New Circular by Government of India for Online Registration

27th February, 2014 - Posted by Sumit - No Comments

Government of India has launched a web enabled system of Online Registration & submission of Online returns by the manufacturers & wholesalers of Psychotropic substance. The System is being implemented to facilitate registration of manufacturers & wholesalers of Psychotropic substance (bulk as well as preparation) in the country to get registered, to submit import/export application & quarterly […] Share this:LinkedInFacebook Read More

Role of RA in Product Life Cycle

21st February, 2014 - Posted by Rahul Agarwal - No Comments

This Diagrammatic Representation represents the Core role and Functions of RA, in the whole Product Life Cycle….i.e. Right from R &D to Post Marketing of the Product…!!!!!! Share this:LinkedInFacebook Read More

New Circular for Fixed Dose Combination

19th February, 2014 - Posted by Sumit - No Comments

DCGI has issued a new circular on 3rd Feb regarding Fixed Dose Combinations For all FDCs approved by the State licensing authority without prior approval from DCGI were requested to submit data to prove Safety and Efficacy of in timely and prescribed manner. In the view of the same CDSCO has requested all applicants to provide […] Share this:LinkedInFacebook Read More

FDA surprise checks on, but DCGI will be kept in loop

17th February, 2014 - Posted by Sumit - No Comments

“”An statement of intent signed between Union health secretary Keshav Desiraju and FDA commissioner Margaret Hamburg on Monday, regulators need to inform “the respective regulatory authorities before undertaking inspections so that host-country inspectors may join inspections as observers”.”” This means any surprise audit or audit undertaken by US FDA in India will be informed to […] Share this:LinkedInFacebook Read More

Mahesh Zagade – FDA Commissioner warns Chemist against mis-selling drugs.

3rd February, 2014 - Posted by Sumit - No Comments

FDA Maharashtra commissioner is appealing to chemist to spread awareness and to put patient safety on top while selling drugs. Maintain authentic prescription records i.e Name of Doctor & Hospital before selling any medicine Maintain copy of prescription in case of sedatives. He also appeal to the citizen to insist on counselling when buying over […] Share this:LinkedInFacebook Read More

DCGI to Inspect Ranbaxy Toansa Facility…..

28th January, 2014 - Posted by Sumit - No Comments

DCGI is set to inspect Ranbaxy Toansa facility after US FDA banned import of drug and api produced in the plant for US Market. DCGI will audit the plant to check if they are violating and norms prescribed under Drugs and Cosmetics ACT.  DCGI has also informed official to collect market sample and check them […] Share this:LinkedInFacebook Read More

Ranbaxy hits FDA prohibits its Toansa facility from Producing & distributing drugs for US Market

27th January, 2014 - Posted by Sumit - No Comments

US FDA has banned import of products from Ranbaxy’s fourth plant,  as per the notification from US FDA, Ranbaxy has been prohibited from manufacturing and distributing APIs  from its facility in Toansa, Punjab.  The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012. Reference http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm382736.htm   Share this:LinkedInFacebook Read More