Two Indian drug manufacturers have come under regulatory control after the syrups coughs associated with a number of children in Madhya Pradesh and Rajasthan. The central drug regulator plunged into action in one of the test syrups. Some countries have banned the sale of these drugs.
This is not the first time that cough syrups in India have been associated with deaths in children. In recent years, cough syrups in India have come under global inspection-rats associated with death children in Uzbekistan, Iraq and Gambia and revealed regulatory gaps in the Indian pharmaceutical industry.
Mint expands why the Indian syrups coughs were again and re -associated with death in children.
What caused death?
The recent death of 11 children in Madhya Pradesh and Rajasthan, all within five years, are assumed that they were caused by contaminated syrup coughs, which made states to swing into action and central probe.
The Indian Ministry of Health said in a statement that the tested samples of the Cough Colldrif, produced by Sresan Pharmaceuticals in Tamil Nadu, contained high levels of diethylene glycol. Deg is an industrial chemical used in antifreeze and brake fluids and can cause kidney failure and death even in small quantities.
The Union’s government controls the production sites of all cough syrups that have been sampled, spread over six countries.
Who’s coughing behind these syrups?
Coldrif Sresan Pharma is a controversy in the middle. Samples of syrup tested by Tamil Nadu revealed that they contained 48.6% of diethylene glycol.
Jaipur, based in Kaysons Pharma, also had a control of his syrup cough, who could lead to the death of children in Rajasthan, although the state government has not yet confirmed the connection.
What happened after deaths?
The sale of Coldrif was banned in Madhya Pradesh, Tamil Nadu and Kerala with immediate effect. Madhya Pradesh also banned all other products manufactured by Sresan Pharmaceuticals and registered the case against the drug manufacturer. A doctor who prescribed the syrup cough was arrested.
Rajasthan suspended the sale of 19 Kaysons Pharma drugs after reports on the adverse effects associated with his syrups coughs. Two healthcare officials and the state drug regulator were suspended due to negligence.
The CEO of the Health Services at the Ministry of Health and the care of the Union family has issued nationwide advice on the reasonable use of cough syrups in children and advises that these drugs should not be prescribed to children younger two.
Is the syrup coughing dangerous for children?
US food and drug administration does not recommend over -the -counter drugs for colds and coughing in children under the age of two, as they could cause serious and potentially life -threatening side effects, the regulatory organ website states. Over -the -counter medicines can be purchased without a prescription. “Numerous Father of Cough and Cold products contain many ingredients that can lead to accidental overdose,” says the American FDA.
According to medical experts, a strict dosage for OTC medicines is required. Dextrometorphan hydrobromide, a common component in cough syrup, can cause side effects such as drowsiness, fast heart rate, seizures and liver damage in children, although it is generally considered safe for adults.
The CEO of the Health Services in recent counseling said that most acute cough diseases in children are “restrictive” itself and often reflect without pharmacological intervention.
Where else were the death of a cough syrup?
In recent years, cough syrups have been associated with death children in Jammu and Gambia and Uzbekistan. Previously, Chennai, Mumbai, Bihar and Grrabram have seen the mass death of children as a result of selling syrup coughs. The reason for this recurrence is that the inability to regulate the manufacturer who cannot test raw materials or final formulations, experts say.
A key problem is the Indian fragmented regulatory system of public health. While drug regulation in the country is primarily governed by the 1940 drug and cosmetics law, public health is a state subject. Health regulations are therefore divided between the central regulatory authorities into central regulation and regulatory authorities at the level of drugs, making it difficult to enforce laws against poor production processes.
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