India’s apex drug regulatory body has asked its officials to take “all measures” to prevent companies from retaining the same brand name for different formulations.
The regulator’s move aims to prevent patients from accidentally taking the wrong medicine in cases where pharmaceutical companies change the composition of their drug brands, but continue to sell the new formulation under the old brand name.
According to a notification issued on Thursday by the Central Drugs Standard Control Organisation (CDSCO), the practice of changing the key therapeutic ingredients in a drug formulation without changing the brand name “is not only misleading but may also result in undesirable pharmacological effects as the consumer would take the formulation assuming that it has the earlier composition.”
The Indian Express has reviewed a copy of this notification, which was issued to all zonal and sub-zonal CDSCO offices. The issue has been under discussion for “quite some time now”, stated Drug Controller General of India Eswara Reddy in the notification. The notification comes nearly eight years after the issue was deliberated by the Drugs Consultative Committee in three separate meetings held between 2008 and 2011.
“DCC further recommended that such type of practice needs to be discouraged and State Drugs Controllers should ensure that the same brand name should not be permitted to retain by the manufacturers if the composition of the API(s) in the new formulation changed,” stated the notification.
“In view of the above, you are requested to take all measures to discourage the practice of marketing of drug formulations with changed composition without changing the brand names and ensure that the same brand name is not permitted to be retained by the manufacturer, if the composition of the API(s) in the new formulation is changed,” it added.
While such a practice does exist in India’s pharmaceutical industry, it is not clear how prevalent it is as there is little to no data on it, say analysts.
One analyst told The Indian Express on condition of anonymity that the move was “negative” for the industry, but that companies would find out a way to “circumvent” it.
Phone calls and text messages to the DCGI remained unanswered by press time Thursday.
For instance, Wockhardt’s fixed dose combination cough syrup ‘Zedex’ was earlier listed by pharmaceutical market research firm AIOCD Awacs PharmaTrac in 2016 as having a combination of Bromhexine + Dextromethorphan + Ammonium Chloride.
However, bottles of the syrup available in the market today have a different—Dextromethorphan Hydrombromide and Chlorpheniramine Maleate.
Queries sent to Wockhardt about its brand remained unanswered by press time Thursday.
PharmaTrac said it does not keep information on brands where formulations have been changed.
“Suppose a company has a popular brand for a particular formulation in a therapeutic category, but the market moves towards another formulation in that category and its competitors beat it to get market share. In those cases, sometimes, the company decides to retain the same brand name, switch the formulation and inform doctors of this change,” said a pharmaceutical analyst on condition of anonymity.
“It is a dangerous practice because, sometimes, doctors associate the brand with a particular formulation. In case there is a lack of awareness of the switch, this could be harmful for patients,” the person told The Indian Express.