[india-drug] Patient Package Insert (PPI)(2) ****************************

["Nusrat Shafiq" <nusrat_shafiq@hotmail.com>]

Dear Dr Sampada,
Thanks for bringing this to our notice. The whole concept of package insert seems to be gravely misconstrued  in this paper. For one thing, package inserts are not merely for patients, they are also for the 
doctors.Secondly,giving relevant and correct information has never been the cause of misuse of prescription medicines as OTC medicines.
While FDA has released fresh guidance documents , not one but four, making 
package inserts more explicit and organized, we are taking a reverse gear 
(the latter is justified if there is a sound reasoning for doing so). As it is package inserts are already in a compromised shape in our country (with no PI being there in local language and font and format not following the international standards), we are being suggested to undo even this. More than a profit making exercise, I feel it is an exercise in downsizing (with no workforce needing to be devoted to making package inserts).
Regards
Dr Nusrat Khan
M.D, D.M,
Deptt of Clinical Pharmacology,
PGIMER, Chandigarh