In October, the World Health Organization warned that the death of 70 children in Gambia between late July and September may have been linked to the consumption of cough syrups manufactured in India that had excessive quantities of diethylene glycol and ethylene glycol.
For long-time observers of the Indian pharmaceutical industry, the deaths brought to mind a similar tragedy in Mumbai 36 years ago when 14 patients at the state-run JJ Hospital died of renal failure. The glycerine with which the patients were being treated contained diethylene glycol – consumption of which can be fatal for human beings.
According to court documents, 150 patients in other hospitals across Maharashtra were also affected or disabled by the same batch of glycerine.
Though two chargesheets were filed in the case in 1990, the JJ Hospital tragedy demonstrates how difficult it is for victims of adulterated drugs to find justice. Nearly four decades on, the case continues to be heard at a metropolitan magistrate’s court in Mumbai but charges have still not been framed against the 24 people accused.
Since hearings began in 1991, two of the people accused have died while one is absconding, probably in the United States. Most of the other accused are now aged between 70 and 90 years.
The next hearing is scheduled for November 23.
“There are terrorism cases with over 1,000 witnesses, and judgement comes faster than this,” said Prashant Reddy, author of recently published The Truth Pill, a book on India’s drug regulatory framework. “Thirty-six years is a ridiculous time for a drug case to drag on.”
Public prosecutor Manjula Rao, who is now 75 years old, said, “It seems everyone has lost interest in this case.” Rao was appointed as the public prosecutor for the case in 1991. The Maharashtra government has not yet paid her any fees, she says.
Despite the lengthy procedure, two advocates representing some of the accused said they are confident of a discharge since the “evidence is weak”.
The glycerine case
The first death in the JJ Hospital case occurred on January 21, 1986. Bapu Thombare, 33, died of renal failure, though he had no kidney ailments. He had been admitted to the general surgery ward on January 15 after a fall. He had been recovering when he suddenly stopped being able to urinate on January 20. The autopsy established the cause of death as cortical necrosis, where tissues in the outer kidney layer die.
Within four days, five other patients died of renal failure. On January 25, the hospital directed its staff to stop using three medications that had been administered to the six deceased patients. These included mannitol, used to reduce swelling, and Diamox, a medication to treat glaucoma, paralysis, heart failure and others.
The hospital also stopped using glycerine, a colourless odourless sweet-tasting liquid administered orally to treat glaucoma and coughs, and used as a laxative. Thombare had been given glycerine for three days before he died. The last patient during this tragic spell was Dawood Dholakia, 76, who was administered glycerine to treat glaucoma between January 20-27. He passed away on February 7.
The postmortem reports showed that all 14 had died of cortical necrosis. This led doctors to suspect that they had died of diethylene glycol poisoning. The impurity could only have been present in adulterated glycerine.
At that time, JJ Hospital was using glycerine from batch number 27 bought from Nanded-based Alpana Pharmaceuticals.
Following an uproar over the deaths, the Maharashtra government appointed an inquiry commission headed by Justice B Lentin of the Bombay High Court.
The 289-page report Lentin submitted to the Maharashtra government more than a year later in November 1987 detailed a series of negligent and corrupt practices that led to the adulterated glycerine entering the hospital ward.
Court documents accessed by Scroll.in show that Alpana Pharmaceuticals had supplied glycerine from the adulterated batch number 27 not just to JJ Hospital but also to government civil hospitals in Beed, Latur, Kolhapur, Satara and Osmanabad.
Glycerine, a by-product of the soap industry, comes in two varieties. Medical-grade glycerine, called Glycerine IP, is 98% pure glycerine with 2% moisture. Industrial-grade glycerine, called Glycerine IW, is used for cosmetics, textile, lubricants, and contains impurities such as diethylene glycol.
Court documents show that the glycerine administered to patients in JJ Hospital had just 9% glycerine, 21% water, 51% polyglycol and a significant 18.9% of diethylene glycol.
The Lentin Commission report traced how the adulterated glycerine ended up in the consignment administered to the patients at JJ Hospital.
Jethalal Soni, the owner of Ganesh Chemicals, had produced a batch of glycerine using 250 kg of industrial glycerine, 187 kg sorbitol, 40 kg diethylene glycol and 25 kg pure glycerine. On the drums, he had stencilled a warning “Not for medicinal use”.
Pure glycerine cost Rs 54 per kg at the time.
Ganesh Chemicals sold this cheaper industrial glycerine for Rs 30 per kg to Mahendra Doshi from HM Chemicals, the Lentin Commission report said. Soni claimed he did not know the purpose for which this glycerine would be used. HM Chemicals then sold the glycerine to Kailash and Co, an intermediary, which sold the glycerine to Alpana Pharmaceuticals. Pune-based Artichem Laboratories acted as a mediator and placed an order on behalf of Alpana Pharmaceuticals.
