A unique vaccine for birth control and treatment of advanced stage cancers secreting ectopically human chorionic gonadotropin

This article is a tribute and homage to Gerard Chaouat who invited me to contribute this article. My years in France have remained very memorable to me. Reviewed briefly is the vaccine that was made against human chorionic gonadotropin (hCG) to prevent unwanted pregnancy in sexually active women. It has now been developed as a genetically engineered recombinant vaccine and passed onto industry for its production under good manufacturing practices (GMP) conditions for confirmatory trials. The trials have received the approval of the Drugs Controller General of India. The trials have started but have been interrupted by the coronavirus disease 2019 (COVID-19) pandemic. This vaccine is likely to have another highly beneficial application in the treatment of cancers expressing ectopically hCG.

Comparison of regulatory approval process for vaccines development and manufacturing in India & USA

The Vaccine Development is a complex and time-consuming process because of stringent quality assessment procedures. The vaccine is approved for release into the market, a stringent regulatory procedure to assess quality, efficacy and safety must be maintained. The regulation of vaccine in India with the licensing and GMP is controlled by the drug controller general of India (DCGI). The USA regulation was controlled by the USFDA in center biologics evaluation and research committee (CBER) and Biologics license application (BLA). These Authorities are responsible for vaccine regulations in India & USA. The current review articles highlight the comparison of registration process of vaccines in INDIA and USA.

A Systemic Review of Clinical Trial of 2 -deoxyglucose in Treating Covid-19

After sudden outbreak of covid-19 pandemic, to overcome this chaotic situation many drug therapies have been used which includes Chloroquine, Hydroxychloroquine (Antimalarial), Lopinavir and Ritonavir (antiviral), Nafamostat (Sirin protease inhibitor), Famotidine (Antihistamines), Nitazoxanide (Anti-infective), Evermectin (Anti-parasitic), Corticosteroids, Tocilizumab & Sarilumab (Inflammatory cytokine), Fluvoxamine(Anti-depressants), but due to prominent effect of 2-DG it has been extensively used against SARS-CoV-2. It is a glucose molecule which was approved for the emergency treatment in covid-19 pandemic against SARS-CoV-2 by inhibiting glycolysis-The energetic cycle. It shows more highlighting effect with combinational approach. This drug was sanctioned by Drug Controller General of India (DCGI) and has been developed by Institute of medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organization (DRDO), together with Dr Reddy’s Laboratories (DRL), Hyderabad.

A Retrospective observational survey of adverse events following immunization comparing tolerability of covishield and covaxin vaccines in the real world

The COVID-19 vaccination drive is on a boost in India. On 16-January-2021 India has successfully driven the biggest vaccination drive for 300 million priority groups against the coronavirus disease (COVID-19) and rolled out the world's largest vaccination drive to vaccinate around. People were confused about which vaccination to choose and many were unaware of how these two vaccines differ from one other, while the government was working hard to build confidence and encourage people to come forward to take the made-in-India Covid-19 vaccine (COVAXIN and COVISHIELD). However, the result of the first phase and second phase vaccination drive clearly shows that both the Indian vaccines are effective and safe. Since, both the Indian vaccines have received Emergency Use Authorization (EUA) by Drugs Controller General of India (DCGI) in India, the regulatory agency and the manufacturers are keeping a close watch and monitoring on the Adverse event reported following immunization (AEFI) and to allow quick identification and action of any new safety information. A retrospective observational cohort survey was conducted on 75 fully vaccinated volunteers. The data was collected and analyzed. The percentage of The AEFI experienced with COVISHIELD vs COVAXIN during 1st does was 92.45 % vs 77.27 % and with 2nd dose 86.79 % vs 72.72 % respectively. However, no SAE was reported during the survey and almost 20 % of subjects were aware of the AEFI reporting but because of negligence, didn't report. Fever was the most common AEFI experienced in both vaccines. Only 6.66 % of volunteers got an infection with COVID-19 post-vaccination.

A Review on Vaccination Drive for COVID-19 in India

The Covid-19 pandemic is destructing the whole world rapidly and also results in changing the order of human life. Various strategies and efforts are being applied by health experts to fight against the pandemic. Various vaccines are developed by researchers of different countries. The aim for developing the vaccines is to produce Herd immunity i.e. to resist the spread of SARS-CoV-2 virus. 8-12 years are required for the development of vaccine in normal circumstances but in emergency like Covid-19 pandemic vaccines get ready in 10 months by various methods like viral vector vaccines, mRNA based vaccines, inactivated vaccines. In India only three vaccines i.e. Covaxin, Covishield, and Sputnik-V get the Emergency Use Authorisation (EUA) from the drug controller general of India (DCGI). Vaccines vary in their efficacy that’s why only few vaccines get the emergency approval across the globe. These vaccines also show mild to moderate and in some case rare adverse effects. Key words: Pandemic, Vaccines, Covid-19, Herd immunity, Adverse effects.

Clinical view on adverse drug reactions, pharmacovigilance in India and role of clinical pharmacist

An Adverse Drug Reaction (ADRs) is still a challenge in modern healthcare, increasing complication of therapeutics, an elderly populace and increasing multimorbidity. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. This article is having objective of evaluating the pharmacist perception about Pharmacovigilance and ADRs monitoring through ample literature review. In India pharmacovigilance activity begins in 1986 with ADR monitoring system under supervision of drug controller general of India. The prescribed National Pharmacovigilance Program was commence in 2005; with unsuccessful attempt in 1998, and renamed as Pharmacovigilance Program of India (PvPI) in 2010. Adverse drug reactions monitoring has become an essential part to be executed together with other health-care services for a safe use of medicines. Pharmacist can play an important role in evaluation of ADRs. Pharmacist – drug expert- having abundant knowledge of pharmacological action, pharmaco-therapeutics, adverse reactions, and disease pathophysiology, can make the drug therapy safer.

