For Quality, Essential, Generic Medicines
Chapter 4: Drug Marketing  
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Lentin Commission Report

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.

 

State of the Country

Will quality be enhanced by appointing more drug inspectors and other functionaries? Or will it be a conduit for greater earnings for more inspectors and functionaries? Is quality a function of just more drug bureaucrats or the moral state of a society? Would not overall quality in generics as well as branded products improve if manufacturers and retailers were ethical in production and marketing?

In its foreword to the report, the Lentin Commission said: These pages describe and illustrate the ugly facets of the human mind and human nature, projecting errors of judgment, misuse of ministerial power and authority, apathy towards 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.

 

EP Drug

High-dose estrogen-progesterone (EP) combination drugs contain the same female sex hormones as the combined oral contraceptive pill but at a higher level. These drugs were used in 1950s as a treatment for missed periods since they were thought to start menstruation in women whose periods were delayed and who were not pregnant. A woman whose periods did not start after taking EP drugs was presumed to be pregnant, and hence EP drugs were used for pregnancy testing. But because the drug could apparently bring on menstruation, EP drugs were misused to induce abortion. Although no pharmaceutical company has ever claimed that these drugs will induce abortion, there was evidence in India that they were prescribed by doctors for this purpose and were also sold over the counter. About 20 years later research uncovered evidence that the EP drugs were unreliable as pregnancy tests and ineffective as treatment for missed periods. In fact evidence showed that the drugs were associated with birth defects. Those women who used this drug for pregnancy testing and continued with their pregnancy exposed their unborn babies to the possibility of birth defects. Those women who took the drug to induce abortion but did not abort, also ran the same risk, Many countries began to withdraw this drug since 1970. In India the drug was used for a variety of disorders and by 1982, an estimated 180,000 were using the drug each year. The Indian health and consumer groups launched a campaign for the withdrawal of this drug and as a result a warning was added in the drug information insert," Not to be used for pregnancy test and suspected cases of pregnancy". In June 1992, the Drug Controller of India banned the manufacture of all EP formulations effective from 31 December 1982, and its sale from 30 June 1983. The ban was severely criticised because though it was considered hazardous enough to be banned, yet it was allowed to be sold for another six months simply so the stocks would finish. However two pharmaceutical companies Unichem and Nicholas contested the ban. Infar, the Indian subsidiary of the Dutch pharmaceutical company, Organon, which is not allowed to manufacture and sell the product in its home country, filed a petition against the ban. Their arguments covered various aspects of the ban: the legalities, drug misuse, hazards and medical details. As a result in January 1983, a stay order against the ban and a two-year extension of the product license was granted by the Calcutta and Bombay High Courts on legal technicalities. The ban was thus effectively stalled by the stay order. This meant that till the case came up for trial, the hazardous drugs could be manufactured and sold in the country. Appalled by this decision, various health and consumer organisations continued the campaign (see Case study of "A Successful Campaign" in Chapter 5) and after five years of relentless struggle, they succeeded when in 1988, the Indian government banned the manufacture and sale of high-dose combination of EP "containing per tablet estrogen content of more than 50 micrograms and of progesterone content of more than 30 milligrams". This judgment is particularly welcome when safer alternatives and non-drug methods for pregnancy testing are available in the country.

       
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