News Analysis India

Tag: Gambia

  • Uzbekistan cough syrup deaths: Marion Biotech into pharma, nutraceuticals, cosmetic products

    By PTI

    NEW DELHI: Noida-based Marion Biotech, under the scanner following the deaths of 18 children in Uzbekistan allegedly after consuming its cough syrup, is the flagship firm of Emenox group which also has a presence in real estate and hospitals.

    The privately held firm has a range of products spanning pharmaceuticals, nutraceuticals, herbals, and cosmetic products.

    Founded in 1999, the company is understood to have a presence in Central Asian countries, Central and Latin America, South East Asia, and Africa.

    It claims to be the brand leader in the categories that it is present in these markets.

    Marion Biotech is a licensed manufacturer and holds the licence for manufacturing Dok-1 Max syrup and tablet for exports granted by the Drugs Controller, Uttar Pradesh.

    It does not sell the Dok-1 Max syrup in India.

    The company has a division, Emenox Healthcare which is into pharmaceutical manufacturing.

    The Emenox group was founded by its Chairman Sachin Jain in 1998.

    It undertakes real estate development under its division Emenox Infratek, which was established in 2006.

    ALSO READ | ‘Shocked, deeply saddened,’ says Maiden pharma after WHO alert on its cough syrups links to child deaths in Gambia

    NEW DELHI: Noida-based Marion Biotech, under the scanner following the deaths of 18 children in Uzbekistan allegedly after consuming its cough syrup, is the flagship firm of Emenox group which also has a presence in real estate and hospitals.

    The privately held firm has a range of products spanning pharmaceuticals, nutraceuticals, herbals, and cosmetic products.

    Founded in 1999, the company is understood to have a presence in Central Asian countries, Central and Latin America, South East Asia, and Africa.

    It claims to be the brand leader in the categories that it is present in these markets.

    Marion Biotech is a licensed manufacturer and holds the licence for manufacturing Dok-1 Max syrup and tablet for exports granted by the Drugs Controller, Uttar Pradesh.

    It does not sell the Dok-1 Max syrup in India.

    The company has a division, Emenox Healthcare which is into pharmaceutical manufacturing.

    The Emenox group was founded by its Chairman Sachin Jain in 1998.

    It undertakes real estate development under its division Emenox Infratek, which was established in 2006.

    ALSO READ | ‘Shocked, deeply saddened,’ says Maiden pharma after WHO alert on its cough syrups links to child deaths in Gambia

  • Cough syrups deaths: Govt panel says info shared by WHO so far inadequate to determine cause

    By PTI

    NEW DELHI: 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 aetiology.

    This was conveyed to the WHO by Drugs Controller General of India (DCGI) VG 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.

    “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.

    NEW DELHI: 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 aetiology.

    This was conveyed to the WHO by Drugs Controller General of India (DCGI) VG 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.

    “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.

  • India in touch with Gambia over deaths linked to cough syrup

    By PTI

    NEW DELHI: India is in touch with the Gambia in the wake of a WHO report that potentially linked the death of 66 children in that country to four Indian-made cough syrups.

    “That is a very very unfortunate story where children have died reportedly due to spurious drugs,” External Affairs Ministry spokesperson Arindam Bagchi said when asked about the issue.

    He said India is in touch with Gambia over it.

    External Affairs Minister S Jaishankar held a telephonic conversation with his Gambian counterpart Mamadou Tangara on Thursday, and conveyed “deepest condolences on the deaths of young children”.

    “In a telecon with Gambian FM Dr.Mamadou Tangara, conveyed our deepest condolences on the deaths of young children recently. Underlined that matter is being seriously investigated by appropriate authorities. We agreed to remain in touch,” Jaishankar tweeted.

    The government on Wednesday formed a four-member panel of experts to examine the details and adverse event reports received from the WHO on the deaths.

    “I think our health authorities issued a detailed statement in this regard a few days ago. Our drug regulatory authorities are undertaking investigation. Certain steps have been taken. We are also in touch with the government of the Gambia,” Bagchi said.

    The WHO had on September 29 had informed the Central Drugs Standard Control Organisation (CDSCO) that they were providing technical assistance and advice to The 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.

    NEW DELHI: India is in touch with the Gambia in the wake of a WHO report that potentially linked the death of 66 children in that country to four Indian-made cough syrups.

