For Quality, Essential, Generic Medicines
Chapter 4: Drug Marketing    
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* The Maharashtra FDA had ordered the closure of German Remedies at Andheri East in Bombay for 15 days from October 25 to November 8, 1993 for failing to observe the "Good Manufacturing Practices" and maintain the quality, purity and strength of its drugs. The company was also found not to be maintaining proper records about rejected drugs and their destruction.
*

Glaxo Laboratories in India was penalised on several occasions for the production of sub-standard drugs. They include:

  -

discovery of a dead mosquito in Macraberin injection ampoule;

  - in May 1986, the Madhya Pradesh Drug Controller found Becadexamin capsules to "fail in disintegration time". When confronted, Glaxo reduced the drug's shelf-life from 18 months to 12 months, and thereafter to nine months;
  -

in 1988, the Haryana Drug Controller found that the contents of Otina ear drops was less than the quantity mentioned on the label;

  -

in February 1989, the Chandigarh Drug Controller issued a show-cause notice to the company to explain why the salicylic acid contained in Codopyrin tablets was more than the specified limit (23).

 
Landmark Judgments in Unethical Marketing of Hazardous Drugs

SMON Tragedy in Japan

Clioquinol, a widely used, over-the-counter drug for the treatment of traveller's diarrhoea is marketed as Mexaform, Entero-Vioform, Enter-Quinol, etc. However there is very little evidence that it is effective against this disorder. In fact it is known to cause subacute myelo-optic neuropathy (SMON), a serious side-effect affecting the nervous system, causing damage to the spinal cords and the nerves, including the optic nerve.

In 1970s, approximately 11,000 Japanese were victims of SMON. When it was clearly established that SMON was caused by the drug clioquinol, they undertook legal action against the drug company, Ciba- Geigy, which has its headquarters in Basel, Switzerland.

SMON litigation began in May 1971 in Tokyo. Ciba-Geigy responded with the statement, "the SMON problem is a peculiarly Japanese one and they there not responsible to Japanese patients". However Ciba-Geigy was responsible because it is a multinational company and Ciba-Geigy (Japan) is its subsidiary. The head office is 100 per cent stockholder of the Japanese subsidiary and Mr. Planta, the president of Ciba-Geigy in Basel is the director of Ciba-Geigy (Japan).

A world-wide study, undertaken by the International Organization of Consumers Unions, of

clioquinol, its brand names and information accompanying the drug, found that vast differences in drug information. Ciba-Geigy's Entero-Vioform manufactured in Switzerland, as sold there and as exported to Greece, Portugal, Kenya, South Africa, Hong Kong, Malaysia and Singapore, limited the maximum dosage to 750 mg, listed the four main contraindications - hyperthyroidism, iodine allergy and impaired liver or kidney function; mentioned the side effects - peripheral and optic neuritis and warning to stop the drug at the first signs of abnormal sensations and visual disturbances. However, when exported from Switzerland to Thailand and Indonesia the instructions specified a maximum dose of 1500 mg, omitted malfunctioning of liver or kidneys from the list of contraindications and failed to warn the user to stop the drug at the first signs of neuritis. Similarly, Entero-Vioform manufactured in U.K., as sold there and as exported to Bahamas, Belize, and New Zealand limited the course of treatment to a total of 3 g (1000 mg for 3 days). On the other hand, when exported to Tanzania their instructions specified a maximum of 15 g. Tanzanians now get their Entero-Vioform from Switzerland, with a maximum course of treatment for chronic diarrhoea specified as 21 g. Why Ciba Geigy maintained different sets of cautionary information for different countries could be explained because drug regulatory authorities in some countries did not require manufacturers to conform to guidelines concerning the use of clioquinol. All the same this double standard on the part of Ciba-Geigy is unconscionable.

As Ciba-Geigy continued to market clioquinol inspite of known hazards and doubtful hazards, 3000 Swedish doctors boycotted Ciba-Geigy products, causing the company to lose 25% of its market in Sweden.

In August 1978, the Tokyo District Court ruled in favour of the SMON victims and ordered Ciba-Geigy to make a settlement which will adequately compensate for their sufferings and to submit an apology to the SMON victims. The Court noted:

"The Ciba Geigy head office in Basel investigated reports that dogs given Entero-Vioform or Mexaform often developed epileptic seizures and died, and the company circulated a warning among veterinarians not to use these drugs in veterinary treatment. However, although 'these drugs were produced for human use', they not only did not take any measures to warn about the dangers of use by humans, but also, they continued to stress thereafter the safety of Entero-Vioform and Mexaform and Mexaform in Japan, which can be considered deplorable.

"If Ciba Geigy had taken the appropriate measures at that time, it is probable that the suffering of most or at least a considerable number of SMON patients could have been avoided. Under such conditions, this must be considered as a matter of deep regret with respect to the Defendant Ciba-Geigy."

Ciba Geigy in its written apology states "... [the plaintiffs'] grievances were all earnest expressions of their pain, distress, and anger; appeals were made for redress. They were heart rending cries that made us realize anew that SMON has caused the patients and their families unimaginable suffering...In view of the fact that medical products manufactured and sold by us have been responsible for the occurrence of this tragedy in Japan, we extend our apologies, frankly and without reservation to the Plaintiffs and their families... We have also realized, with regret, that when recently asked the court to act as mediator we neglected to adequately express our sincerity. Again, we deeply apologise to the plaintiffs and their families." (24)

       
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