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The Drugs Controller General of India (DCGI) issued show-cause notices to Amazon, Flipkart Health plus among others over the online sale of drugs in violation of norms

Amazon, Flipkart among 20 e-tailors given notices for selling drugs without licence

The Drugs Controller General of India (DCGI) issued show-cause notices to Amazon, Flipkart Health plus among others over the online sale of drugs in violation of norms

Amazon and Flipkart Health plus are among the 20 online sellers that have been issued show-cause notices by the Drugs Controller General of India (DCGI) over the online sale of drugs in violation of norms.
The show-cause notice dated February 8 by DCGI V G Somani cited a Delhi High Court order dated December 12, 2018, which prohibits online sales of medicines without a licence.
The notice stated that the DCGI had forwarded the order to all state and Union Territories in May and November 2019 and again on February 3 for necessary action and compliance.
"In spite of the same, you are found to be engaged in such activities without a licence," the notice to the online medicine sellers said.
"...You are hereby asked to show cause within 2 days from the date of issue of this notice, why action shall not be taken against you for sale, or stock, or exhibit or offer for sale or distribution of drugs in contravention of the provisions of the Drugs and Cosmetics Act 1940 and rules made thereunder," the notice said.
The notice states that the sale or stock or exhibit or offer for sale or distribution of any drug requires a licence from the concerned state licensing authority and conditions of a licence are required to be complied with by the licence holders.

Serum Institute seeks drug regulator's approval for market authorisation of its Covid vaccine as booster dose

Serum Institute seeks approval for market authorisation of its booster dose: reports

Once approved, Covovax will be administered to all adults who have already taken two doses of Covishield or Covaxin, according to reports. 

Once approved, Covovax will be administered to all adults who have already taken two doses of Covishield or Covaxin, according to reports

The Serum Institute of India (SII) has sought the drug regulator's approval for market authorisation of its Covid-19 vaccine Covovax as a booster dose for those aged 18 years and above who have been administered two doses of Covishield or Covaxin, official sources said on Thursday.
Prakash Kumar Singh, director, government and regulatory affairs, SII, submitted a market authorisation application for the heterologous booster dose of Covovax to the drugs controller general of India (DCGI) on October 17.
It has been learnt that the DCGI's office had raised a few queries, after which Singh submitted a reply, mentioning about the current emerging situation caused by a new coronavirus variant.
Also watch: <a href="https://www.editorji.com/world-news/twitter-ends-enforcement-of-covid-misinformation-policy-1669810205811">Twitter ends enforcement of Covid misinformation policy</a>
Covovax was approved by the DCGI for a restricted emergency use in children aged seven to 11 years in June.
The DCGI had approved Covovax for a restricted use in emergency situations in adults on December 28, 2021 and for those in the 12-17 age group, subject to certain conditions, on March 9.
Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation.
It was granted emergency-use listing by the World Health Organization (WHO) on December 2017, 2020. In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in India and low-and-middle-income countries

Lucknow-based Central Drug Research Institute (CSIR-CDRI) scientists claim to have created a drug to cure dengue. According to reports, a&nbsp;Mumbai-based pharmaceutical major has obtained the Drug Controller General of India (DGCI) approval to carry out human trials of the medicine.&nbsp;
Presently, there is no known drug for the treatment of dengue. Patients are cured based on their symptoms.&nbsp;
Here's all we know about the new drug:&nbsp;
1. The drug which is called AQCH&nbsp;is anti-viral in nature and has been derived from plants. It was succesfully tested in labs and on mice.&nbsp;
2. Human trials will be conducted at one medical college of each following city: Kanpur, Lucknow, Agra, Mumbai, Thane, Pune, Aurangabad, Ahmedabad, Kolkata, Bengaluru, Mangalore, Belgaum, Chennai, Jaipur, Chandigarh, Visakahapatnam, Cuttack, Khurda and Nathdwara.3.&nbsp;At each centre, a total of 100 patients will receive this treatment.
4. A dengue patient should be at least 18 years of age to be eligible for trials. Additionally, infection in the patient should have been confirmed 48 hours before the testing.
5.&nbsp;The patient will be kept in hospital for eight days, during which he will be administered the drug for seven days. He will be kept under observation for 17 days after being given the medicine.

