DCGI has posted the draft Medical Device Regulation, Schedule M-III at their website . http://cdsco.nic.in/Medical_Devices_Guidelines.pdf

The proposals have been issued in the form of draft guidelines. They would modify the Drugs & Cosmetics Act’s Schedule M III, which deals with requirements for manufacturing, importing and selling medical devices in India. The draft Schedule M-III has been posted on the CDSCO’s website for stakeholders to submit feedback; no deadline for accepting comments is given.

Guidelines For The Regulators For Assessment Of A Medical Device Manufacturing Organization

A. To define the guidelines to be followed by the representative of regulatory body while evaluating an application for registration or granting manufacturing license and for auditing a medical device manufacturer.

Former DCGI Dr Venkateswarlu passed away

The former Drug Controller General of India (DCGI), Dr M Venkateswarlu (61), passed away on Sunday night at Mumbai, Maharashtra, succumbing to a massive heart attack.

AIMED Response to Budget 2009

We are pleased with some of the macro economic issues addressed by the budget. We are pleased that the Government has decided to abolish Fringe Benefit Taxes which was an unnecessary irritant and we are also pleased with the higher allocation of the budget for the Healthcare Sector especially with respect to the National Rural Healthcare Mission. India has got one of the lowest allocations to Healthcare as a percentage of the GDP in the world.