Guest column | Gambia, PGI deaths a wake-up call for Indian pharma

An alert from the World Health Organisation (WHO) on October 5 highlighting unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG) in four cough syrups for children exported to The Gambia.

Of late, common prescription drugs manufactured in India have been making headlines for the wrong reasons, be it 66 deaths in The Gambia (West Africa) due to cough syrups, or the five deaths caused by an anaesthetic agent at the Postgraduate Institute of Medical Education and Research (PGIMER).

Indian drug manufacturing suffers from serious regulatory deficiencies at each level.

These are not stray incidents but reflect a deeper malady. The pharmacological constitution of oral and injectable drugs is a precise multi-step process, which needs correct-to-the-microgram dose of the active ingredient whose sterility, safety, and biological availability are standardised and tested at each level for each batch. The key to safe and effective formulations is stringent regulatory mechanisms.

An alert from the World Health Organisation (WHO) on October 5 highlighting unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG) in four cough syrups for children exported to The Gambia. The two solvents in excess amounts can lead to acute kidney damage and death.

In a strikingly similar incident, two years ago 17 children died in the Udhampur district of Jammu and Kashmir after consuming a cough syrup with high levels of DEG. Concerningly, 30 months on, no chargesheet has been filed.

The 14 deaths at JJ Hospital, Mumbai, in 1986 were also attributed to the same ingredient, and despite the scathing observations of the Justice Lentin Commission, DEG and EG continue to be used without quantification.

The deaths of patients undergoing surgery due to propofol (anaesthetic) have even more serious implications. Drug inspectors from Chandigarh and the Central Drugs Control Organisation (CDSCO) found the drug to be “not of standard quality” as it failed in sterility, pH and other tests. While initially, PGI had warned against the use of one particular brand of propofol, the inquiry report has also found another company’s product to be substandard.

Data manipulation, other unscrupulous practices

Unscrupulous practices are not just limited to small players. Katherine Eban in her 2019 book, ‘Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma’ had exposed open manipulation of data by Ranbaxy, then, one of India’s largest drug manufacturers. Among other irregularities, the crucial high-performance liquid chromatography machines used to test the purity of ingredients were not linked to the company’s main computer system at some plants, leaving scope for manipulation. The US FDA had detected similar data fudging by Wockhardt’s insulin manufacturing plant. What is all the more concerning is that India’s CDSCO had never found problems with Ranbaxy’s products.

Regulatory deficiencies

Indian drug manufacturing suffers from serious regulatory deficiencies at each level. Though there are strict regulations to start a new unit, there is little control thereafter. The state drug controller’s offices do not have enough staff for carrying out regular inspections. For example, in Haryana, there are just about 10 drug inspectors to inspect manufacturing units in 22 districts. Smaller manufacturing units have little to fear for not complying with regulations, what with a pliant inspection team. Resultantly, similar-sounding brand names are available, and even spurious and substandard drugs are sold off to gullible patients. That’s how the exploitative chemist-manufacturer nexus is able to pay crores of rupees as rent for outlets in large hospitals.

Pharma firms go scot-free

It is rare that the authorities take punitive action against offenders, shut down a plant, or jail the offenders. No action has ensued in the 2020 cough syrup-related deaths in Udhampur. Maiden Pharmaceuticals is also a serial defaulter. Bihar, Gujarat, and Kerala have reported some of the company’s drugs to be substandard over the last 10 years. It was also one of the companies flagged by Vietnam for flouting drug quality norms in 2014. Another disturbing fact is that there is little coordination between enforcement agencies in different states. So, a company blacklisted in one state can sell products in another.

The recent incidents are a wake-up call for India. The drug regulatory authorities at the central and state levels need to get their act together and work in close coordination. Punitive action should be taken against the manufacturers of substandard drugs as well as corrupt officials.

(The writer is the former president of the Indian Society of Gastroenterology)