After a major slowdown, new drug approvals are likely to pick up after the National Pharmaceutical Pricing Authority (NPPA) decided to de-link price approval of new drugs with its internal guidelines, a move seen as a major relief to pharmaceutical companies. NPPA says in office memorandum that price approval of new drugs won’t be linked to Integrated Pharmaceutical Database Management System.
In September 2014, the drug pricing regulator had asked all pharmaceutical firms to register themselves under its Integrated Pharmaceutical Database Management System (IPDMS), making this a requirement for fixing and revising drug prices. People from pharmaceutical industry lobby groups said this had caused major delays in launching new drugs in the market. About 150 new drug applications were pending with the NPPA, some as old as one-and-a-half to two years, said two people, both of whom declined to be named.
According to the Drug Pricing Control Order (DPCO) 2013, NPPA is supposed to approve such applications within 30-60 days. However, in what could be a big relief to drug companies, NPPA in an office memorandum said that “price approval of new drugs shall not be linked to IPDMS and any other conditionality”. To further ease things for firms awaiting approval of prices for new drugs, the NPPA has also decided to do away with the practice of deciding a new price for each applicant of a new drug.
The body, in a meeting in December 2017, had approved 59 new drugs in cases where the price of a similar drug had already been approved, by extending the prices already notified for these products. Earlier in January and February of 2017, NPPA had issued guidelines which said that price approval of such new drug applications would not be approved unless industry first complied with IPDMS. The industry has been complaining about this issue for long, with many approaching the PMO too. The launch of IPDMS was seen as a necessary step to create an appropriate mechanism of obtaining market-based data related to all drugs marketed in the country.
NPPA had initially been sourcing the data from IMS Health, subject to validation, for fixing prices under DPCO 2013. Whenever IMS Health data was not available or found to be inadequate, it was supplemented by data from another specialized pharmaceutical data source. Linking of new drug approval with IPDMS did help in speeding up the process of data submission and data bank upgradation. The companies which complied with the IPDMS data submission got their prices approved.