Drug purchase malpractice that led to deaths in 1986 has lessons for India’s health system today

An excerpt from ‘Healers or Predators: Healthcare Corruption in India’.

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. All is over bar the shouting. 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 effiiency 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.

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).

Excerpted with permission from Healers or Predators: Healthcare Corruption in India edited by Samiran Nundy, Keshav Desiraju and Sanjay Nagral, Oxford University Press.

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