopharmaceuticals for restricted emergency use for those aged 18 years and above. As per the source, approval has been given with certain conditions.&nbsp;

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Gennova's mRNA vaccine can be stored at 2-8 degrees, an official source told news agency PTI. Notably, other mRNA vaccines require to be stored at sub-zero temperatures.&nbsp;

Previously, DCGI had approved Covovax for restricted use in adults on December 28. The approval was given to the age group 12 to 17 years, subject to certain conditions, on March 9.&nbsp;

Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII had submitted an application to DCGI in this regard on March 16, official sources had said.&nbsp;

The expert panel, in its last meeting in April, had sought more data from the Pune-based firm over the application.&nbsp;

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The Drugs Controller General of India (DCGI) has approved the restricted emergency use authorisation to the Pune-based Serum Institute of India's coronavirus (COVID-19) vaccine 'Covovax' for children aged between 7 to 12 years, India-based news agencies reported on Tuesday (June 28) citing sources.

The Drugs Controller General of India (DCGI) has approved the restricted emergency use authorisation to the Pune-based Serum Institute of India's coronavirus (COVID-19) vaccine 'Covovax' for children aged between 7 to 12 years, India-based news agencies reported on Tuesday (June 28) citing sources. Sources said that DCGI also approved India's first indigenously developed mRNA vaccine against COVID-19 manufactured by Gennova Biopharmaceuticals for restricted emergency use for those aged 18 years and above. As per the source, approval has been given with certain conditions. ALSO READ | Viruses can stay alive in fresh water for three days by attaching to microplastics, says study Gennova's mRNA vaccine can be stored at 2-8 degrees, an official source told news agency PTI. Notably, other mRNA vaccines require to be stored at sub-zero temperatures. Previously, DCGI had approved Covovax for restricted use in adults on December 28. The approval was given to the age group 12 to 17 years, subject to certain conditions, on March 9. Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII had submitted an application to DCGI in this regard on March 16, official sources had said. The expert panel, in its last meeting in April, had sought more data from the Pune-based firm over the application. WATCH | UK medical students train with life-like holographic patients in world-first WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

COVID-19 in India: DCGI gives emergency use nod to Covovax for kids between 7 and 12 years

The Drug Controller General of India (DCGI) granted emergency use authorisation to Sputnik Light in India, making it the first single-dose COVID-19 vaccine to be approved for use in the country.

DCGI grants emergency use permission to single-dose Sputnik Light Covid-19 vaccine

The Drug Controller General of India (DCGI) on Saturday approved Covaxin for emergency use for children above 12 years. The approval is for children between 12 to 18 years of age only. The vaccine is not for children below 12 years.

Drug Controller General of India approves Covaxin for emergency use for children above 12 yrs

&nbsp;Pointing out that over 100 crore doses of Covishield have been supplied in India and many other countries, Serum Institute of India on Monday sought regular marketing approval for the COVID-19 vaccine, which is currently authorized for emergency use in the country, official sources said.

The application sent to the Drugs Controller General of India (DCGI) by Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) comes just a couple of days after Prime Minister Narendra Modi held a meeting with domestic COVID-19 vaccine manufacturers.

If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval. Pfizer-BioNTech's COVID-19 vaccine has received full US FDA approval for use in individuals 16 years of age and older.

The cumulative COVID-19 vaccines administered in the country has exceeded 102.27 crore. Of all the vaccine doses administered, around 90 per cent are Covishield and close to 10 per cent are Bharat Biotech's Covaxin. Less than one per cent of the doses given are Sputnik V.

The Pune-based SII has submitted the final phase 2/3 clinical study report of India with its application for grant of regular market authorization for Covishield, an official source said.

According to the application by Singh, the firm has already submitted phase-3 clinical study results of 24,244 subjects from the UK, Brazil and South Africa on June 8, 2021, to the Central Drugs Standard Control Organisation (CDSCO).

Also, phase-3 clinical study results of 32,379 subjects from the US, Chile and Peru were submitted on July 9.

"In addition to the successful completion of our phase 2/3 clinical study in India, till now more than 100 crore doses of our Covishield has been administered to people in our country and worldwide.

"Such a large-scale vaccination with our Covishield vaccine and containment of COVID-19 infection is in itself a testimony to the safety and efficacy of Covishield," the official source quoted Singh as having stated in the application.

