In response to the unfortunate deaths of at least 141 children globally linked to cough syrups, the Drug Controller General of India (DCGI) has implemented a ban on the use of a combination of anti-cold medications in children below the age of four. Additionally, the DCGI has mandated proper labelling for drugs and has communicated with all states, urging them to update the package inserts for products containing a combination of chlorpheniramine maleate and phenylephrine. Pharmaceutical companies, including GlaxoSmithKline's T-Minic Oral Drops, Glenmark's Ascoril Flu Syrup, and IPCA Laboratories' Solvin Cold Syrup, among others, have been instructed by the regulatory body to include a 'warning' on their products.
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#ColdFluBan #ChildSafety #HealthAlert #IndianGovernment #MedicationWarning #ChildrensHealth #SafetyFirst #HealthCareUpdate #ParentingNews #PublicHealth #KidsWellness #RegulatoryAction #DrugSafety #StayInformed #HealthDirective #ChildrensMedication #ColdAndFluSyrups #SafetyMeasures #HealthGuidelines #ChildHealthcare
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00:00 In response to the unfortunate deaths of at least 141 children globally linked to cough
00:07 syrups, the Drug Controller General of India (DCGI) has implemented a ban on the use of
00:12 a combination of anti-cold medications in children below the age of four.
00:17 Additionally, the DCGI has mandated proper labelling for drugs and has communicated with
00:21 all states, urging them to update the package inserts for products containing a combination
00:26 of chlorphenidamine malate and phenyllephrine.
00:30 Pharmaceutical companies including GlaxoSmithKline's T. Minnick Oral Drops, Glenmark's Ascoril
00:36 Flu Syrup and IPCA Laboratories' Solvent Cold Syrup, among others, have been instructed
00:41 by the regulatory body to include a warning on their products.
00:44 In a notification released on December 18 by the Central Drug Standard Control Organization,
00:49 Rajiv Singh Raghuvanshree, the head of the Drug Controller General of India, has directed
00:53 drug controllers across all states and Union territories to ensure that manufacturers of
00:58 chlorphenidamine malate and phenylephrine incorporate a warning on their products, explicitly
01:03 stating that they should not be prescribed for infants and children under the age of
01:07 four.
01:08 The communication emphasises that manufacturers must include the warning, "Fixed-dose combination
01:13 should not be used in children below four years of age" on the label, package insert
01:18 and promotional literature of the drug.
01:20 According to Indian authorities, using cough syrups made in the country in 2019 resulted
01:24 in at least 12 child deaths and four severely disabled children.
01:29 The deaths have clouded the quality of exports from India, which is known as the world's
01:33 pharmacy, because of its abundant supply of inexpensive, life-saving medications.
01:38 In June, the government took action by banning 14 fixed-dose combination drugs, asserting
01:42 the lack of therapeutic justification for these medications.
01:45 FDC drugs involve the combination of two or more drugs in specific fixed doses.
01:51 The ban emphasises that if a combination is introduced for the first time, it falls under
01:55 the definition of a "new drug".
01:57 The particular FDC in question comprises chlorphenidamine malate and phenylephrine, commonly used in
02:02 syrups or tablets to address symptoms of the common cold.
02:05 It is notable that the World Health Organization does not endorse the use of over-the-counter
02:09 cough syrups or medicines for treating cough and cold symptoms in children under the age
02:13 of five.
02:14 Chlorphenidamine, an antihistamine, is utilised to alleviate symptoms associated with allergies,
02:19 hay fever and the common cold.
02:21 These symptoms encompass rash, watery eyes, itchy eyes, cough, runny nose and sneezing.
02:26 Similarly, phenylephrine is employed for the temporary relief of congested nose, sinus
02:30 and ear symptoms caused by the common cold, flu, allergies or other respiratory illnesses
02:35 like sinusitis and bronchitis.
02:37 The mechanism of action involves reducing swelling in the nose and ears, thereby alleviating
02:41 discomfort and facilitating easier breathing.
02:44 The widely used combination of these two medications is manufactured by companies such as Glaxo
02:49 SmithKline Pharmaceuticals Ltd's T. Minick, Wanberry Ltd's Cori Minick, Alambic Pharmaceuticals
02:54 Ltd's Vicoryl AF, Wanberry Ltd's Cori Minick QR, Glenmark Pharmaceuticals Ltd's Ascoril
03:01 Flu, IPCA Laboratories Ltd's Solvent Cold AF, among others.
03:06 As per the directive from the Drug Controller General of India, these drug manufacturers
03:09 are required to incorporate the warnings specified by the DCGI on the package.
03:14 [Music]