Lucknow based scientists develop anti-viral drug for dengue, human trials soon 

Scientists claim to have developed a new anti-viral drug for dengue and human trials for it start soon. Here's all you need to know about the new drug

All you need to know about the new anti-viral drug for dengue

Lucknow-based Central Drug Research Institute (CSIR-CDRI) scientists claim to have created a drug to cure dengue. According to reports, a&nbsp;Mumbai-based pharmaceutical major has obtained the Drug Controller General of India (DGCI) approval to carry out human trials of the medicine.&nbsp;
Presently, there is no known drug for the treatment of dengue. Patients are cured based on their symptoms.&nbsp;
Here's all we know about the new drug:&nbsp;
1. The drug which is called AQCH&nbsp;is anti-viral in nature and has been derived from plants. It was successfully tested in labs and on mice.&nbsp;
2. Human trials will be conducted at one medical college each in&nbsp;Kanpur, Lucknow, Agra, Mumbai, Thane, Pune, Aurangabad, Ahmedabad, Kolkata, Bengaluru, Mangalore, Belgaum, Chennai, Jaipur, Chandigarh, Visakahapatnam, Cuttack, Khurda and Nathdwara.
3.&nbsp;At each centre, a total of 100 patients will be enrolled for trials.
4. A dengue patient should be at least 18 years of age to be eligible for trials. Additionally, infection in the patient should have been confirmed 48 hours before the testing.
5.&nbsp;The patient will be kept in hospital for eight days, during which he will be administered the drug for seven days. He will be kept under observation for 17 days after being given the medicine.

Scientists claim to have developed a new anti-viral drug for dengue and human trials for it will start soon&nbsp;

Lucknow-based Central Drug Research Institute (CSIR-CDRI) scientists claim to have created a drug to cure dengue. According to reports, a&nbsp;Mumbai-based pharmaceutical major has obtained the Drug Controller General of India (DGCI) approval to carry out human trials of the medicine.&nbsp;
Presently, there is no known drug for the treatment of dengue. Patients are cured based on their symptoms.&nbsp;
Here's all we know about the new drug:&nbsp;
1. The drug which is called AQCH&nbsp;is anti-viral in nature and has been derived from plants. It was successfully tested in labs and on mice.&nbsp;
2. Human trials will be conducted at one medical college each in&nbsp;Kanpur, Lucknow, Agra, Mumbai, Thane, Pune, Aurangabad, Ahmedabad, Kolkata, Bengaluru, Mangalore, Belgaum, Chennai, Jaipur, Chandigarh, Visakahapatnam, Cuttack, Khurda and Nathdwara. 3.&nbsp;At each centre, a total of 100 patients will be enrolled for trials.
4. A dengue patient should be at least 18 years of age to be eligible for trials. Additionally, infection in the patient should have been confirmed 48 hours before the testing.
5.&nbsp;The patient will be kept in hospital for eight days, during which he will be administered the drug for seven days. He will be kept under observation for 17 days after being given the medicine.

The Drugs Controller General of India (DCGI) has given its approval for a study on mixing of Covaxin and Covishield Covid-19 vaccines in India, according to a report by India Today. This study and its clinical trials will be conducted by Christian Medical College, Vellore.
On July 29, a Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) had recommended conducting this study. In its meeting, the expert committee granted permission to CMC, Vellore for conducting the Phase-4 clinical trial covering 300 healthy volunteers, for mixing of Covid-19 vaccines Covaxin and Covishield.
The purpose of this study is to assess whether a person can be given two different vaccine shots -- one each of Covishield and Covaxin -- to complete the vaccination course.
Also watch:&nbsp;Explained: Should you mix and match 2 different Covid-19 vaccines?
The Indian Council of Medical Research in a separate study said mixing doses of Covaxin and Covishield have shown better results in building immunity against the virus causing Covid-19.
Also watch:&nbsp;Mixing and matching of Covaxin and Covishield shows better results: ICMR