Singh thanked the DCGI office and Subject Expert Committee for granting restricted emergency use approval to Covishield on January 3, because of which, he said, the vaccine played a crucial role in the pandemic control and has been the mainstay of India's Covid inoculation drive.

"It is a matter of pride for us that we have been a part of the world's largest vaccination drive under the dynamic and visionary leadership of our Prime Minister Narendra Modi Ji," Singh is learnt to have said in the application.

Under the kind guidance of Union Health Minister Mansukh Mandaviya, Team Government of India and leadership of CEO Adar C Poonawalla, Team Serum Institute of India has been working relentlessly to manufacture and supply Covishield vaccine for making the world's largest Covid vaccination drive successful, he said.

"In line with our prime minister's clarion call of Aatmanirbhar Bharat, we have made our country Aatmanirbhar for COVID-19 vaccine. In view of the above-mentioned facts, we request for your kind approval for regular market authorization of Covishield," Singh is learnt to have written in the application.

Pointing out that over 100 crore doses of Covishield have been supplied in India and many other countries, Serum Institute of India on Monday sought regular marketing approval for the COVID-19 vaccine, which is currently authorized for emergency use in the country, official sources said.

Pointing out that over 100 crore doses of Covishield have been supplied in India and many other countries, Serum Institute of India on Monday sought regular marketing approval for the COVID-19 vaccine, which is currently authorized for emergency use in the country, official sources said. The application sent to the Drugs Controller General of India (DCGI) by Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) comes just a couple of days after Prime Minister Narendra Modi held a meeting with domestic COVID-19 vaccine manufacturers. If the DCGI grants regular marketing authorisation, Covishied will be the second vaccine in the world to receive such approval. Pfizer-BioNTech's COVID-19 vaccine has received full US FDA approval for use in individuals 16 years of age and older. The cumulative COVID-19 vaccines administered in the country has exceeded 102.27 crore. Of all the vaccine doses administered, around 90 per cent are Covishield and close to 10 per cent are Bharat Biotech's Covaxin. Less than one per cent of the doses given are Sputnik V. The Pune-based SII has submitted the final phase 2/3 clinical study report of India with its application for grant of regular market authorization for Covishield, an official source said. According to the application by Singh, the firm has already submitted phase-3 clinical study results of 24,244 subjects from the UK, Brazil and South Africa on June 8, 2021, to the Central Drugs Standard Control Organisation (CDSCO). Also, phase-3 clinical study results of 32,379 subjects from the US, Chile and Peru were submitted on July 9. "In addition to the successful completion of our phase 2/3 clinical study in India, till now more than 100 crore doses of our Covishield has been administered to people in our country and worldwide. "Such a large-scale vaccination with our Covishield vaccine and containment of COVID-19 infection is in itself a testimony to the safety and efficacy of Covishield," the official source quoted Singh as having stated in the application. Singh thanked the DCGI office and Subject Expert Committee for granting restricted emergency use approval to Covishield on January 3, because of which, he said, the vaccine played a crucial role in the pandemic control and has been the mainstay of India's Covid inoculation drive. "It is a matter of pride for us that we have been a part of the world's largest vaccination drive under the dynamic and visionary leadership of our Prime Minister Narendra Modi Ji," Singh is learnt to have said in the application. Under the kind guidance of Union Health Minister Mansukh Mandaviya, Team Government of India and leadership of CEO Adar C Poonawalla, Team Serum Institute of India has been working relentlessly to manufacture and supply Covishield vaccine for making the world's largest Covid vaccination drive successful, he said. "In line with our prime minister's clarion call of Aatmanirbhar Bharat, we have made our country Aatmanirbhar for COVID-19 vaccine. In view of the above-mentioned facts, we request for your kind approval for regular market authorization of Covishield," Singh is learnt to have written in the application.

Serum Institute of India seeks regular marketing authorisation from DCGI for Covishield

In India schools are open, kids are back in the schools but they are not vaccinated. The Drug Controller General of India (DCGI) is yet to approve the Covaxin rule out for children.

India: Covaxin yet to get DCGI nod for kids

After an expert panel of the Central Drugs Standard Control Organisation (CDSCO) last month recommended granting permission to mix Covaxin and Covishield vaccine doses, India's Drugs Controller General of India (DCGI) has given its approval, reports said.

