Quality control must be rigorous in all manufacturing units

Oct 08, 2022 | 05:44 IST

Quality control must be rigorous in all manufacturing units

The last resort to cure any ailment is to take medicine, but when medicine is actually a “poison”, people will also lose faith and confidence in that. The World Health Organization (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 made by Maiden Pharmaceuticals, a company based in Haryana, 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 over the poor quality of its drugs before the company’s cough and fever syrups killed more than 60 children in the African country. from Gambia last month.

In fact, India had reaped many accolades around the world for the production and distribution of Covid-19 vaccines just two years ago and now, with this cough syrup quality fiasco, it has considerably damaged the reputation of the country. It also surely indicates that the quality control in our country is not well managed.

Media reported that on September 29 this year, the WHO informed the Drug Controller General of India (DCGI), the national drug regulatory body of India, that it is currently providing assistance technique and advice to The Gambia, where children were believed to have died. where a significant contributing factor is suspected to be the use of medications which may have been contaminated with diethylene glycol or ethylene glycol (this was confirmed in some of the samples by further analysis conducted by WHO ).

The Central Drugs Standard Control Organization (CDSCO) immediately took up the matter and a more in-depth investigation was opened. From the preliminary investigation, it has been established that Maiden Pharmaceutical Limited, Sonipat, Haryana is an approved manufacturer by the State Drug Controller for the referenced products and holds the manufacturing authorization for these products. So far, the company has only manufactured and exported these products to The Gambia. Even though the company only exported to the West African country of Gambia, the incident that happened due to the poor quality of the drug has tarnished India’s image in the whole world. 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 said: “CDSCO, while responding to WHO, within 1.5 hours, took up the matter immediately afterwards with the concerned state regulatory authority, under the jurisdiction of which the drug manufacturing unit is located. . Further, a detailed investigation has been initiated to verify the facts or details of the case in conjunction with the National Drug Controller, Haryana (the relevant national drug control authority).

Additionally, based on the primary investigation, it was established that Maiden Pharmaceutical Limited in Haryana was the manufacturer, licensed by the State Drug Controller, for the referenced products, and held the manufacturing authorization for the products. The company had manufactured and exported these products only to The Gambia, the statement said.

The statement also added that it is a practice for the importing country to test these products on quality parameters and ensure the quality of the products before they are made available in the country. However, this statement is more like a shift of responsibility to the importing country. Immediate action should be taken to reprimand the manufacturing company. Haryana Health Minister Anil Vij warned of “strict action if anything is found to be wrong” after the tests.

To save India from embarrassment on the world stage, it is extremely important that proper action is taken to reprimand and penalize the manufacturing company if the investigation reveals the truth in the allegations so far. Whatever the outcome, it gives us an early warning signal that quality control not only in the pharmaceutical industry but also in all manufacturing units must be robust and must be strictly monitored by checks surprises.

About Sally E. Bartley

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