DCGI approves study on mixing of Covishield and Covaxin in India

DCGI approves study on mixing of Covaxin and Covishield in India, study&nbsp;will be conducted by CMC Vellore

DCGI approves study on mixing of Covaxin and Covishield in India Study will be conducted by Christian Medical College, Vellore Phase-4 clinical trial will cover 300 healthy volunteers, to study effects Study will assess if a person can be given 2 different vaccine shots ICMR in a separate study said mixing vaccines results in better immunity

The purpose of this study is to assess whether a person can be given two different vaccine shots -- one each of Covishield and Covaxin -- to complete the vaccination course.

The Drugs Controller General of India (DCGI) has given its approval for a study on mixing of Covaxin and Covishield Covid-19 vaccines in India. This study and its clinical trials will be conducted by Christian Medical College, Vellore.
On July 29, a Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) had recommended conducting this study. In its meeting, the expert committee granted permission to CMC, Vellore for conducting the Phase-4 clinical trial covering 300 healthy volunteers, for mixing of Covid-19 vaccines Covaxin and Covishield.
The purpose of this study is to assess whether a person can be given two different vaccine shots -- one each of Covishield and Covaxin -- to complete the vaccination course.
Also watch:&nbsp;<a href="https://www.editorji.com/story/explained-should-you-mix-and-match-2-different-covid-19-vaccines-1627844423681" target="_blank">Explained: Should you mix and match 2 different Covid-19 vaccines?</a>
The Indian Council of Medical Research in a separate study said mixing doses of Covaxin and Covishield have shown better results in building immunity against the virus causing Covid-19.
Also watch:&nbsp;<a href="https://www.editorji.com/story/mixing-and-matching-of-covaxin-and-covishield-shows-better-results-icmr-1628407689289" target="_blank">Mixing and matching of Covaxin and Covishield shows better results: ICMR</a>

Sanofi, which is developing Covid vaccine with UK firm GSK said in a statement that it has received a green signal for the Phase 3 trial in India.

DCGI nod to Sanofi, GSK for global phase 3 trial of their Covid vaccine in India

Sanofi, which is developing Covid vaccine with UK firm GSK&nbsp;said in a statement that it has received a green signal for the Phase 3 trial in India.

Sanofi, which is developing Covid vaccine with UK firm GSK&nbsp;said in a statement that it has received a green signal for the Phase 3 trial in India.

The Drug Controller General of India (DCGI) has approved the global Phase 3 clinical trial of French pharma major Sanofi's <a href="https://www.editorji.com/story/covid-19-india-reported-45-892-fresh-cases-in-24-hours-positivity-rate-below-3-1625720502441" target="_blank">Covid-19</a> vaccine candidate in India.
This would be the first global trial for a Covid-19 vaccine in India.
Sanofi, which is developing the vaccine with UK firm GlaxoSmithKline (GSK) said in a statement that it has received a green signal for the Phase 3 trial in India to "assess the safety, efficacy and immunogenicity&rsquo; of their Covid-19 vaccine candidate.
Prior to taking part in the trial, participants can get vaccinated with any approved Covid-19 if they wish to do so, the company's statement read.
The randomised, double-blind Phase 3 trial will be conducted globally and will include more than 35,000 volunteers, aged 18 and older, across sites in the US, Asia, Africa, and Latin America.
Also Watch&nbsp;<a href="https://www.editorji.com/story/delta-variant-dominates-us-australia-govts-concerned-as-cases-on-the-rise-1625731921409" target="_blank">Delta variant dominates US, Australia; govts concerned as cases on the rise</a>

