National Pharmaceutical Pricing Authority eases norms for new drug approvals
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.
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 on Tuesday 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. According to the body, at a meeting on 15 December, it 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.
NPPA’s decision is based on a high level meeting held in the Prime Minister’s Office (PMO) recently, people familiar with the matter said.
“Earlier in January and February this year, 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,” said an industry person, requesting anonymity.
The pharma industry welcomed the step. “These are definitely positive steps taken by the NPPA. These rules were causing a lot of complications, this is therefore a relief to some extent,” said Deepnath Roy Chowdhury, national president, Indian Drugs Manufacturers’ Association (IDMA).
The launch of IPDMS was seen as necessary 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. NPPA has so far approved 266 new drug prices under NLEM 2015,” said the NPPA memorandum, which has been reviewed by Mint.
“By rejecting the price approvals, the price regulator had not only protected the existing formulators from new entrants but also abetted monopoly of some of the existing formulators, who enjoy up to 99% market share of these products,” said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), which represents 20 of India’s biggest drug makers.
According to Malini Aisola of the All India Drug Action Network (AIDAN), the step had been taken in consumer interest and a retreat by NPPA is a loss for all. “Since the launch of the IPDMS—an attempt to formulate a robust government pricing database—the companies have shown resistance and poor compliance. Given the state of the Indian market which is riddled full of irrational, unnecessary combinations and formulations, the requirement for prior price approval was to protect consumers to ensure appropriate marketing approvals were in place and certain pricing would be followed. The DoP instruction has undone these procedures the NPPA was following on sound precautionary principles,” she said.
Emails sent to Pfizer Inc, Lupin Ltd, Sanofi India Ltd and Sun Pharmaceuticals Ltd did not elicit any response till press time.