India Warns Drugmakers Once More to Register in Online Database
India’s drug price regulator is again warning drugmakers to immediately register in an online database or face fines and imprisonment.
In a letter last week to the country’s pharmaceutical associations, the National Pharmaceutical Pricing Authority says 32 of the top 100 companies have failed to register with the Integrated Pharmaceutical Database Management System.
Earlier this month, the NPPA sent a similar letter naming 59 companies that had failed to register with the system.
The number of companies failing to register may not be as high as reported. Johnson & Johnson spokesman Gareth Ingham says the firm’s Janssen Pharmaceuticals subsidiary was incorrectly named in the previous notice because it had registered under the parent company’s name.
The IPDMS was launched last September, with registration initially open until Oct. 31. NPPA extended the registration period twice, setting a final date of Dec. 31.
The registration process entails entering company details, supply sources and product lists into the database.
The Indian Drug Manufacturers’ Association expressed concerns in a Dec. 30 letter to NPPA that collating and submitting the data is cumbersome because the information must be in either Excel or text format.
Read the notice here: www.fdanews.com/5-15-NPPA-Letter.pdf. — Jonathon Shacat