    “That is a very very unfortunate story where children have died reportedly due to spurious drugs,” External Affairs Ministry spokesperson Arindam Bagchi said when asked about the issue.

    He said India is in touch with Gambia over it.

    External Affairs Minister S Jaishankar held a telephonic conversation with his Gambian counterpart Mamadou Tangara on Thursday, and conveyed “deepest condolences on the deaths of young children”.

    “In a telecon with Gambian FM Dr.Mamadou Tangara, conveyed our deepest condolences on the deaths of young children recently. Underlined that matter is being seriously investigated by appropriate authorities. We agreed to remain in touch,” Jaishankar tweeted.

    The government on Wednesday formed a four-member panel of experts to examine the details and adverse event reports received from the WHO on the deaths.

    “I think our health authorities issued a detailed statement in this regard a few days ago. Our drug regulatory authorities are undertaking investigation. Certain steps have been taken. We are also in touch with the government of the Gambia,” Bagchi said.

    The WHO had on September 29 had informed the Central Drugs Standard Control Organisation (CDSCO) that they were providing technical assistance and advice to The 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.

  • Manufacturing, testing violations detected during inspection of Maiden Pharmaceuticals: Officials

    By PTI

    CHNADIGARH: The Sonipat firm which has been under the lens after its four cough syrups were flagged by the WHO allegedly violated multiple manufacturing and testing rules, potentially affecting “the quality, safety and efficacy of the drugs being produced” there, according to officials.

    The Haryana government on Wednesday ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceuticals, days after the World Health Organization potentially linked the four syrups to the deaths of 66 children in the African nation of Gambia.

    Officials here said that after the WHO alert, officers from the Central Drugs Standard Control Organisation (CDSCO) and Haryana Food and Drugs Administration inspected the firm’s premises in Kundli industrial area of Sonipat on October 1, 3, 6 and 11.

    They conducted necessary investigations related to the drugs manufactured by the firm and supplied to The Gambia, the officials said.

    During the investigations, it was observed the firm had been manufacturing and testing drugs without adhering to and in contravention of various Good Manufacturing Practice requirements of Schedule M and Schedule U of the Drugs Rules, according to the officials.

    “Firm has not maintained and not produced complete records of manufacturing and testing as per the rules. Various documents were examined by the investigating team, which clearly indicates that the firm is not meeting the requirements of Drugs Rules, 1945 under Drugs and Cosmetics Act, 1940 across its manufacturing and testing activities,” according to an order issued by the State Drug Control Officer, Sonipat Zone.

    “In view of the seriousness of the contraventions observed during the investigations and its potential risk to the quality, safety and efficacy of the drugs being produced, all the manufacturing activities of the firm is being stopped with immediate effect under section 22 (1) (d) of Drugs and Cosmetics Act, 1940 and Rules framed thereunder, till further orders, in public interest, without prejudice to further action in the matter,” read the order dated October 11.

    ALSO READ: WHO probing Indian cough syrup after 66 children die in Gambia

    Health Minister Anil said that during the investigation, the joint team of the state and the Centre found 12 violations or deficiencies.

    “Taking cognisance of this, the state government has ordered to halt the drug production in this unit.”

    Meanwhile , official sources in Delhi said they have taken note of media reports that Atlanta-based Atlantic Pharmaceuticals Company Limited had procured the drugs from Maiden Pharmaceuticals for further export to The Gambia.

    They also shared a communication dated October 4 in which the Medicines Control Agency of Gambia had written to the Managing Director of the Atlantic Pharmaceuticals, Westfield, notifying the temporary suspension of the importation of any Maiden Pharmaceuticals and asking it to immediately recall the contaminated, substandard and falsified medicinal products (syrups, tablets, capsules, injections etc) that it imported from Maiden Pharmaceuticals.

    CHNADIGARH: The Sonipat firm which has been under the lens after its four cough syrups were flagged by the WHO allegedly violated multiple manufacturing and testing rules, potentially affecting “the quality, safety and efficacy of the drugs being produced” there, according to officials.

    The Haryana government on Wednesday ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceuticals, days after the World Health Organization potentially linked the four syrups to the deaths of 66 children in the African nation of Gambia.

    Officials here said that after the WHO alert, officers from the Central Drugs Standard Control Organisation (CDSCO) and Haryana Food and Drugs Administration inspected the firm’s premises in Kundli industrial area of Sonipat on October 1, 3, 6 and 11.

