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Appendix 8 : Resume on the Lentin


The Lentin Commission perobed into the death of 14 patients at J.J. Hospital, Bombay after being administered glycerol adulterated with diethylene glycol. In a painstaking effort over a period 17 months, the Lentin Commission has succeeded in exposing the nexus between politicians, the Food and Drugs Administration (FDA) and the drug manufacturers.

How it All Started
Between January 21 and February 17, 1986, 14 patients died in J.J. Hospital of cute renal failure. All of them were Administered adulterated glycerol which contained 18.5% diethylene Glycol (even 1% diethylene glycol can cause damage). This adulterated glycerol which was meant for industrial and not medicinal use was supplied by Alpana Pharma, whose tender to supply glyceriol had been accepted by the tender Committee, in gross violation of seveal 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 finally at the J.J. Hospital even when the killer drug was more or less identified, the drug continued to be administered due to negligence of the concerned people.
The one man Justice Lentin Commission was set up by the Maharashtra Government to probe into the incident. The Commission shifted through innumerable files, stringently cross examined 120 witnesses and came up with facts that presented a horrifying picture of the health system.

The FDA’s Functioning
The Commission exposed the understanding between manufacturers of sub-standard drugs and the upper echelons of the FDA. The protection these manufacturers received from FDA, the flagrant violation of laws in issuing licenses, deferring prosecution of errant manufacturers and ministerial interference at every stage.
The Commission slapped perjury notices against four persons, including two former health ministers for failing to tell the truth in the witness box. Justice Lentin had this to say about the several witnesses, "I have met shameless witnesses before but the FDA takes the cake." He also added that never in his experience of 14 years at the High Court Bench and 7 years in the Civil Court had he come across any case where barring a few exceptions, witness after witness came determined to suppress the truth and pile the blame on someone else.
Some startling facts that were revealed in the course of the hearing - between January and September ‘86, 582 formulations were found to be substandard with hardly any action taken against the offenders, many of whom were the "reputed" big companies.

  • - 300 formulations were found to be substandard between Feb. ‘87 and July ‘87, but they continued to be sold.
  • - 20% of drug samples drawn were found to be substandard and yet follow up action on the part of FDA had been almost non-existent.
  • - 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 manipultions to pass a drug formulation manufactured by Glindia (formerly Glaxo Laboratories) which was not of standard quality.

The Role of Health Ministers
About Health Ministers, Justice lentin had this to say, "They have encouraged corruption, favouritsm, deliberte violation intentionally and knowingly performed with a view to confer favours, ministerial largesse in the form of transfers and postings of choice, undeserved promotions of FDA officers and concessions, cancellations of stringent orders or withholding of mandatory prosecutions of accordance with the provision of the Act against the licenses viz. Manufacturers and repackers etc. "Former Health Ministers Baliram Hiray and Govind Sarnayak, present health Minister Bhai Sawant, former Chief Minister Shivji Rao Patil Nilangekar, wer all hauled before the Commission for their interference in the working of the FDA, Pramila Tople, another former health Minister was hauled for her role in transferring Commissioner N.C. Venkatachalam, an upright officer who had been brought to set things right at the FDA. Shalinitai Patil, another former Health Minister was criticized for her role in cancelling the transfer orders of Asst. Commissioner S.M. Dolas, who spent 20 out of 28 years in Bombay when transfers are mandatory after every 3 years.

The working of FDA approved Quality Control Labs
The working of FDA approved laboratory like Chem-Med and Apex (the latter issued a clean chit for manmitol supplied to J.J. Hospital which subsequently was found to be substandard.) was another scandal. The Commission exposed both laboratories were guilty of issuing bogus reports. Chem-Med had four or five previous violations and by law should have been shut long ago. But it continued to flourish under FDA protection Chem-Med’s owner explained in Court that wining and dining of FDA officials and giving them presents was routine.

The Report and Afterwards
The report was finally tabled in the Legislative Assembly on March 30 after a High Court direction to the government. This put an end to the Government’s dilly - dallying regarding tabling the report. As an outcome of the Commission, some people may be punished and some cosmetic changes made. Unless major overhauling takes place, all the efforts would be wasted.
The findings of the Commission wre unpalatable in certain quarters. Bhai Sawant resigend from the government three weeks before publication of the findings saying, the Commission has drawn unpermissible conclusions. He also accused it of impeaching a minister and of being predetermined to find all guilty.
In a unique show of solidarity MLA’s from the opposition and the ruling party have joined hands, in criticising the Commission’s findings regrding the politicians role in the whole affair. A notice of breach of privilege was raised against Justice Lentin by an opposition MLA. All these point as an effort to shift attention from the main issue at hand. The rot which has set in the public health care system and drugs administration.

What the Lentin Commission has been able to
In short what the Lentin Commission has exposed is well summed up in the foreward of its report, which says, "These pages describe and illustrate the ugly facets of the human mind and human nature, projecting errors of judgement misuse of ministerial power and authority, apathy towrds human life, corruption, Nexus and quid pro quo between unscrupulous license holders, analytical laboratories elements in the industries department controlling the award of rate contracts, manufacturers, traders, merchants, suppliers, the Food and Drugs Administration and persons holding ministerial rank."

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