The US regulator also cautioned that the drug may cause vivid or strange dreams and affect the patient’s ability to drive or operate machinery.
Indian rules are fuzzy on actions based on such information. The government official responsible for regulating drugs sold in the country, Surinder Singh, the drug controller general of India, or DCGI, could not be reached for comment. Local rules do not mandate patient trials of a drug here if sufficient safety and efficacy data from international studies are produced. The Indian drug regulator gives approval to new drugs if they have been approved by regulators of the US and Europe. No clinical trials were carried out in India in the case of Champix.
Only in specific cases when the safety or efficacy data does not satisfy DCGI are clinical trials asked for but this is always “on a case-to-case basis”, explained a senior official in the DCGI’s office who did not wish to be identified. There is what is called “a pharmacovigilance department to take note of any ADRs (adverse drug reports)” but it is very new and would take time to be fully functional, this official added. Former DCGI M. Venkateswarlu added that there “is always a risk-benefit ratio to a drug. One cannot just keep out a drug especially when it addresses an issue of major public health concern.”
Doctors say that ADRs don’t get adequately reported in India and patients do not have their medical or psychiatric histories mapped, a practice recommended as regular due diligence by FDA and firms such as Pfizer in the US. “No data from India will come up if this drug has side effects,” said Amit K. Mandal, pulmonologist in New Delhi’s Flt Lt Rajan Dhall Hospital run by Fortis Healthcare Ltd.
P.C. Gupta, director of Navi Mumbai’s Healis Sekhsaria Institute for Public Health, said the fact that Champix is a prescription drug limits its risks to some extent. But Mandal is concerned that in India “a six-month-old prescription also gets honoured in a chemist shop.”
Kewal Handa, managing director of Pfizer’s Indian operation, said the need is to balance the benefits of the drug with tightly controlled post-use monitoring of those who take Champix. “The quit rate with Champix is 44%. Compare this to the annual quit rate of smokers in India at 2% when 70% smokers say they want to quit. So there is definitely a need for the drug. We will also be doing a vigorous post-marketing study involving 500 people in the country,” Handa added. The results of Pfizer’s study will be reported to DCGI in six to nine months.
The firm also defends the safety of Champix. “We have put the information up front,” said Anjan Chatterjee, medical director of Pfizer Inc., referring to the product labels. “Smokers in general have higher risk of psychiatric illnesses and breaking an addiction leads to withdrawal symptoms. This is the level playing field with or without Chantix,” he added.
Chatterjee said there has been no scientific evidence linking the drug to suicides. No suicidal tendencies were found in Pfizer’s global trials.