    They conducted necessary investigations related to the drugs manufactured by the firm and supplied to The Gambia, the officials said.

    During the investigations, it was observed the firm had been manufacturing and testing drugs without adhering to and in contravention of various Good Manufacturing Practice requirements of Schedule M and Schedule U of the Drugs Rules, according to the officials.

    “Firm has not maintained and not produced complete records of manufacturing and testing as per the rules. Various documents were examined by the investigating team, which clearly indicates that the firm is not meeting the requirements of Drugs Rules, 1945 under Drugs and Cosmetics Act, 1940 across its manufacturing and testing activities,” according to an order issued by the State Drug Control Officer, Sonipat Zone.

    “In view of the seriousness of the contraventions observed during the investigations and its potential risk to the quality, safety and efficacy of the drugs being produced, all the manufacturing activities of the firm is being stopped with immediate effect under section 22 (1) (d) of Drugs and Cosmetics Act, 1940 and Rules framed thereunder, till further orders, in public interest, without prejudice to further action in the matter,” read the order dated October 11.

    ALSO READ: WHO probing Indian cough syrup after 66 children die in Gambia

    Health Minister Anil said that during the investigation, the joint team of the state and the Centre found 12 violations or deficiencies.

    “Taking cognisance of this, the state government has ordered to halt the drug production in this unit.”

    Meanwhile , official sources in Delhi said they have taken note of media reports that Atlanta-based Atlantic Pharmaceuticals Company Limited had procured the drugs from Maiden Pharmaceuticals for further export to The Gambia.

    They also shared a communication dated October 4 in which the Medicines Control Agency of Gambia had written to the Managing Director of the Atlantic Pharmaceuticals, Westfield, notifying the temporary suspension of the importation of any Maiden Pharmaceuticals and asking it to immediately recall the contaminated, substandard and falsified medicinal products (syrups, tablets, capsules, injections etc) that it imported from Maiden Pharmaceuticals.

  • Haryana govt halts all drug production at factory linked to Gambia deaths

    By PTI

     The Haryana government has halted all drug production at the Sonipat factory of Maiden Pharmaceuticals, a week after the World Health Organization (WHO) potentially linked four cough syrups manufactured at the facility to the deaths of 66 children in Gambia.

    The state authorities also issued a show-cause notice to the pharma company to explain within a week “many contraventions” found during a recent inspection, or face suspension or cancellation of license even as the Centre on Wednesday formed a four-member panel of experts to examine the details and adverse event reports received from the WHO on the deaths of the children in the West African nation.

    Haryana Health Minister Anil Vij said a joint team of the state and the Centre inspected the Sonipat unit during which it found 12 violations or deficiencies.

    “Taking cognisance of this, the state government has ordered that all drug production at this unit be stopped with immediate effect,” Vij told PTI over phone.

    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 was not mentioned in the certificate of analysis report.

    According to the show-cause 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,” the notice issued on October 7 said.

    ALSO READ: Govt panel formed to study WHO report on deaths of 66 Gambian kids linked to 4 Indian syrups

    The inspection of the firm was conducted by a team comprising senior officials from the Central Drugs Standard Control Organisation(CDSCO) and the Haryana Drugs Controller Authority.

    “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,” the notice 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.

    The firm has not performed process validation and analytical method validation for the drug products in question, the notice said.

    Also, the complete plant was 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, it added.

    The batch number, manufacturer name and manufacturing date and expiry date were not found maintained on the purchase invoices of excipients including propylene glycol, it said.

    Samples of four cough syrups manufactured by the firm were sent to the Central Drugs Laboratory in Kolkata on October 6 for examination, a day after the WHO flagged four “contaminated” and “substandard” cough syrups made by the company, warning they could be linked to the deaths of 66 children in Gambia.

    Minister Vij said the report of the cough syrup samples are yet to arrive from the Kolkata Laboratory.

    “Depending on what it says, we will take further action.”

    ALSO READ: Grief and outrage in Gambia over cough syrup deaths

    Official sources said the four-member panel of experts will advise and 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 shared by or to be shared by the WHO.

    The panel is chaired by Dr Y K Gupta, Vice Chairperson, Standing National Committee on Medicines and has Dr Pragya D Yadav, NIV, ICMR, Pune, Dr Arti Bahl, Division of Epidemiology.

