Category: COVID 19

Nov

Covid 19 Booster Dose – Should we consider it?

The idea of booster doses for Covid-19 vaccinations is gaining traction around the world, but India remains a skeptic.

Various countries, including the United States and Israel, have approved these doses. Despite a global lack of vaccines, they were implemented despite countries in Asia and Africa struggling to provide even the first dose to their citizens.

With vaccine supply steadily increasing and research revealing decreasing immunity from immunizations, vulnerable populations may benefit from a fresh injection of antibody-producing sera.

Patients with diabetes, cancer, or AIDS are not only at a higher risk of getting Covid-19, but their medications also impair their immune system. In most circumstances, such individuals’ bodies manufacture fewer disease-fighting antibodies than healthy people’s.

The elderly are at risk as well. Furthermore, this group is particularly vulnerable to severe Covid-19 and mortality. For this group of persons, the World Health Organization advises booster shots as a top priority.

What WHO Says?

For immune compromised individuals, the WHO’s Strategic Advisory Group of Experts suggested “extra doses” in the initial series.

Additional doses, which are essentially an extension of the core vaccine series, are technically distinct from booster doses.

“Immune compromised patients, in particular, frequently fail to generate a protective immunological response following a typical primary series,” according to the WHO. “However, an older adult’s response to a conventional elementary series may be poor.”

A booster, on the other hand, is given when a person’s immunity “has decreased below a rate regarded sufficient in that population” over time, even after receiving the main immunization, according to the WHO.

While there isn’t enough data on falling antibody counts in India, there is enough evidence from around the world to support such doses.

On January 16, India began immunizing its frontline and healthcare personnel, and on March 1, it expanded the program to include the old and immune compromised.

It is estimated that nearly 60.7 percent of the country’s adult population has gotten at least the first dose of the Covid-19 vaccine. According to the ministry, India has the biggest number of beneficiaries (over 181 million) who have received both doses of the vaccine. According to the government’s Cowin dashboard, roughly 90% of them were Covishield and the rest were Covaxin, a homegrown inactivated viral vaccine.

India should consider a more nuanced strategy in the case of healthcare employees, for example.

According to the study’s author, “healthcare staff who work with immune compromised patients may be entitled for increased dosages. “Oncologists, older doctors, and those who are clinically fragile, for example.”

The WHO has objected to countries opting for broad-spectrum booster doses as a strategy.

“In the context of ongoing global vaccine supply constraints, broad-based booster dose administration risks exacerbating vaccine access inequities by driving up demand and diverting supply while priority populations in some countries, or in subnational settings, have not yet received a primary vaccination series,” it said in an interim statement on October 4.

Jul

COVID-19 Emergency Use Authorization Approval Process of US FDA

Emergency Use Authorization Approval Process of US FDA and Treatments Approved for COVID – 19 in the USA

The COVID-19 pandemic has transformed the worldwide regulator performing on approval of medicine as a fast-track process and involved in mutual accord in bringing a drug of importance for the civic. This is a major challenge as the safety and effectiveness of novel therapies are not fully established but ways to bring about a difference to the COVID-19 pandemic response is the need of the hour. Regulators have been go-getting hard in order to bring flexibility in the regulations so as to quicken various approval and adaptive licensing mechanisms. Various institutions have been working together in an alliance to fight this pandemic. The WHO has always promoted such cooperative approaches as these enhance the efficiency of regulatory authorities and also avoids copying. We have focused on details of clinical trials and diverse classes of drugs that are suitable to treat COVID 19 infection.

The nodal agency for the evaluation of safety and efficacy of marketed medicines in the USA is FDA. The Center for Drug Evaluation and Research under FDA reviews drugs, post-marketing surveillance, etc. Pharmaceutical companies will apply for Investigational New Drug (IND) to FDA before commercial marketing for its approval. The application of IND can be investigator IND, treatment IND, or emergency use IND. Investigator IND proposes approved or unapproved drugs for new patient populations or new indications. Emergency use IND permits for emergency use of the experimental pharmaceutical product in an emergency like the COVID-19 pandemic. Treatment IND permits in case of serious or immediately life-threatening conditions.

