Mumbai-based drug maker Cipla Ltd has denied a charge that it has been promoting cancer drug erlotinib for four types of cancers when it has been approved just for two indications by India’s drug regulator.
Cipla stated this in response to a letter from Drug Controller General of India, or DCGI, Surinder Singh’s office seeking clarification on an allegation made by Taksal Pharma Pvt Ltd, a distributor for Roche Scientific Co (India) Pvt Ltd, which is the Indian arm of Swiss drug maker F Hoffmann-La Roche Ltd Erlotinib is the generic form of a drug on which Roche has a patent.
Taksal claimed that Cipla was distributing promotional literature stating benefits for four kinds of cancers, when it did not have regulatory approvals for all of them. The Mumbai drug maker has said that it had “merely informed” the doctors of the effects of the drug during clinical trials on various types of cancers but it had not promoted the drug for any unapproved uses.
Promoting a drug for uses other that what the DCGI has approved it for is a serious violation of provisions of Drugs and Cosmetics Act, 1940, and can lead to action by the drug quality regulator for unethical marketing practices—sometimes as severe as suspension of marketing licence for that drug.
Roche, patent holder for the drug that it sells under the brand Tarceva, has approval to sell erlotinib for patients suffering from non-small cell lung cancer and pancreatic cancer. Cipla was promoting the drug for neck and head cancer as well as colorectal cancer, Taksal Pharma had alleged.
“There is no merit in the complaint. Cipla has not promoted erlotinib tablets for unapproved uses. It has merely informed the doctor about the published clinical trials on the use of erlotinib in different types of cancer other than what it is officially approved for,” said Amar Lulla, Cipla’s chief executive, adding the practice was common in the pharmaceutical industry. Lulla said Cipla had already responded to the regulator on the issue. The response of the DCGI office to Cipla’s explanation could not be immediately ascertained as Singh could not be contacted.
Sameer Khatri, consultant medical oncologist in New Delhi’s Shanti Mukand Hospital, said he was not against sharing such clinical trial information with doctors but admitted that the line between just informing a doctor about all possible uses of a drug and convincing them to prescribe them was blurred.
“Informing the doctor is okay if it is supported with scientific evidence. However, doctors should be clearly informed in that communication which are the approved uses and which are the unapproved ones,” said Dr Khatri who believes that discerning cancer specialists would not be deceived because they have access to a lot of drug research information on their own.
The Taksal complaint has added a twist to the ongoing battle between Cipla and Roche over the Basel, Switzerland-based drug maker’s patented Tarceva medication. Cipla’s generic version of the drug is being sold at Rs1,600 a tablet, which is substantially cheaper than at what Roche sells Tarceva.
Roche is suing Cipla in the Delhi high court for infringing on its patent and the Indian drug maker is trying to invalidate the patent on the grounds that Tarceva is a modified version of an older drug. The court had quashed Roche’s injunction plea in March, saying barring cheaper copies will cause irreparable harm to patients. Roche has filed an appeal on that order before a larger bench in the same court.