BioVoice News June 2016 Issue 2 Volume 1 - Page 45

The government of India will soon reveal the results of the world’s largest ever study taken up to test the quality of more than 47,000 medical products taken up in 2015. The results will be revealed in August 2015, said Mr K L Sharma, joint secretary in the Ministry of Health and Family Welfare while speaking at a pharmaceutical conference in Cambridge, USA organized by the USA-India Chamber of Commerce (USAIC). The drug samples were collected by a mammoth exercise coordinated by the central drugs regulators through the National Institute of Biological and Indian Statistical Institute among other institutions. This is believed to be the largest exercise of its kind in the world. INDIA'S STEMPEUCEL BECOMES 5TH OFF-THESHELF APPROVED STEM CELL PRODUCT IN THE WORLD Stempeutics Research recently announced that the Drugs Controller General (India) has granted limited approval for manufacturing and marketing of its stem cell based biological product Stempeucel for the treatment of Buerger’s disease. Stempeutics is a group company of Manipal Education and Medical Group in a joint venture with Cipla Group. Commenting on the approval of DCGI on May 30th, Mr B N Manohar, CEO of Stempeutics mentioned, "Obtaining DCGI approval for Stempeucel is an important and historic milestone for Stempeutics. We are the FIRST Company in India to achieve such approval. It took almost 9 years to develop Stempeucel for the treatment of Buerger’s Disease. European Medicinal Agency has classified Stempeucel as an Advanced Therapeutic Medicinal Product (ATMP) and designated it as an Orphan Drug (ODD) for the treatment of Buerger’s Disease. Our goal is to globalize Stempeucel for Buerger’s Disease and the market size is approx. US$ 1.5 Billion worldwide”. Buerger's Disease is a rare and severe disease affecting the blood vessels of the legs. It is characterized by inflammation and occlusion of the vessels of extremities resulting in reduced blood flow to these areas, thus leading to severe pain and ulcers or necrosis, which finally may require amputation. JUBILANT LEVERAGES ITS EPIGENETICS EDGE THROUGH $180 MILLION DEAL WITH CHECKPOINT THERAPEUTICS Jubilant Biosys, a subsidiary of Jubilant Life Sciences, and Checkpoint Therapeutics, Inc a subsidiary of US based Fortress Biotech, has announced the signing of an exclusive, worldwide license agreement for compounds having potential to halt cancer growth. Under the agreement signed on May 27th, Jubilant Biosys will outlicense to Checkpoint a family of patents covering compounds that inhibit BRD4, a member of the BET (Bromodomain and Extra Terminal) domain for cancer treatment. The deal includes an upfront payment of US $2 million and contingent preclinical, clinical and regulatory payments including commercial milestones totalling up to US $180 million. Jubilant Biosys will also receive research funding and royalty payments on successful commercialization of the compounds. Checkpoint will assume all further preclinical, clinical development and commercialization responsibilities. The field of epigenetics as a treatment for cancer is a rapidly evolving area of focus for the pharmaceutical and biotech industry. Both parties believe that by working together to further develop these compounds, they will better be able to move towards bringing a product to market that will greatly improve the lives of patients. biotech WORLD'S LARGEST DRUGS QUALITY TEST STUDY HELD IT INDIA, RESULTS TO BE OUT SOON TIME UP FOR BRITISH-ERA DRUG REGULATIONS AS GOVT GOES FOR FRESH RELOOK India will soon overhaul its 76-year old Drugs and Cosmetics Act 1940 and bring in a new, modern legislation to regulate production and consumption pharmaceuticals and other related products. As a precursor to this, the government is bringing in a separate legislation to regulate a wide range of Medical Devices first and based on its success and acceptance by industry and other stakeholders, the drugs regulation Act will follow, said Mr K L Sharma, joint secretary, Ministry of Health and Family Welfare in Government of India, while delivering a Key Note address at the 10thAnnual US India BioPharma and Healthcare Summit 2016 at Cambridge, Massachusetts, organized by the USA-India Chamber of Commerce. Mr Sharma said these decisions were taken by the Union Cabinet headed by Prime Minister, Mr Narendra Modi, while discussing the amendments proposed to the omnibus 1940 Drugs Act to make it more contemporary. The Cabinet asked for scrapping of the British-era Act and bring in separate legislations to regulate various areas covered by the Act. The Drugs and Cosmetics Act 1940 was last amended in 2003 with more guidelines. The Modi government wants a total fresh look to this Act. The government has started an ambitious exercise in August 2015 to equip the drug regulatory set up in India’s 36 states and union territories and the central government set up by equipment modernization, hiring of hundreds of regulatory experts, multiple training programmes for existing staff with help from regulators from US and Europe and overall skill upgradation of human resources in the system, Mr Sharma said. BIOVOICENEWS.COM 45