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Theorem pushes further into India as regulatory hurdles mount

By Zachary Brennan , 16-Jul-2014
Last updated on 18-Jul-2014 at 17:03 GMT

A new Union budget proposal seeks to remove a 12.3% service task exemption on clinical research.
A new Union budget proposal seeks to remove a 12.3% service task exemption on clinical research.

CRO Theorem Clinical Research and Excel Life Sciences have formed a strategic relationship to bolster Theorem’s clinical development offerings in India just as regulations begin to shift on the subcontinent.

As part of the partnership, Theorem will look to leverage ELS’ relationships with more than 1,000 hospitals and research centers across 25 cities throughout India, covering a broad range of therapeutic disciplines. ELS boasts of having one of the largest networks of investigators and investigative sites within India. 

Site management services from Excel Life Sciences help take the burden off investigators so  they can focus on patient care and ensure that the study is conducted to the highest standards for quality, ethics and performance,” said Vijai Kumar, president and chief medical officer of ELS. “Operationally, our site management focus has translated into India patient enrollment and retention numbers that are significantly higher than comparative global performance for the same study.” 

Marc Hoffman, Theorem SVP and general manager of biopharmaceutical development, added, “Collaborating together we can offer sponsor companies access to a wealth of high-quality research centers in India, a well-established research team with a strong understanding of ICH-GCP and, most importantly, the local knowledge for successful conduct of studies in country.” 

Regulatory Hurdles 

But the partnership comes just days after a new Union budget proposal that seeks to remove a 12.3% service task exemption on clinical research thereby upping the cost of trials conducted in India. 

According to a report from Ernst & Young , the removal of the exemption “on clinical trial research on humans is likely to add challenges to clinical trials industry which is already grappling with regulatory issues.” 

Some local CROs in India are already investigating ways to shift their clinical trials abroad, according to India’s Business Standard . The budget proposal still has to make its way through Parliament.

"India remains a significant and important market for drugs, and a place to conduct research. If the tax law changes we would be disappointed but we would retain our same commitment to conducting high quality research around the globe and, whenever applicable, include India in these considerations. Clinical trials in India will continue to be conducted at a faster pace and lower cost while maintaining the high levels of data quality and integrity," Theorem SVP Marc Hoffman told us. 

At the height of the regulatory debacle last summer, the Indian Supreme Court stepped in and demanded state government health secretaries discuss ways to tighten clinical research regulations. Previously, CDSCO (Central Drugs Standards Control Organization) sought to beef up trial regulations through the use of ethics committees and new trial participant compensation rules.

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