Govt sets record straight, gives Biocon’s insulin drug an all-clear

R-human insulin is a fiercely competitive Rs 250-crore market, currently dominated by three players, Wockhardt, Eli Lily and Novo Novartis. In anticipation of an Indian player entering the market, drug prices have already dipped 40%.

These new drugs have been cleared by both the Genetic Engineering Approval Committee (GEAC) and the Drugs Controller of India. GEAC is the apex body in the country for clearing genetically modified organisms.

But the NGO has alleged that there were deaths during Shantha Biotech’s clinical trials to which the Centre ‘‘turned a blind eye.’’

Wrong, says Biotechnology Secretary R Bhan. Since the trials involved terminally ill cancer patients, he told The Indian Express, the number of deaths have to be compared to deaths in the group not being given the drug (placebo). There were no ‘‘(statistically) significantly higher deaths,’’ he said. In fact, the Government’s affidavit says: ‘‘The overall mortality in the clinical study is significantly less than international norms.’’

As for the NGO’s charge that Biocon went ahead with clinical trials without GEAC’s approval, chairman Kiran Mazumdar Shaw said: ‘‘At that point, the guidelines at the Department of Biotechnology (DBT) said we need not go to the GEAC if the end-product is a protein. It’s only later that DBT clarified that the revised guidelines were not notified.’’ Calling the allegations ‘‘baseless, misleading and (meant) to create a fear in the public about the safety of (our) products,’’ Shaw said that Biocon had even posted the clinical trial results on its website. Secretary Bhan said that the fact that Biocon didn’t approach the GEAC was, at worst, a ‘‘procedural lapse,’’ but there was ‘‘no harm done’’ as clinical trials are cleared by the Drug Controller General of India (DGCI).

According to him, there was no ‘‘deliberate lapse’’ but some ‘‘ambiguity’’ in the guidelines issued by the government then. And anyway, according to the GEAC’s new guidelines notified now, Biocon need not go to GEAC for clinical trials. The GEAC will only be concerned with Living Micro Organisms and not drugs.