Biotech startup Moderna&nbsp;became a leading contender in&nbsp;the production of Covid-19 vaccines last year in November&nbsp;as the&nbsp;results of clinical trials revealed that the vaccine was 94.1% effective in Phase 3 trials.With Indian drug regulator giving its nod for the emergency use of vaccine in the country, here are five facts one should know before considering the Moderna&nbsp;vaccine as an option.&nbsp;The vaccine developed&nbsp;by Moderna is an mRNA vaccine, which works differently than a typical vaccine. Instead of preventing infection, the vaccine works to teach the body to better fight the virus, lessening its severity.
Even if the 94.5% efficacy rating, a concern with any vaccine is safety. For Moderna&rsquo;s Covid-19 vaccine, early safety signs are good. Of the participants examined, there have been no major safety concerns reported.&nbsp;Like the Covaxin and Covishield vaccine, two doses will be required of Moderna&rsquo;s jab. You would need to get one shot of the vaccine first, and then come back weeks later to get another shot of the vaccine.A huge win for Moderna&rsquo;s vaccine is that it&nbsp;doesn&rsquo;t require extreme cold storage. This will help greatly with shipping logistics and distribution especially&nbsp;in India where temperature is mostly on the higher side.&nbsp;Based on the evidence so far, the new variants of Coronavirus, including the Delta variant first found in India,&nbsp;do not alter the effectiveness of the Moderna mRNA vaccine.&nbsp;

Moderna Covid-19 vaccine approved in India: 5 things to know

With Indian drug regulator giving its nod for the emergency use of vaccine in the country, here are five facts one should know before considering the Moderna&nbsp;vaccine as an option.&nbsp;

Biotech startup Moderna&nbsp;became a leading contender in&nbsp;the production of Covid-19 vaccines last year in November&nbsp;as the&nbsp;results of clinical trials revealed that the vaccine was 94.1% effective in Phase 3 trials.
With Indian drug regulator giving its nod for the emergency use of vaccine in the country, here are five things one should know before considering the Moderna&nbsp;vaccine as an option.&nbsp;
The vaccine developed&nbsp;by Moderna is an mRNA vaccine, which works differently than a typical vaccine. Instead of preventing infection, the vaccine works to teach the body to better fight the virus, lessening its severity.
 Even if the 94.5% efficacy rating, a concern with any vaccine is safety. For Moderna&rsquo;s Covid-19 vaccine, early safety signs are good. Of the participants examined, there have been no major safety concerns reported.&nbsp;
Like the Covaxin and Covishield vaccine, two doses will be required of Moderna&rsquo;s jab. You would need to get one shot of the vaccine first, and then come back weeks later to get another shot of the vaccine.
A huge win for Moderna&rsquo;s vaccine is that it&nbsp;doesn&rsquo;t require extreme cold storage. This will help greatly with shipping logistics and distribution especially&nbsp;in India where temperature is mostly on the higher side.&nbsp;
Based on the evidence so far, the new variants of Coronavirus, including the Delta variant first found in India,&nbsp;do not alter the effectiveness of the Moderna mRNA vaccine.&nbsp;

With Indian drug regulator giving its nod for the emergency use of vaccine in the country, here are five facts one should know before considering the Moderna&nbsp;vaccine as an option.&nbsp;

Biotech startup Moderna&nbsp;became a leading contender in&nbsp;the production of Covid-19 vaccines last year in November&nbsp;as the&nbsp;results of clinical trials revealed that the vaccine was 94.1% effective in Phase 3 trials. With Indian drug regulator giving its nod for the emergency use of vaccine in the country, here are five facts one should know before considering the Moderna&nbsp;vaccine as an option.&nbsp; The vaccine developed&nbsp;by Moderna is an mRNA vaccine, which works differently than a typical vaccine. Instead of preventing infection, the vaccine works to teach the body to better fight the virus, lessening its severity.
 Even if the 94.5% efficacy rating, a concern with any vaccine is safety. For Moderna&rsquo;s Covid-19 vaccine, early safety signs are good. Of the participants examined, there have been no major safety concerns reported.&nbsp; Like the Covaxin and Covishield vaccine, two doses will be required of Moderna&rsquo;s jab. You would need to get one shot of the vaccine first, and then come back weeks later to get another shot of the vaccine. A huge win for Moderna&rsquo;s vaccine is that it&nbsp;doesn&rsquo;t require extreme cold storage. This will help greatly with shipping logistics and distribution especially&nbsp;in India where temperature is mostly on the higher side.&nbsp; Based on the evidence so far, the new variants of Coronavirus, including the Delta variant first found in India,&nbsp;do not alter the effectiveness of the Moderna mRNA vaccine.&nbsp;