Reports say the study will be conducted by the Christian Medical College (CMC) in Vellore involving 300 healthy volunteers.

A study in the UK had recently revealed that one dosage of the AstraZeneca vaccine with a dose of the Pfizer-BioNTech vaccine produces strong immunological responses.

The Oxford study said mixed does of produced high concentrations of antibodies against the SARS-CoV2 spike IgG protein.

The study said although two doses of Pfizer were effective but one dose of Pfizer and Oxford's AstraZeneca in "mix and match"&nbsp;combination&nbsp;was equally effective.&nbsp;

India's health ministry had said earlier that mixing vaccines hadn't become the protocol yet with harmful effects not ruled out due to lack of research.

However, VK Paul, Niti Ayog member, had informed&nbsp;there were moves to test mixing of vaccines in the future.&nbsp;

The Indian government last week had given emergency use authorisation to Johnson and Johnson’s single-dose COVID-19 vaccine. The vaccine joined Covishield, Covaxin, Moderna and Sputnik V which were earlier approved in the country.

India on Tuesday had reported 38,353 in 24 hours on Tuesday a rise of over 10,000 from Monday as the country continues to grapple with the virus even as the country's health minister said Russia's Sputnik V shot was 83 per cent effective against the hightly transferable Delta variant.

(With inputs from Agencies) 
&nbsp;

After an expert panel of the Central Drugs Standard Control Organisation (CDSCO) last month recommended granting permission to mix Covaxin and Covishield vaccine doses, India's Drugs Controller General of India (DCGI) has given its approval, reports said.

After an expert panel of the Central Drugs Standard Control Organisation (CDSCO) last month recommended granting permission to mix Covaxin and Covishield vaccine doses, India's Drugs Controller General of India (DCGI) has given its approval, reports said. Reports say the study will be conducted by the Christian Medical College (CMC) in Vellore involving 300 healthy volunteers. A study in the UK had recently revealed that one dosage of the AstraZeneca vaccine with a dose of the Pfizer-BioNTech vaccine produces strong immunological responses. The Oxford study said mixed does of produced high concentrations of antibodies against the SARS-CoV2 spike IgG protein. The study said although two doses of Pfizer were effective but one dose of Pfizer and Oxford's AstraZeneca in "mix and match" combination was equally effective. India's health ministry had said earlier that mixing vaccines hadn't become the protocol yet with harmful effects not ruled out due to lack of research. However, VK Paul, Niti Ayog member, had informed there were moves to test mixing of vaccines in the future. The Indian government last week had given emergency use authorisation to Johnson and Johnson’s single-dose COVID-19 vaccine. The vaccine joined Covishield, Covaxin, Moderna and Sputnik V which were earlier approved in the country. India on Tuesday had reported 38,353 in 24 hours on Tuesday a rise of over 10,000 from Monday as the country continues to grapple with the virus even as the country's health minister said Russia's Sputnik V shot was 83 per cent effective against the hightly transferable Delta variant. (With inputs from Agencies)

India's drug regulator DCGI allows study on mixing Covaxin, Covishield vaccines

India's drug regulator DCGI 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.

Moderna's vaccine will be the fourth COVID-19 jab to be available in India after Covishield, Covaxin and Sputnik. 
"Drugs Controller General of India (DCGI) has granted permission to Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country as per the provisions of the New Drugs and Clinical Trial Rules , 2019 under Drugs and Cosmetics Act, 1940," a source told PTI.

In separate communications, Moderna on June 27 informed DCGI that the US government has agreed to donate a certain number of doses of its COVID-19 vaccine through COVAX to India for use here and sought an approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccines.

On Monday, Cipla, on behalf of the US pharma major, requested the drug regulator for import and marketing authorisation of these jabs.&nbsp;"This permission is for restricted use in emergency situations in public interest. The firm has to submit 7 days safety assessment of the vaccine in first 100 beneficiaries before rolling out of vaccine for further immunisation programme, according to the approval order," an official said.

On Monday, Cipla filed the application seeking permission for import of Moderna's vaccine referring to DCGI notices dated April 15 and June 1 according to which if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunisation programme.

Also, the requirement of testing of every batch by Central Drugs Laboratory (CDL), Kasauli can be exempted if the batch/lot is released by the CDL of country of origin, however, summary lot protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release according to standard procedures, Cipla said referring to the DCGI's new revised rules.

