DEG poisoning: Inadequate checks, cost cutting by pharma cos to blame, says former Haryana drug controller

Aditi Tandon

New Delhi, October 10

The death of 66 Gambian children potentially linked to contaminated cough syrups manufactured by Sonepat-based Maiden Pharmaceuticals has raised questions about the drug regulatory framework at home and the safety of manufacturing practices. According to the WHO alert, the cough syrups were contaminated with diethylene glycol and ethylene glycol which can cause renal failure and death. 

Former Haryana drug controller GL Singhal speaks to The Tribune about issues at hand and possible solutions. Excerpts: 

Diethylene glycol (DEG) has caused deaths in the past also. Why is DEG poisoning recurring?

Over the past four decades, deaths due to DEG contamination have been reported at JJ Hospital Bombay, Chennai, Odisha, Bihar, Gurgaon (1998), Udhampur (2020) and now a Sonepat firm’s name is surfacing. Since paracetamol does not dissolve in water, drug makers use solvent Propylene Glycol (PG) to make the cough syrup. This solvent has DEG and EG as impurities.

Under the Drugs and Cosmetics Act 1940, firms must use pharmaceutical grade PG (as per Indian Pharmacopoeia or US Pharmacopeia standards) with nil DEG. The problem is the rampant availability of commercial grade PG which costs much less – around Rs 100 a kg as against Rs 170 a kg pharma grade. Drug manufacturers sometimes use cheaper PG without testing.

Is it so easy for drug firms to use commercial grade PG? No one checks them?

Every drug firm is mandated to test PG for diethylene glycol and other impurities before using it for cough syrups. The test is performed using gas chromatography. This is a highly sophisticated test. One machine costs Rs 15 to 20 lakh. Even operating this machine requires a high degree of training. Firms are supposed to either have this test facility in their own labs or outsource the test. We have seen drug makers sometimes skipping the test to cut costs. They accept quality certification of PG by raw material suppliers which is wrong.

In Haryana for example out of 100 drug firms, barely ten would have gas chromatography facility.

Was commercial grade PG used in past instances of DEG related deaths?

When Udhampur cough syrups were tested, DEG reported by government approved statutory labs was around 34 pc where it should be nil. This is documentary proof that the solvent used — PG — was contaminated or adulterated and could be commercial grade. These days PG is also being imported. There appear to be quality issues with imported PG as well.

As far as import of Indian drugs by the US is concerned, USFDA teams physically visit drug firms in India before approving any Indian drug for import. They don’t take product certifications on face value. They test and audit WHO GMP (good manufacturing practices) compliant Indian manufacturers prior to import.

What is the solution to this problem?

First, we should try to develop solvents other than PG to make drugs that cannot dissolve in water. Second, right now drug makers are required to test only raw materials as per standards prescribed in pharmacopoeias. Guidelines can be issued saying whosoever makes drug formulations using PG must also test the final finished product for DEG and other impurities. So you mandate gas chromatography at both entry and exit levels.

Why is the drug regulatory system unable to check contaminants?

Drug regulatory landscape is reeling under staff shortage and lack of training. In Haryana alone, we have just about ten drug inspectors to inspect manufacturing units in 22 districts. Naturally, efficient law enforcement becomes difficult. Training is another issue. Haryana mandates four weeks training for a drug inspector appointee. At entry level the appointees may not even know how a cough syrup is made. How can you expect them to enforce the law?

As India earns a global reputation as a pharmacy of the world, we must implement urgent reforms. After recruitment, at least 18 month training should be there for drug inspectors plus an exit test after training before he or she goes into the field for inspections.