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

[india-drug-owner@healthnet.org]

I request all I-drug members to comment / debate to the following news published in IDMA Bulletin dated 30th AUG 2006. This may soon be a reality. Indian Drug Manufacturers Association (IDMA) has suggested the below given to Drug Controller General of India, Central Health &  Family Welfare Ministry. Is it a suggestion in view of public health protection or just a commercial view to make more profits?

Dr.Sampada P.Patvardhan
Director, Maharashtra State Pharmacy Council?s Drug Information Centre
Email:dicmspc@hathway.com
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Patient Package Insert (PPI) 

 Prescription products are prescribed by the Doctor and are to be taken by the Patient strictly as per the prescribing doctor's guidance and directions.  It is therefore not necessary for the Patient to read anything extra, which the Doctor is, not apparently knowing and / or being informed via the package insert.  Providing such package inserts directly to patients for prescription products can causes lot of confusion and conflicts in patient's treatment and ultimately, immense harm to his health.

Besides, printing a legible and simple worded patient information sheet indirectly propagates self-medication of prescription drugs.  Incase of any adverse drug events, the manufacturer concerned could be held liable, more so if inadvertently some side effect is not mentioned in the patient information sheet.

Further to the above providing these types of detailed Patient Package Inserts would require separate cartons for each strip / blister pack which will increase the production costs and selling prices unnecessarily.

IDMA feels that such Patient Package Insert may be considered only for Consumer / OTC products and not for prescription products.