Drug Regulation

Pointing Fingers: Accusations fly as Roche-Cipla continue to lockhorns.

The latest in the Roche- Cipla patent war are allegations of wrongful promotion of Erlocip. This is the same drug that Roche held a patent for, but Cipla continued to manufacture in India. Readers will remember Shamnad’s extensive post on the Roche-Cipla judgment that revolved around this very drug.

As per the letter dated 27 March, 2008, Cipla allegedly distributed promotional literature on Erlocip for the treatment of four kinds of cancer (non-small lung cell, pancreatic, neck & head cancer and colorectal) without regulatory approval to treat the same, as per Taksal Pharma Pvt. Ltd, Roche’s Indian distributor. Roche itself has just recently secured approval Roche itself has only secured approval for Erlotinib to be used for only 2 forms of cancer- non small-cell lung & pancreatic.

The Drug Controller in an interview with Livemint has stated on record that he will allow them to make their standpoint clear with evidence before any action is taken for a serious issue such as this. If the Drug Regulator comes to this conclusion, Cipla could potentially be subject regulatory action as the same is viewed very seriously under the provisions of the Drugs and Cosmetics Act, 1940 with regard to the potential danger such marketing practices can cause. Hypothetically, the Drug Regulator could preliminarily issue the Company a warning to desist and, (in the worst case scenario) cancel the licence for manufacture of the drug.

This new twist in the Roche-Cipla case is almost certain to have an impact in the case now in appeal before the Division Bench.

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