Alpana Pharmaceuticals tested the glycerine in raw form but did not retest the finished product after packaging it. The company then sold 270 bottles of this glycerine to JJ Hospital for Rs 10,089. According to the Drugs and Cosmetic Act, a manufacturer has to test raw material after purchasing it and the finished product again after processing it.
How this batch of industrial-grade glycerine received approval for medical use remains a major question.
The Lentin Commission report said that Chem Med, a private laboratory, had issued a fake certificate to Alpana Pharmaceuticals approving the use of the glycerine. Even before the deaths at JJ Hospital, the Maharashtra Food and Drug Administration had previously warned Chem Med at least five times for “false analysis”, the Commission noted.
Omprakash Sadhwani, an independent drug consultant and former joint commissioner of the Food and Drug Administration, said that before 1986, testing glycerine IP for diethylene glycol impurity was not a legal requirement. “It was only after the JJ incident, that testing protocols were changed in the country and we began testing DEG in glycerine,” he said.
Bribes, no checks
The Lentin Commission report exposed the nexus between politicians, Food and Drug Administration officials, hospital authorities and drug suppliers. The JJ Hospital pharmacology panel that approved the Alpana Pharmaceutical glycerine had been bribed, said the commission. The Food and Drug Administration had also not carried out due diligence checks before granting Alpana Pharmaceuticals a repackaging licence.
Alpana Pharmaceuticals had been given the licence on the undertaking that it would set up a testing laboratory – but it never fulfilled that requirement.
It was not just glycerine that was found adulterated. Samples of mannitol, the low-calorie sweetener administered to 10 of the 14 patients who died in JJ Hospital, were found to be pyrogenic, which means that it could induce fever. The investigating officer in the case noted that use of mannitol had aggravated the patients’ condition.
Trans India Pvt Ltd, with a unit in Boisar, had manufactured the mannitol. The unit had continued to manufacture and supply mannitol to government hospitals till 1986 even though its license had expired in 1982 and the Food and Drug Administration refused to grant it a new one.
“Between January and September 1986, the FDA found 582 formulations sold in the market were substandard, including 119 life-saving drugs,” the Lentin Commission said. “No action has been taken against manufacturers and the formulations continue to be sold in Maharashtra. Some of the guilty are reputed pharmaceutical firms, including multinationals.”
Legal delays
Soon after the Lentin Commission submitted its report, the Maharashtra government directed the Food and Drug Administration to take action. In 1988, Mumbai Drug Inspector KT Sudke filed a case under Drugs and Cosmetics Act, 1940, against Alpana Pharmaceuticals and others.
The case was filed under Section 18(A), for the sale of a spurious or substandard drug, Section 17 for the misleading label of a drug and Section 27, which relates to punishment for selling substandard drugs.
A second case was filed by the Mumbai Police under the Indian Penal Code for culpable homicide not amounting to murder under Section 304 and cheating under Section 420 and other sections for abetment to crime and causing grievous hurt.
Court documents accessed by Scroll.in show that two factors led to a significant delay in the case: judges assigned to the matter were frequently transferred while several people accused in the case filed repeated applications seeking to be discharged, claiming that they had wrongly been included in the proceedings.
In the case filed under the Drugs and Cosmetics Act, lower court proceedings were halted several times as these appeals to be discharged went to a higher court.
From 1991 to 1996, the case was heard at the Mazgaon magistrate court by KH Holambe Patil. A lot of time was spent hearing arguments on whether the two cases – one by the Food and Drug Administration and the other by the police – should be clubbed or heard separately, Patil said.
“The proceedings in both cases are different,” Patil told Scroll.in. “Under the Drugs and Cosmetics Act, charges cannot be framed without recording evidence. While in the case with IPC sections, charges can be framed [first] and then evidence can be presented.”
The cases were not clubbed together and continue to be heard separately.
In July 1996, Patil was transferred to the Bandra magistrate’s court. Since Patil had heard substantial arguments and the case was technical, the prosecution in September 1996 asked for the case to be transferred to the Bandra court so that he could continue to hear it. That happened a month later. But before the papers could be transferred to the Bandra court, Patil was transferred again, this time to the Girgaum court.
In 2000, the prosecution again requested that the case be transferred, this time from Bandra to Girgaum. But again, before the case papers could be transferred to the Girgaum court, Patil was transferred to the Esplanade court in June 2001.
An application by the prosecution to have the case transferred was rejected and the matter continued to be heard at the Girgaum magistrate court. According to an advocate for one of the people accused, “At least a dozen judges have been transferred in this case after that.”
Public prosecutor Manjula Rao said since the case was technical and the court had not passed orders to frame charges, the prosecution had to repeat arguments whenever a new judge took over the matter. “Usually the charges are filed quickly after the chargesheet is filed,” she said. “But in this matter, it took exceptionally long.”
Jethalal Soni, who owned Ganesh Chemicals, has been discharged in the Drugs and Cosmetics Act case. The court observed that he had attached a warning on the two drums sold to HM Chemicals that the glycerine was not for medical use. But Soni remains an accused in the criminal case filed by the police. He is now 82.
