The Justice Lentin Commission of Enquiry: A
Case Study
Posted on July 23, 2018 by flamingofeather
Drug purchase malpractice that led to deaths in 1986 has lessons
for India’s health system today.
Justice Bakhtavar Lentin and members of the Commission of Enquiry
into the JJ Hospital Deaths at the laboratory of the Food and Drug
Administration in Mumbai. Photo by Rupa Chinai.
Laying bare the Malaise and Corruption in Our Health System
By Rupa Chinai
In January–February 1986, 14 patients well on the road to recovery in
Mumbai’s government-run JJ Hospital suddenly died, showing
identical symptoms after consuming a routine medicine glycerine
(or glycerol), an anti-oedema drug used to combat swelling.
The glycerine was laced with industrial glycol, a chemical which
attacks the kidneys and kills quickly.
These deaths may not have come to public notice but for
the Maharashtra Times story on it, broken by journalist Jagan
Phadnis. The public furore that followed compelled the Maharashtra
government to announce the institution of an enquiry commission,
led by a sitting judge of the Bombay High Court, Justice B. Lentin,
and presumed that the matter would blow over. It did not, and for
several years thereafter, the Justice Lentin Commission of Inquiry
remained the focus of intense and unprecedented public and media
interest.
In the introduction to the report of the commission, Justice Lentin
wrote, ‘Little did the 14 persons who died in the JJ Hospital tragedy
know that they would arouse an outcry of public indignation (anger)
which would lay bare lack of probity in public life, malaise (sickness)
and corruption in high places indulged in contempt of the laws of God
and man. All is over bar the shouting. It is time to pause and hunt into
the cloudy waters of lies, deceit, conspiracy, ineptitude and corruption
to salvage the truth which led to this shocking and tragic episode.’
This report, made public in March 1988, after much evasion by the
state government, is the first official document of its kind providing a
rare and detailed insight into the state of our public health system. Its
pages describe the ‘ugly facets of the human mind and human nature,
projecting errors of judgement, misuse of ministerial power and
authority, laziness towards human life, corruption, nexus
(connections) and quid pro quo between unscrupulous licence holders,
analytical laboratories, elements in the Industries Department
controlling the awards of rate contracts; manufacturers, traders,
merchants, suppliers, Food and Drugs Administration (FDA) and
persons holding ministerial rank. None of this will be pleasant in the
affected quarters. But that cannot be helped’.
The commission’s sittings, which ran on for one-and-a-half years,
initially focused on the JJ. Hospital staff. Inertia, lack of
accountability, and total absence of communication were the hallmark
of their functioning. It exposed the gross negligence of the top
administration in withdrawing the killer drug, which continued to do
the rounds in the wards for four days, even after some alert hospital
doctors had sounded the ‘red alert’ on January 25, 1986 and identified
the suspect drugs. The hearings revealed the archaic method of
communication within the sprawling hospital, where even on a matter
as vital as stopping a killer drug, the information was conveyed
through a single, roving, handwritten circular. With record keeping in
shambles the system of drug recall needed remodelling on an
emergency footing, the com- mission noted.
Dwelling at length on the qualities and duties of top hospital
administrators who had utterly failed in acting to stop the killer drug
even after being informed about it in writing, Justice Lentin observed,
‘The success of any system must ultimately depend on the integrity
and efficiency of those manning it, and if these attributes are found at
the top, they must percolate downwards. It is here where the system
has utterly failed, resulting in the kind of tragedy which struck the JJ
Hospital.’
The commission provided an important understanding of the drug
purchase system followed in our public hospitals. Kept deliberately
obtuse and secretive, its rules left to individual caprice, it facilitated
racketeering and money making right down the line, at huge public
cost. The JJ Hospital tragedy took place because the FDA (Food and
Drug Administration) granted an illegal licence to Alpana Pharma,
supplier of the killer drug glycerol, without ensuring that basic
regulations were complied with. During the course of the hearings and
even thereafter, one found that the name of Ramanlal Karwa and his
brothers, the owners of Alpana Pharma worked like a ‘magic wand’—
as Justice Lentin put it—in the corridors of power. (Even after the JJ
Hospital tragedy and despite the commission’s strong indictment, the
Karwa brothers continued to find favour as drug suppliers to public
hospitals, using the simple expedient of starting a company with a
new name.)
