Dr. L. Praveen Kumar vs Central Bureau Of Investigation on 6 September, 2022

[Cites 20, Cited by 1]

Delhi High Court

Dr. L. Praveen Kumar vs Central Bureau Of Investigation on 6 September, 2022

1. The applications filed by Dr. L. Praveen Kumar, Dinesh Dua and S. Eswara Reddy i.e. BAIL APPLN. 2202/2022, BAIL APPLN. Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 2 of 35 PS to HMJ ANU MALHOTRA.

2290/2022 & BAIL APPLN. 2262/2022 respectively are taken up together, in as much as, all the three applicants seek the grant of bail in relation to FIR No. RC0032022A0037 dated 19.06.2022 filed by the CBI/(ACB) Delhi under Sections 120B/420/468/471 of the Indian Penal Code, 1860 and Sections 7/7A/8 of the PC Act, 1988. The applicants, through their respective applications submit that they have been falsely implicated in the case.

2. The status report of the CBI in BAIL APPLN. 2202/2022 dated 26.07.2022 and status reports of the CBI in BAIL APPLN. 2290/2022 and BAIL APPLN. 2262/2022 dated 06.08.2022 are premised on the same facts.

3. The version put forth by the CBI is to the effect that the FIR/RC bearing case no. RC0032022A0037, CBI, ACB, Delhi was registered by Respondent/CBI on 19.06.2022 on the basis of source information against:

(1) Sh. S. Eswara Reddy, Joint Drug Controller (JDC), India at Head Quarter, CDSCO, New Delhi (applicant of BAIL APPLN. 2262/2022), (2) Ms. Guljit Sethi @ Guljit Chaudhri, Director M/s Bioinnovat Research Services Private Limited, Delhi; (3) Sh. Dinesh Dua, Director, M/s Synergy Network India Private Limited, Delhi (applicant of BAIL APPLN. 2290/2022); (4) Sh. L. Praveen Kumar, Associate Vice President and Head-

National Regulatory Affairs (NRA), M/s Biocon Biologics Limited, Bangalore (applicant of BAIL APPLN. 2202/2022);

Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 3 of 35 PS to HMJ ANU MALHOTRA.

(5) Sh. Animesh Kumar, Assistant Drug Inspector (ADI), CDSCO, New Delhi and other unknown officials of CDSCO, New Delhi for the alleged commission of offences punishable under Sections 7, 7A, 8 of PC Act, 1988 and under Sections 120-B, 420, 468 and 471 of Indian Penal Code, 1860.

4. It is submitted by the CBI through the status report dated 26.07.2022 that it had been alleged in the FIR that the accused Dr. S Eswara Reddy, Joint Drug Controller, India, Head Quarter, Central Drugs Standard Control Organisation (CDSCO), New Delhi (applicant of BAIL APPLN. 2262/2022) was dealing with the processing of files related to applications for approval of drugs and vaccines by various pharma companies and in relation thereto, he received three files of M/s Biocon Biologics Limited, Bangalore including one file related to waiver of Phase-III, Clinical trial of "Insulin Aspart Injection" for processing and approval and that a bribe amount of Rs. 30,000/- was paid by the accused Guljit Sethi to Animesh Kumar, Assistant Drug Inspector (ADI) for processing the file.

5. It is stated through the status report that the accused S. Eswara Reddy (applicant of BAIL APPLN. 2262/2022) in alleged criminal conspiracy with co-accused persons and other unknown officers of CDSCO, had manipulated minutes of meeting of Subject Expert Committee dated 18.05.2022 and further included the aforesaid third file of M/s Biocon Biologics Limited, Bangalore in SEC meeting on 15.06.2022 which resulted in wrongful gain to M/s Biocon Biologics Limited, Bangalore. It was also submitted through the said status report that the investigation conducted till then revealed that Guljit Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 4 of 35 PS to HMJ ANU MALHOTRA.

Sethi was acting as a conduit on behalf of pharmaceutical companies including above-mentioned Pharma companies and had delivered/ arranged huge bribe amounts for senior officers of CDSCO on different occasions for processing their respective files favorably and that the source revealed that Dr. L. Praveen Kumar (applicant of BAIL APPLN. 2202/2022) Associate Vice President and Head-National Regulatory Affairs (NRA), M/s Biocon Biologics Limited, Bangalore had agreed to pay an undue pecuniary advantage of Rs 9,00,000/- (Rupees Nine Lacs) as motive/reward to Dr. S. Eswara Reddy, Joint Drug Controller, CDSCO, New Delhi (applicant of BAIL APPLN. 2262/2022) for processing his file favorably and that the source further revealed that Guljit Sethi directed Dinesh Dua (applicant of BAIL APPLN. 2290/2022) to pay a part of the agreed amount to Dr. S. Eswara Reddy at his residence on 20.06.2022.

