India has released a draft bill calling for greater accountability from clinical trial sponsors and contract research organizations (CROs). Companies will need to pay damages and treat participants who suffer from injuries during any trials. If the trial sponsors do not comply, companies would face a fine or even imprisonment. The draft also calls for the legal beneficiaries of participants to be paid in the event that the patient dies as a result of a trial. Apart from this, the bill also demands stricter punishment for selling counterfeit or substandard drugs, and the punishment could range from a minimum of 10 years of imprisonment, along with hefty fines. The government also intends to set up medical device test labs at both state and central levels and create two new advisory bodies — the Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB). The draft bill is available for public observation for the next 45 days.
The Malaysian Medical Device Authority (MDA) has now become an official member of the Medical Device Single Audit Program (MDSAP). Effective immediately, manufacturers and authorized representatives will be able to use MDSAP audit certificates and audit reports in their applications for pre-market approval purposes from the MDA. The MDA sees this as an important milestone to facilitate the promotion of global regulatory trust, deliver timely access to safe and effective medical technologies, and establish Malaysia as a reliable global regulatory authority.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.