New Delhi : Joint Drug Controller, Dr. S. Eswara Reddy who was arrested day before yesterday for accepting bribe had simply changed the word ‘Data’ to ‘Protocol’ in the recommendations, consequently, causing a substantial wrongful gain to M/S Bicon Biologics Limited of Banglore.
An FIR lodged by Anti Corruption Bureau wing of CBI, New Delhi in this connection says further that the functions of CDSCO (Central Drugs Standard Control Organisation) includes approval of new drugs, conduct of clinical trials and laying down the standards for Drugs among other responsibilities.
The FIR further says that it was revealed that Dr.S. Eswara Reddy, Jt. Drug Controller of India at the headquarter of CDSCO at New Delhi has been dealing with processing of files related to applications for approval of drugs and vaccines by several Pharma Companies. So, three files related to M/S Biocon Biologics Limited including one that was related to waiver of Phase-3 Clinical Trial of ‘Insulin Aspart Injection’ was sent to Dr. Reddy for processing and approval.
As per reliable sources, Mr. Guljit Sethi alias Guljit Chaudhari, Director, M/S Bionnovat Research Services Private Limited located at Delhi has been handling the Government Regulatory works related to M/S Biocon Biologics Limited located at Bangalore and at the same time one Dinesh Dua had business relationship with the said Guljit Sethi. It had also been revealed to CBI that Sethi was acting as acting as conduit on behalf of several pharmaceutical companies and he was playing major role in settling bribe related issues related different companies through Dinesh Dua and others for luring CDSCO officers on several occasions for processing the files favorably.
CBI has found through sources that Guljit Sethi, Director of M/S Bionnovat Research Services Private Limited located in Delhi has conspired with one L. Praveen Kumar, Associate Vice President and Head-National Regulatory Affairs (NRA) and others executives of the same company to pay amount worth Rs.9,00,000 to Dr. Reddy for favorably processing the three files along with one file related to ‘Insulin Aspart Injection’ for favorable recommendation by Subject Expert Committee (SEC) of which meeting was that was held on 18th of this June. As per information revealed to CBI, Dr. Reddy, Jt. Director Drug Controller had supported the company during the meeting for waiver of Phase-3 for the ‘Insulin Aspart Injection’ a drug of Biocon Biologics Limited. In the meeting Dr. Reddy manipulated the minutes of meeting of SEC held on 18th Jun. by changing the word ‘Data’ to ‘Protocol’ in recommendations that caused a wrongful gain to company namely Bicon Biologics Limited.
Meanwhile, it has been informed by CBI that yesterday Dr. Reddy was produced before the concerned CBI special court and it had remanded him to one day CBI custody. One official of CBI told that today CBI would produce him again in court but till filing of this report no information has been received regarding his production in the court.