Further, Moderna through a separate communication has informed that the US government has agreed to donate a certain number of doses of the Moderna vaccine, mRNA-1273, through COVAX to the government of India for use in the country and has submitted the dossiers through e-mail.

"This correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines," Moderna said.

On June 1, in a bid to expedite the rollout of vaccines, the DCGI decided to waive testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK's MHRA or the WHO.

The central government in April issued detailed guidelines and proactively eased entry of foreign made COVID-19 vaccines approved by US FDA, EMA, UK's MHRA and Japan's PMDA, and WHO's Emergency Use Listing into India.

According to the guidelines, these vaccines will not need to undergo prior bridging trials. The provision was further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.

India's drug regulator DCGI 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.

India's drug regulator DCGI 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. Moderna's vaccine will be the fourth COVID-19 jab to be available in India after Covishield, Covaxin and Sputnik. "Drugs Controller General of India (DCGI) has granted permission to Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country as per the provisions of the New Drugs and Clinical Trial Rules , 2019 under Drugs and Cosmetics Act, 1940," a source told PTI. In separate communications, Moderna on June 27 informed DCGI that the US government has agreed to donate a certain number of doses of its COVID-19 vaccine through COVAX to India for use here and sought an approval from the Central Drugs Standard Control Organisation (CDSCO) for the vaccines. On Monday, Cipla, on behalf of the US pharma major, requested the drug regulator for import and marketing authorisation of these jabs. "This permission is for restricted use in emergency situations in public interest. The firm has to submit 7 days safety assessment of the vaccine in first 100 beneficiaries before rolling out of vaccine for further immunisation programme, according to the approval order," an official said. On Monday, Cipla filed the application seeking permission for import of Moderna's vaccine referring to DCGI notices dated April 15 and June 1 according to which if the vaccine is approved by the USFDA for EUA, the vaccine can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunisation programme. Also, the requirement of testing of every batch by Central Drugs Laboratory (CDL), Kasauli can be exempted if the batch/lot is released by the CDL of country of origin, however, summary lot protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release according to standard procedures, Cipla said referring to the DCGI's new revised rules. Further, Moderna through a separate communication has informed that the US government has agreed to donate a certain number of doses of the Moderna vaccine, mRNA-1273, through COVAX to the government of India for use in the country and has submitted the dossiers through e-mail. "This correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines," Moderna said. On June 1, in a bid to expedite the rollout of vaccines, the DCGI decided to waive testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK's MHRA or the WHO. The central government in April issued detailed guidelines and proactively eased entry of foreign made COVID-19 vaccines approved by US FDA, EMA, UK's MHRA and Japan's PMDA, and WHO's Emergency Use Listing into India. According to the guidelines, these vaccines will not need to undergo prior bridging trials. The provision was further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.

Cipla gets DCGI nod to import Moderna's Covid vaccine for restricted emergency use in India: Sources

Drugs Controller General of India (DCGI) has given its approval to an anti-Covid drug developed by Defence Research and Development Organisation (DRDO). The drug has been approved for emergency use as an adjunct therapy in moderate to severe coronavirus cases. The drug is to be administered orally.

Clinical trials of the drug 2-deoxy-D-glucose (2-DG) showed that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.

The approval to the drug has come at a time when India has been grappling with a record-breaking wave of coronavirus pandemic that has stretched the country's healthcare infrastructure to its limit.

The announcement of the approval was made by India's health ministry

"In the ongoing second COVID-19 wave, a large number of patients are facing severe oxygen dependency and need hospitalisation.

"The drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells. This also reduces the hospital stay of COVID-19 patients," the ministry said.

It said the anti-COVID-19 therapeutic application of 2-DG drug has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy's Laboratories (DRL) in Hyderabad.

"On May 01, DCGI granted permission for emergency use of this drug as adjunct therapy in moderate to severe COVID-19 patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country," the ministry said in a statement.

Adjunctive therapy is a treatment used together with the primary treatment to assist it.

The drug comes in powder form in a sachet and is taken orally by dissolving it in water.

"It accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique," the ministry said.

In terms of efficacy trends, the ministry said, patients treated with 2-DG showed faster symptomatic cure than the standard of care (SoC) on various endpoints.

"A significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalisation of specific vital signs parameters when compared to SoC," it said.

