The last resort for curing any ailment is to take medicine, but when medicine is actually a ‘poison’ people will lose trust and faith on that too. The World Health Organisation (WHO) issued an alert on Wednesday, October 5 advising regulatory authorities and the public to stop consumption of four medical products made by Maiden Pharmaceuticals that were found to be substandard.
The WHO identified the products as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, all manufactured by Maiden Pharmaceuticals, a company based in Haryana in India. These drugs are said to have claimed the lives of 66 children in The Gambia.
Vietnam and at least three Indian States had taken action against Maiden Pharmaceuticals for the poor quality of its drugs before the company’s cough and fever syrups allegedly caused the deaths of over 60 children in the African country of The Gambia last month.
In fact, India had garnered many accolades all over the world for the production and the distribution of Covid-19 vaccines barely two years ago and now with this fiasco in the quality of cough syrups, it has given a major dent in the reputation of the country. It also surely indicates that quality control in our country is not well managed.
Media has reported that the WHO on September 29 this year, had informed Drugs Controller General of India (DCGI), the National Drug Regulator of India, that it is currently providing technical assistance and advice to The Gambia, where children were suspected to have died where a significant contributing factor, is suspected to be the use of medicines which may have been contaminated with Diethylene glycol or Ethylene glycol (this has been confirmed in some of the samples by further analysis conducted by WHO).
The Central Drugs Standard Control Organisation (CDSCO) took up the matter immediately and further investigation was launched. From the preliminary enquiry, it has been made out that Maiden Pharmaceutical Limited, Sonipat, Haryana is a 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. Even if the company has only exported to Western African country of The Gambia the incident which happened due to the poor quality of the drug has maligned India’s image world-over. It is absolutely necessary for India and the manufacturing companies to ensure that the quality of the product must be clean and safe.
In a statement, the Indian government stated, “The CDSCO, while responding to WHO, within an hour-and-a-half, took up the matter immediately thereafter with the concerned State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located. Further, a detailed investigation was launched to ascertain the facts or details in the matter in collaboration with State Drugs Controller, Haryana (the concerned State Drug Control Authority).”
Also, according to the primary investigation, it has been made out that Maiden Pharmaceutical Limited in Haryana was the manufacturer, licensed by the State Drug Controller, for the products under reference, and held manufacturing permission for the products. The company had manufactured and exported these products only to The Gambia, the statement reads.
The statement also added that it is a practice that the importing country tests these products on quality parameters, and satisfies itself as to the quality of the products before their release for usage in the country. However, this statement sounds more like passing the buck to the importing nation. Immediate steps should be taken to reprimand the manufacturing company. The Health Minister of Haryana Anil Vij has warned of “strict action if anything is found wrong” after the tests.
To save India from embarrassment at the global stage it is extremely important that proper steps are taken to reprimand and penalise the manufacturing company if investigation reveals truth in allegations so far. Whatever be the result, it gives us an early warning signal that quality control not only in the drug industry but also in all the manufacturing units must be robust and it should be strictly monitored by surprise checks.