Cipla&nbsp;has got the nod from the DCGI&nbsp;to import Moderna's&nbsp;Covid&nbsp;19 vaccine into India as per reports.&nbsp;Cipla had sought DGCI's permission for importing and marketing authorisation of Moderna&rsquo;s coronavirus vaccine earlier on Tuesday.&nbsp;. It will be the fourth vaccine to be administered in India after Covishield, Covaxin and Sputnik V.Moderna has proposed to launch a single-dose vaccine for the Indian market. Cipla&nbsp;has not yet confirmed a supply agreement with Moderna&nbsp;though the company said the logistics and storage are already in place for importing the vaccine.&nbsp;Moderna&nbsp; has an&nbsp;mRNA-based vaccine with an efficacy rate of 94.1 percent, according to WHO estimate.

Cipla gets nod to import Moderna Covid 19 vaccine

Gear up for vaccine number 4, Drug regulator gives Cipla&nbsp;the nod to import Moderna's&nbsp;Covid&nbsp;19 vaccine

Vaccine No. 4 is here 

Cipla&nbsp;has got the nod from the DCGI&nbsp;to import Moderna's&nbsp;Covid&nbsp;19 vaccine into India as per reports.&nbsp;
Cipla had sought DGCI's permission for importing and marketing authorisation of Moderna&rsquo;s coronavirus vaccine earlier on Tuesday.&nbsp;. It will be the fourth vaccine to be administered in India after Covishield, Covaxin and Sputnik V.
Moderna has proposed to launch a single-dose vaccine for the Indian market. Cipla&nbsp;has not yet confirmed a supply agreement with Moderna&nbsp;though the company said the logistics and storage are already in place for importing the vaccine.&nbsp;
Moderna&nbsp; has an&nbsp;mRNA-based vaccine with an efficacy rate of 94.1 percent, according to WHO estimate.

Drugs Controller General of India&rsquo;s (DCGI) has give the nod to import Moderna's COVID-19 vaccine for restricted emergency use in India.&nbsp;

Cipla&nbsp;has got the nod from the DCGI&nbsp;to import Moderna's&nbsp;Covid&nbsp;19 vaccine into India.&nbsp; Cipla had sought DGCI's permission for importing and marketing authorisation of Moderna&rsquo;s coronavirus vaccine earlier on Tuesday.&nbsp;. It will be the fourth vaccine to be administered in India after Covishield, Covaxin and Sputnik V. Moderna has proposed to launch a single-dose vaccine for the Indian market. Cipla&nbsp;has not yet confirmed a supply agreement with Moderna&nbsp;though the company said the logistics and storage are already in place for importing the vaccine.&nbsp; Moderna&nbsp; has an&nbsp;mRNA-based vaccine with an efficacy rate of 94.1 percent, according to WHO estimate. Read Also: <a href="https://www.edtr.ai/9q00">Why Covishield&nbsp;is not on the vaccine passport list for EU</a>

Covaxin maker Bharat Biotech has submitted Phase III trial data for the coronavirus vaccine to the Drug Controller General of India.

Bharat Biotech submits Covaxin Covid-19 vaccine Phase 3 trial data to drug regulator

Bharat Biotech submits Covaxin Phase 3 trial data to drug regulator

Covaxin maker Bharat Biotech has submitted Phase III trial data for the coronavirus vaccine to the Drug Controller General of India. The drug regulator's subject expert committee is expected to meet today to discuss the results, news agency ANI has reported.
Hyderabad-based Bharat Biotech is also expected to hold a 'pre-submission' meeting on Wednesday with the World Health Organization for international emergency use listing of its vaccine.
An nod from WHO will allow Bharat Biotech to export its vaccines and enable easier international travel for Indian citizens vaccinated with Covaxin. It is not yet recognised as a valid Covid-19 vaccine by foreign governments.

