Earlier this year., India's Drugs Controller General granted permission to Pune Maharashtra-based Serum Institute of India to supply over 32,000 doses of its COVID-19 jab Covovax under the brand name Nuvaxovid to the U.S. Covovax is manufactured through technology transfer from Novavax, an American Company and is approved by the...
Two Korean Firms to Manufacture Zydus Cadila’s Covid Vaccine
Ahmedabad, India headquartered pharmaceutical firm Zydus Cadila announced that its Covid-19 plasmid DNA vaccine ZyCoV-D will be manufactured in Korea by two firms - Enzychem Lifesciences and Hanmi Pharmaceutical. The firms have begun the optimization process for transferring technology and setting up production facilities to manufacture the Indian-developed vaccine starting...
India's Health Ministry to Regulate Prices of Critical Medical Devices
Critical medical devices and diagnostic equipment will be regulated by India's health ministry. Under the Medical Devices Rules, 2017, which will come into effect from January 1, 2018, prices of devices such as catheters, stents and orthopedic implants, heart valves, intra-ocular lenses, syringes and needles will be regulated by the...
India Calls for Post-Sales Monitoring of Cancer Drugs
An "Apex Committee for Clinical Trials" has been constituted by the Union Health Ministry on the directive of the Supreme Court of India. Outsourcing Pharma.Com reports that this committee now requires developers of cancer treatments approved without trials to monitor the first 500 patients to assess the drug’s safety and...
Technical Advisory Board for Medical Devices to Be Set Up in India
The Health Ministry of India proposes to constitute a Medical Devices Technical Advisory Board to counsel the federal and state government on technical issues related to medical devices. The Director General, Indian Council of Medical Research, will be the ex officio chairperson of the board, and the Drugs Controller General...
Biocon receives authorization to sell Psoriasis drug in India
Biocon (a Biotechnology Company with headquarters in Bangalore, India) has received the marketing authorization from the Drugs Controller general of India for Novel Biologic Itolizumab (used for the treatment of chronic plaque Psoriasis). Itolizumab has an excellent safety profile as indicated during the 52-week clinical study conducted in India. This...