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The Central Drugs Standard Control Organisation (CDSCO) has prohibited the use of anti-cold fixed drug combinations in children below four years of age.

Centre bans anti-cold drug combination for children aged under four 

The Central Drugs Standard Control Organisation (CDSCO) has prohibited the use of anti-cold fixed drug combinations in children below four years of age.

The Central Drugs Standard Control Organisation (CDSCO) has prohibited the use of an anti-cold drug combination in children aged below four, responding to global concerns after at least 141 deaths linked to cough syrups.&nbsp;
The regulator said concerns raised about the promotion of an unapproved anti-cold drug formulation in infants prompted a discussion and a resulting recommendation to not use the combination for that age group.
Rajeev Raghuvanshi, the Drugs Controller General of India (DCGI), has directed regulatory authorities in all states and Union territories to instruct manufacturers of the fixed drug combination (FDC) containing Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL IP 5mg per ml drops to include a warning on the label, package insert, and promotional literature stating that the FDC should not be administered to children below the age of four.
"The committee recommended that the FDC should not be used in children below four years of age and accordingly the firms should mention warnings in this regard on label and package insert. The recommendation of the SEC has been considered by this office," the letter stated.
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In February, Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drops. Before that, India-made cough syrups were allegedly linked to the deaths of 66 and 18 children in Gambia and Uzbekistan

'Zero tolerance on spurious medicines': Govt as India-made cough syrups come under scanner

In February, Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drops. Before that, India-made cough syrups were allegedly linked to the deaths of 66 and 18 children in Gambia and Uzbekistan

Asserting that India follows a zero-tolerance policy on spurious medicines, Union Health Minister Mansukh Mandaviya has said 71 companies have been issued show-cause notices following concerns raised in some quarters about reported deaths due to contaminated India-made cough syrups and 18 of them have been asked to shut shop.
In an exclusive interview with PTI video, the minister also said an extensive risk-based analysis is done continuously to ensure the production of quality medicines in the country, and the government and regulators are always alert to ensure that no one dies due to spurious medicines.
"We are the pharmacy of the world and we want to assure everyone that we are the 'quality pharmacy of the world'," he said.
In February, Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drops. Before that, India-made cough syrups were allegedly linked to the deaths of 66 and 18 children in Gambia and Uzbekistan, respectively, last year.
India exported cough syrups worth USD 17.6 billion in 2022-23 as against USD 17 billion in 2021-22. Overall, India is the largest provider of generic drugs globally, supplying over 50 per cent of global demand for various vaccines, about 40 per cent of generic demand in the US and about 25 per cent of all medicines in the UK.
"We need to get into facts whenever questions are raised about Indian medicines. For example in Gambia, it was said that 49 children have died. Someone at WHO had said it and we wrote to them asking what the facts are. No one got back to us with the facts," Mandaviya said.
He said, "We checked the samples of one company. We tried to find out the cause of death and we found that the child had diarrhoea. If a child had diarrhoea, who recommended cough syrup for that child?" The minister further said that a total of 24 samples were taken, of which four failed.
"The question is if there was just one batch made for exports and if that fails, all samples would fail. It is not possible that 20 samples are passed and four samples fail. Still, we are alert. We are continuously doing risk-based analysis to ensure the production of quality medicines in our country," he said.
From June 1, India has made tests mandatory for cough syrups before they are exported. Cough syrup exporters will have to produce a certificate of analysis issued by a government laboratory before it is exported, effective June 1, the Directorate General of Foreign Trade (DGFT) said in a notification last month.
Mandaviya said, "We have conducted risk-based analysis at more than 125 companies and our squads have visited their facilities. Of these, 71 companies have been served show-cause notices and 18 have been given closure notices." "I want to assure the world through you that India will never do any bargain with the quality of medicines. We follow a zero-tolerance policy. Spurious medicines would be treated the same way in the country as it is done abroad. We are always alert to ensure that no one dies because of spurious medicines," he added.
The change in the export policy followed quality concerns raised globally for cough syrups exported by Indian firms.
Following the order, the Drugs Controller General of India (DCGI) also asked the specified states and central laboratories to test the samples received from the manufacturers of cough syrups for export purposes on "top priority and issue the test report at the earliest".
The specified central government labs include Indian Pharmacopoeia Commission, regional drug testing lab (RDTL - Chandigarh), central drugs lab (CDL - Kolkata), central drug testing lab (CDTL - Chennai Hyderabad, Mumbai), RDTL (Guwahati) and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of state governments.
Globally, India ranks third in terms of pharmaceutical production by volume and 14th by value.
The Indian pharmaceutical industry is a prominent manufacturer and exporter of medical products to the entire globe, ranging from highly developed countries to low and middle-income countries (LMIC).
The industry includes a network of 3,000 drug companies and about 10,500 manufacturing units. It facilitates the availability and supply of high-quality, affordable and accessible medicines around the world. India enjoys an important position in the global pharmaceuticals sector.&nbsp;

