New Delhi: The Drug Controller General of India has sought an explanation from Cipla Ltd after a distributor for rival Roche Scientific Co. (India) Pvt. Ltd raised an alarm that Cipla was promoting a cancer drug for ailments it wasn’t meant for.
The development adds a new twist to the ongoing battle between the Indian non-patented drug maker and Switzerland-based F Hoffmann-La Roche Ltd over Erlocip, a copy of Roche’s patented lung cancer drug, Tarceva.
If the drug regulator concludes Cipla was indeed doing so, it could potentially lead to serious regulatory action as such marketing practices can endanger lives and is considered a serious violation of provisions of the Drugs and Cosmetics Act, 1940, according to one industry expert who didn’t want to be identified.
“You need clinical trials if a drug is being used for newer purposes,” the expert added.
In a letter dated 27 March, Taksal Pharma Pvt. Ltd, a distributor for Roche Scientific, the Indian arm of the Swiss drug maker, alleged Cipla was distributing promotional literature on Erlocip to doctors for treating four kinds of cancers, even though it didn’t have regulatory approval for using the drug to treat all four cancers.
Roche itself has only secured approval for Erlotinib to be used for non small-cell lung cancer and pancreatic cancer. “Cipla is promoting the drug (Erlocip) for neck and head cancer as well as colorectal cancer, besides the two indications that Roche has approval for. They are selling it for uses that even the innovator hasn’t discovered,” claimed one industry person close to the development.
This person, who didn’t want to be named, said Cipla, on its own, only had approval for using its drug for lung cancer. The drug, that goes by the chemical name Erlotinib, is being sold in India as Erlocip by Cipla, and costs Rs1,600 a tablet.
Malignant growths in the lower intestines such as colon, rectum and appendix, are referred to as colorectal cancer.
Roche Scientific’s managing director, Girish Telang, confirmed that Taksal had indeed written to the regulator. “They have brought it to our notice. We have written to Cipla, asking them to respond within a specific time frame. We will give them a chance to make their standpoint clear, produce scientific evidence supporting their claims to doctors and then take appropriate action. It is a serious issue,” said drug controller Surinder Singh in a telephone interview with Mint .
Singh said his office could issue a warning to the company asking it to desist and, in an extreme case, even cancel the licence for manufacture of the drug. A response from Cipla was expected early next week, he said. Amar Lulla, chief executive of Cipla, said he couldn’t immediately comment on the issue as he was out of India and unaware of the development. Even though Roche had a patent on the drug, Cipla had gone ahead with marketing of its version in India. The issue snowballed into a high-decibel patent infringement lawsuit before the Delhi high court, with Roche asking for an injunction to restrain Cipla from selling cheaper copies of its drug.
In turn, Cipla filed a counter-complaint seeking to revoke the Tarceva patent, alleging that the drug was merely a tweaked version of a pre-1995 drug and, hence, ineligible for patent protection under Indian law. The Indian pharmaceutical company also said that its drug, at Rs1,600, cost a third of the patented version, while Roche blamed its higher prices on the steep import duties .
The court quashed Roche’s injunction plea a month ago, saying barring cheaper copies will cause irreparable harm to the patients. Roche then filed an appeal before a larger bench in the same court last week and hearings are continuing on the Tarceva patent revocation case.
According to information available under the National Cancer Control Programme, cancer has become one of the 10 leading causes of death in India, with nearly 1.5-2 million cases at any given point of time. Another statistic from Indian Council of Medical Research shows that in India at least 90,000 men and 79,000 women are diagnosed each year with lung and bronchial cancer alone.