India's drug&nbsp;regulator on Wednesday (Dec 20) prohibited the use of an anti-cold drug combination in children aged below four. The regulatory body has mandated that drug labels should clearly reflect this restriction.

The move follows concerns raised about the promotion of an unapproved anti-cold drug formulation for infants.&nbsp;

A letter issued to the states and the Union Territories by the Drugs General Controller (India) stated that the concern has been recognised after the promotion of unapproved anti-cold drug formulation for infants.

Also read |&nbsp;<a href="https://www.wionews.com/india-news/indias-50-cough-syrup-manufacturers-fail-to-clear-quality-tests-report-666751">50 Indian cough syrup manufacturers fail to clear quality tests: Report</a> 
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"Subsequently concerns have been raised regarding promotion of unapproved anti-cold drug formulation for infants. The matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting held on June 6, 2023, wherein, In light of the issue regarding the use of the FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5mg drop/ml was discussed before the committee," the letter said.

"The committee recommended that the FDC should not be used in children below 4 years of age and accordingly the firms should mention warning in this regard on label and package insert," it read further.

The cough syrups manufactured in India have been linked with a series of deaths of children aged less than four in parts of the world.

Also watch |&nbsp;Gravitas: 50 Indian cough syrups found to be sub-standard

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These incidents have raised concerns about the quality of pharmaceutical exports from India, often referred to as the "world's pharmacy"&nbsp;due to its widespread supply of life-saving drugs at affordable prices.&nbsp;

In response to the global outcry, the World Health Organization (WHO) has underscored its recommendation against the use of over-the-counter cough syrups or medicines for treating coughs and cold symptoms in children under five years of age.

India implemented mandatory testing for cough syrup exports in June and has intensified scrutiny of drug manufacturers.&nbsp;

<h2>What's the bottom line?</h2>

The regulatory directive now obliges drugmakers to prominently label their products with a warning against the use of the specified FDC in children below four years of age.

(With inputs from agencies)

India's drug regulator on Wednesday (Dec 20) prohibited the use of an anti-cold drug combination in children aged below four. The regulatory body has mandated that drug labels should clearly reflect this restriction.

India's drug regulator on Wednesday (Dec 20) prohibited the use of an anti-cold drug combination in children aged below four. The regulatory body has mandated that drug labels should clearly reflect this restriction. The move follows concerns raised about the promotion of an unapproved anti-cold drug formulation for infants. A letter issued to the states and the Union Territories by the Drugs General Controller (India) stated that the concern has been recognised after the promotion of unapproved anti-cold drug formulation for infants. Also read | 50 Indian cough syrup manufacturers fail to clear quality tests: Report "Subsequently concerns have been raised regarding promotion of unapproved anti-cold drug formulation for infants. The matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting held on June 6, 2023, wherein, In light of the issue regarding the use of the FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5mg drop/ml was discussed before the committee," the letter said. "The committee recommended that the FDC should not be used in children below 4 years of age and accordingly the firms should mention warning in this regard on label and package insert," it read further. The cough syrups manufactured in India have been linked with a series of deaths of children aged less than four in parts of the world. Also watch | Gravitas: 50 Indian cough syrups found to be sub-standard × These incidents have raised concerns about the quality of pharmaceutical exports from India, often referred to as the "world's pharmacy" due to its widespread supply of life-saving drugs at affordable prices. In response to the global outcry, the World Health Organization (WHO) has underscored its recommendation against the use of over-the-counter cough syrups or medicines for treating coughs and cold symptoms in children under five years of age. India implemented mandatory testing for cough syrup exports in June and has intensified scrutiny of drug manufacturers. What's the bottom line? The regulatory directive now obliges drugmakers to prominently label their products with a warning against the use of the specified FDC in children below four years of age. (With inputs from agencies)

India raises onus on cough syrup manufacturers; bans anti-cold drug combination for kids under four

In some relief to the parents who have lost their children due to contaminated cough syrup, an Indonesian court has allowed them to file a class action lawsuit, said a report by BBC. The lawsuit has sought compensation of $195,000 for every child killed and about $130,000 for every child injured, said the lawyer of a mother who lost her daughter due to the cough syrup.&nbsp;

Nur Asiah, whose four-year-old daughter died last year due to the contaminated cough syrup told BBC that she and the relatives of 24 other victims will file a case against the Indonesian government as well as eight pharmaceutical companies. Notably, more than 200 children in the country have lost their lives due to acute kidney injury since 2022. &nbsp;

This also comes as countries Gambia and Uzbekistan reported around 100 deaths after children consumed toxic cough syrup. However, the Indonesian authorities have not found evidence that the two incidents are linked.&nbsp;

The investigation did find that the local chemical companies used industrial-grade solvent materials named Ethylene Glycol and Diethylene Glycol which are typically used in antifreeze solutions for air-conditioners or as brake fluid, amid a global shortage of pharmaceutical-grade solvents.&nbsp;

The cases have also prompted World Health Organization (WHO) to issue warnings about six cough syrups made in India and Indonesia. “We have tried our best by quickly finding causes, exchanging information with other countries, the WHO, and bringing in antidotes to treat toxic substances,” said an Indonesian Health ministry spokesperson as per BBC, adding that they are working on a compensation plan.&nbsp;