Meanwhile, the members of the hospital’s drug purchase committee,
which included hospital doctors and government departments, went
out of their way to place the hospital’s drug supply order with Alpana
Pharma, far exceeding the proportion allotted to them by the
industries department in their rate contract. The quid pro quo was
evident with the discovery of money placed by the drug supplier in
the private bank account of committee members, as in the case of the
hospital’s then head of pharmacol- ogy department.
The absence of checks to ensure that quality drugs reached the public
was revealed with painful clarity during the commission’s
investigations. At that time there were only four government-owned
drug-testing laboratories in the country and in order to cope with the
huge workload the government appointed ‘government approved’
private laboratories that certified the purity of drugs. One such was
Chem Med Laboratory that certified Alpana Pharma’s killer glycerol
as being of standard quality. This company enjoyed special protection
of FDA officials who had been wined and dined by the owners. Even
after its role in the JJ Hospital tragedy was known to them, the FDA
indulged in a massive cover up to shield this company by raising ‘red
herrings’ and leading investigators up the wrong path.
In the case of yet another firm, Apex Laboratory, 14 assistant chemist
employees had complained to the FDA about the firm writing ‘false,
incomplete, misleading and imaginary reports’ related to drug
analysis tests, but the organization did not take action.
An issue intensely debated at that time, as an outcome of the
commission’s hearings, was whether public hospitals as also drug
manufacturers should set up in-house drug- testing laboratories to
ensure drug purity.
Although a mandatory precondition for issuing of a drug
manufacturing license, the FDA did not insist on its implementation.
Small drug manufacturers insisted that they could not afford it. The
trouble, however, was that even large drug companies— including
multinationals that had in-house drug-testing laboratories—
produced substandard drugs and could not be trusted to voluntarily
withdraw them from the market unless caught by the FDA and
severely penalized, which the latter was not inclined (motivated) to
do.
The fact that even ‘reputed’ drug companies were repeat offenders
was discovered by Justice Lentin when he visited the FDA
headquarters during the commission’s investigations and examined
the FDA’s Register of Sub-Standard Drugs, which he dubbed ‘The
Murder Book’. It revealed the FDA’s failure in prosecuting 582
completely blundering drug manufacturing concerns, whose drugs
were found to be substandard, misbranded, or sub- therapeutic, the
majority of which were termed as ‘life saving drugs’. Many of these
‘merchants of death’ were habitual offenders, having committed as
many as 41 offences during the span of five months in 1986, but the
FDA turned a blind eye. When questioned, FDA joint commissioner
S. Dolas told the commission that ‘someone has to die first’, before
the FDA could issue prohibitory orders against a firm.
This pointed to the enormous (huge) scale on which the public health
system had been reduced to a captive market for profit spinning,
where human life was of least concern.
An examination of this register or ‘murder book’, if monitored
today, would clearly provide the clues we need to explain why —
despite the JJ Hospital tragedy — no lessons have been learnt and
killer drugs continue to stalk patients in both public and private
hospitals.
This and a multitude of such incidents exposed by the commission
revealed how the system of drug purchase and licensing was
vulnerable (weak) to the pressures of vested interests.
In consequence, the commission underlined that the cheapest-priced
drug was not a criterion to guarantee quality drugs. It
recommended scrapping (wasting) of drug procurement through the
rate contract system and reservation for backward areas. It instead
suggested that government hospitals directly purchase their quota
from reputed manufacturers and conduct their own tests to ensure
standard-quality drugs, amongst other measures.
Looking beyond the specific JJ Hospital episode, the commission
then expanded its scope to a thorough probe into the state of the
public health system in Maharashtra.
Over 10 politicians, which included health ministers past and present,
MPs, and MLAs, were forced to disclose—after much avoidance and
loss of memory and when challenged with documentary evidence—
how their interference in the workings of the FDA had harmed public
interest by the protection they gave to manufacturers of substandard
drugs and destroyed the moral fibre of the FDA, reducing it to a
‘lapdog body’, according to the judge.
The Lentin report strongly indicted then health minister Bhai Sawant
who was charged with gross ministerial interference, favouritism
for extraneous (extraordinary) considerations, and misuse of power,
while irresistible inference of corruption was also drawn against him.
It recommended an Anti-Corruption Bureau investigation against
him as also former health minister Baliram Hiray, who was similarly
indicted.