6. It is stated further through the status report that on the basis of the said information, a trap was laid on 20.06.2022 and during the trap proceedings, Dr. S. Eswara Reddy and Dinesh Dua were caught red- handed with a bribe amount of Rs.4,00,000/- (Rupees Four Lacs), whereafter, searches were conducted at the residential premises of Dr. S. Eswara Reddy at D-II, 235, Vinay Marg, Chanakya Puri, New Delhi, of Dinesh Dua at A-103, Narang Colony, Janak Puri, New Delhi, of Guljit Sethi at A-1/17, Safdarjung Enclave, New Delhi, of Animesh Kumar at J-803, Skytech Mattrot, Sector - 76, Noida, Flat No. 202, Brindeshwar Enclave, Road no. 5, Indira Puri, Patna and of Dr. L. Praveen Kumar at C-403, Hinduja Lake, Front Estate, Cave Temple Road, Hulimavu, Bengaluru.

7. It is stated through the status report further that searches were also conducted at the office premises of the aforesaid accused persons and various incriminating articles and documents related to the case were seized from the residential and office premises of the accused persons and that consequent to the trap proceedings, Dr. S. Eswara Reddy, Joint Drug Controller (India), CDSCO, Head Quarter, New Delhi, Dinesh Dua, Director, M/s Synergy Network India Private Limited, Delhi, Guljit Sethi @ Guljit Choudhri, Director of M/s Bioinnovat Research Services Private Limited, Delhi were arrested on 20.06.2022 whilst Animesh Kumar, Assistant Drug Inspector (ADI), CDSCO, New Delhi was arrested on 21.06.2022 and Dr. L. Praveen Kumar was arrested on 20.06.2022 at Bengaluru and was produced before the concerned competent Court of ACMM at Bengaluru on 21.06.2022, whereby, transit remand was granted from Bengaluru to Delhi and he was produced before the Vacation Judge, CBI-19 (PC Act), Rouse Avenue Courts, New Delhi on 22.06.2022.

8. The CBI has alleged to the effect that credible information had been received that Dr. L. Praveen Kumar had conspired with other co- accused Guljit Sethi to pay Rs. 09 Lacs to the CDSCO officials for getting favour in matters of Biocon Biologicals Limited pertaining to 03 files including one file related to waiver of phase-III clinical trial of „Insulin Aspart‟ injection pending in CDSCO and in furtherance of this conspiracy, Rs. 04 Lacs was delivered to the accused Shri S. Eswara Reddy on 20.06.2022.

9. Inter alia, the CBI submitted that Dr. L. Praveen Kumar was holding a very senior position in M/s Biocon Biologics Limited, with Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 6 of 35 PS to HMJ ANU MALHOTRA.

an authority within his office. The CBI further submitted that there was sufficient evidence that Dr. L. Praveen Kumar had committed the offence in pursuance of a criminal conspiracy and that in a case of conspiracy, the evidence against a particular accused has to be read against the co-accused as well and that the evidence of recovery during the proceedings in Delhi from the co-accused which is also an evidence against Dr. L. Praveen Kumar and there are other evidences including the telephonic conversation of Dr. L. Praveen Kumar with the co-accused which clearly established his involvement in the commission of the offence and also that the bribe amount was being paid in connivance with him and with his consent.

10. It is further submitted by the CBI that in the "Whatsapp" chat with the co-accused, Dr. L. Praveen Kumar had suggested that the word "data" be changed to "protocol" as was subsequently done in the Minutes of Meeting of the Subject Expert Committee (SEC) held on 18.05.2022 and that there were other corroborative evidence against Dr. L. Praveen Kumar.

11. Inter alia, the CBI has submitted that the matter has huge implications qua the health standards of the country which are being compromised by the accused persons by indulging in a conspiracy with each other and the applicants are involved in a serious economic offence with serious implications over the health standard and the economy of the country. Inter alia, the CBI submitted that the offence was committed with a cool calculation and deliberate design with an eye on personal profit regardless of the consequences to the community and that the present case constitutes a class apart and Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 7 of 35 PS to HMJ ANU MALHOTRA.

needs to be visited with a different approach in the matter of bail in view of the serious economic and health implications in the matter pursuant to a deep-rooted conspiracy which has necessarily to be viewed seriously.

12. The CBI has submitted that M/s Biocon Biologics Limited was the ultimate beneficiary of the favorable recommendation and Dr. L. Praveen Kumar was taking care of the application and approval process from the CDSCO and that he was the prime conspirator in the huge money transaction which took place on his behalf.

13. The status report dated 06.08.2022 that has been submitted under the signatures of the Inspector of Police, CBI, ACB, New Delhi in BAIL APPLN. 2290/2022 qua the applicant named Dinesh Dua apart from reiterating the submissions made in the status reports in BAIL APPLN. 2202/2022 and BAIL APPLN. 2262/2022, it has been submitted by the CBI that in pursuance of the conspiracy between Dr. L. Praveen Kumar, Guljit Sethi to pay Rs. 9 Lakhs to CDSCO officials for getting favors with M/s Biocon Biologics Limited, Bangalore pertaining to 03 files including one file related to waiver of phase-III clinical trial of „Insulin Aspart‟ injection pending in CDSCO, Rs. 04 Lacs was delivered by the applicant- Dinesh Dua (applicant of BAIL APPLN. 2290/2022) to the accused Shri S. Eswara Reddy on 20.06.2022 and that Dinesh Dua, the accused was caught red handed and was arrested and that apart from the recovery of the bribe amount during the trap proceedings in Delhi from the co-accused, there was other evidence including telephonic conversation of Dinesh Dua with the co-accused which clearly established his involvement in the Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 8 of 35 PS to HMJ ANU MALHOTRA.

