Introduction

With all the facts and reports in hand, there cannot be a dispute over the fact that India is the “pharmacy” of the world. Its pharmaceutical industry is expected to hold a significant 13% in the global market supplying generic drugs to over 200 countries. With so much investment and dedication in the production of generic drugs, the country has a 20% export share in the global market of generic drugs. India is also lauded for its contribution towards making medicines available at affordable prices for the developing countries using the generic version of drugs. Even in such an unprecedented global pandemic like the COVID-19, Indian managed to supply over 282 million doses of vaccine to over 101 countries. While these contributions to the world remain undisputedly noble, 4 alerts were issued against generic medicines produced in India by the WHO in the last 10 months. This article aims to bring out the aspects where India needs self-inspection.

Background

On October 2022, WHO issued an alert against 4 cough syrups manufactured by the Indian company named Maiden Pharmaceuticals Limited based in Haryana, linking them to the death of 66 kids in the African country of Gambia The report stated that these 4 products failed to meet their quality standards and it was important to remove these 4 products from the market.

Not many days after the above tragedy, In December 2022, Uzbekistan’s health ministry came up with an allegation that 18 kids in their country have died after consuming 2 cough syrups manufactured by Marion Biotech ltd. based in Noida. The WHO, acting quickly issued a similar alert against these two cough syrups, pursuant to which India cancelled the license of Marion Biotech to manufacture medicines.

Later on April 2023, the WHO yet again issued an alert against a cough syrup manufactured by QP Pharmaceuticals based in Haryana which was later backed by the Nigerian authority’s public announcements against the syrup after due laboratory analysis of the same

And recently, on 8 August 2023, the WHO issued an alert against a cough syrup manufactured by Fourrts laboratories private Ltd based in Tamil Nadu. This is the latest of the series of alerts against the drugs manufactured in India

Is there a pattern?

It is to be noted that all of the alerts were against a specific type of drug namely the “cough syrup” and all of these alerts had the same allegation against the drugs which is “unacceptable amounts of ethylene glycol and diethylene glycol”.

Breaking down the drug called cough syrup

Generally a drug has two types of ingredients, the active and inactive ingredients, as they are called. Generic medicines, when they are produced after the expiry of the patent production period of the drug, are made using the same active ingredient/ingredients of the drug to produce same results because it is the active ingredients which give the same medical result. The active ingredient in cough syrups is known as Guiaifenesin. While this is the case about active ingredients, drugs in general and cough syrups in specific have some inactive ingredients which are necessary for the manufacture. One such ingredient in the cough syrup is the glycerol. Glycerol is used majorly as a solvent in cough syrups but it has other properties which improve the efficacy of the syrup like its sweetness, its humectant property etc. The ingredients in dispute in the above incidents, which are the ethylene and diethylene glycol, are cheaper substitutes of glycerol while there is a major difference that the former two ingredients are toxic while the latter is not. If these are consumed over prescribed levels, central nervous system depression, nausea, vomiting, intoxication, euphoria, stupor, respiratory depression, and reduced excretion of urine can occur due to ethylene glycol intoxication and abdominal pain, diarrhea, organ failure in kids can be the consequences of dietheylene glycol. There are no regulations as to completely not use these ingredients in medicines, but the WHO prescribes the limit of 0.10% to each of these two ingredients but in the above mentioned 5 instances, it was over the prescribed limits as per the WHO statement issued.

Why is this regular and not regulated?

As it is evident from whatever was provided above, the complaint against the Indian cough syrups is a regular event. The next primary question which arises after this point it, how are these drugs regulated. What are the standards that generic drugs need to meet?

The generic drugs need to have the same active ingredient used in the patent protected drug which was granted approval. This is the primary standard that needs to be met. To ensure the drug’s effectiveness against the same problem, this is ensured. While there is no bar against the substitution of inactive ingredients like what was done in the instant case. The authority still ensures whether the inactive ingredient is edible and safe for consumption. The usage of ethylene and diethylene glycol cannot be a concern when it is used in acceptable limits and there is no contamination but when it is used over the acceptable limits, it has serious consequences. Other than this, there are other requirements like the generic has to have the same strength, same method of usage, same shelf life of the brand drug. If there are unacceptable amounts of the above mentioned toxic ingredients, it is definitely a regulatory failure to not check the same. The amount of attention given to the active ingredients should be given to the inactive ingredients also. Factors like safety, edibility, contamination, shelf life etc. of the inactive ingredient should be verified and ensured too.

Conclusion

There cannot be a dispute over the statement that “nothing will go on perfectly forever” and with the market share Indian Generic medicines have in the world, small mistakes do happen, but, we have to remember the fact that we are not dealing with any common good here but medicines, the products which directly have an effect over a humans life. Also, mistakes do happen but a pattern of mistakes over the same type of goods imply nothing but that we haven’t self-introspected to correct the same and in a sensitive market like medicine, that becomes unacceptable. India should be lauded for its contribution to the world though the market called “Generic medicines” but there is definitely a need for self-introspection of the regulatory measures of generics. 

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