India Threatens Drugmakers Who Don’t Register on Online Database With Penalties
The Integrated Pharmaceutical Database Management System was launched last September, with registration initially open until Oct. 31. However, following industry complaints that the process of collating and submitting data was cumbersome, NPPA extended the registration period twice, with a final date set for Dec. 31.
It’s not only large companies that need to register in IPDMS, notes Vince Suneja, CEO of TwoFour Insight Group.
As of February, only about 800 of about 8,000 total drugmakers had registered or were in the process of registering.
Suneja expects NPPA may face some type of administrative or court challenge to the registration requirement if it decides to impose penalties, which include fines and imprisonment. If companies continue to provide the information in hard-copy form, as was the case pre-IPDMS, what harm would NPPA demonstrate by lack of compliance, other than the cost of manual review by the agency, he asks.
Read the letter here: www.fdanews.com/5-15-NPPA-Notice.pdf. — Jonathon Shacat