In February, the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drops. Before that, India-made cough syrups were allegedly linked to the deaths of 66 children in Gambia and 18 children in Uzbekistan, last year

New rule for export of cough syrup: Testing at govt labs mandatory from this date

In February, the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drops. Before that, India-made cough syrups were allegedly linked to the deaths of 66 children in Gambia and 18 children in Uzbekistan, last year

Cough syrup exporters will have to undertake testing of their products at specified government laboratories from June 1 before getting permission for the outbound shipments.
The direction has come after quality concerns were raised globally for cough syrups exported by Indian firms.
&ldquo;The export of cough syrup shall be permitted to be exported subject to export samples being tested and production of certificate of analysis issued by any of the laboratories&hellip;, with effect from June 1, 2023,&rdquo; the Directorate General of Foreign Trade (DGFT) said in a notification on Monday.
The specified central government labs include Indian Pharmacopoeia Commission, regional drug testing lab (RDTL - Chandigarh), central drugs lab (CDL - Kolkata), central drug testing lab (CDTL - Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of state governments.
Explaining further, an official said that to re-emphasize India's commitment towards assuring the quality of various pharmaceutical products exported from India, the central government has decided to initiate a process of a pre-quality check of the cough syrup formulations being exported.
&ldquo;The finished goods (cough syrup in this case) are to be tested at laboratories before being permitted for export,&rdquo; the official said, adding that necessary steps are being taken to ensure the smooth implementation of this testing requirement, and MoHFW would partner with the state governments and the exporters to ensure smooth implementation of this notification.
In February, the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drops. Before that, India-made cough syrups were allegedly linked to the deaths of 66 and 18 children in Gambia and Uzbekistan, respectively, last year.
India exported cough syrups worth USD 17.6 billion in 2022-23 as against USD 17 billion in 2021-22.
The Indian pharmaceutical industry is a prominent manufacturer and exporter of medical products to the entire globe; ranging from highly developed countries to the LMIC (low and middle income countries)..
India is the largest provider of generic drugs globally, supplying over 50 per cent of global demand for various vaccines, about 40 per cent of generic demand in the US and about 25 per cent of all medicine in the UK.
Globally, India ranks third in terms of pharmaceutical production by volume and 14th by value..
The industry includes a network of 3,000 drug companies and about 10,500 manufacturing units. It facilitates the availability and supply of high-quality, affordable and accessible medicines around the world. India enjoys an important position in the global pharmaceuticals sector.
Presently over 80 per cent of the antiretroviral drugs used globally to combat AIDS are supplied by Indian pharmaceutical firms.

The WHO said that Marion's "substandard" medical products "fail to meet quality standards or specifications".

WHO warns against Indian company Marion's cough syrup use for children in Uzbekistan after death reports

The WHO said that Marion's "substandard" medical products "fail to meet quality standards or specifications".

In fresh trouble for Indian pharma company Marion Biotech, the World Health Organisation has recommended against use of its products in Uzbekistan.
The global health body said on 11 January 2023 that two cough syrups made by the Noida-based company should not be used for children in Uzbekistan. The WHO said that Marion's "substandard" medical products "fail to meet quality standards or specifications".
The two cough syrups are AMBRONOL and DOK-1 Max.
The recommendation follows reports of children dying after consuming the cough syrups in Uzbekistan.
Also Watch: <a href="https://www.editorji.com/world-news/indian-cough-syrup-under-scanner-after-66-children-die-in-gambia-who-1664988276911">Indian cough syrup under scanner after 66 children die in Gambia: WHO</a>

The WHO on October 13 had written to the DCGI seeking to know the progress with the investigation of the manufacturer of the four cough syrups -- the Sonipat-based Maiden Pharmaceuticals.

