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JJ Deaths
In 1986, 14 patients died of acute renal failure at the J. J. Hospital in Bombay after being administered glycerol adulterated with diethylene glycol.
The one-man Justice Lentin Commission was set up by the Maharastra Government to investigate the reasons for this tragedy.
The Commission, over a period of 17 months, sifted through numerous files, cross-examined 120 witnesses and exposed the nexus between politicians, the Food and Drugs Administration (FDA) and the drug manufacturers. It revealed the protection these manufacturers received from FDA, the flagrant violation of laws in issuing licences, deferring prosecution of errant manufacturers and ministerial interference at every stage.
It was found that the adulterated glycerol which is meant for industrial use was supplied by Alpana Pharma, whose tender to supply had been accepted by the Tender Committee, in gross violation of several rules of acceptance of tender. In addition, Chem Med Lab had given a quality control report stating the drug to be of standard quality without even conducting the requisite tests. And most horrendous of all, even after the killer drug was more or less identified, it continued to be administered due to negligence of those concerned.
The Commission revealed some startling facts:
* 300 formulations were found to be sub-standard between February and July 1987, yet they continued to be sold.
* 20 per cent of drug samples were found to be substandard, yet the FDA made no attempt at follow-up action.
* several summons to the State Government and FDA to produce a missing file evoked no response. When a newspaper reporter finally unearthed the file, it contained evidence of FDA manipulations to pass a drug formulation manufactured by Glindia (Glaxo Laboratories) which was not of standard quality.
The outcome of the Lentin Commission Report may not have been spectacular. Some heads may have rolled and some minor cosmetic change may have been made. Prior to the publication of the Commission Report, the Health Minister, Bhai Sawant resigned saying the Commission had drawn unpermissible conclusions. In an unprecedented show of solidarity, MLAs from the opposition and the ruling party joined hands in criticising the Commission's findings regarding the role of the politicians in the glycerol scandal. Indeed one opposition MLA even raised a notice of breach of privilege against Justice Lentin. However the Lentin Commission has atlast made public what was always suspected - the rot which has set in the public health care system and the drugs administration, and the corruption of high-level officials, ministers and the drug industry.
Administration of contaminated glycerol had led to the death of 14 patients at the J.J. Hospital in Mumbai between 21 January and 7 February1986. The state government appointed Justice Bhaktawar Lentin under the Commissions of Inquiry Act, 1952 to probe into the tragedy. (For a review of Justice Lentin’s report on these deaths see Natl Med J India 1988;1:144–8.) Ten years later, on 1 December 1997, The Indian Express carried a news item entitled ‘Lentin report on J.J. deaths lies in cold storage’:
‘The commission had passed strictures and recommended immediate departmental action against the then Dean R. S. Chandrikapure, S. V. Shaligram (Professor and Head of the Department of Pharmacology), V. G. Deshmukh (Medical Superintendent), A. K. Jamadagni (pharmacist), S. B. Satalkar, N. D. Dharap, P. K. Torvi, S. M. Dolas, P. K. Kochar and B. K. Bijamwar (all from the department of industries). In addition, the commission had recommended that the Anti-Corruption Bureau (ACB) should be directed to hold a high-level probe against the officials of the industries department.
‘… However, the state government has cold-shouldered … the recommendations.
‘… The then health minister Bhai Sawant, former health minister Baliram Hiray, officials from the Food and Drug Administration (FDA), R. D. Kulkarni, V. C. Sane, S. D. Bhirud, V. D. Deshmukh and N. D. Kulkarni were liable to be proceeded against for charges of corruption after appropriate inquiries were made by the ACB or any other competent investigating authority on its behalf.
‘As per official records, though the FDA officials were suspended for some period, most of them were reinstated with back wages after they were acquitted on the basis of departmental inquiry. Shaligram had failed to withdraw the contaminated drug though it was brought to his notice. The commission held him grossly negligent in not providing proper circulars to the department. However, the departmental inquiry found no substance in the charges levelled against him. In most of the cases, the departmental inquiry officer had given almost similar findings. "Such findings by the departmental inquiries make a mockery of the commission’s recommendations," remarked a senior official of the law and judiciary department.’
