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Source: The post is based on an article “The message in a bottle on quality from Gambia” published in Live Mint on 11th October 2022.
Syllabus: GS 2 – Governance
Relevance: loopholes present in the regulation of pharma companies in India
News: 66 children have lost their lives in Gambia after consuming contaminated cough syrup manufactured in India. Findings of the various reports highlight quality issues in the cough syrup.
What are the findings of WHO?
WHO found unacceptable amounts of diethylene glycol and ethylene glycol in the syrups. They both are toxic for humans and can lead to serious injury or death, especially in children.
Diethylene glycol is cheaper, which is why it could have been used by the manufacturer. However, manufacturers are responsible for maintaining quality and following good manufacturing practices.
The health ministry’s statement that the four syrups made by Maiden Pharmaceuticals were meant for sale only in Gambia and not India is also misleading.
Moreover, investigation by other agencies also highlights that there has been violation of laws by the pharma company.
What are the findings of Central Drugs Standard Control Organisation (CDSCO)?
The investigation carried out by the Central Drugs Standard Control Organisation (CDSCO) and state regulators suggest that there has been violation of laws by Maiden Pharmaceuticals.
Maiden’s products have failed regulatory tests in several states. It was fined in Kerala for selling low-quality drugs and was blacklisted by Bihar.
Even though the drug maker continued to manufacture low quality drugs.
What are the regulatory problems associated with drug manufacturing companies in India?
The drug regulation in India works in isolation with other states and drugs that fail quality tests in one state can keep selling in other states.
There is also a lack of coordination among states and central regulators and it is further worsened by the absence of a central drug recall mechanism.
The CDSCO estimated that around 5% sub-standard drugs are being sold by Indian manufacturers and there is no proper measure to stop it.
Indian pharma companies have also been penalized by the US in the past for selling low quality drugs.
Therefore, compromise with medicines on standards can have devastating consequences at home or elsewhere in the world.
Bad drugs can cost lives and such losses make global news which may provide a negative image for India as a ‘pharmacy of the world’.
Therefore, the government must take urgent steps to correct all issues in our drug testing and regulatory system.
