One of the most significant medical advancements in human history is the development of vaccines. Progress in vaccine development has always been greatly influenced by scientific human innovation. The main objective of vaccine development would be to acquire sufficient evidence of vaccine effectiveness, immunogenicity, safety, and/or quality to support requests for marketing approval. Vaccines are biological products that enhance the body’s defenses against infectious diseases. From the first smallpox vaccine to the latest notable coronavirus disease 2019 nasal vaccine, India has come a long way. The development of numerous vaccines, driven by scientific innovation and advancement, combined with researcher’s knowledge, has helped to reduce the global burden of disease and mortality rates. The Drugs and Cosmetics Rules of 1945 and the New Drugs and Clinical Trials Rules of 2019 specify the requirements and guidelines for CMC (chemistry, manufacturing, and controls) for all manufactured and imported vaccines, including those against coronavirus infections. This article provides an overview of the regulation pertaining to the development process, registration, and approval procedures for vaccines, particularly in India, along with their brief history.

INTRODUCTIONThis study aimed to compare the effects of the two most commonly prescribed atypical antipsychotics, olanzapine and risperidone, on fasting blood sugar and serum lipid profile of the recipients.

METHODSA randomised, comparative, open clinical study was conducted on 60 schizophrenic patients. The patients were divided into two groups, one receiving olanzapine and the other receiving risperidone. The patients were assessed for changes in fasting blood sugar and serum lipid profile (triglycerides [TG], high-density lipoprotein [HDL], low-density lipoprotein [LDL], very-low-density lipoprotein [VLDL] and total cholesterol) eight weeks after starting treatment. The number of patients positive for fasting blood sugar and lipid profile criteria of metabolic syndrome was calculated by applying the modified National Cholesterol Education Programme Adult Treatment Panel III guidelines (NCEP ATP III) criteria at eight weeks.

RESULTSPatients treated with olanzapine showed a highly significant increase in the observed parameters, whereas those treated with risperidone showed a significant increase in fasting blood sugar, HDL and LDL levels, and a highly significant increase in other parameters. Intergroup comparison was insignificant except for TG, VLDL and total cholesterol levels. More men as compared to women fulfilled the NCEP ATP III criteria for metabolic syndrome in both groups.

CONCLUSIONOlanzapine has a higher propensity to cause derangement of some parameters of lipid profile than risperidone. These parameters include TG, VLDL and total cholesterol levels.

Adolescent ; Adult ; Antipsychotic Agents ; pharmacology ; Benzodiazepines ; pharmacology ; Blood Glucose ; drug effects ; Cholesterol ; blood ; Female ; Humans ; Lipids ; blood ; Lipoproteins, HDL ; drug effects ; Lipoproteins, LDL ; blood ; Lipoproteins, VLDL ; drug effects ; Male ; Metabolic Syndrome ; complications ; diagnosis ; Reproducibility of Results ; Risperidone ; pharmacology ; Schizophrenia ; blood ; drug therapy ; Triglycerides ; blood

STUDY DESIGN: Prospective, randomized, double blind, placebo-controlled study.PURPOSE: To compare clonidine and pregabalin with placebo for the attenuation of postoperative pain after thoracolumbar spinal surgery and instrumentationOVERVIEW OF LITERATURE: Spine surgery is associated with moderate to severe postoperative pain that needs to be controlled to improve patient’s outcome. Alpha 2 agonists (e.g., clonidine) and gabapentenoids (e.g., pregabalin) are successfully used as part of a multimodal analgesic regimen.METHODS: Total 75 patients were enrolled and randomly allocated into three groups. Group P received pregabalin (150 mg), group C received clonidine (150 mcg), and group N received placebo 90 minutes preoperatively. A standard anesthesia protocol comprising fentanyl, thiopentone, vecuronium, nitrous oxide, and oxygen in isoflurane was used for all patients. Postoperative recovery profile, pain, time for first analgesic, 24-hour analgesic requirement, sedation, and hemodynamic parameters were noted.RESULTS: Recovery profile was similar in all three groups; however, the patients in group P and C were more sedated (p<0.05). Group N patients had a higher Visual Analog Scale (VAS) score (p<0.05) and the time for first analgesic was also lower (p=0.02). Postoperative (24-hour) analgesic requirement was maximum in group N, followed by that in group C and group P. The VAS score was highest in the control group; however, after 12 hours, it was similar in all groups.CONCLUSIONS: Postoperative pain and analgesic requirement is significantly attenuated by preoperative administration of a single dose of clonidine (150 mcg) or pregabalin (150 mg); pregabalin was more effective. Thus, their use offers a reasonable strategy for pain management in patients undergoing spine surgery.
Analgesics ; Anesthesia ; Clonidine ; Fentanyl ; Hemodynamics ; Humans ; Isoflurane ; Nitrous Oxide ; Oxygen ; Pain Management ; Pain, Postoperative ; Pregabalin ; Prospective Studies ; Spine ; Thiopental ; Vecuronium Bromide ; Visual Analog Scale

