FDA to send notice to Tumhari Sulu producer for promoting cough syrup without advisory
Pharma firm will also be issued a notice, as may be actress Vidya Balan, who advises people to use it for throat infections in the moviemumbai Updated: Dec 05, 2017 08:57 IST
The producer of Bollywood movie Tumhari Sulu and Chandigarh-based pharmaceutical company Torque will receive notices this week from the Food and Drug Administration, Maharashtra, for not issuing an advisory before advertising a cough syrup as part of movie promotions.
Officials from FDA said a similar notice is likely to be sent to actress Vidya Balan too, for promoting the over-the-counter cough syrup via newspapers and electronic media.
Earlier this month, HT had reported that a medical expert had approached the state FDA commissioner with concerns over the promotion of the cough syrup in the movie, and thereby encouraging self-medication. In a scene from Tumhari Sulu, the protagonist, played by Balan, promotes the cough syrup Torex by advising her audience to use it for throat infections.
“The movie campaign violated a basic norm - that of advising readers and audience to exercise caution while using the medicine,” FDA commissioner Pallavi Darade told HT. “The notices point out that the advertisers have not warned the public against using the cough syrup without consulting their physician.”
This is not the first time that Torque, a Chandigarh-based pharmaceutical company that manufactures the OTC cough syrup, has got into trouble with the FDA in Maharashtra. In 2015, the company was pulled up for promoting a fairness cream that allegedly contained corticosteroid, a cocktail of steroids. The FDA had prohibited the marketing of the product in Maharashtra.
“We are aware that Torque pharma is behind both these products. We will definitely check the contents of the syrup and issue notices based on the complaint,” Arjun Khadtare, FDA joint commissioner (drugs) had said.
Torque Pharmaceutical has not responded to multiple phone calls and e-mails sent by HT on the issue.
Dr Tushar Jagtap, the medical activist who complained to the FDA, said: “A drug is prescribed taking into consideration factors such as safety, efficacy, need of that particular molecule, age of the patient, dosage schedule, drug interactions, history of allergy, and other important aspects.”
This cough syrup contains diphenhydramine hydrochloride, terpine hydrate, ammonium chloride and sodium citrate, all of which have known side-effects, he said, adding: “General information provided by the advertisement and the leading actress are misleading and can endanger the lives of unsuspecting patients. In our country, self-medication is rampant and these kind of advertisements promote it.”
Other doctors, however, said that many cough syrups currently in the market have similar composition to Torex, and almost all of them OTC products. “Self-medication is an issue indeed, but a lot of research goes into the product before it is sold without the need for prescription. Moreover, the dosage or its habituation are more subjective issues. Having said that, it is true that self-medication should not be promoted through such advertisements,” said Dr Pradip Shah, an MD physician at Fortis Hospital, Mulund.