commission of the offence and that the investigation had revealed that in telephonic conversation with the co-accused, Dinesh Dua had agreed to deliver the bribe amount with the public servant in view of a favour extended by him to M/s Biocon Biologics Limited, Bangalore and that the role of Dinesh Dua could not be ignored, in as much as, he had played a very important role in the delivery of the bribe amount on behalf of other accused so that M/s Biocon Biologics Limited, Bangalore gets a favorable recommendation from the CDSCO and that Dinesh Dua was the prime conspirator in a huge money transaction where he delivered the bribe money to the accused.

14. During the pendency of the present applications, the charge sheet dated 18.08.2022 has since been filed by the CBI, copy of which has been placed on the record by the CBI which indicates that it has been filed against Sh. S. Eswara Reddy, Joint Drug Controller (JDC), India at Head Quarter, CDSCO, New Delhi (applicant of BAIL APPLN. 2262/2022) (A-1), Ms. Guljit Sethi @ Guljit Chaudhri, Director, M/s Bioinnovat Research Services Private Limited, Delhi (A-2); Sh. Dinesh Dua, Director, M/s Synergy Network India Private Limited, Delhi (applicant of BAIL APPLN. 2290/2022) (A-3); Sh. L. Praveen Kumar, Associate Vice President and Head-National Regulatory Affairs (NRA), M/s Biocon Biologics Limited, Bangalore (applicant of BAIL APPLN. 2202/2022) (A-4); Sh. Animesh Kumar, Assistant Drug Inspector (ADI), CDSCO, New Delhi (A-5).

15. As per the investigation conducted by the CBI, the CBI as put forth through the charge sheet, it has been submitted that the investigation revealed that Sh. S. Eswara Reddy (Al) (applicant of Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 9 of 35 PS to HMJ ANU MALHOTRA.

BAIL APPLN. 2262/2022) who was posted as Joint Drug Controller in Biological Division of the office of the Drug Controller General of India (DCGI), Central Drug Standard Control Organisation (CDSCO) (HQ), FDA Bhawan, New Delhi since 2014 and was the head of the Biological Division; that Sh. Animesh Kumar (A2) was working as an Assistant Drug Inspector in Biological Division of CDSCO (HQ) since February 2017; that Sh. Dinesh Dua (A3) (applicant of BAIL APPLN. 2290/2022) was a Marketing Consultant in Synergy Networks Pvt. Ltd and was known to Sh. S. Eswara Reddy and Ms. Guljit Sethi; Ms. Guljit Sethi @ Guljit Chaudhri (A4), Managing Director, M/s Bioinnovat Research Service Pvt. Ltd. who was a consultant for various pharmaceutical companies and looked after the regulatory affairs of all such companies and charged retainer fee as well as project fee also for the same. Inter alia, it was stated through the charge sheet that she also pursued the regulatory matters of M/s BBL as consultant and that Sh. L. Praveen Kumar @ Praveen Kumar Lakshminarayana (A5) was the Associate Vice President in M/s Biocon Biologics Ltd. (hereinafter called as M/s BBL) since 17.01.2022 and was the Head of National Regulatory Affairs of M/s BBL.

16. It has been stated further through the charge sheet that investigation revealed that an application dated 10.01.2022 was received in the office of the DCGI, Delhi from M/s BBL vide which the said company had requested for pre-submission meeting prior to submission of an application in form CT-18 for the grant of permission to import Insulin Aspart Bulk and its formulations (vials, Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 10 of 35 PS to HMJ ANU MALHOTRA.

pre-filled pens and cartridges) and that the company had requested the DCGI to provide guidance to proceed with the application for permission to import and market Insulin Aspart Bulk and its formulations with waiver of local clinical trial and that the company had specifically mentioned the waiver of phase-III clinical trial in its application. The said application is stated to have been reviewed by Sh. Chinmay Patel, Drug Inspector and after taking replies from M/s BBL regarding certain queries, the proposal of M/s BBL was taken up during the SEC (Subject Expert Committee) meeting dated 17.03.2022 wherein it was recommended that the firm i.e. M/s Biocon Biologics Limited would be required to generate the safety and efficacy data on the Indian Population alongwith other requirements as per guidelines on similar Biologics and the said recommendation was communicated to M/s BBL vide letter dated 05.04.2022.

17. It has further been stated through the charge sheet that the investigation revealed that on 19.04.2022, M/s BBL submitted 04 applications online in CDSCO SUGAM portal with the following application numbers in respect of drug namely 'Insulin Aspart':-

1. BIO/CT18/FF/2022/31689-Vial.

2. BIO/CT18/FF/2022/31691-Pre-filled pens.

3. BIO/CT18/FF/2022/29555-Bulk.

4. BIO/CT18/FF/2022/31694-Cartridges.

and that vide all the aforesaid applications, M/s BBL had requested the CDSCO for granting the permission to import and market the drug namely Insulin Aspart and the company had also requested for waiver of local clinical trial on the basis of already generated clinical data. Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 11 of 35 PS to HMJ ANU MALHOTRA.

