Mumbai: Indian drug regulator has askedPfizer Ltd, the Indian arm of the world’s largest drug maker Pfizer Inc., to submit data of a compulsory post-sales study on its smoking cessation drug Champix. This follows increased safety concerns on such psychotropic medication drugs worldwide, though Indian doctors haven’t so far raised any issues with Pfizer drug.
This study aims at providing data on the so-called real world experience with Champix in India where the drug was launched in March 2008.
“We are conducting a post-marketing surveillance on Champix with 300 patients and 21 sites,” said Chandrashekhar Potkar, director, medical and regulatory affairs, Pfizer.
Pfizer’s post-marketing study (technically called Phase 4 trials) approved by the Drug Controller General of India, or DCGI, in January is expected to be completed by May 2010. However, the company will keep on updating the regulator on findings of the study at regular intervals.
Though a post-launch study of drugs is in compliance with regulatory requirements once they are approved in the country, most of the drug makers in India do not follow the norm strictly unless they are specifically asked to do so.
This is the key reason why the Indian regulator often lacks enough data on adverse reactions of drugs that are already available in the market.
Also known as post-marketing surveillance, these studies are mandated in drug regulation. This is because they can offer extensive data since the drug is available in the market and a large patient population is under treatment.
Such a study offers the authority an opportunity to immediately recall a product in the event of adverse reports.
Every approved drug is treated as “new drug” for the first four years.
A senior official at the Central Drugs Standard Control Organisation, the department responsible for drug safety in India headed by DCGI, said varenicline (the chemical name of Champix) is approved for marketing in India.
“We don’t have it (Champix) on pharmacovigilance, but the company is conducting post marketing surveillance,” the official added.
Pharmacovigilance is a drug watch system and the drug regulator initiates this when adverse reactions such as deaths and critical side effects are reported elsewhere on the use of an approved drug.
Smoking cessation medication drugs, like any psychotropic drugs, are capable of affecting the mind, emotions, and behaviour, besides known side effects such as nausea, among others.
Champix, also marketed as Chantix in the US and a few other markets, is the latest smoking cessation drug introduced in the global market after Glaxo SmithKline Plc.’s Zyban (known as bupropion hydrochloride in generic name) in the recent past.
Both these drugs were linked with serious adverse reactions, including deaths, in the West soon after they were introduced. Subsequently, the drug regulators in the US as well as Europe had asked the manufacturers to submit additional data to prove the safety of these drugs.
Asked about the reported deaths while undergoing smoking cessation treatments with Chantix in Europe, Pfizer Asia’s regional medical affairs manager Alaster Allum, said “The original reason for those deaths were not confirmed to be due to the drug.”
Alaster was in Mumbai last week to announce his company Pfizer (India)’s plan to tie up with private sector hospital groups to start a large network of smoking cessation clinics in India.
Pfizer, which has already partnered with Delhi’s Max health care and a few other institutions for this project, is currently in talks with several big health care groups to set up some 600 such clinics in the country by 2010.