    NCDC, New Delhi and A K Pradhan, JDC(I), CDSCO as members.

    Official sources said the government has taken note of media reports that Atlanta- based Atlantic Pharmaceuticals company Limited had procured the drugs from Maiden Pharmaceuticals for further export to Gambia.

    They said the WHO has not yet made available certificate of analysis and has informed that the same will be made available in the near future.

    “The exact one to one causal relation of death has not yet been provided by WHO to CDSCO although the latter has requested the WHO twice in this regard,” sources said.

    Also, it is a usual practice that the importing country tests such imported medicines on quality parameters and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country, they said.

    ALSO READ: WHO probing Indian cough syrup after 66 children die in Gambia

    “In the present case it is not yet clear whether these medicines were tested in Gambia before release,” they added.

    According to official sources, the WHO on September 29 had informed the 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 medicines (Promethazine Oral Solution BP, KOFEXNALIN Baby Cough Syrup, MaKOFF Baby Cough Syrup and MaGrip n Cold Syrup).

    These medicines are manufactured and exported by Maiden Pharmaceuticals Ltd, and the WHO had informed they may have been contaminated with Diethylene glycol or Ethylene glycol.

    The CDSCO took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located, and a detailed investigation was launched by CDSCO in collaboration with the State Drugs Controller.

    It has also been indicated by the WHO that as per the tentative results received by the WHO, out of the 23 samples of the products under reference which were tested by WHO, four have been found to contain Diethylene Glycol/ Ethylene Glycol, sources said.

    On further follow up done by CDSCO with the WHO, the Certificate of Analysis (COAS) of the sampled products and the summary of the adverse events etc were shared by the WHO on October 11.

     The Haryana government has halted all drug production at the Sonipat factory of Maiden Pharmaceuticals, a week after the World Health Organization (WHO) potentially linked four cough syrups manufactured at the facility to the deaths of 66 children in Gambia.

    The state authorities also issued a show-cause notice to the pharma company to explain within a week “many contraventions” found during a recent inspection, or face suspension or cancellation of license even as the Centre on Wednesday formed a four-member panel of experts to examine the details and adverse event reports received from the WHO on the deaths of the children in the West African nation.

    Haryana Health Minister Anil Vij said a joint team of the state and the Centre inspected the Sonipat unit during which it found 12 violations or deficiencies.

    “Taking cognisance of this, the state government has ordered that all drug production at this unit be stopped with immediate effect,” Vij told PTI over phone.

    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 was not mentioned in the certificate of analysis report.

    According to the show-cause 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,” the notice issued on October 7 said.

    ALSO READ: Govt panel formed to study WHO report on deaths of 66 Gambian kids linked to 4 Indian syrups

    The inspection of the firm was conducted by a team comprising senior officials from the Central Drugs Standard Control Organisation(CDSCO) and the Haryana Drugs Controller Authority.

    “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,” the notice 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.

    The firm has not performed process validation and analytical method validation for the drug products in question, the notice said.

    Also, the complete plant was 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, it added.

    The batch number, manufacturer name and manufacturing date and expiry date were not found maintained on the purchase invoices of excipients including propylene glycol, it said.

    Samples of four cough syrups manufactured by the firm were sent to the Central Drugs Laboratory in Kolkata on October 6 for examination, a day after the WHO flagged four “contaminated” and “substandard” cough syrups made by the company, warning they could be linked to the deaths of 66 children in Gambia.

    Minister Vij said the report of the cough syrup samples are yet to arrive from the Kolkata Laboratory.

    “Depending on what it says, we will take further action.”

    ALSO READ: Grief and outrage in Gambia over cough syrup deaths

    Official sources said the four-member panel of experts will advise and 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 shared by or to be shared by the WHO.

    The panel is chaired by Dr Y K Gupta, Vice Chairperson, Standing National Committee on Medicines and has Dr Pragya D Yadav, NIV, ICMR, Pune, Dr Arti Bahl, Division of Epidemiology.

    NCDC, New Delhi and A K Pradhan, JDC(I), CDSCO as members.

    Official sources said the government has taken note of media reports that Atlanta- based Atlantic Pharmaceuticals company Limited had procured the drugs from Maiden Pharmaceuticals for further export to Gambia.

    They said the WHO has not yet made available certificate of analysis and has informed that the same will be made available in the near future.