Mr Justice Lentin passed away on 22 April 2000 without seeing any disciplinary action against those indicted by him.
The one-man Justice Lentin Commission was set up by the Maharastra Government to investigate the reasons for this tragedy.
The Commission, over a period of 17 months, sifted through numerous files, cross-examined 120 witnesses and exposed the nexus between politicians, the Food and Drugs Administration (FDA) and the drug manufacturers. It revealed the protection these manufacturers received from FDA, the flagrant violation of laws in issuing licences, deferring prosecution of errant manufacturers and ministerial interference at every stage.
It was found that the adulterated glycerol which is meant for industrial use was supplied by Alpana Pharma, whose tender to supply had been accepted by the Tender Committee, in gross violation of several rules of acceptance of tender. In addition, Chem Med Lab had given a quality control report stating the drug to be of standard quality without even conducting the requisite tests. And most horrendous of all, even after the killer drug was more or less identified, it continued to be administered due to negligence of those concerned.
The Commission revealed some startling facts:
* 300 formulations were found to be sub-standard between February and July 1987, yet they continued to be sold.
* 20 per cent of drug samples were found to be substandard, yet the FDA made no attempt at follow-up action.
* several summons to the State Government and FDA to produce a missing file evoked no response. When a newspaper reporter finally unearthed the file, it contained evidence of FDA manipulations to pass a drug formulation manufactured by Glindia (Glaxo Laboratories) which was not of standard quality.
The outcome of the Lentin Commission Report may not have been spectacular. Some heads may have rolled and some minor cosmetic change may have been made. Prior to the publication of the Commission Report, the Health Minister, Bhai Sawant resigned saying the Commission had drawn unpermissible conclusions. In an unprecedented show of solidarity, MLAs from the opposition and the ruling party joined hands in criticising the Commission's findings regarding the role of the politicians in the glycerol scandal. Indeed one opposition MLA even raised a notice of breach of privilege against Justice Lentin. However the Lentin Commission has atlast made public what was always suspected - the rot which has set in the public health care system and the drugs administration, and the corruption of high-level officials, ministers and the drug industry.
Administration of contaminated glycerol had led to the death of 14 patients at the J.J. Hospital in Mumbai between 21 January and 7 February1986. The state government appointed Justice Bhaktawar Lentin under the Commissions of Inquiry Act, 1952 to probe into the tragedy. (For a review of Justice Lentin’s report on these deaths see Natl Med J India 1988;1:144–8.) Ten years later, on 1 December 1997, The Indian Express carried a news item entitled ‘Lentin report on J.J. deaths lies in cold storage’:
‘The commission had passed strictures and recommended immediate departmental action against the then Dean R. S. Chandrikapure, S. V. Shaligram (Professor and Head of the Department of Pharmacology), V. G. Deshmukh (Medical Superintendent), A. K. Jamadagni (pharmacist), S. B. Satalkar, N. D. Dharap, P. K. Torvi, S. M. Dolas, P. K. Kochar and B. K. Bijamwar (all from the department of industries). In addition, the commission had recommended that the Anti-Corruption Bureau (ACB) should be directed to hold a high-level probe against the officials of the industries department.
‘… However, the state government has cold-shouldered … the recommendations.
‘… The then health minister Bhai Sawant, former health minister Baliram Hiray, officials from the Food and Drug Administration (FDA), R. D. Kulkarni, V. C. Sane, S. D. Bhirud, V. D. Deshmukh and N. D. Kulkarni were liable to be proceeded against for charges of corruption after appropriate inquiries were made by the ACB or any other competent investigating authority on its behalf.
‘As per official records, though the FDA officials were suspended for some period, most of them were reinstated with back wages after they were acquitted on the basis of departmental inquiry. Shaligram had failed to withdraw the contaminated drug though it was brought to his notice. The commission held him grossly negligent in not providing proper circulars to the department. However, the departmental inquiry found no substance in the charges levelled against him. In most of the cases, the departmental inquiry officer had given almost similar findings. "Such findings by the departmental inquiries make a mockery of the commission’s recommendations," remarked a senior official of the law and judiciary department.’
Mr Justice Lentin passed away on 22 April 2000 without seeing any disciplinary action against those indicted by him.