How Haryana's Maiden Pharma flouted safety norms and made cough syrup that 'killed' children

Maiden Pharma, the company under the scanner for its ‘spurious’ cough syrups which may have led to the deaths of 66 children in The Gambia, skipped a key test of raw material used in the manufacture in one of its medicines, according to several media reports. The report, prepared by the Central Drugs Standard Control Organisation (CDSCO) after an official inspection by Haryana drug authorities, has been sent to the  Union health ministry and the Prime Minister’s Office. The authorities had on 7 October issued a show-cause notice to the firm stating, “The firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol.” This comes as Haryana has shut production of drugs at Maiden Pharmaceuticals, and the state Food & Drugs Administration has issued a show cause notice for 12 violations found at its plants, as per CNBC. The pharma company has been ordered to reply by 14 October, “failing which ex-parte action shall be liable to be taken against you as per the Drugs and Cosmetics Act 1940 & Rules, 1945,” the notice read as per CNBC-TV18. The World Health Organisation (WHO) had said that propylene glycol, an ingredient used in the manufacture of cough syrups, which often has traces of two toxic contaminants –diethylene glycol and ethylene glycol –may have caused the death of the children. The four cough syrups allegedly linked to the deaths are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. Let’s take a closer look: As per The Federal, inspection at the manufacturing plants of Maiden Pharmaceuticals in Haryana’s Kundli and Sonepat showed that the pharma company had skipped the quality testing of propylene glycol to check for the presence of the two contaminants. [caption id=“attachment_11401571” align=“alignnone” width=“640”] Maiden Pharmaceuticals Limited factory in Sonepat district. PTI[/caption] The report stated that propylene glycol received and analysed in March 2022 matched what was used in manufacture of MaGrip n Cold Syrup in December 2021. This indicated that no separate tests were conducted to test for the quality of the ingredient. “Propylene glycol (batch number E009844) having manufacturing date of Sept 2021 and expiry date of Sept 2023 was used in manufacturing of Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, and MaGrip n Cold Syrup having a product expiry of November 2024,” the notice said, as per The Federal. This indicated that the shelf life of the drugs was longer than the expiry period of the raw material. Manufacturing, expiry dates missing Authorities also found that the manufacturing and expiry dates were missing on the certificate of analysis of certain batches of propylene glycol. “Propylene glycol (batch number E1007/UP, E1105149) had failed as per certificate of analysis for the test in respect of water but was declared as of standard quality,” the notice added, as per Hindustan Times. Batch numbers, manufacturer name, and manufacturing and expiry dates were not found on purchase invoices of items used including propylene glycol. [caption id=“attachment_11401591” align=“alignnone” width=“640”] Officials said inspections at the manufacturing plants of Maiden Pharmaceuticals in Haryana’s Kundli and Sonepat showed that the pharma company had skipped the quality testing of propylene glycol to check for the presence of the two contaminants.[/caption] Pharmaceutical experts told the newspaper tests should have been performed on the propylene glycol stocks to check for the contamination of diethylene glycol and ethylene glycol. As per Moneycontrol, DEG and EG, beyond a very miniscule limit, can cause symptoms such as acute kidney failure and may be fatal especially for children with low body weights. “Propylene glycol is expensive and many a times, defaulting pharmaceutical companies mix it with diethylene glycol and ethylene glycol,” the newspaper quoted an expert as saying. “The firm has not performed process validation and analytical method validation for the drug products in question. The firm has submitted six month real time and accelerated stability data of drugs in question. However, at the time of investigation none of above said products were found to be (monitored) in stability chamber,” the state drug controller said in the notice, as per the newspaper. The inspecting authorities also found that the manufacturing and expiry dates were missing on the certificate of analysis of certain batches of propylene glycol. “Propylene glycol (batch number E1007/UP, E1105149) had failed as per certificate of analysis for the test in respect of water but was declared as of standard quality,” the notice added. “Samples of three drugs mentioned by the WHO (World Health Organization) of Sonipat’s pharmaceuticals company were sent to the Central Drug Lab in Kolkata. The reports are not in yet. Action will be taken after that,” he was quoted by ANI as saying. A government source told Moneycontrol, “There are evidences of shocking lapses in maintaining GMP (Good Manufacturing Practices) standards on the part of the manufacturer and necessary action would be initiated against once the lab test results are received.” “There are multiple issues with the way drugs were being prepared at the plants and unfortunately it may not have been limited to flagged drugs but other drugs prepared at the units as well,” said a CDSCO official, citing anonymity. [caption id=“attachment_11401561” align=“alignnone” width=“640”] The four cough syrups that have come under the scanner are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. Image Courtesy: WHO[/caption] Jammu parents struggle for justice This comes in the backdrop of families in Jammu waiting for justice more than two years after 12 children died after taking ColdBest PC cough syrup. As per Mint, the Drugs Control Administration is yet to file a criminal complaint – the first step towards getting justice – against Himachal Pradesh-based Digital Vision, which made the syrup. The “poisonous compound” in the syrup was found to diethylene glycol. In January 2020, several ill children from Jammu were rushed to Chandigarh’s Postgraduate Institute of Medical Education and Research (PGIMER).  The children who consumed the ColdBest syrup suffered acute kidney injury, and the results of tissue biopsies from the kidneys were consistent with diethylene glycol poisoning. The doctors had apex regulator CDSCO and the Himachal regulator of their findings in February 2020. This led to the Himachal regulator inspecting the manufacturer’s premises and finding multiple quality control failures. In July 2020, a two-year-old from Himachal Pradesh died after taking Cofset cough syrup, also manufactured by Digital Vision, and also found to be contaminated with diethylene glycol, as per PGIMER doctors. Himachal regulatory officials told Mint there were hurdles to taking the company to court. They said when drug regulatory labs analysed several samples from the batch of ColdBest PC that children consumed, some contained diethylene glycol, but others didn’t. The regulator said this ‘raised questions’ about who adulterated the syrup. Officials also blamed the failure to conduct autopsies as making it difficult to establish a link between the deaths to diethylene glycol. “It is a complicated case. So, we want to file the case after taking all things into consideration so that no lacuna is there at a later stage," Garima Sharma, assistant drug controller, Himachal Pradesh Drug Control Administration, told Mint. As per The Tribune, while the J&K Police had on 4 March 2020, constituted a special investigation team (SIT) to probe the case. The police order, a copy of which the newspaper accessed, signed by then SSP Rajiv Pandey clearly mandated a time-bound inquiry into the FIR. “The above SIT shall carry out the investigation of the case on a day-to-day basis and work it out on merit within a month.” However, the chargesheet is yet to be filed. Udhampur SSP Vinod Kumar told The Tribune that the chargesheet would be filed “within a week or two.” Speaking to The Mint, Kundan Lal Sharma, a former joint secretary in the health ministry, said such delays are nothing new. Sharma said the 36 drug regulators of India prosecute only a “minuscule" number of the substandard-drug cases identified and that they are stymied in their attempts due to a lack of training, inadequate staffing, and pressure from local politicians and the industry. With inputs from agencies Read all the  Latest News ,  Trending News ,  Cricket News ,  Bollywood News , India News  and  Entertainment News  here. Follow us on  Facebook,  Twitter and  Instagram.