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The Ministry of Health has notified the Medical Devices Provisions, 2017, which will come into effect from January 2018. The government has also notified 15 devices, as the drugs automatically bring them under strict price control. In addition to catheters, stents and orthopedic implants, the list also includes heart valves, intraocular lenses, syringes, and needles.
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In an effort to create a globally competitive biopharmaceutical industry that addresses the countrys major concerns about barriers to affordable healthcare, the Department of Biotechnology (DBT) has launched the Innovate in India (i3) program, As well as the systemic support to pursue their aspirations in biotechnological innovation, and to transform India into a global hub for cutting-edge biotechnology research and development.
A collaborative mission between industry and academia to accelerate discovery research for the early development of biopharmaceuticals, this USD 250 million DBT program is a unique mission that brings together industry and academia to promote entrepreneurship and Indigenous manufacturing in the biopharmaceutical sector.
This collaborative mission between industry and academia is expected to change the game for the Indian biopharma industry. This flagship program of the DBT, in collaboration with the World Bank, will be implemented by the Biotechnology Industry Research Assistance Council (BIRAC) of the DBT.
The program will specifically focus on the development of new vaccines, bio-therapeutics, diagnostics and medical devices to better address the growing burden of disease in the country. It will also bring together isolated centers of excellence, improve regional capacities and strengthen the existing network of bio-clusters in terms of capacity as well as quantity and quality of production.
The program aims to create an ecosystem conducive to promoting entrepreneurship and indigenous manufacturing in the sector. It will help nurture the next generation of technical skills; Promoting entrepreneurship; And support institutions in adopting innovations, technologies and models of global licenses. The program will help deliver 6 to 10 new products over the next five years, create several dedicated facilities for next-generation skills and hundreds of jobs in the process. It will provide young entrepreneurs with the confidence and systemic support to pursue their aspirations in biotechnological innovation and transform India into a world center of research and development.
As a flagship program of the Government of India in collaboration with the World Bank, it promises to boost the national biopharma growth curve in India by accelerating the translation of research concepts to viable products, supporting clinical validation, enabling sustainable networks of collaboration between industry And Academy and supporting business ecosystems among many others.
Currently India has only 2.8% share in the global biopharmaceutical market, the program would elevate this to 5% resulting in an additional business opportunity of 16 billion USD.
The Monitoring of the program would be provided by the Interministerial Steering Committee composed of members from various Ministries; And it would have the support of the Technical Advisory Group of the Program composed of world and national leaders of the industry and the academic world. Therefore, the program is unique in its approach with the participation of global experts, industry leaders and the World Bank in its drive and ensuring that world-class biomedical products are born out of the initiative.
Cytokinetics, Inc announced that data relating to patient baseline characteristics and the reasons for patient screen failure, both from the first cohort of the Phase 2 clinical trial of CK-2127107 in spinal muscular atrophy (SMA), were presented at the Cure SMA 2017 Annual SMA Conference in Orlando, FL by Stacy Rudnicki, M.D., Director, Clinical Research at Cytokinetics. In collaboration with Astellas Pharma Inc.Cytokinetics is developing CK-2127107 as a potential treatment for people living with SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue.
Recro Pharma, Inc. a revenue generating specialty pharmaceutical company focused on therapeutics for hospital and other acute care settings, today announced the acquisition of exclusive global rights to two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent from Cornell University.
The Central Drugs Standard Control Organization (CDSCO) has recommended Acellbia, the first rituximab biosimilar made in Russia, for approval in India.
In August 2017, BIOCAD will receive permanent market authorization in India, which represents a strategic milestone for BIOCAD’s international expansion
Glenmark Pharmaceuticals Europe (Glenmark) has been granted final approval by the MHRA (Medicines and Healthcare products Regulatory Agency) for Maloff Protect (250mg/100mg atovaquone/proguanil film-coated tablets), anti-malarial medication, as a pharmacy license in the United Kingdom.
New maximum prices for 814 programmed formulations were made effective with the NPPA drug price regulator setting the limit in sync with the new GST regime. These formulations include drugs used to treat cancer, HIV, diabetes and infections, among others.
Patients can continue to buy essential drugs in the MRP before the GST, ie not at the highest prices, until the new lots reach pharmacies and stockists, and reach the shelves.
Medical devices that are declared as "drugs", such as stents, valves, orthopedic implants, syringes and tools for operations, will now have to declare their retail maximum price (MRP) and other details including that of the manufacturer and the importer.
A recent survey on the state of label management in the pharmaceutical industry undertaken by NiceLabel in cooperation with Pharmaceutical Manufacturing revealsthe challenges facing pharmaceutical manufacturers as they try to produce accurate, compliant labels, and highlights the increasing importance of a single, integrated label management system.
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