The tragic demise of 66 children in the West African nation of Gambia as a result of the use of suspect cough remedies has brought into focus a dangerous aspect of India’s massive pharmaceutical industry.
The Indian medical regulatory body, the Central Drugs Standard Control Organisation (CDSCO), announced it had launched an investigation into Maiden Pharmaceuticals, the maker of four cough and cold syrups the World Health Organization (WHO) said might be responsible for the deaths of the children.
The syrups contained “unacceptable amounts” of contaminating diethylene glycol and ethylene glycol, a WHO analysis found.
The disastrous incident has come as a rude shock to India’s flourishing pharmaceutical industry, often touted to be the “pharmacy of the world”.
The industry is one of the major contributors to the economy and it is the world’s third-largest industry by volume.
Pharmaceuticals world leader
India is the largest provider of generic medicines, occupying a 20 percent share in global supply by volume, and is the leading vaccine manufacturer.
The pharmaceutical industry is worth around €50 billion, according to various estimates.
“We don't seem to learn from such previous incidents. This has repeated itself again. Drug regulation is governed by a law that is ill-equipped to regulate a complex market like India,” Vikas Bajpai, a public health expert told RFI.
“We continue to be in denial over quality-related concerns expressed by national and international observers."
There have been several high-profile incidents in the recent past that has cast a shadow on the thriving industry which has been concerned by allegations of problems of quality and weak regulation.
In 2020, 14 children died in Jammu and Kashmir after consuming a syrup with high levels of diethylene glycol. Tests found that three samples of the cough syrup, made by an Indian drug company called Digital Vision, contained diethylene glycol or DEG, similar to the Gambia incident.
After this tragedy, India phased out cough syrups in favour of suspensions that do not carry the risk of containing the two toxins.
A few years earlier, in 2016, two Indian pharmaceutical companies were charged for exporting counterfeit diabetes drugs.
Every state and union territory has drugs controllers who are responsible for licencing manufacturing facilities and for market surveillance, and prosecutions.
More regulation required
The central drugs regulator, on the other hand, has a smaller role mainly confined to keeping a check on what type of drugs can be sold in the Indian market, and the import and export of drugs.
"There's very little that states can do under the present legal framework to block companies situated in another state from selling in their states,” says lawyer Prashant Reddy.
"One of the suggestions is to centralise at least part of the drug regulation with the central government. At least licencing and inspection of manufacturing facilities should be conducted by one central authority."
Even during the second wave of coronavirus infections which swamped India last year, fake vials of remdesivir, an antiviral used to treat Covid-19, were sold in bulk at astronomical prices and even exported.
Experts believe that adulteration and contamination of drugs is a major problem that goes unnoticed and hence permits gaps in the healthcare supply chain. Regulatory oversight and enforcement are inconsistent, they claim.
According to a 2017 WHO report, about 10.5 percent of medicines sold in low and middle-income countries, including India, are substandard and falsified.
A report by United States Trade Representative said that 20 percent of all pharmaceutical products sold in the Indian market are counterfeit.
