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

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 issues New Pre –Screening Checklist for BA/BE Applications effective 1st Feb 14

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

DCGI has issued New Pre –Screening Checklist for BA/BE Applications on their website Effective From – This new Checklist will be effective from 1st February 2014 Major Change - An Application for BA/BE NOC for export purpose is now required to be filled even for old drugs ( Drugs which have been approved for more than 4 years […] Share this:LinkedInFacebook Read More