In New Drug Application (NDA), IND data from animal and human studies will be submitted for approval. NDA application is critically reviewed by FDA reviewers for safety and efficacy in a proposed use, risk-benefit analysis, appropriateness of package inserts, and quality and purity of drug during manufacturing, maintenance, and preservation. The generic drug product receives approval under Abbreviated ANDA. The generic drug product can be safe and effective or a low-cost alternative for the intended disease and marketed with an alternative brand name. Therapeutic biologics application deals with cytokines, monoclonal antibodies, enzymes, thrombolytics, growth factors, immunomodulators, animal-derived proteins, or their recombinant version and other nonvaccine therapeutic immunotherapies. Expedited approval mechanisms for new drug products: in this category, pharmaceutical companies can propose their product under various categories for faster approval for drugs. Different mechanisms for faster approval of drugs are discussed below.

Fast track procedure

Under this, the development and review of drugs is expedited for the treatment of serious or unmet medical conditions. This process enables access to new drugs to the patient. An unmet medical need is defined as “providing a therapy where none exists or providing a therapy which may be potentially better than available therapy,” Drugs under this category will conduct clinical trials using specific biomarkers to prove their efficacy.

Breakthrough therapy

Under this category, drug products fill the gap in the treatment of a serious condition designed for development. The efficacy of these products is derived from the early clinical trial outcomes related to clinically significant endpoints. The drug products under this category receive benefits of fast-track approval along with senior mentors of the FDA from the Phase 1 trial.

Accelerated approval

Under this pathway, a surrogate endpoint is used instead of clinical endpoints to fill an unmet medical need for serious conditions. The pharmaceutical agents who received approval under this category need to complete phase 4 confirmatory trials to the actual benefit for which the drug was approved. In 2020, FDA proposed the withdrawal of hydroxyprogesterone caproate injection from the market for the prevention of recurrent preterm birth. The neonatal outcomes in the treatment group showed that there was no significant improvement.

Priority review

This shortens the duration of the FDA’s review. Priority review is given for serious conditions for which the pharmaceutical product is shown to be safe and effective from the available treatment.

The USFDA along with NIH is involved in Accelerating COVID-19 Therapeutic Interventions and Vaccines for the development of therapeutic candidates and vaccines that can help end the COVID-19 global pandemic.

Table 1– Novel drug approvals for 2020

Novel drug approvals for 2020

A statutory requirement for emergency use authorizations

This is granted when a medical product shows effectiveness in serious or life-threatening diseases. While authorizing emergency use for any product, the probable benefit for the proposed use should outweigh its recognized and potential hazards. As of December 18, 2020, total in vitro diagnostic products was 305 (molecular tests and sample collection devices-233, antibody tests-62, and antigen tests-10), Personal Protective Equipment and Related Devices were 24, and >100 Ventilators and accessories, and Drug and Biological Products were 10. In [Table 1], details of drugs and biologics approved by the USFDA under Emergency Use Authorizations (EUA) are mentioned and in [Table 2] all the COVID – 19 Emergency Use Authorization treatments are described. Shuren and Stenzel observed that molecular diagnostic tests for COVID-19 that received approval under EUA was a reasonable step in accessing diagnostic steps during emergency situation-like the COVID-19 pandemic. Initiatives such as international collaboration, large scale production of small number of well designed, well-developed, and validated tests along with the reliable methods of validation and its test performance are essential for molecular diagnostic test to beat a pandemic like COVID-19.

Hydroxychloroquine sulfate (HCQ) and Chloroquine phosphate (CQ) received EUA for the treatment of COVID-19. However, a scientific review of CQ and HCQ observed that potential benefits outweigh the known (serious cardiac adverse events) and other potential adverse effects.

Table 2– Drug and biological products approved by US Food and Drugs Act under emergency use authorization

Drug and biological products approved by US Food and Drugs Act under emergency use authorization

References :

https://www.ijp-online.com/article.asp?issn=0253-7613;year=2020;volume=52;issue=6;spage=457;epage=466;aulast=Mahalmani#ref20

Jul

COVID 19 clinical trials and emergency marketing approval process in India

COVID 19 clinical trials and emergency marketing approval process in India – Overview

Clinical trial at ProRelix Research

Various institutions have been working together in an alliance to fight this pandemic. The WHO has always promoted such cooperative approaches as these enhance the efficiency of regulatory authorities and also avoids copying. We have focused on details of clinical trials and diverse classes of drugs that are suitable to treat COVID 19 infection.