AIMTo evaluate the effects of tamoxifen citrate on gene expression during nuclear chromatin condensation in male rats.

METHODSThe effects of an oral dose of 0.4 kg/(kg.d) tamoxifen citrate on rates of in vitro chromatin decondensation, acridine orange (AO) dye uptake, concentration of thiol-groups, levels and/or expression of transition proteins 1, 2 (TP1, TP2), protamine 1 (P1), cyclic AMP response element modulator-tau (CREMtau), androgen-binding protein (ABP) and cyclic adenosine 3',5' monophosphate (cAMP) were evaluated after 60 days of exposure in adult male rats. Controls received the vehicle.

RESULTSTamoxifen citrate enhanced the rates of chromatin decondensation, increased AO dye uptake and reduced free thiols in caput epididymal sperms and reduced the levels of TP1, TP2, P1, and CREMtau in the testis, while cAMP was unaffected. P1 deposition was absent in the sperm. The transcripts of TP1, TP2 were increased, of P1 and ABP decreased, while those of CREMtau unaffected in the testis.

CONCLUSIONTamoxifen citrate reduced caput epididymal sperm chromatin compaction by reducing the testicular levels of proteins TP1, TP2 and P1 and the CREMtau involved in chromatin condensation during spermiogenesis. Tamoxifen citrate affects the expression of these genes at both the transcriptional and post-transcriptional levels.

Animals ; Base Sequence ; Blotting, Western ; Cell Nucleus ; drug effects ; metabolism ; Chromatin ; metabolism ; Cyclic AMP ; metabolism ; DNA Primers ; Gene Expression ; drug effects ; Male ; Rats ; Rats, Sprague-Dawley ; Reverse Transcriptase Polymerase Chain Reaction ; Spermatogenesis ; Spermatozoa ; drug effects ; metabolism ; ultrastructure ; Sulfhydryl Compounds ; metabolism ; Tamoxifen ; pharmacology ; Testis ; metabolism ; ultrastructure

Pleomorphic adenoma is the most common tumour of the salivary gland. While the majority arises from the parotid gland, only a small percentage arises from the minor salivary glands. The cheek, however, is a rarely affected site with respect to pleomorphic adenomas of the minor salivary glands. Herein, we report a case of pleomorphic adenoma of the cheek, which presented with intraoral swelling, and conclude that complete surgical excision can be a curative treatment for this benign tumour.
Adenoma, Pleomorphic ; pathology ; Adult ; Biopsy, Fine-Needle ; Cheek ; Diagnosis, Differential ; Humans ; Male ; Salivary Gland Neoplasms ; pathology ; Salivary Glands, Minor ; pathology

Rationale: Guillain Barre syndrome (GBS) is an acute neurological illness leading to quadriparesis with respiratory involvement. It can be triggered by infections, vaccinations, surgery, trauma, transplantation and drugs. Anti-rabies cell culture vaccines introduced to overcome the high rate of neurological complications associated with tissue based rabies vaccine, can be very rarely associated with GBS. Patient concerns: A 50-year-old female presented with acute severe upper back pain evolving into pure motor quadriparesis following administration of human diploid cell vaccine for rabies. Diagnosis: Acute motor axonal neuropathy variant of GBS following anti-rabies human diploid cell vaccine. Interventions: Intravenous high dose steroids. Outcomes: Patient recovered completely within 1 month. Lessons: Although anti-rabies cell culture vaccines are highly immunogenic and safe, they are rarely associated with GBS. Clinicians should be aware of this link because prompt diagnosis and treatment can result in complete recovery and avoid complications.