&nbsp;“No amount of compensation will make up for what has happened. It won’t bring back my child,” Asiah told BBC. Meanwhile, a lawyer from PT Afi Farma, one of the eight companies which are being sued that made the cough syrup used by the majority of children in this case said that it is “not appropriate” for the blame to only be placed on the pharmaceutical industry and that the government should also be held accountable.&nbsp;

“Honestly, pharmaceutical companies are also victims - victims of a crime by the suppliers of the raw materials,” said a lawyer from PT Universal Pharmaceutical Industries told BBC. The company said that it had been using the same Indonesian Food and Drug Authority (FDA), certified system for three decades now which included its buying the ingredients from an FDA-approved supplier. 
 
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In some relief to the parents who have lost their children due to contaminated cough syrup, an Indonesian court has allowed them to file a class action lawsuit, said a report by BBC.

In some relief to the parents who have lost their children due to contaminated cough syrup, an Indonesian court has allowed them to file a class action lawsuit, said a report by BBC. The lawsuit has sought compensation of $195,000 for every child killed and about $130,000 for every child injured, said the lawyer of a mother who lost her daughter due to the cough syrup. Nur Asiah, whose four-year-old daughter died last year due to the contaminated cough syrup told BBC that she and the relatives of 24 other victims will file a case against the Indonesian government as well as eight pharmaceutical companies. Notably, more than 200 children in the country have lost their lives due to acute kidney injury since 2022. This also comes as countries Gambia and Uzbekistan reported around 100 deaths after children consumed toxic cough syrup. However, the Indonesian authorities have not found evidence that the two incidents are linked. The investigation did find that the local chemical companies used industrial-grade solvent materials named Ethylene Glycol and Diethylene Glycol which are typically used in antifreeze solutions for air-conditioners or as brake fluid, amid a global shortage of pharmaceutical-grade solvents. The cases have also prompted World Health Organization (WHO) to issue warnings about six cough syrups made in India and Indonesia. “We have tried our best by quickly finding causes, exchanging information with other countries, the WHO, and bringing in antidotes to treat toxic substances,” said an Indonesian Health ministry spokesperson as per BBC, adding that they are working on a compensation plan. “No amount of compensation will make up for what has happened. It won’t bring back my child,” Asiah told BBC. Meanwhile, a lawyer from PT Afi Farma, one of the eight companies which are being sued that made the cough syrup used by the majority of children in this case said that it is “not appropriate” for the blame to only be placed on the pharmaceutical industry and that the government should also be held accountable. “Honestly, pharmaceutical companies are also victims - victims of a crime by the suppliers of the raw materials,” said a lawyer from PT Universal Pharmaceutical Industries told BBC. The company said that it had been using the same Indonesian Food and Drug Authority (FDA), certified system for three decades now which included its buying the ingredients from an FDA-approved supplier. WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Indonesia court allows lawsuit over cough syrup-related deaths: Report

The World Health Organisation (WHO) said on Friday (December 30) that it is in touch with Uzbekistan's authorities after the government and multiple media reports said that 18 children in the country died after consuming Dok-1 Max,&nbsp;a cold and flu syrup manufactured by Indian-based pharmaceutical Marion Biotech.

"We are in touch with the Uzbek authorities and are still in the process of gathering information and validating these reports," the WHO told news agency ANI.&nbsp;

Earlier, Uzbekistan's health ministry had said that the Dok-1 Max syrup contained ethylene glycol,&nbsp;a toxic substance. The ministry said the syrup was administered in doses that were higher than the standard for children, either by their parents who mistook it for an anti-cold remedy or on pharmacists' advice. The victims, most of them between five months and four years old, died of acute renal failure, news agency AFP reported on Thursday.&nbsp;

ALSO READ | <a href="https://www.wionews.com/india-news/doc-1-max-india-made-cough-syrup-blamed-for-childrens-deaths-in-uzbekistan-probe-begins-547776">India-made cough syrup blamed for kids' deaths in Uzbekistan, production halted at unit</a>

Sales of all medicines by Marion Biotech have been temporarily suspended in Uzbekistan.&nbsp;

Currently, Marion Biotech has halted production of all medicines at its unit in Noida, Uttar Pradesh. Taking to Twitter, India's health minister Mansukh Mandaviya said on Friday, "All manufacturing activities of Marion Biotech at Noida unit have been stopped yesterday night, while further investigation is ongoing."

WION Dispatch | Uzbekistan: 18 children dead due to cough syrup made by Indian firm

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Additionally, India's chemicals and fertilisers ministry issued an order on Thursday where it laid out specifications to regulate the sale of ethylene glycol from the end of March.&nbsp;

The deaths of 18 children in Uzbekistan come months after at least 70 children in Gambia died from acute kidney injury (AKI) linked to the consumption of cough and cold syrups manufactured by Maiden Pharmaceuticals, another Indian firm.&nbsp;

(With inputs from agencies)&nbsp; 
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The World Health Organisation (WHO) said on Friday (December 30) that it is in touch with Uzbekistan's authorities after the government and multiple media reports said that 18 children in the country died after consuming Dok-1 Max, a cold and flu syrup manufactured by Indian-based pharmaceutical Marion Biotech.