    “The exact one to one causal relation of death has not yet been provided by WHO to CDSCO although the latter has requested the WHO twice in this regard,” sources said.

    Also, it is a usual practice that the importing country tests such imported medicines on quality parameters and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country, they said.

    ALSO READ: WHO probing Indian cough syrup after 66 children die in Gambia

    “In the present case it is not yet clear whether these medicines were tested in Gambia before release,” they added.

    According to official sources, the WHO on September 29 had informed the 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 medicines (Promethazine Oral Solution BP, KOFEXNALIN Baby Cough Syrup, MaKOFF Baby Cough Syrup and MaGrip n Cold Syrup).

    These medicines are manufactured and exported by Maiden Pharmaceuticals Ltd, and the WHO had informed they may have been contaminated with Diethylene glycol or Ethylene glycol.

    The CDSCO took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located, and a detailed investigation was launched by CDSCO in collaboration with the State Drugs Controller.

    It has also been indicated by the WHO that as per the tentative results received by the WHO, out of the 23 samples of the products under reference which were tested by WHO, four have been found to contain Diethylene Glycol/ Ethylene Glycol, sources said.

    On further follow up done by CDSCO with the WHO, the Certificate of Analysis (COAS) of the sampled products and the summary of the adverse events etc were shared by the WHO on October 11.

  • Orders issued to halt drug manufacturing at Maiden Pharma’s Sonipat unit: Haryana minister Anil Vij

    By PTI

    CHANDIGARH: The Haryana government has given orders to halt drug manufacturing at the Maiden Pharmaceuticals Sonipat unit, and the action was taken due to various violations at the pharma unit, state Health Minister Anil Vij said on Wednesday.

    “We have ordered that all drug production of this unit be stopped with immediate effect,” Vij told PTI over phone.

    Samples of four cough syrups manufactured by the firm had been sent to the Central Drugs Laboratory in Kolkata for examination soon after the WHO potentially linked them to the deaths of 66 children in The Gambia.

    READ HERE | Locals clueless about Haryana factory producing syrups blamed for Gambia children deaths

    Vij said that after the incident, a joint team of the state and the Centre inspected the unit and found 12 violations or deficiencies.

    “Taking cognisance of this, the state government has ordered to halt the drug production in this unit,” Vij said.

    He further said the report of the samples of four cough syrups which had been recently sent to the Central Drugs Laboratory in Kolkata for examination was awaited.

    “When that report comes, depending on what it says, we will take further action,” he said.

    READ HERE | Grief and outrage in Gambia over cough syrup deaths

    CHANDIGARH: The Haryana government has given orders to halt drug manufacturing at the Maiden Pharmaceuticals Sonipat unit, and the action was taken due to various violations at the pharma unit, state Health Minister Anil Vij said on Wednesday.

    “We have ordered that all drug production of this unit be stopped with immediate effect,” Vij told PTI over phone.

    Samples of four cough syrups manufactured by the firm had been sent to the Central Drugs Laboratory in Kolkata for examination soon after the WHO potentially linked them to the deaths of 66 children in The Gambia.

    READ HERE | Locals clueless about Haryana factory producing syrups blamed for Gambia children deaths

    Vij said that after the incident, a joint team of the state and the Centre inspected the unit and found 12 violations or deficiencies.

    “Taking cognisance of this, the state government has ordered to halt the drug production in this unit,” Vij said.

    He further said the report of the samples of four cough syrups which had been recently sent to the Central Drugs Laboratory in Kolkata for examination was awaited.

    “When that report comes, depending on what it says, we will take further action,” he said.

    READ HERE | Grief and outrage in Gambia over cough syrup deaths

  • ‘Shocked, deeply saddened,’ says Maiden pharma after WHO alert on its cough syrups links to child deaths in Gambia

    By Express News Service

    NEW DELHI: The New Delhi-based Maiden Pharmaceuticals Limited, which is in the eye of a storm after the World Health Organisation (WHO) issued a global alert on four of its cough syrups linked to 66 child deaths in The Gambia, said on Saturday that they are “shocked and deeply saddened” about the incident. They also said that they are “not selling anything” in India.

    The company, which has two manufacturing units in Haryana, broke its silence after WHO on October 5 flagged four of their cough syrups as “contaminated” and “substandard”, said in a media statement, that they are in “the field of medicines for over three decades and have been diligently following the protocols of the health authorities including Drugs Controller General of India and the state drugs Controller, Haryana.”

