Lentin Commission Report
Drug purchase malpractice that led to deaths in 1986 has lessons for India’s health system today.
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 which would lay bare lack of probity in public life, malaise and corruption in
high places indulged in contempt of the laws of God and man. It is time to pause and forage
into the murky waters of lies, deceit, intrigue, ineptitude and corruption to salvage the truth
which led to this ghastly and tragic episode.”
This report, made public in March 1988, after much prevarication 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, apathy
towards human life, corruption, nexus 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 palatable 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 commission 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 pharmacology 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 to do.
Outcomes
Some key thinking emerging from the debates of that time is that the government will not be
able to stem such tragedies unless it addresses itself to two tasks. 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. Evidence shows that
even these measures come to nought in the absence of strong political commitment to weed
out corruption and disallow the shielding of politician cronies.
In the long term, many see that the only solution lies in curbing the number of drugs,
reducing them to the 270 basic drugs recommended by the WHO (World Health
Organization).
Now that Justice Bakhtawar Lentin's task is over, the Maharashtra Government's work has
begun. The 289-page report of the Lentin Commission which was tabled recently in the
Vidhan Sabha has made a scathing indictment of public health administration and called for
major changes. The commission was examining the death of 14 patients at Bombay's state-
run J.J. Hospital in early 1986 after they were administered contaminated glycerol.
Twenty days before it was made public, the report had already claimed the head of health
minister Bhai Sawant who resigned on March 10. Lentin has also held Sawant's predecessor,
Baliram Hiray, guilty of perjury. As suggested by the judge, seven FDA (Food and Drugs
Administration) officials, including the controversial Joint Commissioner (drugs) S.M.
Dolas, have been suspended and 11 others will face inquiries. Two doctors of the J.J.
Hospital have also been suspended. Others found guilty of interference and nepotism are
former Congress(I) ministers G.S. Sarnayak, K.M. Bapu Patil, and Pramila Tople, a minister
during the Janata Party regime.
The report was submitted to the Government on November 30 last year after the commission,
over 648 days, heard 140 witnesses, perused 2,424 files and documents and recorded 3,732
pages of evidence. The pages, in Lentin's words, describe the "misuse of ministerial power
and authority, (and) apathy towards human life".
As expected (INDIA TODAY, August 31,1987), the report has spared no one. At the
receiving end are the state's Health Department, the FDA, the pharmaceuticals industry and
hospitals. Lentin has been particularly critical of the FDA which oversees the state's Rs
2,000-crore drug industry.
Also exposed were ill-equipped laboratories: faulty procedures of licensing; granting of plum
postings to favourites: violations of the drugs and Cosmetics Act; and political failure to
control the powers of officials. And with regard to the J.J. Hospital tragedy, Lentin found that
though the deaths had been discovered, the authorities did nothing to check the use of the
killer glycerol.
While the Government has accepted most of the findings in toto, some are being considered
with modifications. The onus for initiating programmes for reorganising the FDA find
creating a system of checks is on B.B. Sharma, an IAS officer who now heads the
organisation. "The Lentin report has made valuable suggestions," he said.
Recommendations by the report
Plans are afoot to have a Rs 4-crore complex which will house new laboratories that could
double the present capacity of testing 5,000 drug samples every year. Lentin has also
recommended regular refresher courses for FDA officials,, the hiring of more inspectors, and
the immediate cancellation of licences in cases involving the manufacture of substandard
drugs.
Nevertheless, the Government has not been even-handed in meting out justice as laid down
by Lentin. In the case of Sawant, the Government has chosen an easy way out of a sticky
situation. Though Lentin had recommended his prosecution - along with Hiray - under the
Prevention of Corruption Act, the Government has appointed a retired high court judge to
inquire into their conduct. Fumed Professor S.S. Varde, Janata Party MLA: "The basic
judicial process is over. Then why should a retired judge sit in judgement over the verdict of
a sitting high court judge?"
Sawant who Lentin called "a disaster of the first magnitude", was, according to the judge,
"guilty of corruption, misuse of power and deliberate dereliction of duty. He is unfit to hold a
ministerial post." He found Sawant guilty of giving false evidence: arbitrarily transferring
officials; favouring Dolas; permitting a firm (Cyma Pharma) which had made substandard
drugs to manufacture life-saving drugs: and misusing power to secure rate contracts for two
firms (Samarth Pharmaceuticals and Welcome Laboratories).
But even above action against individuals, the crucial point is whether the Government will
indeed follow up serious questions about drug policy and hospital management that the report
has raised. There is reason for cynicism. For instance, in 1973, the Surinder S. Pruthi
Committee had gone into the working of J.J. Hospital but the follow-up on its
recommendations was poor.
That the Bombay tragedy made up a rule rather than an exception was proved when, in
January, 11 deaths were reported from Bihar - again due to glycerol poisoning. But if the
drug purchase policy of hospitals is reviewed, small firms are likely to suffer the most. As
things stand, many hospitals buy drugs from many small firms which can offer lower prices.
But says Dr Mira Shiva of Delhi's Voluntary Health Association of India: "It is important
that drugs are obtained from established firms - which need not mean multinationals, but
those that ensure strict quality control."
If the Government doesn't act now, it may lose its last chance of restoring public faith in a
health administration gone to seed.
