CCI orders detailed probe against pharma major Roche

The Competition Commission of India (CCI) has ordered a detailed investigation against pharmaceutical major Roche and its two group firms for alleged unfair business ways in the market for a cancer drug. The regulators decision has come on a complaint filed by drug makers Biocon and Mylan Pharmaceuticals. After a detailed analysis of the various allegations made against Switzerlands F Hoffmann-La Roche AG and its group entities — US-based Genentech and Roche Products (India) — CCI has concluded that there is "prima-facie" evidence of competition norm violations.

CCI considered market for biological drugs based on Trastuzumab, including its biosimilars in India as the relevant one. Trastuzumab block the effects of HER-2 protein, which sends growth signals to cancer cells, and targets a specific form of breast cancer. In a 36-page order, made public, the CCI said a dominant enterprise is endowed with a special responsibility not to allow its conduct to impair undistorted competition in the relevant market.

"Prima facie, it appears to the Commission that Roche Group has shirked such responsibility and indulged in abusive conduct," the order, dated April 21, said. According to the watchdog, Roche Group is dominant in the relevant market and can operate independently of the market forces. The CCI said it is of the considered view that "prima facie, the contravention with regard to Section 4(2)(c) of the (Competition) Act is made out against Roche Group, which warrants detailed investigation into the matter."

Section 4(2)(c) pertains to practices that impact market access. Among others, it was alleged that Roche Group implemented or attempted to implement a series of actions to impede the entry and/ or growth of biosimilar Trastuzumab in India, thereby adversely affected competition in the relevant market.

"We are dealing with a case which involves a highly sensitive sector, where the safety of the patient is of paramount importance. "Thus, creating any iota of doubt in the minds of doctors can adversely affect the market for biosimilars, which is prescription induced, beyond repair. Such disparagement may also have ripple effects within the medical community," the CCI said.

In this scenario, those biosimilar manufacturers who do not have strong marketing channels amongst doctors may be forced out of the market because of abusive denigration by a dominant player, it added.