‘Tumhari Sulu’ producer, pharma firm face FDA ire

The Food and Drugs Administration is likely to send a notice to the producer of the Bollywood movie ‘Tumhari Sulu’ and north-based pharmaceutical company Torque for not adding an advisory before promoting a cough syrup as a part of movie promotion.

A senior official said they can not feature an over-thecounter (OTC) cough syrup that contains ingredients which can cause adverse health effects if taken without proper guidance from doctors.

Earlier this month, a medical expert had approached the FDA commissioner of Maharashtra citing concerns over promotions of medicine aiding the idea of self-medication. The cough syrup Torex was promoted as the cough reliever of a protagonist from the movie who suggested the audience to use the same for any throat complication.

“The advertisement campaign violated the basic norm of advising the readers and target audience to exercise caution while using the medicine. The notices pointed out that the advertisers did not advice the patients to not use the drug without a physician’s consultation,” said FDA commissioner Pallavi Darade.

Darade further added they will ask them to include a statutory warning stating that the syrup to be taken under the guidance of a doctor only. FDA officials said a similar notice may be sent to actress Vidya Balan, for promoting the OTC cough syrup in advertisements through newspapers and electronic media channels.

Torque, a Chandigarhbased pharmaceutical company which manufacturers the cough syrup was pulled up by FDA Maharashtra in 2015 for promoting a fairness cream which allegedly contained a corticosteroid. Later, FDA prohibit the marketing of the product in Maharashtra.

“We are aware of the fact that Torque Pharmaceutical is involved in both of these products. We will definitely check the contents of the syrup and issue notices based on the complaint,” Arjun Khadtare FDA Joint Commissioner (drugs) has said.

Dr Tushar Jagtap, a medical activist filed a complied with FDA stating that “As you are aware that, whenever a drug is prescribed by a qualified doctor he/she takes into account many factors regarding the safety, efficacy and need of that particular molecule. The doctor also takes into account the age of the patient, dosage schedule, drug interactions, history of allergy, its tolerability, efficacy, cost-effectiveness, its form and many other aspects which are of vital importance.”

“Self-medication is an issue indeed but a lot of research goes into the product before its sold without the need for a prescription.