Emergency Approval Mechanisms for Human Vaccines in India.

The coronavirus disease 2019 (COVID-19) pandemic highlighted the world's level of preparedness in managing public health emergencies (PHEs). It revealed the critical need for timely medical therapeutics, especially vaccines. To expedite response, many nations, including India, adopted emergency approval mechanisms and offered new ways of review, such as the rolling review along with the accelerated review procedure.

Post-trial access to investigational drugs in India: addressing challenges in the regulatory framework.

Through the New Drugs and Clinical Trials Rules, 2019 (2019 Rules), India has developed the rules governing post-trial access (PTA) to new drugs or investigational new drugs. However, inconsistencies and interpretational challenges exist in the application of the 2019 Rules and the Indian Council of Medical Research Guidelines 2017. This conflation poses a real harm to the trial participants, specifically the ones with limited access to healthcare facilities.

Bioinspired 3D porous human placental derived extracellular matrix/silk fibroin sponges for accelerated bone regeneration.

Critical bone defects arising from traumatic injury and diseases are of major health concern since they are unable to heal spontaneously without clinical intervention. In this context, bone tissue engineering provides an attractive approach to treat bone defects by providing a bioactive template which has the potential to guide osseous tissue regeneration. In this study, porous hybrid placental extracellular matrix sponge (PIMS) was fabricated by a combinatorial method using silk fibroin (SF)/placental derived extracellular matrix and subsequently evaluated its efficacy towards bone tissue regeneration.

Novel pH-sensitive alginate hydrogel delivery system reinforced with gum tragacanth for intestinal targeting of nutraceuticals.

The present study utilizes the novel combination of Gum tragacanth (GT) and sodium alginate (SA) to reinforce SA hydrogel beads. The composite hydrogel beads were encapsulated with phenolic compounds extracted from Basella sps. The rheological studies conferred increased elastic property of GT incorporated formulations.

Biofunctionalized cellulose paper matrix for cell delivery applications.

The present study delineates the preparation, characterization, and application of (3-Aminopropyl)triethoxysilane (APTES)/Caprine liver-derived extracellular matrix (CLECM) coated paper matrix for cell delivery. Here, we exploited positively charged surface of the paper matrix (as imparted by APTES derivatization) to improve the biological responses of the cells. Our results demonstrated that the functionalized paper matrixes favored the adhesion, growth, and proliferation of multiple cell types including normal, transformed, cancerous, and stem cells as compared to the pristine paper matrix.

Silk Sponges Ornamented with a Placenta-Derived Extracellular Matrix Augment Full-Thickness Cutaneous Wound Healing by Stimulating Neovascularization and Cellular Migration.

Regeneration of full-thickness wounds without scar formation is a multifaceted process, which depends on in situ dynamic interactions between the tissue-engineered skin substitutes and a newly formed reparative tissue. However, the majority of the tissue-engineered skin substitutes used so far in full-thickness wound healing cannot mimic the natural extracellular matrix (ECM) complexity and thus are incapable of providing a suitable niche for endogenous tissue repair. Herein, we demonstrated a simple approach to fabricate porous hybrid ECM sponges (HEMS) using a placental ECM and silk fibroin for full-thickness wound healing.

Identification and characterization of bioactive phenolic constituents, anti-proliferative, and anti-angiogenic activity of stem extracts of .

is an important green leafy vegetable species of Chenopodiaceae family and is known for its medicinal properties. Hydroxy-benzoic acids, hydroxy-cinnamic acids and flavones groups were identified and characterized from the aqueous stem extracts of and species. Higher values of phenolics as well as antioxidant activity were noted from species extracts.

Patents in Nanobiotechnology: A Cross Jurisdictional Approach.

Background: Bionanomaterials create new opportunities for advancing medical sciences and diseases treatment in relation to human health care. Innovations in the use of such nanomaterials and nanodevices can lead to significant improvements in the use of drugs/devices.

Objective: The present study attempts to analyse patenting trends in different areas and compare the patentability criteria and the disclosure norms for nanobiotechnology inventions in countries such as US, EU and India in the field of diagnostics and therapeutics.

Herbal drug regulation and commercialization: an Indian industry perspective.

Objectives: To assess the constraints for Indian herbal drug industry with respect to manufacturing and commercialization of herbal medicines.

Methods: A questionnaire-based survey was conducted to obtain primary data on challenges faced during production, commercialization, and marketing approval for traditional or herbal drugs in India and abroad. Responses were collected from 150 companies by email, telephone, and in-person interviews from June 2009 to August 2010 and were analyzed to draw appropriate conclusions.

Herbal drug patenting in India: IP potential.

Ethnopharmacological Relevance: Herbal drugs are gaining worldwide prominence due to their distinct advantages. Developing countries have started exploring the ethnopharmacological approach of drug discovery and have begun to file patents on herbal drugs. The expansion of R&D in Indian herbal research organizations and presence of manufacturing units at non-Indian sites is an indication of the capability to develop new products and processes.

Recombinant drug development, regulation, and commercialization: an Indian industry perspective.

Introduction: The Indian biopharmaceutical sector comprises nearly 40 companies that manufacture and/or market 14 recombinant drugs that account for nearly 50 products. Among these, 22 companies have manufacturing facilities in India.

Objective: The aim of the present study was to analyze the patenting trends, commercialization, and regulatory system for biopharmaceuticals in India.

Herbal drugs: standards and regulation.

The use of herbal drugs for the prevention and treatment of various health ailments has been in practice from time immemorial. Generally it is believed that the risk associated with herbal drugs is very less, but reports on serious reactions are indicating to the need for development of effective marker systems for isolation and identification of the individual components. Standards for herbal drugs are being developed worldwide but as yet there is no common consensus as to how these should be adopted.

Manufacturing of biodrugs: need for harmonization in regulatory standards.

Biodrugs (biologics) are much more complex than chemically synthesized drugs because of their structural heterogeneity and interactions within a given biologic system. The manufacturing process in the biodrug industry varies with each type of molecule and is far more elaborate and stringent due to the use of living organisms and complex substrates. Product purity and altered structural characteristics leading to potential immunogenicity have often been of concern when establishing quality and safety in the use of biodrugs.