The Indian government has recommended the cancellation of Marion Biotech’s licence to manufacture their popular cough syrup brand, ‘Codeine-based Cough Syrup’. This recommendation came after a recent inspection led to the discovery of contaminated samples- something that poses a serious risk to the public’s health. The Central Drugs Standards Control Organisation (CDSCO) conducted this inspection and found that the syrup contained codeine and chlorpheniramine, which are controlled substances.
Marion Biotech is a well-known pharmaceutical company based out of Chandigarh that has been manufacturing and distributing cough syrup for a long period of time. However, in recent years, the company gained notoriety due to a scandal involving their Codeine-based Cough Syrup.
In 2018, there were reports that the syrup was being misused as a recreational drug and had led to several deaths. To counter this, the Indian government banned the manufacture, sale and distribution of codeine-based cough syrup without a prescription, as part of its drive against substance abuse.
However, it seems that Marion Biotech continued to manufacture and sell the syrup illegally, without the necessary approvals, and even altered the formulation of the syrup to bypass regulations. As a result, the CDSCO began a series of inspections of the company’s manufacturing facilities and products.
On analysis of the samples obtained during these inspections, they found that several batches of the syrup were contaminated with fungi, including Aspergillus niger and Aspergillus flavus. These fungi are known to produce highly toxic compounds, such as aflatoxins, which are carcinogenic (cancer causing) in nature.
This discovery has put the general public at great risk, as the contaminated syrup had already been distributed and sold to various retailers across the country. The CDSCO has now issued a notice stating that the Marion Biotech cough syrup is an unapproved and highly dangerous medicine, and must not be sold, distributed or consumed under any circumstances.
The Indian government has taken a strong stance against the production and distribution of this cough syrup, and as a result, has recommended that Marion Biotech’s licence to manufacture the product be canceled immediately. This recommendation highlights the government’s commitment to ensuring public safety and protecting individuals from the dangers of contaminated medicines.
This is not the first time that Marion Biotech has found itself in the middle of a controversy. In 2018, the company’s manufacturing facility was shut down due to non-compliance with Good Manufacturing Practices (GMP). It was only recently reopened after the facility had undergone significant changes and improvements.
The company’s missteps also highlight a broader problem in India’s pharmaceutical industry, as many manufacturers and distributors often bypass regulations to make quick profits. Consequently, the Indian government has been stepping up its efforts to regulate pharmaceuticals more strictly in order to protect the public’s safety and prevent such incidents from happening in the future.
The Marion Biotech case emphasizes the fact that there is a need for stricter regulation and monitoring of pharmaceutical products in India. The government must ensure that all manufacturers comply with GMPs and other safety standards to ensure that only safe and effective medicines are being sold in the country.
It is essential that pharmaceutical companies prioritize safety and quality control, as the consequences of poorly regulated medicines can be disastrous for the public, an issue in which Marion Biotech’s shareholders have not been attentive enough. These implications can include anything from serious health risks to death.
In conclusion, Marion Biotech’s latest scandal highlights the need for stronger governance and regulation of pharmaceutical products in India. The government’s decision to recommend the cancellation of the company’s licence shows that it takes such incidents seriously and is committed to safeguarding the public’s health. Moving forward, it is critical that all pharmaceutical manufacturers in India adhere to the highest safety standards to ensure that the people of the country do not fall victim to contaminated or harmful medicines.