Cough syrup alert: India says information given by WHO inadequate

The committee set up by the government to examine reports potentially linking the death of 66 children in The Gambia to four made-in-India cough syrups has observed that the clinical information shared by the World Health Organization so far is inadequate

The WHO on October 13 had written to the DCGI seeking to know the progress with the investigation of the manufacturer of the four cough syrups -- the Sonipat-based Maiden Pharmaceuticals.

The committee set up by the government to examine reports potentially linking the death of 66 children in The Gambia to four made-in-India cough syrups has observed that the clinical information shared by the World Health Organization so far is inadequate to determine the cause of the disease
This was conveyed to the WHO by Drugs Controller General of India (DCGI) V G Somani on Saturday.
Rutendo Kuwana from the WHO on October 13 had written to the DCGI seeking to know the progress with the investigation of the manufacturer of the four cough syrups -- the Sonipat-based Maiden Pharmaceuticals.
In an email response, Dr Somani on Saturday said the Union Ministry of Health has constituted a committee of technical experts to examine and analyse the details of the adverse event reports and all related details shared by or to be shared by WHO and to recommend follow up action.
Somani said the four-member committee chaired by Dr Y K Gupta, Vice Chairperson, Standing National Committee on Medicines, in its first meeting has examined the reports and communications so far received from WHO and has made several observations.
Mentioning the observations, Dr Somani said, "The clinical features and the treatment received by the children as shared by WHO so far are inadequate to determine the aetiology."
The details of initial illness, sign and symptoms, duration of anura in the cases, results of laboratory investigations conducted including various markers and parameters, specific investigations for diethylene glycol and ethylene glycol on critical samples of the patients, treatment received before and after hospitalization at the tertiary hospital in Gambia, treatment received before and after acute kidney injury was suspected and reasons thereof, names and brands of the drug formulations used in the treatment before and after hospitalization, their manufacturers, their expiry other relevant information in each of the cases, are necessary, he said.
Dr Somani further said in case, verbal autopsy was conducted, a detailed report may be shared by WHO.
Dr Somani has sought details on the number of stool samples collected and analysed and the number of children with a similar clinical presentation to acute kidney injury from whom the biological samples were collected.
He also sought the details of the product samples collected and tested (with their compositions, manufacturers) which were reported to be negative for EG and DEG, the details of cases who received these products.
Also Watch| <a href="https://www.editorji.com/world-news/explained-why-who-issued-alert-against-4-indian-cough-syrups-1665031324520">Explained: why WHO issued alert against 4 Indian cough syrups</a>
"You are therefore requested to share the report on causal relations along with above details, as observed by the said Technical Committee at the earliest for further examination and follow up action at our level," he wrote.
The DCGI further informed that the investigation of the manufacturer in question has progressed.
"The manufacturing site has been inspected, test reports of sampled products from the laboratory are awaited and all the manufacturing activities of the manufacturer in question have been stopped," he said.
The Union Health Ministry on Wednesday formed the four-member panel of experts to examine the details and adverse event reports received from the WHO on the deaths of 66 children in Gambia being linked potentially to the four cough syrups made by the Sonipat unit of Maiden Pharmaceuticals.
The committee will recommend further course of action to the Drugs Controller General of India (DCGI) after examining and analysing the adverse event reports, causal relationship and all related details already shared by or to be shared by the World Health Organization.
The causal relation of deaths is yet to be provided by WHO. The WHO has so far shared with CDSCO, the certificates of analysis of each of the sampled products, their photographs and summary of the adverse events.
WHO has stated that it is in process of further investigation, official sources said.
The CDSCO has already requested WHO to share at the earliest with it, the report on establishment of causal relation to death with the medical products in question and photographs of labels/products etc, they said.
While the Haryana State Drug Controller issued show cause notice to Maiden Pharmaceuticals on October 7 asking it to explain within a week "many contraventions" found during a recent inspection, or face suspension or cancellation of license, the Haryana government on October 11 issued an order to stop all the manufacturing activities of the firm with immediate effect.
The WHO had on September 29 had informed the Central Drugs Standard Control Organisation (CDSCO) that they were providing technical assistance and advice to Gambia, where children have died and where a contributing factor was suspected to be the use of four medicines: Promethazine Oral Solution BP, KOFEXNALIN Baby Cough Syrup, MaKOFF Baby Cough Syrup and MaGrip n Cold Syrup.
They are manufactured and exported by Maiden Pharmaceuticals Ltd, Sonepat, Haryana, and the WHO had informed they may have been contaminated with Diethylene glycol or Ethylene glycol.&nbsp;