    “We have valid drug approvals for the export of the products in question, and we are not selling anything in the domestic market, so it is for export only,” the statement of its Director Vivek Goyal said. Soon after the alert was issued, the company’s website was unavailable, and its phones were not reachable.

    The company said they had obtained raw materials from certified and reputed companies.

    “We are shocked to hear media reports regarding the deaths and deeply saddened by this incident, but we received the official information from our agent at The Gambia on October 5, and on the subsequent date, the World Health Organisation alert was issued against us,” the statement said.

    It further said that government agencies visited their factory on October 1, 3, 6 and 7.

    They noted that the CDSO took samples of the medicines along with all relevant documents in question in the presence of its directors.

    The company said that they are “awaiting results” and “since the matter is already pending investigations and subjudice, we cannot comment on any other issues and shall update you in future as and when we receive the information.”

    The world body had also said syrups have been “potentially linked with acute kidney injuries and 66 deaths among children.”

    The four cough and cold syrups are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

    Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia but may have been distributed, through informal markets, to other countries or regions, the WHO said. 

    Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Harmful effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may lead to death.

    Soon after the alert, India’s CDSO launched an urgent investigation and said that the company had manufactured and exported these products only to The Gambia.

    NEW DELHI: The New Delhi-based Maiden Pharmaceuticals Limited, which is in the eye of a storm after the World Health Organisation (WHO) issued a global alert on four of its cough syrups linked to 66 child deaths in The Gambia, said on Saturday that they are “shocked and deeply saddened” about the incident. They also said that they are “not selling anything” in India.

    The company, which has two manufacturing units in Haryana, broke its silence after WHO on October 5 flagged four of their cough syrups as “contaminated” and “substandard”, said in a media statement, that they are in “the field of medicines for over three decades and have been diligently following the protocols of the health authorities including Drugs Controller General of India and the state drugs Controller, Haryana.”

    “We have valid drug approvals for the export of the products in question, and we are not selling anything in the domestic market, so it is for export only,” the statement of its Director Vivek Goyal said. Soon after the alert was issued, the company’s website was unavailable, and its phones were not reachable.

    The company said they had obtained raw materials from certified and reputed companies.

    “We are shocked to hear media reports regarding the deaths and deeply saddened by this incident, but we received the official information from our agent at The Gambia on October 5, and on the subsequent date, the World Health Organisation alert was issued against us,” the statement said.

    It further said that government agencies visited their factory on October 1, 3, 6 and 7.

    They noted that the CDSO took samples of the medicines along with all relevant documents in question in the presence of its directors.

    The company said that they are “awaiting results” and “since the matter is already pending investigations and subjudice, we cannot comment on any other issues and shall update you in future as and when we receive the information.”

    The world body had also said syrups have been “potentially linked with acute kidney injuries and 66 deaths among children.”

    The four cough and cold syrups are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

    Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in The Gambia but may have been distributed, through informal markets, to other countries or regions, the WHO said. 

    Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. Harmful effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, which may lead to death.

    Soon after the alert, India’s CDSO launched an urgent investigation and said that the company had manufactured and exported these products only to The Gambia.

  • Locals clueless about Haryana factory producing syrups blamed for Gambia children deaths

    By PTI

    HARYANA: Kunti cradles her three-year granddaughter in the courtyard of humble accommodation unaware of the tragic development concerning the factory located just opposite her house here.

    “Humko toh nahi pata aisa hua hai. Shukar hai, humne kabhi dawai nahi li yahan se. (We are not aware of the development. Thank God, we did not take medicine from here),” a shocked Kunti said when told about the tragedy that happened in the South African nation of Gambia where 66 children died after allegedly consuming substandard cough syrups produced at the factory.

    She held her granddaughter tightly while telling her daughter-in-law about the incident.

    “That is why there were so many officials yesterday. We thought something has happened in the factory. Some fight or something,” Simmi (25) said on Friday.

    “This factory is situated here for eight or 10 years. We never suspected that substandard products are being made here. Are they being sold in the Indian market as well? What is the name of the cough syrup, I will ensure that I don’t buy it,” she queried.

    She was interrupted by her neighbour who informed her that medicines from this factory were only exported to other countries.

    The locals are unaware of the magnitude of the controversy that broke out recently.

