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Fix Drug Approval System: Bribery Charges Need To Be Proved, But An Overhaul Of Mechanism Is Required Urgently

Fix Drug Approval System: Bribery Charges Need To Be Proved, But An Overhaul Of Mechanism Is Required Urgently

The Central Bureau of Investigation’s (CBI) decision to arrest the Joint Drugs Controller on charges of receiving a bribe to waive the phase three clinical trial of an insulin injection again brings into focus the poor state of the Indian drug approval mechanism. Though they are just charges at this point, they are serious enough to merit attention. Strong accusations have been made against a high-ranking regulatory official and a reputed company like Biocon Biologics, a subsidiary of Biocon. CBI claims it has got enough evidence for the arrests under IPC sections of criminal conspiracy and corruption for bypassing regulatory processes and manipulating the minutes of the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO), which actually considered the case. On its part, Biocon has denied the allegations of bribery and said it adopts global best practices in corporate governance and business responsibility. The entire application process, Biocon said, is online, and all meeting minutes can be found on the website of the CDSCO.

The truth must be found, and the CBI must provide enough evidence for the charges leveled against all the accused, as there are much bigger stakes here. The Indian pharmaceutical industry is the world’s third-largest by volume and 14th largest by value. Its image is linked with that of Brand India. It would be unfair to blame the entire industry, which has generally been carrying out globally benchmarked practices, but the misdemeanours of a few can have a damaging impact.

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There have been several instances of the shady practices of some in the industry and in the regulatory system. The example of Ranbaxy is still fresh in memory. One of India’s biggest drug manufacturers at the time, Ranbaxy pleaded…

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