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This is an archive article published on September 25, 2004

SC declines to stay Biocon trials, admits PIL but asks who’s funding this petition

The Supreme Court today admitted a PIL seeking proper guidelines on drug clinical trials but refused to grant an injunction against Bangalor...

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The Supreme Court today admitted a PIL seeking proper guidelines on drug clinical trials but refused to grant an injunction against Bangalore-based Biocon India Ltd’s clinical trials on diabetic patients.

The PIL filed by Adar Destitute and Old Age Home — an investigation by The Indian Express had proved the dubious antecedents of this Mumbai-based NGO — alleges that Biocon and Shantha Biotech were allowed by the Government to go ahead with trials of their diabetes and cancer drugs violating norms.

The Government, however, gave both companies an all-clear, saying that the lapse, if any, was purely ‘‘procedural’’ because of some confusing guidelines.

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In the Supreme Court today, a bench comprising Justice N Santosh Hegde, Justice S B Sinha and Justice C K Thakker admitted the PIL but asked counsel Mukul Rohatgi as to who was funding it and for what purpose.

The counsel said the issue the petitioner had raised was important as it involved human lives. He suggested that if the court wanted, it could throw out the petitioner and appoint an amicus curiae in its place.

But the bench admitted the petition, despite objections from the pharmaceutical firms, saying ‘‘the petition pertains to lives of human beings and cannot be thrown out just like that.’’

The Centre admitted that some deaths did occur but this did not call for a stop on all clinical trials.

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The Union Ministry of Environment and Forests on Monday filed an affidavit in the apex court stating that the Centre had complied with all the provisions of notified rules for the manufacture, use, import/export and storage of hazardous micro-organisms/genetically engineered organisms or cells. The rules have been in force since 1993, the affidavit stated.

The affidavit also stated that Biocon had obtained the approval of all the competent authorities under the Drugs & Cosmetics Rules to undertake clinical tests of r-human insulin to cure diabetes.

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