Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Tuesday, August 05, 2008

GSK's Second Hand Drugs

Thanks to The Truthman for sending me this story.

Yet another example of 'misconduct' by GSK perhaps?

SOURCE

A story by Arun Bhatia [Arun Bhatia is a retired I.A.S officer and has served as Commissioner, Food and Drug Administration.]

In India, applying the due process of law to a powerful individual or institution is seen as confrontation because governance is feudal, though garbed in democratic jargon. The establishment will not support an officer who wants to go all the way in applying the law unless there are vested interests equally powerful on the other side who wish to use the law to settle scores. In this playing field the official remains a glorified puppet.

Inspecting the Glaxo factory and then attempting to punish the company for a gross violation of the prescribed and established procedures and rules, demonstrated arbitrary governance, misuse of authority and protection given to the company by abruptly and prematurely dislodging the Commissioner, Food and Drugs Administration, by a sudden and unjust transfer. I was then the F.D.A. Commissioner.

Few people know that I was transferred in the midst of the inspection of the second Glaxo factory at Nasik. Just a few days after that inspection commenced I was removed from the post! I had only completed about a year.

Action against three drug companies was taken for violating safety regulations, enabling recycling and sale of spurious drugs etc. The companies were Glaxo India Ltd., German Remedies and Boots India. Of these, Glaxo opted to flex its muscles. German Remedies were charged with selling drugs using raw materials whose expiry dates were over. The company's licenses for two drugs were cancelled - Testoviron and Ultralan.The charge against Glaxo was that it had violated codified rules and procedures and not destroyed the waste from the Bombay factory. Consequently the contractor for lifting waste received labels, packaging material and packed medicines which he used for marketing spurious/rejected drugs. This spurious drug business extended up to Agra. Also Glaxo could not fully account for the sale of drugs. The Glaxo case had been detected before I came but no action against the company had been taken. Closure of the factory for ten days was therefore ordered. Glaxo appealed the High Court against the closure of the factory and made typical and false allegations that I had a grudge against the company, that my action in ordering the inspection was not bona fide etc. I was not even allowed to remain in the post to defend myself against these charges.

Yes, the system will say it is impartial and the successor in office will handle the defence. This is not true. I can give numerous examples of transfers made in order to protect powerful interests. Successors are brought in precisely to change the course of events. Glaxo lost in the High Court. The court upheld my bona fide performance of duty but have a look at the following points:

(a) The Chief Minister and the Chief Secretary should explain to the public why the Commissioner was transferred. The physical event may be over but the question of accountability remains alive.

(b) The findings of the inspection of the Nasik factory of Glaxo should be made public and provided to the press.

(c) What was the action taken against the Glaxo officials who did not Bureaucratic Travails corporate crimes destroy the material before handing it over to the contractor.

(d) I had asked for action to be taken against an official in the F.D.A. laboratory for corruption. The Government ignored the report. My report and the explanation of the Health Secretary should be made public. This was not connected with the Glaxo case. The laboratory which tests drug samples is the heart of the F.D.A. If this limb of the FDA becomes corrupted, the monitoring of the drug market by the FDA will become a façade.

(e) Justice Shah of the High Court wrote, "I am satisfied that Mr. Bhatia acted honestly and in the interest of the department". But what about the defamation that had already taken place. One magazine reported that Glaxo had stated that Bhatia had done this for publicity etc. The Government should have contradicted this and lodged defamation proceedings against Glaxo to defend its officers. It is common for corruption fighters to be classified as publicity seekers or mentally imbalanced.

(f) Glaxo had also lodged a civil case for compensation. Fearful that the giant would launch personal attacks to redeem its reputation and claim massive compensation and the system had already indicated its displeasure by transferring me, the fact that the transfer was made while the second inspection was in progress was not divulged to the public. Normally an inspection takes a few weeks


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