Coronavirus disease (COVID-19) is a transmittable disease caused by Coronavirus. Most people are infected with the COVID-19 virus would experience mild to moderate respiratory illness and recover without requiring special treatment. Older people with medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop severe illnesses.

The best way to prevent transmission is to be well informed about the spread of the COVID- 19 viruses. The COVID-19 virus spreads mainly through saliva or from the nose when an infected person coughs or sneezes.

The “Emergency use authorization” term is not used in India as per 2019 vaccine approval. A window of “accelerated approval” is used in “special situations”. The Covid-19 pandemic is one such special situation.

The New Drugs & Clinical Trial Rules 2019 in India say, “Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious, or life-threatening condition, or disease of unusual relevance to the country, and addresses unmet medical requirements. “There is a special provision for accelerated approval of vaccine if the phase-II of clinical trial result show “remarkable efficacy”.

According to New Drugs & Clinical Trial Rules 2019 in India: “If the remarkable efficacy is observed with a defined dose in the phase-II clinical trials of the investigational new drug for the un-met medical emergency of serious and life-threatening disease in the country, it may be considered for grant of marketing approval by the central licensing authority based on phase-II clinical trial data.”

The Central Drugs Standard Control Organization (CDSCO) has the authority of granting approval for a vaccine or any other drug rests, headed by the Drug Controller General of India (DCGI), a works under the Union health and family welfare ministry.

COVAXIN Approval:

The DCGI stated that COVAXIN was “developed on Vero cell platform, which has a well- established track record of safety and efficacy in the country and globally”.

The DCGI also stated that COVAXIN developer, Bharat Biotech has shared its “safety and immunogenicity data” from its trials on animals including “challenge studies on non-human primates (Rhesus macaques) and hamsters” with the CSDSCO.

Human clinical trials – The DCGI stated for phase-I and phase-II “demonstrated that the vaccine is safe and provides a robust immune response”. Mentioning phase-III data from around 22,500 participants, the drug regulator said, “the vaccine has been found to be safe as per the data available to date.”

The DCGI stated that “before recommending grant of permission for restricted use of this COVID-19 vaccine in an emergency situation”, the Subject Expert Committee (SEC) of the CSDSCO reviewed the data on the safety and immunogenicity of the COVAXIN.

How India approves vaccines?

The science of vaccine development is universal, the regulatory process for its use and authorization varies in each country. According to New Drugs and Clinical Trial Rules – 2019 of India steps need to be followed for approval of vaccine or drug.

Under usual circumstances, the approval for a Vaccine or New Drug follows the following steps:

Identification and development of suitable vaccine strain that is actually safe and immunogenic.
Full characterization of the vaccine strain by in-vitro
Pre-clinical studies in small animals like mice, rabbits, guinea pigs, etc to work out safety and dose
Preclinical studies in large animals to determine safety, protective efficiency, and potential dose and
Phase 1 human clinical trials on less than 100 individuals to determine the safety of the
Phase 2 human clinical trials on usually less than 1,000 individuals to work out the immunogenicity or immune
Phase 3 human clinical trials to work out the efficacy. The numbers range in several thousand. After the successful completion of phase III studies, regulatory approval is accorded.

“Phase 4 human clinical trials refer to post-marketing surveillance studies, whose data are analyzed for long-term decision-making”. “A key aspect of granting approval to a vaccine or a drug in India is the requirement of clinical trials conducted within the country from phase 1 to Phase 3”.

How “2DG” COVID-19 Tablets Released in Market?

DCGI approves anti-COVID drug developed by DRDO for emergency use. (PTI Photo)

The 2-deoxy-D-glucose drug, the first such medicine in India meant to treat COVID-19 infections. The anti-COVID therapeutic application of the drug has been developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of the DRDO, in collaboration with Dr Reddy’s Laboratories (DRL) in Hyderabad.

The Drugs Controller General of India (DGCI) has approved the oral drug for emergency use as an adjunct therapy in moderate to severe coronavirus patients. The approval of the drug has come at a time when India is grappling with a record-breaking wave of the coronavirus pandemic that has pushed the country’s healthcare infrastructure to its limit.

DRDO Chairman Dr G Satheesh Reddy said that “DRDO and Dr Reddy’s lab had gone through the complete trials and conducted trials across 30 hospitals and on a large number of patients.”