<a href="https://www.editorji.com/story/calf-serum-in-covaxin-govt-and-bharat-biotech-clarify-1623843301997" target="_blank">Covaxin</a> maker Bharat Biotech has submitted Phase III trial data for the coronavirus vaccine to the Drug Controller General of India.
The drug regulator's subject expert committee is expected to meet today to discuss the results, news agency ANI has reported.
Hyderabad-based <a href="https://www.editorji.com/story/150-per-covaxin-dose-not-sustainable-in-long-run-bharat-biotech-1623754822908" target="_blank">Bharat Biotech</a> is also expected to hold a 'pre-submission' meeting on Wednesday with the World Health Organization for international emergency use listing of its vaccine.
An nod from WHO will allow Bharat Biotech to export its vaccines and enable easier international travel for Indian citizens vaccinated with Covaxin. It is not yet recognised as a valid Covid-19 vaccine by foreign governments.
Also Read | <a href="https://www.editorji.com/story/full-data-of-phase-iii-trials-for-covaxin-in-july-bharat-biotech-1623249261226" target="_blank">Full data of phase III trials for Covaxin in July: Bharat Biotech</a>

Zydus Cadila on Friday said that the company plans to make five crore doses of its Covid-19 vaccine by the end of this year, and looking to further scale it up. At present, its vaccine candidate is in the phase 3 clinical trial in India. Zydus Cadila was the second Indian company to receive an approval to start vaccine trial in the country.
Dubbed as ZyCoV-D, it will be the first Made-in-India DNA vaccine candidate against coronavirus. The drugmaker will submit the trial results to the regulator by the end of this month. 
Sharvil Patel, managing director (MD) of Zydus Group told CNBC TV18 in an interview, that they are still on track for May-end submission to the drug regulator once they have trial data about the efficacy of the drug, following which they will file for an emergency use authorisation.

Zydus Cadila to produce 5 crore Covid vaccine doses by year-end

Zydus Cadila&nbsp;plans to produce 5 crore Covid vaccine doses by year-end, will send trial results to regulator soon

Zydus Cadila&nbsp;plans to make 5 crore&nbsp;vaccine doses by December
Zydus' vaccine candidate currently in phase 3 clinical trials
Zydus Cadila was the second Indian firm to get approval
ZyCoV-D will be the first made-in-India DNA vaccine
Drugmaker will submit trial results to DCGI&nbsp;by end of month
&nbsp;

Zydus Cadila on Friday said that the company plans to make five crore doses of its Covid-19 vaccine by the end of this year, and looking to further scale it up. At present, its vaccine candidate is in the phase 3 clinical trial in India. Zydus Cadila was the second Indian company to receive an approval to start vaccine trial in the country.
Dubbed as ZyCoV-D, it will be the first Made-in-India DNA vaccine candidate against coronavirus. The drugmaker will submit the trial results to the regulator by the end of this month. 
Sharvil Patel, managing director (MD) of Zydus Group told CNBC TV18 in an interview, that they are still on track for May-end submission to the drug regulator once they have trial data about the efficacy of the drug, following which they will file for an emergency use authorisation.

Covaxin, Bharat Biotech's vaccine, cleared for Phase 3 trials

Covaxin, the coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has been cleared for the third phase of clinical trials.
The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission.
The study would cover 28,500 subjects above the age of 18, and would be conducted in 19 sites - including Delhi, Mumbai, Patna and Lucknow.
Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials.

Covaxin & Bharat Biotech's vaccine, cleared for Phase 3 trials

Covaxin, the coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has been cleared for the third phase of clinical trials.
The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission.
The study would cover 28,500 subjects above the age of 18, and would be conducted in 19 sites - including Delhi, Mumbai, Patna and Lucknow.
Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials.