    The factory Maiden Pharmaceuticals Ltd— could be easily missed amid hundreds of similar-looking factories in the industrial hub of India.

    The only thing that is giving it a distinct look is the notices from authorities pasted outside the main gate about the substandard products.

    One of the notices is an alert from WHO on four ‘cough & cold’ syrups made by Maiden Pharmaceuticals Ltd.

    When this PTI reporter visited the factory on Friday, Haryana Drug Control Officials were on the premises for investigation.

    An ominous silence shrouded the factory on Friday.

    The guards manning the door are not allowing anyone around the premises.

    The factory has become a source of curiosity among the locals.

    A few people from nearby localities have come here to see the factory.

    “I read about it on the phone. I told my friend let’s go and see the factory. We live very close to this. Not many people are aware of the development,” said Bharat, who works as a labourer in a nearby factory.

    Though people are not aware of the complete development, they were seen sharing their views on the incident at a tea shop at a nook.

    “They added some chemicals in large quantities and that is why children died,” said a local.

    “Humko toh pata nahi tha yahan cough syrups bante hai. Das saal ho gaye hain mujhe yahan (I have no idea this factory was producing cough syrups. I have been living here for 10 years),” said another local laughing.

    The World Health Organisation (WHO) on Wednesday warned that four “contaminated” and “substandard” cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana’s Sonipat could be the reason for the deaths in the West African nation.

    The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

    A probe has been initiated by India’s drug regulator after the WHO issued an alert.

    Haryana’s Health Minister Anil Vij on Thursday said samples of four cough syrups manufactured by the firm have been sent to the Central Drugs Laboratory in Kolkata for examination.

    HARYANA: Kunti cradles her three-year granddaughter in the courtyard of humble accommodation unaware of the tragic development concerning the factory located just opposite her house here.

    “Humko toh nahi pata aisa hua hai. Shukar hai, humne kabhi dawai nahi li yahan se. (We are not aware of the development. Thank God, we did not take medicine from here),” a shocked Kunti said when told about the tragedy that happened in the South African nation of Gambia where 66 children died after allegedly consuming substandard cough syrups produced at the factory.

    She held her granddaughter tightly while telling her daughter-in-law about the incident.

    “That is why there were so many officials yesterday. We thought something has happened in the factory. Some fight or something,” Simmi (25) said on Friday.

    “This factory is situated here for eight or 10 years. We never suspected that substandard products are being made here. Are they being sold in the Indian market as well? What is the name of the cough syrup, I will ensure that I don’t buy it,” she queried.

    She was interrupted by her neighbour who informed her that medicines from this factory were only exported to other countries.

    The locals are unaware of the magnitude of the controversy that broke out recently.

    The factory Maiden Pharmaceuticals Ltd— could be easily missed amid hundreds of similar-looking factories in the industrial hub of India.

    The only thing that is giving it a distinct look is the notices from authorities pasted outside the main gate about the substandard products.

    One of the notices is an alert from WHO on four ‘cough & cold’ syrups made by Maiden Pharmaceuticals Ltd.

    When this PTI reporter visited the factory on Friday, Haryana Drug Control Officials were on the premises for investigation.

    An ominous silence shrouded the factory on Friday.

    The guards manning the door are not allowing anyone around the premises.

    The factory has become a source of curiosity among the locals.

    A few people from nearby localities have come here to see the factory.

    “I read about it on the phone. I told my friend let’s go and see the factory. We live very close to this. Not many people are aware of the development,” said Bharat, who works as a labourer in a nearby factory.

    Though people are not aware of the complete development, they were seen sharing their views on the incident at a tea shop at a nook.

    “They added some chemicals in large quantities and that is why children died,” said a local.

    “Humko toh pata nahi tha yahan cough syrups bante hai. Das saal ho gaye hain mujhe yahan (I have no idea this factory was producing cough syrups. I have been living here for 10 years),” said another local laughing.

    The World Health Organisation (WHO) on Wednesday warned that four “contaminated” and “substandard” cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana’s Sonipat could be the reason for the deaths in the West African nation.

    The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

    A probe has been initiated by India’s drug regulator after the WHO issued an alert.

    Haryana’s Health Minister Anil Vij on Thursday said samples of four cough syrups manufactured by the firm have been sent to the Central Drugs Laboratory in Kolkata for examination.

