India drug pricing body ready to crack whip on registration rules

Several of India's largest drug makers are among at least 59 facing possible court action by regulators claiming they failed to register under a new information system of the nation's price-control agency. A few multinationals also are on the list.

The NPPA is getting ready to inaugurate its Integrated Pharmaceutical Database Management System that relies on companies filling online forms for each of their drugs and supplying documents outlining the cost of producing a drug.

A two-year-old amendment to India's drug law requires companies to register their wares online for the Integrated Pharmaceutical Database Management System intended to make it easier to compile data and set annual price caps.

The NPPA circulated a letter to all pharmaceutical associations to remind their members about the requirement and the threat of "appropriate action" if they fail to comply. The agency already had extended the filing deadline to give companies another chance to comply.

It listed the 59, which it said were among the top 100 pharma companies, the other 41 having complied. Among the 59 on the NPPA's list were Biocon, Cipla, Dr. Reddy's Laboratories ($RDY), Mankind, Ranbaxy Laboratories, Wockhardt and Zydus Cadila. MNCs on the list included Johnson & Johnson's ($JNJ) Janssen, MSD Pharmaceutical and Sanofi ($SNY).

Daara Patel, secretary general of the Indian Drug Manufacturers Association, and Ranjana Smetacek, director general of the Organisation of Pharmaceutical Producers of India, told the Financial Express their organizations plan to notify all of their members.

S.V. Veeramani

But, IDMA President S.V. Veeramani complained of several problems with the new forms, mainly conflicting intricacies in what is to be filed and by whom. He also said the new system would be a burden on small-scale drug makers.

The Financial Express said the NPPA would be launching the new system shortly.

- here are the NPPA notice and form
- and the story from the Financial Express