 After WHO alert on its cough syrups, Haryana firm asked to halt production, faces licence cancellation

Haryana cough syrup firm shut after WHO alert; faces license cancellation

The order to halt production came days after WHO potentially linked four cough syrups manufactured at the facility to the deaths of 66 children in African nation of The Gambia.

The order to halt production came days after WHO potentially linked four cough syrups manufactured at the facility to the deaths of 66 children in African nation of The Gambia.

The Haryana government has ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceuticals, asking it to explain within a week "many contraventions" found during a recent inspection, or face suspension or cancellation of licence.
The order to halt production came days after the World Health Organization (WHO) potentially linked four cough syrups manufactured at the facility to the deaths of 66 children in African nation of The Gambia.
"We have ordered that all drug production at this unit be stopped with immediate effect," Haryana Health Minister Anil Vij told PTI over phone on Wednesday.
After the WHO alert, samples of the four cough syrups manufactured by the firm was sent to the Central Drugs Laboratory in Kolkata on October 6 for examination.
Vij said a joint team of the state and the Centre inspected the unit during which it found 12 violations or deficiencies. "Taking cognisance of this, the state government has ordered to halt the drug production in this unit." He further said the report of the cough syrup samples are yet to arrive from the Central Drugs Laboratory in Kolkata. "Depending on what it says, we will take further action," he said.
According to a notice issued by the Haryana Drugs Controller following the inspection of the firm's plant, Maiden Pharmaceuticals Limited did not perform quality testing of propylene glycol, the raw material used for making one of the formulations.
"The firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol," said the notice.
The showcause notice issued on October 7 stated, "The inspection of your firm was conducted by a team comprising senior officials from CDSCO (Central Drugs Standard Control Organisation) and Haryana Drugs Controller Authority to conduct the necessary investigation for following drugs manufactured by you." "During inspection many contraventions were detected. You are hereby served with the show cause notice rule 85(2) of drug rules, 1945 as to why your manufacturing license may not be suspended or cancelled," it said.
The state authority had asked the firm to respond within seven days, failing which it said ex-parte -- done with respect to or in the interests of one side only or of an interested outside party -- action will be taken against the company as per the drugs act.
Among the 12 "violations" highlighted by the state drugs regulator was that the batch number of propylene glycol, sorbitol solution and sodium methyl paraben used in the making of the drugs in question were not mentioned in the certificate of analysis report.
The firm has not performed process validation and analytical method validation for the drug products in question, according to the authority.
Besides, the complete plant is found under renovation and the firm failed to produce the log books of equipment and instruments regarding manufacturing and testing for the drugs in question, the notice read.
The batch number, manufacturer name and manufacturing date and expiry date were not found maintained on the purchase invoices of excipients including propylene glycol.
Also watch: <a href="https://www.editorji.com/india-news/maiden-pharma-cough-syrup-maker-has-who-s-good-manufacturing-practices-certification-1665110747494">Maiden Pharma: Cough syrup maker has WHO's Good Manufacturing Practices certification</a>

The All India Organisation of Chemists and Druggists has issued a statement saying that there is no supply of Maiden Pharmaceuticals Limited drugs in India adding that the company only exports its products. 
4 cough syrups manufactured by Maiden Pharmaceuticals Limited have been flagged by World Health Organisation to potentially be linked to the deaths of 66 children in The Gambia. 
The cough syrups are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. 
The chemist association also said that even though no Maiden Pharma is in supply in India it will follow any guideline that is issued by Drugs Controller General of India. 

No supply of WHO-mentioned cough syrups in India: chemist association

The All India Organisation of Chemists and Druggists has issued a statement saying that there is no supply of Maiden Pharmaceuticals Limited drugs in India adding that the company only exports its products. 

