Emerging CROs – One Step Forward And Two Steps Back

By Rob Wright, Chief Editor, Life Science Leader magazine

In discussions with executives in pharma and bio, emerging markets are a hot topic. No longer are emerging markets places where companies can expect to be successful simply by attempting to market products developed in other countries and retrofittedto function in the developing country. According to leading experts on emerging markets, we can anticipate greater innovation to occur in emerging markets which will then move into developed countries. As with anything, however, one can expect some growing pains to take place in the process.

In the pharmaceutical and biopharma industries, companies are increasingly turning to outsourcing in emerging markets as not only a cost savings initiative, but as a growth opportunity. It is easy to see why when you consider just China and India represent 2 billion potential new customers. Over the last five years, the economies in both emerging countries have grown significantly and outsourcing has played a prominent role. Though outsourcing to emerging markets continues to rise, so too does the debate as to the quality of products being manufactured and caliber of research being conducted.

For example, Lambda Therapeutic Research Limited is a multinational CRO headquartered in Ahmedabad, India. Lambda boasts having more than 45 years of service in the biopharmaceutical and generic industries, completing more than 4,500 clinical studies globally, and more than 50 successful regulatory audits and inspections. Synchronis another CROin India and offers, “Competitive and high quality clinical trial services to domestic and international pharmaceutical and Bio-Pharmaceutical companies,” according to its website. Unfortunately for these two companies, this past March, Chris Hansen of NBC’s Dateline, conducted an investigation portraying Lambda and Synchronin a rather negative light. One CRO executive bluntly told the Dateline team that Indian patients would take whatever a doctor prescribed. "Doctor is god," he stated, "So if I go to him, I will blindly follow what he says."

In response to the report, Lambda and Synchron have accused Dateline of smearing their reputations and comments being taken out of context. A spokesperson for the Association of Clinical Research Organizations (ACRO) believe the program could hurt the business of smaller CROs as drug companies increasingly seek to test and market their new products in India. I couldn’t agree more.

Brand equity and trust are tough to build and can be quickly destroyed. I recall a local example of a physician, having practiced medicine without issue for more than 30years, being accused of molesting a patient and having his name appear on the front page of the newspaper just six months prior to his planned retirement. Soon, other accusers came forward. Before long, this physician went to trial to fight the accusation. Eventually, he was found innocent on all counts with the first accuser admitting having made up the accusations in an attempt to make some money. Unfortunately, that part of the story must not have been as sensational, as it was relegated to one of the back pages of the same newspaper. Whether or not the Dateline story is an accurate portrayal of Indian CROs, the damage has been done. Perhaps the exposure will help all Indian CROs to improve upon how they conduct their businesses. In the meantime, if feels like CROs in India took one step forward just to take another two steps back.