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Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinicalresearch, and how did you enter the field? So I’ve been working in that space about 43 years.
India is strengthening its scope in contract manufacturing as the global customers commend the strengths and dependability of its pharma and biotech sectors.
The Drugs Consultative Committee (DCC), the advisory committee of the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws across the country, has recommended to all the States to set a deadline for the manufacturing companies to upload all the formulation details in the Sugam portal, (..)
The Indian Council of Medical Research (ICMR) has issued list of technologies supported under ICMR-Medical Device and Diagnostics Mission (MDMS) Secretariat to foster indigenous manufacturing of medical devices and diagnostics.
Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinicalresearch. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.
BPS offers parenteral delivery systems, sterile contract manufacturing solutions and customised support services to the pharma and biotech industries. It will become an independent, end-to-end contract development and manufacturing organisation, as a separate company and in collaboration with Warburg Pincus and Advent International.
The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.
Patients of cystic fibrosis (CF) and their relatives have requested the Department for Promotion of Industry and Internal Trade (DPIIT) to take steps to provide CF drugs at an affordable cost using the provisions of the Patents Act, 1970, considering that the drugs at present cost anywhere from Rs. 21 lakh to Rs. crore. […]
The Drugs Technical Advisory Board (DTAB) of the Union health ministry has once again recommended prohibiting the manufacture, sale and distribution of pain relief drug combination S(+) etodolac+paracetamol, after considering a sub-committee report.
The Central Drugs Standard Control Organisation (CDSCO) has released guidance for the companies to attain export No Objection Certificate (NOC) for manufacture of unapproved, banned or new drugs, a process which was centralised recently.
Generate Life Sciences is establishing a GMP facility in La Jolla, California that it says will enable end-to-end manufacturing of newborn stem cell biologics, bolstering supply and safeguarding clinicalresearch.
Data in clinical trials For example, huge amounts of data can be mined from electronic health records (EHRs) and other sources to optimise clinicalresearch, from drug identification to treatment plan design.
The shortage is due to higher-than-expected demand and manufacturing issues. Last week, the Australian Therapeutic Goods Administration added intravenous (IV) fluids to the growing list of medicines in short supply. Two particular IV fluids are affected: saline and compound sodium lactate (also called Hartmann’s solution).
The collaboration between IVD manufacturers and lab testing partners is central to precise and efficient diagnostic processes. So, what considerations should IVD manufacturers bear in mind when determining this crucial partnership? She did her clinical microbiology fellowship at Mayo Clinic in Rochester, Minnesota.
Indian pharma’s mainstay in the areas of CRAMS (contract research and manufacturing services), product development, regulatory protocol adherence, and dossiers submissions in the required CTD (Common Technical Document) format are big growth opportunities, said Suresh Khanna, chairman, Karnataka Drugs and Pharmaceutical Manufacturers Association and (..)
Drug manufacturers have hailed the Drugs (Eighth Amendment) Rules, 2022 mandating barcode or quick response (QR) code on the label of top 300 brands of formulations from August 1, 2023, saying that QR codes will help identify misbranded or counterfeit medicines as well as recall the products if its quality gets compromised during manufacturing.
The Karnataka drugs control department is insisting that all the cough syrup manufacturers dealing in ethylene glycol and diethylene glycol will now need to procure solvents like glycerin and propylene glycol complying to pharmacopeia standards directly from manufacturers as required under para 10 of the Schedule M of the Drugs & Cosmetics Act, (..)
Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries. Pharmaceutical Manufacturing and Supply Chain Changes.
This is because air moisture is a critical factor in pharmaceutical manufacturing processes, as it can affect the quality and stability of medications. Indian pharmaceutical industry is adapting to the revised Schedule M guidelines by considering the deployment of new-generation quality air solutions.
The Association of Biotechnology Led Enterprises (ABLE) plays an intrinsic role as India’s bioeconomy propels innovation to leap towards the next phase of bio-manufacturing potential.
