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Delays in permissions and regulatory clearances are resulting in companies taking clinical trials abroad, said Dilip Shanghvi, Chairman and Managing Director of Sun Pharma Advanced Research Company (SPARC), even as the company unveiled its research line-up and plans to license out some of its prospective products.
The first and second phase of clinical trials on several of SPARC’s products are being done overseas, Shanghvi said, responding to a query on the domestic clinical trial environment.
Though companies can do equally good studies in India, trials were going abroad because getting permissions and regulatory clearance involved long and unjustified delays, he said. And though doing trials overseas pushed up costs significantly, Shanghvi added, they do result in giving companies an understanding of those markets.
SPARC is the de-merged research entity of Sun Pharma. And Shanghvi’s observations come even as several foreign and local companies complain of the glacial pace of getting regulatory approvals for clinical trials. Under the Supreme Court’s watch after some tests went wrong, clinical trials (involving the testing of drugs on humans) have come under close scrutiny.
Out-licensingSpeaking to analysts on SPARC’s research pipeline, its top management said talks were on with partners to license out some under-research products to bring in funds for further study.
SPARC’s products under research are in therapeutic areas including ophthalmology, oncology, respiratory and the central nervous system. Shanghvi said, they would look to out-license the research product beyond the proof of concept at the pre-registration or close to market stage.
A key product in the SPARC basket, Paclitaxel Injection Concentrate for Nanodispersion (PICN) used to treat breast cancer, is scheduled for Phase III trials in the US in the third quarter of the financial year 2014-15.
Shanghvi said PICN would start Phase III trials (to test for safety and efficacy) shortly, and it will be “fairly expensive”. If the company is not able to out-license some of these products, it would have to raise funds to support further research, he said, adding that they may out-license PICN too. The product has received patent protection in the US up to 2028.
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