18. It is stated through the charge sheet that the investigation revealed that on 19.04.2022, the details of the aforesaid applications were shared by Shri L Praveen Kumar (A5) with Ms. Guljit Sethi (A4) in a whatsapp chat and that the investigation revealed that the aforesaid applications were marked by Shri Jayant Gangakhedkar, Assistant Drug Controller (ADC), the Nodal Officer to the reviewing officers namely Shri Chinmay Patel, DI; Sh. Animesh Kumar (A2), ADI and Shri Navin Yadav, DI (02 applications-Bulk and Cartridges) respectively on 20.04.2022.

19. It is stated further through the charge sheet that the investigation revealed that on 13.05.2022, Ms. Guljit (A4) shared the invitation letter dated 13.05.2022 (Proposal of M/s BBL was not included in this), sent by CDSCO to the experts regarding the SEC meeting scheduled to take place on 18.05.2022, with Shri L Praveen Kumar (A5) on whatsapp after which the following chat is stated to have taken place between Ms. Guljit (A4) and Dr. L. Praveen Kumar (A5) (applicant of BAIL APPLN. 2202/2022) of them:

"A-4 Guljit-have to make the invite happen A-5 L Praveen Kumar- Yeah Guljit. Please discuss with Dr. Reddy (A1) and get it included. A-4 Guljit-DI has to process These are older app Will do A-5 L Praveen Kumar-Ok Thanks, Guljit."

20. It is stated further through the charge sheet to the effect that thereafter, an email dated 16.05.2022 was sent by Ms. Amita Nawani, M/s BBL to CDSCO requesting therein for inclusion of the Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 12 of 35 PS to HMJ ANU MALHOTRA.

applications related to Insulin Aspart in the upcoming SEC dated 18.05.2022.

21. It is stated through the charge sheet further that on receipt of the said email on 17.05.2022, Shri S. Eswara Reddy (A1) directed Shri Jayant Gangakhedkar to include the agenda of M/s BBL in the upcoming SEC i.e. SEC meeting 18.05.2022 and on the same day i.e. Shri Jayant Gangakhedkar directed Shri Animesh Kumar, ADI (A2) to put up the proposal for sending the same to the SEC division for including the agenda of M/s BBL as additional agenda in the SEC Meeting dated 18.05.2022 and as directed by Shri Jayant Gangakhedkar, Sh. Animesh Kumar, Assistant Drug Inspector (A2) put up the said proposal on 17.05.2022 and marked the same to Sh. Jayant Gangakhedkar, ADC who further marked the proposal to Shri A.K. Pradhan, Joint Drug Controller, SEC Division, CDSCO and thereafter the invitation letter dated 17.05.2022 was sent to the experts mentioning the agenda of M/s BBL.

22. The charge sheet further states that as per investigation conducted, it was revealed that on 17.05.2022, Ms. Guljit (A4) had following conversation with Shri L.Praveen Kumar (A5):-

"A-4 Guljit- Am At DCGI working on Insulin Aspart...... You should receive the SEC invite for tomorrow..... Have prepared Dr Reddy (A1) for the same."

23. The charge sheet states that investigation further revealed that thereafter, Shri L Praveen Kumar (A5) shared with Ms. Guljit (A4) an invitation letter dated 17.05.2022, sent by CDSCO to the experts regarding the additional agenda of M/s Biocon Biologics Limited in Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 13 of 35 PS to HMJ ANU MALHOTRA.

respect of Insulin Aspart for inclusion of same in SEC meeting scheduled to take place on 18.05.2022 and on 18.05.2022, the applications of M/s BBL were taken up in SEC meeting and during the said meeting, Shri S.Eswara Reddy (A1) (applicant of Bail Appl. No.2262/2022) was present online through Webex and the draft recommendations of the meeting pertaining to biological division were prepared by Shri Animesh Kumar, ADI (A2) and that the said draft recommendation prepared by Shri Animesh Kumar, ADI (A2) on 18.05.2022, in respect of M/s BBL's applications was stated in the charge sheet to be to the effect:-

"After detailed deliberation, the committee recommended for grant of permission to import and market the drug with waiver of Phase 3 clinical trial in the country with the condition that firm shall conduct Phase 4 clinical trial in India (which also includes a sub-set population to generate PK/PD and immunogenicity and submit the 'data' to this office before placing the drug in the market) as per existing guidelines in the country."