The drug comes in the precipitate form in a sachet, which can be 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 discriminatory accumulation in virally infected cells makes this drug unique.

Clinical trial results have shown that this drug helps in the faster recovery of hospitalized patients and reduces supplemental oxygen dependence. A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients.

In April 2020, during the 1st wave of the pandemic, INMAS-DRDO scientists conducted laboratory experiments with the help of Center for Cellular and Molecular Biology (CCMB), Hyderabad, and found that this molecule works effectively against the SARS-CoV-2 virus and inhibits viral growth.

May 2020 – Based on the results, the CDSCO) allowed Phase-II clinical trial of 2- DG in Covid-19 patients. The DRDO, along with its industry partner DRL, Hyderabad, started the clinical trials to test the safety and efficacy of the drug in Covid-19 patients.

May-October 2020 – Phase-II trials (including dose-ranging), the drug was found to be safe in Covid patients and showed significant improvement in their recovery, the ministry statement said adding, “Phase-II was conducted in six hospitals and Phase IIb (dose-ranging) clinical trial was conducted at 11 hospitals all over the country. Inefficiency trends, the patients treated with 2-DG showed faster symptomatic cure than “Standard of Care (SoC)” on various endpoints. A significantly favorable trend (2.5 days difference) was seen in terms of the median time to achieving normalization of specific vital signs parameters when compared to SoC.”

November 2020 – Phase-3 trials were approved – from December to April. DCGI further permitted the Phase-III clinical trials

May 1 – The drug was approved for emergency use. Dr Reddy’s Labs is engaged in its production. Based on successful results, in November 2020.

December 2020 to March 2021 – The Phase-III clinical trial was conducted on 220 patients between at 27 Covid hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu. The detailed data of phase-III clinical trial was presented to DCGI. In 2-DG arm, a significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42% vs 31%) by Day-3 in comparison to SoC, indicating an early relief from Oxygen therapy/dependence. On May 01, 2021, DCGI granted permission for Emergency Use of this drug as an adjunct therapy in moderate to severe Covid-19 patients.

References:

Nov

It’s YOU!!!! Not the Vaccine that can keep you away from COVID19!!!!

It’s YOU! Not the Vaccine that can keep you away from COVID19!!!

According to WHO, there are 42 vaccine candidates that have reached various phases of the clinical stage of development. “The vaccine is coming soon” is what the general mindset is. The question, however, we are facing currently in these worldwide clinical trials, is that will a vaccine be able to control this novel enemy called COVID-19?

Before we get into finding an answer to this question, let’s have a quick background about how vaccines and medicines are tested in humans in various phases. Phase 1 clinical trials involve 20 – 80 healthy subjects testing whether the product is too toxic for humans, and how it gets metabolized in the body. If that is successful, Phase 2 trial is initiated with even more subjects who have the target infection/disease, thereby giving the idea whether the product being tested is effective as well as safe. However, these results of phase 2 are needed to be confirmed in a larger subject population (thousands of subjects) in Phase 3 clinical trials.

Due to the current situation, the testing and approval process for COVID-19 treatment and vaccine candidates has been fast tracked . An expedited approach would mean, not having enough animal studies data and subsequent clinical trial data. It poses a danger of rushing into a decision on moving forward when there are unclear trends on safety and efficacy. The consequences for the fast track approvals could be the increased number of safety issues and exposure of the patients to unnecessary risks. The fast-tracking of the approval process could lead to an increase in the number of product recalls as is the latest case of the proposed recall of a hydroxyl progesterone caproate injection by USFDA.

USFDA CDER has recently proposed that a certain hydroxyl progesterone caproate injection be withdrawn from the market as the required post-marketing assessment study failed to verify clinical benefit. This hydroxyl progesterone caproate injection had received accelerated approval in 2011 to reduce the risk of preterm birth in women who previously had a spontaneous (unexplained) preterm birth.

Phase 3 trials are as important, if not more, as the phase 2 and phase 1 trials, as a larger subject population studied for a longer duration, generates the necessary amount of safety and efficacy data for a marketing approval. The consideration of the benefits against the risks that the patients are exposed to, is the most important one. The recent experiences of the AstraZeneca – Oxford Vaccine trial and Johnson & Johnson vaccine trial, indicate the same.