The Indian Council of Medical Research (ICMR) has announced an Expression of Interest (EoI) inviting eligible organizations, companies, and manufacturers to participate in the ‘Transfer of Technology’ for a CRISPR Cas-based TB detection system.
The Central Drugs Standard Control Organisation (CDSCO) has revised the guidance document for functions and responsibilities of its zonal, sub-zonal and port offices after almost 13 years, updating the adding procedures including for Risk Based Inspection (RBI) of drug manufacturing sites.
Currently, there are around six major manufacturers of […] This is particularly significant in the development of targeted therapies for conditions like cancer, where precise delivery of medication to specific cells or tissues is crucial.
The Central Drugs Standard Control Organisation (CDSCO) has released a list of 59 drug samples declared as Not of Standard Quality (NSQ) during the month of August, with samples of drugs labelled as manufactured by some of the major companies failing the quality test. The State drug regulators have reported 11 NSQs to the CDSCO […]
Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinicalresearch and drug development issues. It focuses on accelerating clinicalresearch and enhancing Germany’s appeal to pharmaceutical companies. Are Pricing Incentives Enough to Shift Focus to Germany?
The Union Ministry of Ayush (MoA) is taking steps to amend the Drugs and Cosmetics Act, 1940 to add the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia under the standards on which the imports and manufacturing of homoeopathic drugs will be allowed in the country.
As per the circular, the prescribed timeline for drug manufacturers’ plant layout […]. The Maharashtra Food and Drugs Administration (FDA) has set timelines for various regulatory approvals with an aim to make approval process transparent and facilitate ease of doing business.
Indian Ayurveda propels its growth supported by the industry guidelines of Good Agricultural and Collection Practice (GACP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), said Dr. Rangesh Paramesh, director – Intellectual Property, Himalaya Wellness Company.
In an effort to ensure a stable and cost-effective supply chain for active pharmaceutical ingredients (APIs) in the country, the Department of Pharmaceuticals (DoP) may look at tapping the potential of international collaborations for sourcing of raw materials and manufacturing of ingredients in the country.
It added that two drug samples tested as not of standard quality during June were also alerted by the manufacturer as spurious. The Central Drugs Standard Control Organisation (CDSCO) has declared three drug samples it tested in the month of July as spurious and another 51 samples as Not of Standard Quality (NSQ). The central […]
The Ayush cluster in Kerala, Care-Keralam Ayurvedic Resource Centre at Koratty in Thrissur, is planning to adopt a multi-pronged strategy to support the small and medium ayurvedic drug manufacturing enterprises (SMEs) by focusing on their production growth and marketing of products.
Ten collective stakeholders of Indian healthcare industry, including the industry associations of medical devices manufacturers, patient interest group, and healthcare providers, have jointly demanded to the Union health minister Dr Mansukh Mandaviya to recall the New Drugs, Medical Devices & Cosmetics Bill, 2023 that is listed to be tabled in (..)
The Department of Pharmaceuticals (DoP) has approved the applications of five medical devices companies under the production linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices, in the category it has added through an amendment of guidelines in August, 2022.
Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)
The point of contention, they pinpoint, is that if any retailer and manufacturer fails to display the license in a prominent place and is not conspicuous to the public, it amounts to violation of the […]
The Central Drugs Standard Control Organisation (CDSCO) has approved two more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules (MDR), 2017.
The Union health ministry has issued a notification prohibiting the manufacture, sale and distribution of pain killers, ketoprofen and aceclofenac and their formulations for animal use with immediate effect, as they are likely to involve risk to animals.
The Central Drugs Standard Control Organisation (CDSCO) has approved four more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules, 2017.
The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]
On the occasion of National Ayurveda Day, the Ayurveda Medicine Manufacturers Association of India (AMMOI) has called upon the state governments that the constructive steps being taken by the Union Ayush Ministry to make Ayurveda system of treatment as an alternative treatment method for the world population should be taken forward by all state governments (..)
The drug regulator, in a drug alert issued, said that a batch of Typbar, manufactured by Bharat Biotech International Ltd in Genome Valley in Hyderabad, Telangana, failed […]
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