24. The charge sheet states that as per the investigation conducted, it was revealed that on 18.05.2022, Dr. L. Praveen Kumar (A5) (applicant of BAIL APPLN. 2202/2022) on whatsapp requested Ms. Guljit (A4) to check with Animesh (A2) regarding draft SEC minutes and to share and the investigation revealed that on 19.05.2022, the whatsapp chat that took place between Shri L Praveen Kumar (A5) and Ms. Guljit (A4) is as under:-

Guljit Firm presented proposal for import and marketing the drug with waiver of Phase 3 trial in the country. (A4) The firm presented detailed proposal alongwith CMC, pre-clinical and clinical trial data. The committee Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 14 of 35 PS to HMJ ANU MALHOTRA.

noted that, firm has conducted Phase 1 and Phase 3 trial with the drug in Germany and USA respectively and based on the results of the trial, the drug has been granted marketing authorization by EMA and Health Canada. After detailed deliberation, the committee recommended for grant of permission to Import and market the drug with waiver of Phase 3 clinical trial in the country with a condition that firm shall conduct Phase 4 clinical trial in India (which also includes a sub-set population to generate PK/PD and immunogenicity and submit the data to this office before placing the drug in market) as per existing guidelines in the country.

                                        Highly confidential
                                        Even the time was set up at 310 pm

                               L        Thanks Guljit
                            Praveen
                            Kumar       "and submit the data to this office before placing the
                             (A5)       drug in market"

means cannot launch the product until Phase IV trial is completed & data submitted to CDSCO? Which is like Phase III trial, we should try to see whether It can get modified as follows:

.....firm shall conduct Phase 4 clinical trial in India (which also includes a sub-set population to generate PK/PD and Immunogenicity and *get the protocol approved by* this office before placing the drug In market) as per existing guidelines in the country.

25. The charge sheet states further that the investigation revealed that on 20.05.2022, Sh. Animesh Kumar, ADI, (A2) got modified the draft recommendations dated 18.05.2022 and substituted the word „data' to 'protocol in the draft recommendations pertaining to M/s BBL as per directions of Shri S. Eswara Reddy (A1) and thereafter, draft recommendation pertaining to the aforesaid meeting was finally Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 15 of 35 PS to HMJ ANU MALHOTRA.

got approved by SEC members on 23.05.2022, which is stated to be as follows:

"After detailed deliberation, the committee recommended for grant of permission to import and market the drug with waiver of Phase III clinical trial In the country with the condition that firm should conduct Phase IV clinical trial in India (which also includes a sub-set population to generate PK/PD and immunogenicity and submit the 'protocol' to CDSCO before placing the drug in the market) as per existing guidelines in the country."

26. It is stated through the charge sheet that the investigation revealed that the draft recommendations dated 18.05.2022 were modified by substituting the word from 'data' to 'protocol' to favour the company M/s BBL and that the investigation revealed that the telephonic conversations dated 18.05.2022, 19.05.2022, 15.06.2022, 19.06.2022 & 20.06.2022 between Ms. Guljit Sethi, Shri L. Praveen Kumar (A5), Shri Animesh Kumar (A2) and Shri Dinesh Dua (A3) have established that 50% of undue advantage of Rs. 09 Lakhs was agreed by L.Praveen Kumar (A5) to be paid to Shri S.Eswara Reddy (A1) and that the investigation further established that Ms. Guljit (A4) handed over Rs. 5 Lakhs as undue advantage to Shri Dinesh Dua (A3) on 20.06.2022 for handing over the same to Shri S.Eswara Reddy (A1) and on 20.06.2022, a trap team comprising of Sh. Sanjay Malhotra, (TLO/Inspector) and other CBI staff from the CBI, ACB, Delhi along with independent witnesses reached near the residence of Shri S.Eswara Reddy @ Sanapa Reddy (A1) situated at D-II/235, Vinay Marg, Chanakyapuri, New Delhi at about 6.35 AM and took suitable Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 16 of 35 PS to HMJ ANU MALHOTRA.

position and the TLO Shri Sanjay Malhotra was informed by the source that Sh. Dinesh Dua (A3) would come to the residence of Sh. Eswara Reddy @ Sanapa Reddy (A1) to handover the bribe amount of Rs.5 lakhs to Sh. Eswara Reddy @ Sanapa Reddy (Al) as undue advantage in return of favour done by Sh. Eswara Reddy @ Sanapa Reddy (A1) in facilitation of the work of the company named M/s Biocon Biologics Limited.

27. The charge sheet states that the investigation revealed that at about 09.00 AM, Shri Dinesh Dua (A3) reached at the residence of Sh. Eswara Reddy @ Sanapa Reddy (A1) in a Toyota Innova car of a Metallic Grey Colour and on alighting from the same, entered through the main gate carrying a white coloured bag in his hand into the residence of Sh. Eswara Reddy @ Sanapa Reddy (A1) and at 9.30 AM, Sh. Dinesh Dua (A3) came out from the main gate of the residential premises of Sh. Eswara Reddy @ Sanapa Reddy (A1) without the bag and immediately thereafter, all the team members rushed towards the main gate of the residence of Sh. Eswara Reddy @ Sanapa Reddy (A1) and intercepted Sh. Dinesh Dua (A3) outside the main gate. It is stated further through the charge sheet that the investigation revealed that after disclosing the identity of the CBI team, Sh. Dinesh Dua (A3) was challenged by the TLO Shri Sanjay Malhotra that he had given undue advantage of Rs.5 Lakhs to Sh. Eswara Reddy @ Sanapa Reddy on which he got perplexed and kept mum and he was enquired about the white coloured bag which he was carrying while entering into the residence of Sh. Eswara Reddy @ Sanapa Reddy (A1), upon which he admitted to have kept the same, Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 17 of 35 PS to HMJ ANU MALHOTRA.

on a chair which was placed in the sit-out of the residence of Sh. Eswara Reddy @ Sanapa Reddy (Al).

