- The Indian pharmaceutical industry is widely recognized as a generics powerhouse, a deserved reputation given about 40% of generic drugs in the U.S. are imported from India. But now several large Indian pharma companies, such as Sun Pharma and Dr. Reddy's, are increasing R&D spending to develop new drugs targeting unmet needs in the U.S., reports the The Wall Street Journal.
- During the first nine months of 2015, almost one-third of all FDA applications for new product approvals were from Indian pharmaceutical companies, up from 19% during the same period in 2014, according to a Journal analysis.
- One of the main strategies Indian pharma companies are turning to is creating new drugs from off-patent molecules which have established safety profiles. This cuts drug development costs and hastens approval.
Take Lupin for example. One of the biggest Indian pharma companies by market capitalization, Lupin increased R&D by 17% last year, working on injections for less targeted cancers and a better delivery mechanism for pulmonary drugs, the Journal reports.
Dr. Reddy's, another active firm in R&D, received FDA approval this year for a spray for plaque psoriasis and an injection for migraine headaches. The injection was formulated from an off-patent molecule, which was tweaked to make deliverable via syringe. The goal is to serve a subset of migraine patients who find swallowing pills challenging.
With an already established safety profile for the molecule, Dr.Reddy's developed its injection in five years—extremely quick in the drug development world—and spent a fraction of the cost typical of a new drug approval.
But while the top Indian companies are well-known brands in India, they may face a marketing challenge in the U.S. This could prove more difficult as Congress and the FDA take a closer look at quality concerns among Indian manufacturing facilities. The FDA has sent more than a dozen warning letters citing compliance violations to a number of Indian firms, including Sun and Dr. Reddy's, over the past year or so.
While those letters are unrelated to the companies efforts in the U.S., increased scrutiny could heighten the reputational challenge for Indian firms.