  • Cough syrup consumed illogically in India: Doctors

    Express News Service

    BENGALURU: Following the alert raised by World Health Organisation (WHO) over four India-made cough syrups as the possible reason behind the death of 66 children in Gambia, doctors raised concerns over cough syrup being one of the top drugs being consumed “illogically” and bought Over-the-Counter (OTC) in India.

    Dr Rajath Athreya, head of department, Paediatrics and Neonatology, Sakra World Hospital, said cough syrups were illogically prescribed and bought in the country, despite many ailments like regular cold and cough “being self-limiting and getting cured” on their own.

    However, the Indian pharmaceutical market is flooded with cough syrups and combination medication without any proven benefits, Dr Athreya said, raising concerns over unnecessary prescriptions given these days, and drugs being easily available OTC, which caused people to buy and consume it without proper prescription. He suggested that in case there was no proper diagnosis of an ailment, it was more beneficial to consume less medication.

    Dr Nandana Bala, paediatrician at Rainbow Children’s Hospital, raised similar concerns. She also said she had not heard the names of the particular syrups until questions were raised on them by WHO.Many cough syrups are only available and prescribed in India, a concept which does not exist in other countries. Most people don’t find them necessary as well, Dr Nandana added. Agreeing with Dr Rajath, she said that syrups were not needed for coughs.

    However, she suggested that it was vital to ensure proper diagnosis of a cough. Parents should also be guided not to give children cough syrup for every ailment. Doctors also voiced the lack in regulation of drugs in India, which often caused many low-quality drugs or prescribed/banned drugs being easily available OTC. They also suggested to people not to consume four cough syrups until further investigation by the Drug Controller General of India.  WHO had raised concerns over four cough and cold syrups manufactured by Maiden Pharmaceuticals — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

    BENGALURU: Following the alert raised by World Health Organisation (WHO) over four India-made cough syrups as the possible reason behind the death of 66 children in Gambia, doctors raised concerns over cough syrup being one of the top drugs being consumed “illogically” and bought Over-the-Counter (OTC) in India.

    Dr Rajath Athreya, head of department, Paediatrics and Neonatology, Sakra World Hospital, said cough syrups were illogically prescribed and bought in the country, despite many ailments like regular cold and cough “being self-limiting and getting cured” on their own.

    However, the Indian pharmaceutical market is flooded with cough syrups and combination medication without any proven benefits, Dr Athreya said, raising concerns over unnecessary prescriptions given these days, and drugs being easily available OTC, which caused people to buy and consume it without proper prescription. He suggested that in case there was no proper diagnosis of an ailment, it was more beneficial to consume less medication.

    Dr Nandana Bala, paediatrician at Rainbow Children’s Hospital, raised similar concerns. She also said she had not heard the names of the particular syrups until questions were raised on them by WHO.
    Many cough syrups are only available and prescribed in India, a concept which does not exist in other countries. Most people don’t find them necessary as well, Dr Nandana added. Agreeing with Dr Rajath, she said that syrups were not needed for coughs.

    However, she suggested that it was vital to ensure proper diagnosis of a cough. Parents should also be guided not to give children cough syrup for every ailment. Doctors also voiced the lack in regulation of drugs in India, which often caused many low-quality drugs or prescribed/banned drugs being easily available OTC. They also suggested to people not to consume four cough syrups until further investigation by the Drug Controller General of India.  WHO had raised concerns over four cough and cold syrups manufactured by Maiden Pharmaceuticals — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

  • India, Gambia sign MoU to strengthen cooperation in governance reforms

    By PTI
    NEW DELHI: India and Gambia on Thursday signed a memorandum of understanding (MoU) to strengthen and promote bilateral cooperation in personnel administration and governance reforms.

    The cooperation in improving performance management system in government, implementation of contributory pension scheme and e-recruitment in government form part of the areas to be covered under the MoU, a statement issued by the Personnel Ministry said.

    “It was mutually decided that towards formation of work plan, a meeting of joint working group would be held soon,” it said.

    The MoU was signed by Sanjay Singh, Secretary of the Department of Administrative Reforms and Public Grievances, and Lamin E Singhateh, Charge d’Affairs on behalf of the Public Service Commission of the Gambia, the statement said.

    The signing ceremony was attended virtually by senior officers of the Gambian Public Service Commission, Ministry of External Affairs and the Ambassador, Embassy of India, Senegal, which is accredited to the Gambia, it added.