Earlier the World Health Organisation had written to the Indian government, saying stringent rules would push away pharma companies from conducting clinical trials in India while also ‘hampering’ WHO’s work. The Bharatiya Janata Party-led NDA government is reportedly set to remove a…
KEY CHANGES IN NEW DRAFT RULES FOR CLINICAL TRIALS IN INDIA
CDSCO has published the new draft Clinical Trial Rules 2018 in Feb 2018 after consultation with the Drugs Technical Advisory Board. This draft Rules shall be taken into consideration on or after the expiry of a period of forty five…
To market new drugs in India, global trials must include Indians
HIGHLIGHTS The move is expected to benefit clinical research organisations and hospitals operating in India The decision has been taken keeping in mind the safety of the Indian patients In a move to ensure efficacy of medicines sold in India,…
FDA is Advancing the Goals of the Orphan Drug Act
Three months ago, FDA committed to fully eliminate a backlog of about 200 orphan drug designation requests that were pending review with FDA, and to implement policies that would require FDA to respond to all new designation requests within 90…
New Recommendations for speeding approvals of Global Clinical Trials
In 34th Apex Committee which was held on 02 June 2017, there were recommendation to remove three tier review of the studies in India. Here are the highlights The Committee was apprised that the system of examination of proposals in…
EMA Offers Draft Guideline on Trial Master Files
The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the…
India has come up with Medical Devices Rules, 2017
CDSCO has published the Medical Devices Rules 2017. This Rule has been published in the Gazette of India Extraordinary on 31 Jan 2017. The Rules are very explicitly explains the requirements from various stake holders and balanced in managing…
Minutes of 74th Meeting of Drugs Technical Advisory Board
CDSCO has shared the minutes of 74th meeting of Drugs Technical Advisory Board Held on 15th nov 2016 at DGHS, Norman Bhawan, New-Delhi Important point which was discussed in the meeting pertaining to Clinical Trials are it was recommended that…
CDSCO has come up with the list of NABL accredited NABL certified Laboratory
CDSCO has come up with the list of NABL accredited laboratory in India which is good for the Pharma companies and CRO who are conducting clinical studies in India. This step of CDSCO has been welcomed by Pharma and CRO…
Govt Consults Top Foreign Regulators to Rewrite Drug Laws
Finally junking the 75-year-old Drug and Cosmetics Act, the health ministry is consulting top drug regulation bodies worldwide in order to write a new laws for drugs. Until last year, the government is trying to tweak its archaic Drugs and…