28. The charge sheet states that thereafter the CBI team along with both independent witnesses Shri V. Vignesh & Shri C Satyamoorthi and Sh. Dinesh Dua (A3) entered into the residential premises of Sh. Eswara Reddy @ Sanapa Reddy (Al) who was standing inside the lawn of his residence, the CBI team apprehended him after disclosing its identity and the TLO Shri Sanjay Malhotra challenged Shri S.Eswara Reddy (A1) of having demanded and accepted an undue advantage of Rs.5 lakhs from Sh. Dinesh Dua (A3) upon which Sh. Eswara Reddy @ Sanapa Reddy (Al) became perplexed and kept mum and thereafter, Sh. Dinesh Dua (A3) pointed out towards one chair made up of bamboo placed in the sit out of the said residence on which the white coloured bag was kept, which on directions of the TLO, Sh. V. Vignesh, the independent witness checked and found within the said white coloured bag, a black coloured cloth bag and a transparent plastic bag and on the black color cloth bag "KAREN MILLEN" was written which was opened by independent witness Sh. V. Vignesh on the directions of the TLO and from the same, eight bundles of Indian currency notes having denomination of Rs.500/- which were counted by both the independent witnesses which were found to be total amounting to Rs. 4,00,000/- (Rs.500X800) and the said recovered amount of Rs.4 lakhs was kept in the same black coloured cloth bag from which it was recovered and the said black coloured cloth bag was signed by the TLO and both the independent witnesses and thereafter, the said black coloured cloth bag containing Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 18 of 35 PS to HMJ ANU MALHOTRA.

Rs.4 Lakhs was kept in a Yellow colour envelope and sealed with the CBI brass seal and marked as "Trap Money in RC-37(A)/2022".

29. It is further stated through the charge sheet that the investigation further revealed that when the independent witness opened the transparent plastic bag on which 'Christina' was written, he found one painting wrapped in yellow coloured paper, one paper was found on the backside of the painting on which it was written 'Warlukurlangu Artist of Yuendumu' and the paper found on the backside of the painting which was signed by the TLO and both the independent witnesses and it was also sealed in a white cloth parcel with the CBI brass seal.

30. It is further stated through the charge sheet that the investigation revealed that on personal search of Sh. Dinesh Dua (A3) by the independent witness, a bundle of Indian Currencies totalling to Rs.1 lakh, out of which Rs. 98,000/- were in the denomination of Rs. 2,000/- and remaining amount of Rs. 2,000/- were in the denomination of Rs. 500/-, was recovered from the left side front pocket of Sh. Dinesh Dua‟s pant. The said bundle of Indian Currency notes amounting to Rs.1 lakh was kept in a brown coloured envelope, sealed using the CBI brass seal and marked as "Money recovered from Dinesh Dua in RC 37(A)/2022."

31. It has been further stated through the charge sheet that the investigation established that the accused Shri L. Praveen Kumar (A3), National Regulatory Head, M/s Biocon Biologics Limited had the duty to look after all the regulatory issues of his company and for the regulatory work pertaining to drug namely Insulin Aspart, he had Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 19 of 35 PS to HMJ ANU MALHOTRA.

engaged Ms. Guljit Sethi @ Guljit Chaudhri (A4) who was pursuing the applications filed by M/s BBL in CDSCO and that the investigation has also established that Shri Animesh Kumar (A2) and Shri S.Eswara Reddy (Al) were instrumental in putting the agenda pertaining to M/s BBL in SEC meeting dated 18.05.2022 and during the SEC meeting also, Shri S.Eswara Reddy (Al) played an important role in getting favour for the company M/s BBL and that after completion of the SEC, the draft minutes were also got amended by Shri S.Eswara Reddy (Al) and Shri Animesh Kumar (A2) to favour the company. It has further been stated through the charge sheet that the investigation further revealed that Dinesh Dua (A3) in connivance with Ms. Guljit Sethi @ Guljit Chaudhri (A4) and Shri L. Praveen Kumar (A3), delivered Rs.04 Lakh as undue advantage to Shri S.Eswara Reddy (Al) for favouring the company M/s BBL in the matter of Insulin Aspart.

32. The CBI further submits thus, that the accused Shri S.Eswara Reddy (A1), Shri Animesh Kumar (A2), Shri Dinesh Dua (A3), Ms. Guljit Sethi (A4) & Shri L.Praveen Kumar (A5) entered into a criminal conspiracy with each other, the purpose of which was to favour M/s BBL in terms as mentioned above and in lieu of such favour, the bribe was to be given to accused Shri S.Eswara Reddy (A1) and in pursuance of the said criminal conspiracy, the accused Shri S. Eswara Reddy (A1) in connivance with other co-accused persons, favored M/s BBL and accordingly Shri S.Eswara Reddy (A1) accepted the bribe amount of Rs.04 Lacs from Shri Dinesh Dua (A3) at his residence on 20.06.2022 and during the transaction, the accused Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 20 of 35 PS to HMJ ANU MALHOTRA.