Earlier in September, AstraZeneca halted its COVID-19 vaccine trial due to a serious adverse event called transverse myelitis in a patient. Transverse myelitis is a serious condition involving inflammation of the spinal cord. The trials are still paused in India, Brazil, USA and South Africa. In a recent turn of events, Johnson & Johnson have also put their COVID-19 vaccine trial on hold, due to an unexplained illness in a participant. Although more details are not available about the illness at the moment, this does establish that a potentially effective vaccine may still get held up because of its safety complications.

According to a report by USFDA team led by Peter G. Lurie (former associate commissioner for public health strategy and analysis at the Food and Drug Administration), 22 detailed case studies of products with promising Phase 2 results were studied. 14 of these featured Phase 3 studies failed to confirm product effectiveness found in Phase 2, one identified a safety issue and seven could not confirm either safety or effectiveness. Five of these 22 were for vaccines; four failed to demonstrate efficacy in their Phase 3 trials, while the fifth failed to prove either safety or efficacy.

Not all the vaccine candidates that have entered phase 2 or phase 3 are going to be successful in clinical trials. Moreover, there is a high possibility of the successful vaccine being effective against only certain strains of the virus. Mutation of the virus and continuous change of the strains may bring all development work back to square one.

We all are rooting for successful vaccines and treatments for COVID-19. But the challenges of mass production and distribution can be greater than the challenges faced in clinical development. The mass production and subsequent supply chain has to be robust enough to support the huge demand. Governments will have a hard time ensuring its reach to all of its affected citizens. A country as big as India will be facing humongous challenge of keeping the vaccine or the treatment affordable for all its citizens. Even if the government tries to shoulder the load with the pharmaceutical companies and provide the vaccine free of cost or at subsidized rates in government hospitals, the financial burden will be huge on an already burdened economy.

The claims that a successful vaccine is just around the corner and will end the deadly pandemic of coronavirus, may not be as real and practical as it seems to be. There is a long road ahead in this fight; and while it is appropriate for the pharmaceutical industry and the governments to prepare for the advent of a successful vaccine, we must continue following the preventive measures and be prepared to rely on prevention of infection by maintaining social distance and wearing of appropriate face masks in the future as well.

Jul

Beyond COVID-19! Learn to live with New Normal Life

The world is now several months into the “Coronavirus disease (COVID-19)” global pandemic caused by the SARS-CoV-2 virus. As lockdown restrictions slowly begin to lift in certain regions, the pursuit for a safe and effective vaccine against the virus continues – and more research groups are joining the efforts.

Over the course of 2020, the COVID-19 pandemic has caused an unprecedented global crisis, resulting in a devastating death toll and threatening our economic order and societal structures. It started in late 2019 and now has infected more than 200 countries and territories. On 20th June 2020, WHO has reported globally 8,525,042 confirmed cases (Americas- 4,163,813; Europe- 2,509,750; Eastern Mediterranean 878,428; South-East Asia- 560,825; Africa- 208,535; Western Pacific- 203,490) including 456,973 deaths over time.

The COVID-19 (coronavirus) pandemic has substantial health, social, and economic impacts in all countries, rich and poor. It is a sharp reminder that everyone everywhere should have access to quality and affordable health services. We will be living with COVID-19 and its consequences for a long time to come.

Humans are blessed with the clinical research industry. This industry is working around the clock efficiently to find the treatment or cure for COVID 19. There are so many clinical trials that are ongoing in the whole world to get a permanent treatment for this novel coronavirus.

The World Health Organization recognizes that, as of July 9, there are over 140 vaccines in various stages of development. Some are being fast-tracked by regulatory authorities, whilst others remain at the very early stages of pre-clinical testing.

Clinical research industry has escalated the efforts in the development of vaccines against COVID 19. The pharmaceutical industry and research sectors are working to develop the prophylactic vaccine by using different platforms including mRNA, DNA, adenoviral vector, and recombinant protein. We at ProRelix Research are feeling privileged in supporting some of the industrial efforts through our clinical research services.

Health systems has now been facing the dual challenge of responding to the outbreak and maintaining routine services which we have never thought that we would be facing.