"Clinical trial results of the drug have shown that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients," it added.

(With inputs from agencies)

Drugs Controller General of India (DCGI) has given its approval to an anti-Covid drug developed by Defence Research and Development Organisation (DRDO). The drug has been approved for emergency use as an adjunct therapy in moderate to severe coronavirus cases.

Drugs Controller General of India (DCGI) has given its approval to an anti-Covid drug developed by Defence Research and Development Organisation (DRDO). The drug has been approved for emergency use as an adjunct therapy in moderate to severe coronavirus cases. The drug is to be administered orally. Clinical trials of the drug 2-deoxy-D-glucose (2-DG) showed that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. The approval to the drug has come at a time when India has been grappling with a record-breaking wave of coronavirus pandemic that has stretched the country's healthcare infrastructure to its limit. The announcement of the approval was made by India's health ministry "In the ongoing second COVID-19 wave, a large number of patients are facing severe oxygen dependency and need hospitalisation. "The drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells. This also reduces the hospital stay of COVID-19 patients," the ministry said. It said the anti-COVID-19 therapeutic application of 2-DG drug has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy's Laboratories (DRL) in Hyderabad. "On May 01, DCGI granted permission for emergency use of this drug as adjunct therapy in moderate to severe COVID-19 patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country," the ministry said in a statement. Adjunctive therapy is a treatment used together with the primary treatment to assist it. The drug comes in powder form in a sachet and is taken orally by dissolving it in water. "It accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique," the ministry said. In terms of efficacy trends, the ministry said, patients treated with 2-DG showed faster symptomatic cure than the standard of care (SoC) on various endpoints. "A significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalisation of specific vital signs parameters when compared to SoC," it said. "Clinical trial results of the drug have shown that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients," it added. (With inputs from agencies)

Anti-Covid drug by India's Defence Research and Development Organisation gets regulator nod

In a major development related to COVID-19 vaccine, Subject Expert Committee (SEC) of Drugs Controller General of India (DCGI) has asked for more safety and efficacy data from Serum Institute of India (SII) and Bharat Biotech for their COVID-19 vaccines.

According to government sources, an SEC meeting was held on Wednesday to review the application submitted by the Pharma majors for emergency use authorisation (EUA) for their vaccine candidates.

"Serum Institute of India has been asked for an updated safety data of phase 2 and 3 clinical trial in the country and immunogenicity data from the clinical trial in the United Kingdom and India. While considering the application of Bharat Biotech Company, the SEC after detailed evaluation recommended that the pharma major should submit the safety and efficacy data from its ongoing phase 3 clinical trial in India for more analysis," a source said.

The application submitted by the Pfizer was not discussed at the SEC meeting as the company has requested for more time for giving its presentation, sources said.

In a major development related to COVID-19 vaccine, Subject Expert Committee (SEC) of Drugs Controller General of India (DCGI) has asked for more safety and efficacy data from Serum Institute of India (SII) and Bharat Biotech for their COVID-19 vaccines.

In a major development related to COVID-19 vaccine, Subject Expert Committee (SEC) of Drugs Controller General of India (DCGI) has asked for more safety and efficacy data from Serum Institute of India (SII) and Bharat Biotech for their COVID-19 vaccines. According to government sources, an SEC meeting was held on Wednesday to review the application submitted by the Pharma majors for emergency use authorisation (EUA) for their vaccine candidates. "Serum Institute of India has been asked for an updated safety data of phase 2 and 3 clinical trial in the country and immunogenicity data from the clinical trial in the United Kingdom and India. While considering the application of Bharat Biotech Company, the SEC after detailed evaluation recommended that the pharma major should submit the safety and efficacy data from its ongoing phase 3 clinical trial in India for more analysis," a source said. The application submitted by the Pfizer was not discussed at the SEC meeting as the company has requested for more time for giving its presentation, sources said.

DCGI expert panel asks SII, BHARAT Biotech to provide more safety, efficacy data for Covid-19 vaccines

There is the good news of coronavirus vaccine trials to be conducted in India. Pharma major Dr. Reddy’s Laboratories and Russia’s sovereign wealth fund RDIF have received approval from the Drugs Controller General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for the Sputnik V vaccine in the country.

Coronavirus Pandemic: Clinical trials for Sputnik V to resume and to be held in India

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