The World Health Organisation (WHO) said on Friday (December 30) that it is in touch with Uzbekistan's authorities after the government and multiple media reports said that 18 children in the country died after consuming Dok-1 Max, a cold and flu syrup manufactured by Indian-based pharmaceutical Marion Biotech. "We are in touch with the Uzbek authorities and are still in the process of gathering information and validating these reports," the WHO told news agency ANI. Earlier, Uzbekistan's health ministry had said that the Dok-1 Max syrup contained ethylene glycol, a toxic substance. The ministry said the syrup was administered in doses that were higher than the standard for children, either by their parents who mistook it for an anti-cold remedy or on pharmacists' advice. The victims, most of them between five months and four years old, died of acute renal failure, news agency AFP reported on Thursday. ALSO READ | India-made cough syrup blamed for kids' deaths in Uzbekistan, production halted at unit Sales of all medicines by Marion Biotech have been temporarily suspended in Uzbekistan. Currently, Marion Biotech has halted production of all medicines at its unit in Noida, Uttar Pradesh. Taking to Twitter, India's health minister Mansukh Mandaviya said on Friday, "All manufacturing activities of Marion Biotech at Noida unit have been stopped yesterday night, while further investigation is ongoing." WION Dispatch | Uzbekistan: 18 children dead due to cough syrup made by Indian firm × Additionally, India's chemicals and fertilisers ministry issued an order on Thursday where it laid out specifications to regulate the sale of ethylene glycol from the end of March. The deaths of 18 children in Uzbekistan come months after at least 70 children in Gambia died from acute kidney injury (AKI) linked to the consumption of cough and cold syrups manufactured by Maiden Pharmaceuticals, another Indian firm. (With inputs from agencies) WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Uzbekistan cough syrup deaths: WHO says it's in touch with Uzbek authorities

Following the deaths of over a 100 kids from acute kidney injury (AKI), Indonesia's food and drugs agency has said it will pursue criminal action against the two pharmaceutical firms that made the products linked to the issue. There has been a spike in cases and deaths among children this year due to AKI. The number jumped from 99 to around 141.

Sales of some syrup-based medications have been banned after the products were found to contain ethylene glycol and diethylene glycol, possible factors in the deaths of the children.&nbsp;

BPOM chief Penny K. Lukito said the agency would work with police to investigate the two firms with a view to criminal proceedings over the composition of their products. Penny did not identify the two companies.

Also Read |&nbsp;<a href="https://www.wionews.com/india-news/india-committee-to-who-information-on-killer-cough-syrups-inadequate-525793">India committee tells WHO: Information on 'killer' cough syrups 'inadequate'</a>

"There are indications in their products ... (of concentrations) that are highly excessive, highly toxic, and suspected to cause the kidney injury," Penny told a news conference.

Authorities said a spike in cases was seen from August to October. Health Minister Budi Gunadi Sadikin said the spike was recent since it was most likely due to changes in the raw ingredients of medications. He said the government has data about the recent imports of raw ingredients and would share it later.

Indonesia imports most of its raw ingredients for medicines from India and China, according to its health ministry.

Indonesia is investigating its rise in AKI cases in consultation with paediatric experts and the World Health Organization (WHO). &nbsp;following a similar pattern in Gambia, which has seen at least 70 child AKI deaths related to syrup medications.

(With inputs from agencies)

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Following the deaths of over a 100 kids from acute kidney injury (AKI), Indonesia's food and drugs agency has said it will pursue criminal action against the two pharmaceutical firms that made the products linked to the issue.

Following the deaths of over a 100 kids from acute kidney injury (AKI), Indonesia's food and drugs agency has said it will pursue criminal action against the two pharmaceutical firms that made the products linked to the issue. There has been a spike in cases and deaths among children this year due to AKI. The number jumped from 99 to around 141. Sales of some syrup-based medications have been banned after the products were found to contain ethylene glycol and diethylene glycol, possible factors in the deaths of the children. BPOM chief Penny K. Lukito said the agency would work with police to investigate the two firms with a view to criminal proceedings over the composition of their products. Penny did not identify the two companies. Also Read | India committee tells WHO: Information on 'killer' cough syrups 'inadequate' "There are indications in their products ... (of concentrations) that are highly excessive, highly toxic, and suspected to cause the kidney injury," Penny told a news conference. Authorities said a spike in cases was seen from August to October. Health Minister Budi Gunadi Sadikin said the spike was recent since it was most likely due to changes in the raw ingredients of medications. He said the government has data about the recent imports of raw ingredients and would share it later. Indonesia imports most of its raw ingredients for medicines from India and China, according to its health ministry. Indonesia is investigating its rise in AKI cases in consultation with paediatric experts and the World Health Organization (WHO). following a similar pattern in Gambia, which has seen at least 70 child AKI deaths related to syrup medications. (With inputs from agencies)

Indonesia to pursue criminal action against two pharma firms amid rise in AKI deaths