Shri S.Eswara Reddy (A1) & Shri Dinesh Dua (A3) were apprehended and the amount of Rs. 04 Lakhs was recovered and that further, a sum of Rs.01 Lakh was also recovered from the physical possession of Shri Dinesh Dua (A3) (which was also part of bribe amount of Rs. 05 Lakh) and as such all the said accused persons committed the offence.

33. It has been stated through the charge sheet that the accused persons had committed the offences punishable u/s 120-B IPC r/w Section 7, 7A & 8 of the PC Act, 1988 (as amended in 2018) on the part of Sh. S. Eswara Reddy @ Sanapa Reddy (A1), Shri Animesh Kumar (A2), Shri Dinesh Dua (A3), Ms. Guljit Sethi @ Guljit Chaudhri (A4) & Sh. L. Praveen Kumar @ Praveen Kumar Lakshminarayana (A5) and further constituted the substantive offence punishable under Section 7 of PC Act 1988 (as amended in 2018) on the part of Sh. S. Eswara Reddy @ Sanapa Reddy (A1), under Section 7A of PC Act 1988 (as amended in 2018) on the part of Shri Dinesh Dua (A3) and under Section 8 of PC Act 1988 (as amended in 2018) on the part of Ms. Guljit Sethi @ Guljit Chaudhri (A4) & Sh. L. Praveen Kumar @ Praveen Kumar Lakshminarayana (A5) and that the sanction order qua the accused Sh. S. Eswara Reddy @ Sanapa Reddy (A1), Joint Drug Controller, CDSCO (HQ), New Delhi and Shri Animesh Kumar (A2), Assistant Drug Inspector, CDSCO (HQ) are awaited from the concerned department and that the further investigation with respect to other allegations as alleged in the FIR and the favour done to M/s BBL in respect of other drugs, analysis of digital evidences, obtaining expert opinion from CFSL regarding Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 21 of 35 PS to HMJ ANU MALHOTRA.

voice sample analysis and also on certain other aspects that cropped up during investigation in the case, is still continuing.

34. The CBI has also submitted on record the rough transcript of calls between L. Praveen Kumar (the applicant of Bail Appln. No. 2202/2022) and Guljit Sethito contend to the effect that L. Praveen Kumar, Guljit Sethi, Animesh Kumar and Dinesh Dua, were all involved in conspiring to put forth the amount of Rs.9 lakhs as bribe money to Dr.S.Eswara Reddy to enable him to change the word "Data" to "Protocol" so that the launch of the product "Insulin Aspart" in India was made without the Phase-III clinical trial in the country. During the stage when the application were being heard the fulcrum of opposition on behalf of the CBI was that the applicant could influence the investigation and tamper with the evidence being in influential positions. As has been observed elsewhere herein above, the charge sheet in relation to RC No. RC0032022A0037 has already been filed.

35. Though undoubtedly during the course of submissions made on behalf of the accused L.Praveen Kumar, the applicant of Bail Appln. No 2202/2022, reliance was sought to be placed on the verdict of the Hon‟ble Supreme Court in Satender Kumar Antil V. CBI: 2022 SCC OnLine SC 825 and Arnesh Kumar v. State of Bihar & Anr. (2014) 8 SCC 273, it is essential to observe that as rightly contended by the CBI that in this instant case, the CBI prima facie had information and suspicion of commission of cognizable offences by the applicants as a consequence of which issuance of the notice under Section 41A of the Cr.P.C., 1973, was not required and all that was required was the Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 22 of 35 PS to HMJ ANU MALHOTRA.

recording of reasons whilst making arrest of the applicants in terms of Section 41(1)(b) thereafter which reads to the effect:

"41. When police may arrest without warrant.--

1. Any police officer may without an order from a Magistrate and without a warrant, arrest any person-

(a) .......

(b) against whom a reasonable complaint has been made, or credible information has been received, or a reasonable suspicion exists that he has committed a cognizable offence punishable with imprisonment for a term which may be less than seven years or which may extend to seven years whether with or without fine, if the following conditions are satisfied, namely:--

(i) the police officer has reason to believe on the basis of such complaint, information, or suspicion that such person has committed the said offence;

(ii) the police officer is satisfied that such arrest is necessary--

(a) to prevent such person from committing any further offence; or

(b) for proper investigation of the offence; or

(c) to prevent such person from causing the evidence of the offence to disappear or tampering with such evidence in any manner; or

(d) to prevent such person from making any inducement, threat or promise to any person acquainted with the facts of the case so as to dissuade him from disclosing such facts to the Court or to the police officer; or Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 23 of 35 PS to HMJ ANU MALHOTRA.

(e) as unless such person is arrested, his presence in the Court whenever required cannot be ensured, and the police officer shall record while making such arrest, his reasons in writing:

Provided that a police officer shall, in all cases where the arrest of a person is not required under the provisions of this sub-section, record the reasons in writing for not making the arrest." Thus, the arrest of the applicants in the instant case cannot be faulted with.

