CBI’s Allegation Of Changing Of Word “Data” To “Protocol” Baseless, Submits Arrested Biocon Official In Court

Biocon Biologics Ltd’s (BBL) regulatory affairs official who was arrested by the Central Bureau of Investigation


New Delhi : Biocon Biologics Ltd’s (BBL) regulatory affairs official who was arrested by the Central Bureau of Investigation (CBI) on an alleged bribery case submitted to the Delhi High Court that the investigating agency’s allegation against Dr S Eswara Reddy, joint drug controller, Central Drug Standard Control Organisation (CDSCO) that he has changed the word “data” to “protocol” in the minutes of Subject Expert Committee (SEC) for alleged wrongful gain for the company, is baseless.

According to the regulation, only protocol has to be provided and no clinical trial data required for the drug and there was no question of changing the word “data” to “protocol”, it said.

The submission was made during the hearing of an appeal filed by the CBI against an order by a lower court refusing police custody remand of the five accused in the alleged bribery case, for four days. The High Court, hearing all the arguments, allowed police custody remand of L Praveen Kumar, associate vice president and head-national regulatory affairs (NRA), Biocon Biologics till July 6, while denying further police custody remand for the four other accused including Reddy.

Biocon Biologics has vehemently and repeatedly denied the allegations of bribery against the company and its officials associated with the approval process of Insulin Aspart injection.

On behalf of Praveen Kumar, it was urged in front of the Single Judge of Delhi High Court, that the allegations against him are wholly erroneous.

As regards the allegations against Reddy, that “data” was changed to “protocol”, the same is baseless in as much as the drugs approved outside India which had suffered clinical trials in view of Para 8.3.1. under Similar Biologics Guidelines 2016 , need not suffer clinical trial again and again in India and thus there is an exemption of phase-III and this exemption is on the basis that no clinical trial ‘data’ is required to be provided for such an already approved drug, argued the official.

On behalf of the company official, it was further urged that the medicine in question has already been launched by the BBL and has undergone phase I trial in Germany and phase II trial in USA and the drug had been granted marketing authorization by EMA and Health Canada and thus it was a case of a launch of an approved drug and only protocol had to be provided and there was no question of change of the word “data” to “protocol”.

The Delhi High Court, in an order on June 4, rejected CBI’s appeal seeking Reddy, Sethi, Dua and Animesh Kumar under police custody for four more days, as it is apparent from the Special Judge’s (CBI) order that ample opportunities had been granted to the CBI to conduct the interrogation of these accused and as it is still open to the CBI to conduct further interrogation of these accused persons and confront them with documents are well as the electronic devices even during their being incarcerated in judicial custody after moving and seeking such permission from the Magistrate concerned.

However, as regards Praveen Kumar, it observed that the accused was produced before the Court on June 22 after having been brought on transit remand in the night of June 21, on which date he was remanded to judicial custody at 5.45 pm. The Special Judge’s direction was to produce all the accused persons before the court at 11 am. The High Court observed that the CBI court’s observation that the CBI had ample opportunity to interrogate Kumar cannot be accepted.

The Court ordered Superintendent Jail, Delhi to hand over the custody of Kumar to the investigating officer till July 6, on which date the investigating officer shall ensure production of Kumar before the competent Court concerned by 12 pm, where after the competent court concerned shall pass appropriate orders in accordance with law, ordered Justice Anu Malhotra.

It may be noted that the CBI has arrested four persons including Dr S Eswara Reddy, joint drug controller, India; Guljit Sethi, director, Bioinnovat Research Services Pvt Ltd; Dinesh Dua, directors, Synergy Network India Pvt Ltd; L Praveen Kumar, associate vice president and head-national regulatory affairs (NRA), Biocon Biologics Ltd, Bengaluru on July 20 for alleged bribery of the CDSCO officials for favourable orders. On July 21, Animesh Kumar, assistant drug inspector, CDSCO, was also arrested in the same case. Case was charged against unknown officers of CDSCO.

According to CBI’s allegation, Reddy, who was dealing with processing of files related to applications for approval of drugs and vaccines by various pharmaceutical companies, received three files of BBL, including one file related to waiver of phase III clinical trial of Insulin Aspart Injection for processing and approval.

CBI accused that Reddy, in criminal conspiracy with co-accused persons and other unknown officers of CDSCO, manipulated minutes of the meeting of Subject Expert Committee including the third file of Biocon Biologics in the SEC meeting on June 15, 2022, which resulted into wrongful gain to Biocon Biologics.

The Agency further alleged that as per the investigation conducted so far, it had been revealed that Guljit Sethi was acting as a conduit on behalf of pharmaceutical companies including Biocon Biologics and had delivered/arranged huge bribe amounts for senior officers of CDSCO on different occasions for processing their respective files favorably.

Praveen Kumar had agreed to pay an undue pecuniary advantage of Rs. 9 lakh as motive/reward to Reddy for processing his file favourably. Based on the information, CBI laid a trap on June 20 and during the trap proceedings, Reddy and Dua were caught red-handed with a bribe amount of Rs. 4 lakh, alleged CBI.

The four persons arrested from Delhi were produced before the Vacation Judge of CBI Court, on June 21 and the Court observed that one day, instead of five days requested by the CBI, was sufficient for police custody remand. Praveen Kumar, who was arrested in Bengaluru and moved to Delhi following Court orders, was produced at the CBI Court on June 22. Though the CBI sought four day’s custody of all the five accused persons, the Court refused the application.

The CBI approached the High Court against this order. The CBI submitted the High Court in its appeal that the investigation of the case is still at its initial stage with it having been submitted by the CBI that the accused persons are to be confronted with one another as also with the incriminating documents, Intercepted conversations and data contained in electronic devices for the just investigation of the case.

It argued that the matter is of serious concern related to public health and safety, requires deeper investigation and to unearth the larger conspiracy, hence further police custody of accused persons is required. In the event of the police custody remand of the accused persons not being given to the petitioner, the CBI, the investigation would be hampered which would have a debilitating impact on the public health system and the safety of the citizens.

The respondents have submitted that the prayer made by the CBI seeking extension of police custody remand is only in the hope of extracting some admission of guilt from the accused persons which is contrary to the spirit of the law enshrined in Article 20 (3) of the Constitution of India, interrogation of the accused persons and confrontation of documents and electronic evidence to the accused persons by the CBI can certainly be made even when the accused are in judicial custody.


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