The commission found that the ‘government machinery was utilised
by these politicians to extort money from the drugs industry to
inflate (Expand) the coffers (Funds) of private trusts with which the
ministers were associated.’ Dr Hiray was hard-pressed (push) to
explain to the commission how the Bhau Saheb Hiray Smarnika
Samiti Trust had received a large number of donations from beer
bars, distilleries, and liquor vendors from all over Maharashtra as
well as several hundred pharma concerns, including multinationals,
which fell within his jurisdiction as minister. He had also assisted
(abetted) the trust in acquiring government-allotted land in Bandra,
measuring 1,927 square metres at a throwaway price of Rs3.49 lakh.
The findings of the Lentin Commission are important not just for
Maharashtra’s public health system but also for other states, as the
majority of the drugs produced in India are manufactured in
Maharashtra and patients from across the country come here for
tertiary treatment.
The commission found that far from regulating and imposing
standards on the drug industry, the FDA had wilfully allowed
substandard drugs to be sold in the market.
The commission undertook a detailed investigation into the manner in
which the FDA functioned, both in terms of licensing and
controlling the standard of drugs produced. The licensing of the
then Rs2,000 crore drugs industry in Maharashtra was solely handled
by the FDA joint commissioner and licensing authority, who was
answerable to none but the health minister. This official handled all
applications for licences and had the power to refuse or grant them.
He was also responsible for launching prosecutions against
offenders amongst drug manufacturers. These untrammelled powers
that he enjoyed could only be challenged in an appeal to the health
minister.
‘In the hands of unscrupulous (dishonest) Joint -Commissioners and
Licensing Authority, it could be an instrument of harassment and a
device to make vast sums of money.
This added to the inducements of the manufacturer of substandard,
spurious (false) and misbranded drugs and total lack of fear of the
consequences provided by the Act and Rules.’ the judge stated.
Dividends (bonus, Extra funds) came to those FDA officials who said
‘Yes Minister’ promptly enough. Their talent lay in wresting
donations from the profit-spinning pharma companies which
increased the funds of the private trusts controlled by ministers. It
was this talent that enabled officers like S.M. Dolas, the FDA joint
commissioner and sole licensing authority in the state to thwart every
transfer order, supported as he was by a galaxy of politicians, thereby
enabling an uninterrupted 20-year posting in Mumbai. Politicians
stepped in to cancel every transfer made on Dolas since 1978 and
overruled adverse reports made against him by successive FDA
commissioners.
India’s hard-earned reputation as one of the top-ranking global
producers of medicines continues to take a beating for its inability to
tackle this nexus of corruption as highlighted by the
Lentin Commission.
While the government has moved to decentralize the powers of the
licensing authority, the FDA is still unable to perform its role as a
watchdog.
A policy brief published by The Foundation for Research in
Community Health on ‘Accessing Medicines in Africa and South
Asia (July 2013) states: ‘Its (Indian government) failure to
establish a strong drug regulatory mechanism is casting doubt on
the safety and quality of Indian drugs. With complaints of sub-
standard drugs coming from major international buyers the US,
Uganda, South Africa, there is deep concern within the Indian
pharmaceutical industry that the ‘black sheep can tar the credibility of
the entire industry’. The country’s pharmaceutical industry today
valued at Rs.1,00,000 crore is seeing a rapid growth at approximately
10 per cent per year. It meets 95 percent of the domestic needs and
has a 10 per cent share by volume in the global market.
The Lentin Commission of Inquiry had highlighted how the safety
and quality of drugs produced in Maharashtra, where 29 per cent of
the country’s manufacturing and sales units are based.
The government should addresses itself to two tasks.
1. To begin with in the short term, given Indian conditions—where
we contend with an irresponsible pharmaceutical industry and
an inadequate vigilance machinery— there is need for stiff
penal action against errant manufacturers (which includes
FDA confiscation of machinery and property in extreme cases)
and prevention of cases from languishing in the courts.
2. Disallow the shielding of politician cronies.
In the long term, many see that the only solution lies in decrease the
number of drugs, reducing them to the 270 basic drugs
recommended by the WHO (World Health Organization) Several
consumer and medical bodies have asserted the need to start by
weeding out drugs banned the world over, but continue to be
manufactured and sold in India, in some cases even in defiance of the
ban order of the Drug Controller of India, under the shield of court-
granted stay orders. Also highlighted is the need to use drugs by
their generic rather than brand names, which would curb their
proliferation and bring down prices.
Despite the work of the Lentin Commission and several other reports
of official expert committees, nothing has changed. The nexus of
corruption and negligence in our healthcare system is intact but is
rarely exposed in the absence of a vigilant media, strong public
pressure, and government commitment.
