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Substandard drugs may be a common phenomenon

One in seven medications prescribed in India are deemed to be substandard. This is according to a report published in the Indian Journal of Pharmaceutical Sciences, which says that, “there is urgent requirement of more stringent regulation and legal action against the problem.” According to the Report, “Being the world’s largest manufacturers of active pharmaceutical ingredients and finished products, it is likely that India along with China could be the major contributors to spurious medications” supplied globally

To be clear, this is not to say that one in every seven different brands of medication is substandard; rather that  every seventh dose taken in India of many medications will be deemed to be substandard. This is a public health risk as the term “substandard”  could mean  a lower (and thus ineffective) dose or  a higher, and so potentially dangerous, amount or many other kinds of defective products

Prior this report, surveys conducted by  the Central Drugs Standard Control Organization (CDSCO), the central regulator of drugs standards in India, stated that 4.5% of medications in India may be substandard. This figure has since been considered to be an underestimation. Tests on batches of popular painkillers such as diclofenac sodium have revealed that 15.62 percent did not meet expected standards.

An issue raised by the report is that India is a global supplier of generic medications, with a reputation as the “pharmacy of the developing world”. As a result, problems such as this present a two fronted attack on India. Firstly, the health of its own citizens is endangered because of lapses in the quality of medicine. Secondly, health issues may occur globally through exported medication. This would both endanger people’s health on a global scale and diminish the reputation of India as a pharmaceutical export giant – one it seemingly already must defend in the face of international pressure.

This manner of accusation has been put forward in the past. A notable example from 2013 occurred where accusations were made that India and China had exported antimalarial, antibiotic and contraceptive pills to Uganda and Tanzania, of which potentially a third where substandard or counterfeit. Laboratory testing revealed some of the medication to be of a lower dose, some contained no active ingredient, some had a different formula entirely.

Worth noting is that very few of these studies have been large scale and randomised, many studies studying only a single batch and applying the results to all medication produced. The small sample size however should not be an excuse to disregard the claims, but seen as a cause for more thorough investigations to be conducted.

It has been pointed out in a paper by the Indian Council for Research on International Economic Relations that investigations should be altered to take into account both rural and urban areas as spurious and substandard drugs are theorised to be far more prevalent in rural and semi-urban areas, which may alter the percentage of faulty medications considerably.

Regardless of the location of these substandard drugs it is a situation that needs to be addressed quickly to avoid any further global accusations. The Indian pharmaceutical industry brings a large amount of economic benefit and accusations as to its quality may hamper growth in the area.

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