4 cough syrups manufactured by Maiden Pharmaceuticals Limited have been flagged by World Health Organisation to potentially be linked to the deaths of 66 children in The Gambia.&nbsp;

The All India Organisation of Chemists and Druggists has issued a statement saying that there is no supply of Maiden Pharmaceuticals Limited drugs in India adding that the company only exports its products.&nbsp;
4 cough syrups manufactured by Maiden Pharmaceuticals Limited have been flagged by World Health Organisation to potentially be linked to the deaths of 66 children in The Gambia.&nbsp;
The cough syrups are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.&nbsp;
Also watch: <a href="https://www.editorji.com/world-news/explained-why-who-issued-alert-against-4-indian-cough-syrups-1665031324520">Explained: why WHO issued alert against 4 Indian cough syrups</a>
The chemist association also said that even though no Maiden Pharma is in supply in India it will follow any guideline that is issued by Drugs Controller General of India.&nbsp;

The row over an Indian cough syrup firm's possible involvement in the death of 66 Gamibian student due to alleged consumption of substandard syrups has caused stir in India.
Its primary reason is the alarm bells raised by World Health Organisation that warned that the four contaminated cough syrups- namely Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, were allegedly produced by Haryana-based Maiden Pharmaceuticals Limited.
Secondly, it also raises questions over the consumption of cough syrup by children, especially those below 2 years.
The 66 Gamibian children who reportedly died following acute kidney failure aged between 5 months to 4 years.
SO, ARE COUGH SYRUPS SAFE FOR CHILDREN?
The scientific use of cough syrup generally does not recommend its use for children below 2 years. In fact, the most common cough syrups have the disclaimer that they are not meant for kids under 2 years.
Experts suggest that cough syrups, especially Over-The-Counter (OTC) ones should not be consumed by the under 2 category kids as it can have serious implications including hospitalisations.
An Indian Express reported quoting a private Paediatrician stated that the cough syrups can have mild to serious side effects. Among the most common symptoms are sleepiness, restlessness, electrolyte imbalance.
WHAT ABOUT CHILDREN ABOVE 2 AND ADULTS?
For children above 2 years and in fact, adults, the use of cough syrups has been prescribed for bare-minimum use.
Contrary to under 2 kids, older children or those above 2 years are recommended to use cough syrups judiciously. Experts point that the syrups are relatively safer if given in correct doses. The 'safe to consume' quotient is determined by formulation of a cough syrup.
While for adults,  OTC cough syrup consumption is likely to result in side-effects. Given the presence of anti-histamines,  an anti-allergy drug, the syrups tend to be addictive. This can cause dizziness or sleepiness among those above 18 years,.

WHO alarm on cough syrups: are they good or bad for children

The 66 Gambian children who reportedly died following acute kidney failure aged between 5 months to 4 years.

WHO alarm on cough syrups: are they good or bad for children?

The 66 Gambian children who reportedly died following acute kidney failure aged between 5 months to 4 years.

The row over an Indian cough syrup firm's possible involvement in the death of 66 Gamibian student due to alleged consumption of substandard syrups has caused stir in India.
Its primary reason is the alarm bells raised by World Health Organisation that warned that the four contaminated cough syrups- namely Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, were allegedly produced by Haryana-based Maiden Pharmaceuticals Limited.
Secondly, it also raises questions over the consumption of cough syrup by children, especially those below 2 years.
The 66 Gamibian children who reportedly died following acute kidney failure aged between 5 months to 4 years.
<h3>SO, ARE COUGH SYRUPS SAFE FOR CHILDREN?</h3>
The scientific use of cough syrup generally does not recommend its use for children below 2 years. In fact, the most common cough syrups have the disclaimer that they are not meant for kids under 4 years.
Experts suggest that cough syrups, especially Over-The-Counter (OTC) ones should not be consumed by the under 2 category kids as it can have serious implications including hospitalisations.
An Indian Express reported quoting a private Paediatrician stated that the cough syrups can have mild to serious side effects. Among the most common symptoms are sleepiness, restlessness, electrolyte imbalance.
<h3>WHAT ABOUT CHILDREN ABOVE 2 AND ADULTS?</h3>
For children above 2 years and in fact, adults, the use of cough syrups has been prescribed for bare-minimum use.
Contrary to under 2 kids, older children or those above 2 years are recommended to use cough syrups judiciously. Experts point that the syrups are relatively safer if given in correct doses. The 'safe to consume' quotient is determined by formulation of a cough syrup.
While for adults, &nbsp;OTC cough syrup consumption is likely to result in side-effects. Given the presence of anti-histamines, &nbsp;an anti-allergy drug, the syrups tend to be addictive. This can cause dizziness or sleepiness among those above 18 years.
Also watch: <a href="https://www.editorji.com/india-news/medicine-board-launches-probe-after-who-alert-on-cough-syrups-1665041749450">Medicine board launches probe after WHO alert on cough syrups</a>