2-Deoxy-d-glucose: from diagnostics to therapeutics

Glucose is the most common source of cellular energy and a substrate for many biochemical processes. Abnormal glucose signalling has been found in many diseases including cancers and inflammatory diseases. A glucose analog, 2-deoxy-D-glucose (2DG) which interferes with the cellular glucose metabolism has shown promising results both as a diagnostic and therapeutic agent in certain diseased conditions such as cancer, cardiovascular diseases, Alzheimer disease, etc. More recently, Viral-infected cells have also been found to increase their glucose uptake and recently Drug Controller General of India (DCGI) has given approval for the therapeutic use of 2DG in managing severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection which has received worldwide attention and has been declared a public health emergency of global concern. An attempt has accordingly been made in this article to review the diagnostic and therapeutic potentials of 2-deoxy-glucose with special emphasis on to its implications in SARS-CoV-2.

Circulating tumor cells demonstrate a positive biomarker in head and neck squamous cell carcinoma (HNSCC) in tobacco consuming population of Bangladesh.

e18011 Background: Tobacco consumption accounts for 1.6 million deaths annually in the South East Asia Region (SEAR). Notably, amongst 10-20% of the global population consuming the betel quid and tobacco, about 81% concentration is in SEAR regions, including India and Bangladesh. The prevalence of HNSCC in these regions is rising alarmingly. For example, HNCs account for 23% of total 156775 cancer incidences in Bangladesh. Liquid biopsy tools are unavailable and expensive for most patients in this region. However, early cancer detection using tumor biomarkers, for example, Circulating Tumor Cells (CTCs) is highly implicated. Furthermore, such biomarkers are being validated and have potential for screening of high-risk patients, such as genetic predisposition, tobacco consumption, etc. We report the first observational study in HNSCC patients in Bangladesh correlating the presence of CTCs to chronic tobacco consumption. Methods: The study involved 70 cancer patients and 10 healthy volunteers (no prior cancer history). 87% of the patients had a specified history of chronic tobacco consumption. CTCs were isolated in 1.5 ml of blood using OncoDiscover Liquid Biopsy Test, which is clinically approved by the Drug Controller General of India, that contains an enriching anti-EPCAM antibody immunomagnetic kit. CTCs are qualified as CK18+, DAPI+and CD45-. Subsequently, CTCs were imaged using Zeiss Axio Observer 7 and quantified for Mean Fluorescence Intensity (MFI) for clinicopathological parameters; age/gender, HNSCC sub-population, and CTC distribution. Results: This is the 1st study on Bangladesh phenotype accounting for the presence of CTCs in HNSCC patients. In this population, 34 males (66%) and 10 females (52%) accounted for 91 CTCs. CTC distribution was 0 to 6 with mean and median ̃ 2.02 and 2, respectively. 25 patients (17 males, 8 females) were negative for any CTCs. Interestingly, 02 patients exhibited CTC clusters indicative of aggressive metastasis in which 01 patient had no prior tobacco usage or family cancer history. There was no correlation between CTC presence in males (66 %) and females (52 %). Healthy volunteer samples exhibited no false positives. The MFI values ranged between 23 and 766, with mean and median MFI values were 157 and 96, respectively, indicative of CK overexpression on CTCs of HNSCC patients. Conclusions: HNSCC patients with a history of chronic tobacco consumption in Bangladesh correlated the presence of CTCs in 64 % of the cases. Prospectively, CTCs may be validated as a biomarker for screening chronic tobacco users in Bangladesh to detect early cancers and HNSCC. Clinical trial information: BMRC/Grants/2018/99 (1-100).

PHYTO-PHARMACEUTICAL DEFINITION UNDER DRUG REGULATIONS, INDIA NEEDS AN URGENT REVIEW

Dear Reader, An Amendment to the Drugs and Cosmetics Regulations to permit scientifically developed plant based leads as drugs named “phytopharmaceuticals”, was notified for the first time in November 2015. This regulation has now been further amended and revised to put it under new drug definitions and provided more provisions for greater clarity in 2019. However, having championed these regulations (as part of the Indian Pharmacopoeia Commission’s Expert Committee on Herbals) for nearly a decade a greater number of drugs should have come out through this route given the scientific capability of the Indian drug sector and academia. However, the only information in the public domain as on date is the approval for conducting human clinical trials of a plant based lead for testing the protective or curative potency of Coculous hirsutus against SARS – CoV-2 given by the Drugs Controller General of India. A purified fraction of the stem of this plant commonly called broom creeper has been tested for sinnococculine markers as the lead drug candidate.

The initial experience of COVID-19 vaccination from a tertiary care centre of India

To the Editor Drugs Controller General of India (DCGI) has approved the Bharat biotech vaccine against COVID-19, which is a locally manufactured inactivated vaccine named ''COVAXIN'' in collaboration with the Indian council of medical research (ICMR) on 3rd January 2021 for emergency use along with the "Covishield" Oxford-AstraZeneca vaccine manufactured locally by the Serum Institute of India... *The Safdarjung COVID-19 Vaccination group: KR Meena (Professor, Paediatrics), U Venkatesh (Assistant Professor, Community Medicine), Pushpa Kumari (Associate Professor, Medicine), Sonal Burman (Specialist, Medicine), Neeraj Kumar Gupta (Professor and Head, Pulmonary Medicine), Nitesh Gupta (Assistant Professor, Pulmonary Medicine), Rohit Kumar (Assistant Professor, Pulmonary Medicine), Swetabh Purohit (Senior resident, Pulmonary Medicine), Arjun Ramaswamy (Senior resident, Pulmonary Medicine)