In wake of the recent Uzbekistani deaths, in addition to the ones earlier this year in The Gambia, S Srinivasan, of the not-for-profit organization, Low-Cost Standard Therapeutics, flags poor adherence to standard procedures to ensure quality in the manufacturing process, and the need to follow Indian Pharmacopoeia standards.
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ON December 29, a press note, issued by the Press Information Bureau (‘PIB’), disclosed that the Union Ministry of Health and Family Affairs is conducting an inspection of Marion Biotech, a firm based in NOIDA, Uttar Pradesh, for allegedly manufacturing and exporting contaminated cough syrup to Uzbekistan in violation of rules. According to the PIB’s press note, the Central Drugs Standard Control Organisation (‘CDSCO’), the Indian national regulatory authority for cosmetics, pharmaceuticals and medical devices, is in regular contact with the national drug regulator of Uzbekistan.
The CDSCO’s move follows a statement by the Health Ministry of Uzbekistan that linked the death of 18 children to the consumption of Dok-1 Max manufactured by Marion Biotech. Marion Biotech is licensed by Haryana Drugs Controller for the manufacturing of Dok-1 Max syrup and tablets for export purposes. According to Uzbekistani health authorities, the cough syrup was consumed in large amounts without a prescription.
However, preliminary lab investigation showed the cough syrup to contain unacceptable amounts of ethylene glycol, the Uzbekistani authorities informed. Ethylene glycol is a toxic contaminant to humans when consumed beyond certain levels and can prove fatal.
According to the PIB’s press note, “Immediately on receipt of the information, joint inspection of the NOIDA facility of the manufacturer, Marion Biotech, was carried out by UP Drug Control and CDSCO team and further action as appropriate would be initiated based on the inspection report”. The samples of the cough syrup, taken from the manufacturing premises, were sent to the Regional Drugs Testing Laboratory, Chandigarh for testing, the note added.
On October 5, the World Health Organization (‘WHO’) issued a Medical Product Alert for four “contaminated” cold and cough syrups manufactured by Maiden Pharma Ltd., a firm licensed by the Haryana Drugs Controller. The consumption of these medicines is reportedly linked to the deaths of more than 66 children in The Gambia, and has been termed as “one of the worst such incidents involving drugs from India”. Laboratory analysis of samples of each of the four products confirms that they contain ‘unacceptable’ amounts of diethylene glycol and ethylene glycol as contaminants.
Also Read: Fixing the accountability for the avoidable tragedy in The Gambia: Lessons for Indian regulators
Reportedly, following WHO’s alert after the Gambian deaths linked to Indian-manufactured cough syrups, the Department of Drug Administration of Nepal, the national regulatory body of the country, has prohibited the export of pharmaceutical drugs, manufactured by 16 Indian pharmaceutical companies, to Nepal. According to the authorities, the drugs fail to comply with regulatory requirements and WHO’s good manufacturing practices (‘GMP’).
GMPs, as a part of the quality management system, aim to ensure that products are consistently produced and controlled to quality standards according to their intended use and as required by marketing authorisation.
S Srinivasan, of the not-for-profit organisation, Low-Cost Standard Therapeutics, and Co-Convenor of the All India Drug Action Network, an independent network of non-government organisations, shared his views on the repeated reports of deaths linked to cough syrups exported by Indian pharmaceutical companies. Srinivasan told The Leaflet, “There is poor adherence to standard procedures that ensure quality in the manufacturing process. For instance, the need to monitor the use of pharmagrade Propylene glycol, the solvent of choice in syrups.”
According to Srinivasan, the Propylene glycol that is used as solvent should be tested as per Indian Pharmacopoeia (‘IP’) standards. Explaining it further, he said that IP standards require safe to zero levels of diethylene glycol (‘DEG’) in pharmagrade propylene glycol. Srinivasan clarified that the presence of unsafe levels of DEG is toxic and can be fatal for the patient. He emphasized that DEG inevitably creeps in small quantities in the process of manufacture of propylene glycol. “The safe alternative is to prescribe suspensions rather than syrups as in the former, we do not use propylene glycol, and therefore, there is no risk of DEG contamination,” he added.
In the present case of reported deaths in Uzbekistan, Srinivasan explained the next steps that are expected from the CDSCO after the ongoing investigation on Marion Biotech and said, “CDSCO should ask all the alleged contaminated samples to be tested from the indicted batch from Uzbekistan, and all batches of the same product of the company should be withdrawn.” He emphasised that the test reports of the indicted batch including that of raw material used should be inspected to ensure proper procedures for testing and manufacturing are followed.
According to Srinivasan, the law should take its course if the product is found to be contaminated. In case of contradictory reports, both importer and exporter should test in a commonly agreed quality lab, he noted.
Section 27(a) of the Drugs and Cosmetics Act, 1940 penalises the sale or manufacturer of drugs deemed to be ‘adulterated’ under the Act, and provides for a punishment of imprisonment for ten years, which can be extended up to life imprisonment, and fine of not less than ten lakh rupees or three times the value of the drugs confiscated.