Serum Institute gets nod to resume Covid vaccine trials

Drugs Controller General of India on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford Covid-19 vaccine candidate

Drugs Controller General of India on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford Covid-19 vaccine candidate. The DCGI, Dr V G Somani, has however, put certain conditions like taking extra care during screening, providing additional information in informed consent to be followed during the trials. The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford Covid-19 vaccine in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of "an unexplained illness" in a volunteer.

New Delhi, PTI: Drugs Controller General of India (DCGI) Dr V G Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford Covid-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial.
The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be "scrupulously" followed by Serum Institute of India (SII).
SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford Covid-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ''an unexplained illness'' in a participant in the study.
On Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority's (MHRA) confirmed that the trials were safe.
SII, which has partnered with AstraZeneca for manufacturing the vaccine candidate for Covid-19, on Tuesday submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested for permission to restart enrolment in the clinical trial.
According to Tuesday's order issued by DCGI, the DSMB, UK, recommended that the investigators recommence all immunization in their clinical trials subject to certain conditions.
DSMB, India, also has recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to certain conditions.
According to the order, SII has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants.

Serum India told to halt recruitment for vaccine trials

India's drug regulator has directed Serum Institute of India to suspend recruitment of new volunteers for phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate

India's drug regulator has directed Serum Institute of India to suspend recruitment of new volunteers for phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate. The directive came in the backdrop of pharma giant AstraZeneca pausing the trials in other countries. The DCGI on Friday also directed Serum Institute to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report. The drugmaker&nbsp;had on Thursday hit a pause after AstraZeneca put the trials on hold following an unexplained illness in a volunteer in the UK.

New Delhi, PTI: Drugs Controller General of India (DCGI) has directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate in the backdrop of pharma giant AstraZeneca pausing the trials in other countries.
In an order, a copy of which has been accessed by PTI, DCGI Dr V G Somani on Friday also directed Serum Institute of India (SII) to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
Somani also asked the firm to submit clearance from Data and Safety Monitoring Board (DSMB) in the UK as well as in India to obtain clearance from his office (DCGI) prior to resumption of future recruitment in the trial. The central drug regulator DCGI had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries and also for not submitting casualty analysis of the "reported serious adverse events".
Following which the Pune-based firm, which has partnered with the British-Swedish biopharmaceutical giant AstraZeneca for manufacturing the Oxford vaccine candidate, on Thursday said it is pausing the clinical trials in India.
Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study. "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials," SII said in a statement on Thursday. According to the DCGI's order issued on Friday, the SII in its reply stated that DSMB has noted no safety concerns from the Indian study (part 1-phase-2 study) with the first dose and seven days post vaccination safety data. In its reply, SII also stated that DSMB further recommended "to pause further enrolment into the study until ongoing investigations of SAE reported in the UK study is completed and the sponsor and the UK DSMB are satisfied that it doesn't pose any safety concerns".
"In the view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India, in exercise of the powers vested under Rule 30 of the New Drugs and Clinical Trials Rules, 2019, direct to you suspend any new recruitment in the phase 2 and 3 clinical trial till further orders," the order read.
"Increase the safety monitoring of the subjects already vaccinated with the vaccine under trial and submit the plan and report," the order further stated.

Oxford vaccine India trial on hold after DGCI notice

Phase 2 of Covid-19 trials being conducted across 17 sites in India have now been paused till further instructions from the regulator.

Serum pauses COVID vaccine trials till further DGCI instructions

Phase 2 of Covid-19 trials being conducted across 17 sites in India have now been paused till further instructions. &nbsp;DCGI on Wednesday issued a show-cause notice to Serum Institute of India for not informing about AstraZeneca suspending the clinical trials of the Oxford vaccine candidate in other countries, and also for not submitting casualty analysis of the "reported serious adverse events".&nbsp;&nbsp;
Following a scathing show-cause notice from the drug regulator, the Serum Institute of India has paused trials till further instructions from the Drug Controller General of India.

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