COVID-19 demands that we think about global protection and calls for a renewed and urgent focus on specific public health systems to overcome this critical situation that mankind has been facing now. This includes special attention to disease surveillance, laboratories and diagnosis, health information systems, communications about changing behaviors, engagement of communities, and building public trust in the health system.

COVID-19 is a global crisis requiring sustained international solidarity and action. Strengthening our community and health care system has an important role to play in bringing partners together on a joint vision for resilient health systems and priority actions.

Conclusion:

Hopefully, a new norm is emerging where we share information across countries, collectively coordinate resources, and work jointly for the survival of the human race. And more importantly, live on a planet where we don’t mess with nature. Hopefully, we find the balance and make sure that we don’t overconsume what we have given, we spend more time with our families and take care of our health more.

References:

1. https://pubmed.ncbi.nlm.nih.gov/32365466/
2. https://covid19.who.int/
3. https://pubmed.ncbi.nlm.nih.gov/32295814/
4. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novelcoronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments
5. https://www.ayush.gov.in/docs/123.pdf
6. http://apjai-journal.org/wp-content/uploads/2020/03/1.pdf
7. file:///C:/Users/Admin/Downloads/novel-coronavirus-landscape-covid-19-24062020.pdf
8. https://www.who.int/health-topics/international-health-regulations#tab=tab_1
9. https://www.who.int/health-topics/common-goods-for-health#tab=tab_1

Jun

Regulatory Guidance For Clinical Trials Conduct in India During COVID-19 – Public Health Emerg …

Regulatory Guidance For Clinical Trials Conduct in India During COVID-19

– Public Health Emergency

The Central Drugs Standard Control Organization (CDSCO) acknowledges the potential impact of COVID-19 pandemic on the healthcare system and broader society, and the impact it may have on clinical trials and subjects. The present situation across the country may affect approved protocol adherence, regulatory provisions/procedures, trial subjects’ recruitment, laboratory testing, and the supply of investigational products, adverse event reporting, visits, assessments, and many other aspects of clinical trial conduct.

To address the present crisis, CDSCO issued a new notification for conducting clinical trials in India. This guidance covers actions that sponsors of ongoing clinical trials affected by the present pandemic should take to ensure the integrity of the research studies and interpretation of study results while safeguarding the safety of clinical trial participants as a priority. The below guidance will provide further clarity for all parties involved in clinical trials during this time in India.

Guidance on the Management of Clinical Trials during COVID-19 in India:

• As per the New Drugs and Clinical trials Rules, 2019, the sponsor will conduct any clinical trial as per approved clinical trial protocol and other related documents. The trials must comply with the Good Clinical Trial Practice (GCP) Guidelines and the provision of said rules.
• The Central Drug Authority reiterates patient rights, wellbeing, and safety are of paramount importance even at this hour of crisis.
• In the present situation, the sponsor of all ongoing clinical trials needs to coordinate with investigators and respective Ethics Committee (EC) and decide on whether to continue the trial or otherwise in the interest of trial subjects.
• There may be a necessity, in some cases, of protocol amendment or deviation or modification in the procedures of the clinical trials due to unavoidable circumstances. The sponsor, in consultation with the investigator and EC, should assess any such impact and take appropriate decisions whenever necessary. Such changes should ensure the rights, safety, and wellbeing of trial subjects, and the integrity of clinical data remains uncompromised.
• The sponsor needs to maintain complete records of all changes in the clinical trial, including the reasons for any amendments or deviations in the study.
• The sponsor needs to maintain complete records of all changes in the clinical trial, including the reasons for any amendments or deviations in the study.
• Any submissions or reporting related to the above changes in the conduct of clinical trials can be made to CDSCO by email at [email protected] and with a copy marked to the concerned division of CDSCO (HQ).
CDSCO understands the various challenges in the conduct of clinical trials during the COVID-19 pandemic in India and has come up with the new guidance to help conduct clinical trials at this hour of crisis

Reference:

Gazette notification F. No-DCGI/MISC/2020(104), Government of India, Director General of Health Services, Central Drug Standard Control Organization. Dated 30th March 2020.

Cookie	Duration	Description
cookielawinfo-checkbox-analytics	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional	11 months	The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy	11 months	The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.

Covid 19 Booster Dose – Should we consider it?

Covid 19 Booster Dose – Should we consider it?

What WHO Says?

COVID-19 Emergency Use Authorization Approval Process of US FDA