“I have lost my vision,” he told Scroll.in. “I can’t go to the court anymore. I don’t even remember the case details now. My advocate goes.”
In 1993, prime accused Omprakash Ladda, a director at Alpana Pharmaceuticals, filed an application to be released from the drugs case. The magistrate’s court rejected it. In 1996, Ladda requested an adjournment in the case as he had filed a revision plea in the Bombay High Court against the discharge plea being rejected.
In 2002, directors Ramanlal and Rameshwar Karwa of Pune-based Artichem laboratory, which had placed the order on behalf of Alpana Pharmaceuticals to buy the glycerine, filed an application seeking to be discharged. The same year, the owners of HM Chemicals also applied to be discharged and managed to get a stay on the magistrate’s court proceedings from the higher court.
In 2007, the magistrate’s court rejected Ramanlal and Rameshwar Karwa’s discharge plea. The next year, they approached the sessions court, which rejected the plea as well following which the matter reached the High Court. In July 2010, the Bombay High Court, too, rejected their discharge plea.
The High Court observed that the case had been pending trial for a long time. “Several proceedings have been filed by one or other accused, who are intended to quash the proceedings, though unsuccessfully, but they have succeeded in stopping the trial for a very long time,” said the court.
The Karwas then approached the Supreme Court, which rejected their plea. In 2009, the Supreme Court directed the magistrate’s court to expedite the case.
In 2002, KT Sudke retired as assistant commissioner of the Food and Drug Administration in Pune. He said he had stopped attending hearings since the Maharashtra government did not pay him an allowance to travel to Mumbai.
Business as usual
Even after the deaths at JJ Hospital, Alpana Pharmaceuticals continued to be a supplier to government hospitals. Between 1990 and 2010, it expanded its business to supplying surgical instruments and hospital equipment and furniture. It did business with hospitals in Nanded, Parbhani and Hingoli.
Advocate Dimple Shah, who represents Alpana Pharmaceuticals director Omprakash Ladda, said the prosecution has laid out the evidence and the court will decide whether to frame charges or discharge the accused. Shah said that the evidence presented in court so far “holds no ground to frame charges”.
According to Shah, Alpana Pharmaceuticals has also contested a laboratory report by the government analyst stating that the glycerine sample tested by JJ Hospital was found to be substandard. The report said the sample was “pale yellow in colour” with a “burnt sugar odour” – glycerine is usually odourless and colourless.
Alpana Pharmaceuticals had demanded a retest from the Central Drug Laboratory in Kolkata, as per protocol. “The retest was never conducted,” Shah said. “We continue to contest this lab report.”
This is an indication of the Food and Drug Administration’s failure to build a water-tight case, and the dearth of laboratories to conduct complex drug tests. Maharashtra has just three government drug testing laboratories – in Mumbai, Nagpur and Aurangabad.
Testing hurdle
The lessons from the JJ tragedy continue to be ignored. The deaths of 70 children in The Gambia reiterated the need for India to institute a robust testing mechanism for drugs.
As The Gambia deaths drew international attention, Director General of the World Health Organization Dr Tedros Adhanom Ghebreyesus on October 5 announced a medical alert for the four cough syrups manufactured by a firm called Maiden Pharmaceuticals at their plant in Haryana’s Sonepat.
Ghebreyesus said the syrups had been found to contain excessive quantities of diethylene glycol and ethylene glycol, and were linked to acute renal disease in children and the deaths.
DR Gahane, joint commissioner (drugs) of the Food and Drug Administration in Maharashtra, said the deaths in The Gambia drew points to how Indian drug inspectors do not routinely test the level of diethylene glycol in cough syrups. “We assume that when the manufacturer buys glycerine, he tests the raw material for quality,” said Gahane.
More than a month after the deaths, the Haryana drug controller on October 12 stopped production at the Sonepat unit of Maiden Pharmaceuticals until further inquiry. The Pharmaceuticals Export Promotion Council of India also suspended Maiden’s export licence. The batch of syrups sold in The Gambia are undergoing testing at a Central Drugs Standard Control Organisation laboratory.
So far, Kerala is the only Indian state to have suspended the sale of drugs manufactured by Maiden Pharmaceuticals. Apart from this, there is little indication that Maiden Pharmaceuticals may face more than a rap on the knuckles.
Gahane of the Food and Drug Administration said that since the punishment for the offence of manufacturing substandard drugs is not stringent, it fails to deter manufacturers from committing future malpractices.
Researcher and author Prashant Reddy said that in less egregious matters of substandard drugs that do not result in significant health hazards, punishment is relatively light and manufacturers usually tend to plead guilty. “We studied several judgments while researching for the book,” he said. “In some, manufacturers were given imprisonment till the court rises for the day.”
This reporting was supported by a grant from the Thakur Family Foundation. Thakur Family Foundation has not exercised any editorial control over the contents of this article.
Drug purchase malpractice that led to deaths in 1986 has lessons for India’s health system today
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