 In the wake of the WHO cautioning that cough syrups manufactured by an Indian company could potentially be linked to the deaths of at least 66 children in The Gambia, official sources said the global health body is yet to provide the exact "one to one causal relation of deaths".
The World Health Organisation on Wednesday warned that four "contaminated" and "substandard" cough syrups, allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation.
The United Nations health agency, however, has not yet shared details of labels and products with the Central Drugs Standard Control Organisation (CDSCO), which would enable it to confirm the identity and source of manufacturing of the products, official sources said.
Based on available information, the CDSCO has already taken up an urgent investigation into the matter with the regulatory authorities in Haryana, they said.
"While all required steps will be taken, as a robust regulatory authority, WHO has been requested to share with CDSCO at the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc," an official source said.
According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia.
It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.
The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority.
Further, a detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained.
"From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited, Sonepat, Haryana, is the manufacturer licensed by the state drug controller for the products under reference, and holds manufacturing permission for these products.
"The company has manufactured and exported these products only to The Gambia so far," the source said.
It is a practice that the importing country tests the products for quality before sanctioning their usage there.
According to the tentative results received by the WHO, four out of the 23 samples tested have been found to contain either Diethylene Glycol/Ethylene Glycol.
WHO has also informed India that it will share the certificate of analysis soon.
"At the same time, the exact one to one causal relation of the deaths has not yet been provided by the WHO, nor have the details of labels or products been shared with CDSCO, which would enable it to confirm the identity and source of the manufacturing of the products," the source added.

Medicine board launches probe after WHO alert on cough syrups

The World Health Organisation on Wednesday warned that four "contaminated" and "substandard" cough syrups, allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation.

The World Health Organisation on Wednesday warned that four "contaminated" and "substandard" cough syrups, allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation.

&nbsp;In the wake of the WHO cautioning that cough syrups manufactured by an Indian company could potentially be linked to the deaths of at least 66 children in The Gambia, official sources said the global health body is yet to provide the exact "one to one causal relation of deaths".
The World Health Organisation on Wednesday warned that four "contaminated" and "substandard" cough syrups, allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation.
The United Nations health agency, however, has not yet shared details of labels and products with the Central Drugs Standard Control Organisation (CDSCO), which would enable it to confirm the identity and source of manufacturing of the products, official sources said.
Based on available information, the CDSCO has already taken up an urgent investigation into the matter with the regulatory authorities in Haryana, they said.
"While all required steps will be taken, as a robust regulatory authority, WHO has been requested to share with CDSCO at the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc," an official source said.
According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia.
It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.
The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority.
Further, a detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained.
"From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited, Sonepat, Haryana, is the manufacturer licensed by the state drug controller for the products under reference, and holds manufacturing permission for these products.
"The company has manufactured and exported these products only to The Gambia so far," the source said.
It is a practice that the importing country tests the products for quality before sanctioning their usage there.
According to the tentative results received by the WHO, four out of the 23 samples tested have been found to contain either Diethylene Glycol/Ethylene Glycol.
WHO has also informed India that it will share the certificate of analysis soon.
"At the same time, the exact one to one causal relation of the deaths has not yet been provided by the WHO, nor have the details of labels or products been shared with CDSCO, which would enable it to confirm the identity and source of the manufacturing of the products," the source added.
Also watch: <a href="https://www.editorji.com/world-news/explained-why-who-issued-alert-against-4-indian-cough-syrups-1665031324520">Explained: why WHO issued alert against 4 Indian cough syrups</a>

cough syrup

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