The Central Drugs Standard Control Organisation is alleged to have ordered a pharmaceutical company with headquarters in Madhya Pradesh to stop producing cough syrup that has been connected to child fatalities in Cameroon, prompting the Centre’s direction.
Source: IAS Gyan
After their cough syrups were blamed for the deaths of children in the Gambia and Uzbekistan, respectively, pharma businesses with headquarters in Haryana and Uttar Pradesh ran into difficulty last year. These incidents have damaged the reputation of Indian pharmaceutical companies and diminished India’s position as the world’s leading pharmacy, particularly in the Global South.
Lack of WHO GMP certification among India’s pharmaceutical manufacturing facilities, the majority of which fall under the MSME (micro, small and medium enterprises) category, is a serious reason for worry. Drug authorities have recently conducted inspections and discovered a number of anomalies, including inadequate paperwork, a lack of analytical validation, a lack of quality failure investigations, and a lack of internal product quality reviews.
Source: CNBC- TV 18
It is clear that the government’s efforts to encourage pharmaceutical firms to implement the GMP system through self-regulation have failed. If the regulatory mechanism’s inadequacies are not urgently filled, the road to forced compliance is sure to be rocky. Regardless of whether they are produced for local use or export, the quality and safety of pharmaceuticals produced in the nation shouldn’t be compromised. Actions that set an example for others to follow might dissuade other businesses from lowering the bar.
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