BioVoice News December 2016-January 2017 Issue 8 Volume 1 - Page 43

entities including government , private , clinicians , hospitals , Industries etc in the country . The document should be restricted to 2 pages describing the claims with details of the team involved and with approval from Head of the organization . A separate set of documents should be submitted for each condition / disease .

The ‘ Letter of Claim ’ should reach Dr Geeta Jotwani , Scientist E , Division of Basic Medical Sciences , ICMR Headquarters latest by 31st December 2016 . This is first and the last opportunity to all the concerned claimants for submission of their data . No such claims will be entertained after the deadline , mentioned the notification .
ASTRAZENECA WINS ' CORPORATE CSR BEST PRACTICES AWARD '
AstraZeneca Pharma India , a leading biopharmaceutical company was announced the ‘ Winner ’ in the Corporate CSR Best Practices category at the 20th NHRD National Conference held on December 8th and 9th at Bangaluru . The award was given in recognition for the company ’ s CSR initiative - The Young Health Programme ( YHP ), a community based initiative focused on primary prevention of non-communicable diseases in young people . AstraZeneca was also a finalist in the category of HR Best Practices for its focus on ‘ gender diversity ’.
Commenting on the company ’ s win , Ms Smita Saha , Vice President – HR , AstraZeneca Pharma India said , “ I accept this award on behalf of an incredible team at AstraZeneca and our valued partners , whose passion and dedication have played a big role in where we are today . I would like to thank the National HRD Network for this honour . This award reinforces our commitment to target the various risk behaviours that lead to non-communicable diseases in young people , especially those in marginalised communities .”
DCGI SIMPLIFIES REGULATORY PROCESSES FOR VACCINE & R-DNA PRODUCTS
The office of Drugs Controller General India ( DCGI ) under the Directorate General of Health Services has decided to discontinue the practice of prior joint inspection for issuance of Form 29 licenses to vaccine and r- DNA products . As per the revised memorandum issued on December 13 , 2016 , the applicant shall submit application along with self declaration in a prescribed format to State Licensing Authority & Central Licensing Authority by hardcopy and by an emails to dci @ nic . in , testlicensebio @ cdsco . nic . in , and on the email of the concerned State Licensing Authorities . The State Licensing Authority shall now issue Form 29 licenses within
three working days of receipt of the application .
The new order is to promote research and development of new drugs . Form 29 licence is issued to manufacture drugs for the purposes of examination , test , or analysis for biological vaccines and r-DNA products .
In another order , it has been decided that Central Drugs Standard Control Organization ( CDSCO ) will now communicate the recommendations of Committee to the concerned applicants within five working days . CDSCO reviews applications in consultation with the various committees like the subject expert committee , investigational new drug committee , cell biologybased therapeutic drug evaluation committee , technical committee , and apex committee .
Further , the timelines for CDL Kasauli to review and process applications referred for CMC or post approval change have been streamlined . CDL Kasauli will now issue its comments within 30 days to CDSCO . The applicants will also have to submit their responses to queries raised by CDL Kasauli on behalf of CDSCO within 30 days . Failure to furnish the requisite information sought by CDL Kasauli within the prescribed time of 30 days will be presumed that the applicant is not interested in pursuing the application and the application would be treated as terminated for further processing .
CATALENT BIOLOGICS COLLABORATES WITH PATH MALARIA VACCINE INITIATIVE
Catalent Pharma Solutions , the leading global provider of advanced delivery technologies and development solutions for drugs , biologics and consumer health products , today announced that it has signed an agreement with PATH , an international nonprofit organization and a leader in global health innovation , to advance a project funded by its Malaria Vaccine Initiative ( MVI ).
Under the agreement , Catalent Biologics will employ its proprietary GPEx ® cell line technology , coupled with a state-of-the-art ambr ® workstation , which mimics the characteristics of classical bioreactors at micro scale , to develop , optimize the process for expression , and manufacture antibodies under cGMP conditions at its state-of-the-art Madison , Wisconsin facility , for

PATH ’ s MVI is working to accelerate the development of malaria vaccines and to ensure access where they are needed biotech most across the globe . Through innovative partnerships such as this , PATH helps drive the development of better malaria vaccines . Through these strategic partnerships , MVI maintains a portfolio of candidates , both preclinical and early clinical , and at least one advanced clinical project .

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