36. Reliance was placed on behalf of the applicant Dinesh Dua, the applicant of Bail Appln. No. 2290/2022, inter alia on the verdict of the Hon‟ble Supreme Court in Sushila Aggarwal V. the State of NCT; (2020) 5 SCC 1which relates to the aspect of anticipatory bail and is de hors the issue involved in the present bail application. Reliance was also placed on behalf of the applicant Dinesh Dua on the verdict of the Co-ordinate Bench of this Court in CBI V. Devendra Jain; 2022 SCC OnLine Delhi 588 on observations in paragraphs 26, 27 and 29 thereof which read to the effect:-

"26. It was contended on behalf of the petitioner that the accused/Akil Ahmad was habitual of demanding bribe from contractors and so, there is a larger conspiracy involved which needs to be unearthed. But till date, no other material besides what is already part of case records has been placed on record to substantiate the allegation.

27. Notably, one of the grounds of challenge of the impugned order is that sustained custodial interrogation of the respondent is required, so he may be confronted with co-accused persons, including Uma Soni. However, this Court is of the Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 24 of 35 PS to HMJ ANU MALHOTRA.

opinion that in view of the role assigned to the respondent and in the absence of any other material to substantiate the allegations levelled, the ground raised is without any merit.

28. ........

29. Keeping in view the foregoing, this Court is of the view that the order granting bail does not suffer from any kind of perversity. No ground is made out to cancel the bail granted to the respondent. However, to ensure the respondent's availability during the trial, it is directed that in addition to the bail conditions imposed by the Court below, the respondent shall also surrender his Passport with the concerned Investigating Officer/CBI official within a period of 01 week from the date of this judgment."

to contend to the effect that where no material has been collected by the Investigating Agency to unearth the alleged larger conspiracy involved in the matter, the same is no ground to negate the grant of bail to the applicant.

37. Reliance was also placed on behalf of the applicant Dinesh Dua on the verdict of the Hon‟ble Supreme Court in Satender Kumar Antil V. CBI; 2022 OnLine SCC 825 on the observations in paragraphs 66 and 67 thereof which read to the effect:-

"66. What is left for us now to discuss are the economic offences. The question for consideration is whether it should be treated as a class of its own or otherwise. This issue has already been dealt with by this Court in the case of P. Chidambaram v. Directorate of Enforcement, (2020) 13 SCC 791, after taking note of the earlier decisions governing the field. The gravity of the offence, the object of the Special Act, and the attending circumstances Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 25 of 35 PS to HMJ ANU MALHOTRA.

are a few of the factors to be taken note of, along with the period of sentence. After all, an economic offence cannot be classified as such, as it may involve various activities and may differ from one case to another. Therefore, it is not advisable on the part of the court to categorise all the offences into one group and deny bail on that basis. Suffice it to state that law, as laid down in the following judgments, will govern the field:--

Precedents • P. Chidambaram v. Directorate of Enforcement, (2020) 13 SCC 791: 23. Thus, from cumulative perusal of the judgments cited on either side including the one rendered by the Constitution Bench of this Court, it could be deduced that the basic jurisprudence relating to bail remains the same inasmuch as the grant of bail is the rule and refusal is the exception so as to ensure that the accused has the opportunity of securing fair trial.

However, while considering the same the gravity of the offence is an aspect which is required to be kept in view by the Court. The gravity for the said purpose will have to be gathered from the facts and circumstances arising in each case. Keeping in view the consequences that would befall on the society in cases of financial irregularities, it has been held that even economic offences would fall under the category of "grave offence" and in such circumstance while considering the application for bail in such matters, the Court will have to deal with the same, being sensitive to the nature of allegation made against the accused. One of the circumstances to consider the gravity of the offence is also the term of sentence that is prescribed for the offence the accused is alleged to have committed. Such consideration with regard to the gravity of offence is a factor which Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 26 of 35 PS to HMJ ANU MALHOTRA.

is in addition to the triple test or the tripod test that would be normally applied. In that regard what is also to be kept in perspective is that even if the allegation is one of grave economic offence, it is not a rule that bail should be denied in every case since there is no such bar created in the relevant enactment passed by the legislature nor does the bail jurisprudence provide so. Therefore, the underlining conclusion is that respective of the nature and gravity of charge, the precedent of another case alone will not be the basis for either grant or refusal of bail though it may have a bearing on principle. But ultimately the consideration will have to be on case-to case basis on the facts involved therein and securing the presence of the accused to stand trial.

(emphasis supplied) • Sanjay Chandra v. CBI, (2012) 1 SCC 40:

"39. Coming back to the facts of the present case, both the courts have refused the request for grant of bail on two grounds : the primary ground is that the offence alleged against the accused persons is very serious involving deeprooted planning in which, huge financial loss is caused to the State exchequer; the secondary ground is that of the possibility of the accused persons tampering with the witnesses. In the present case, the charge is that of cheating and dishonestly inducing delivery of property and forgery for the purpose of cheating using as genuine a forged document. The punishment for the offence is imprisonment for a term which may extend to seven years. It is, no doubt, true that the nature of the charge may be relevant, but at the same time, the punishment to which the party may be liable, if convicted, also bears upon the issue. Therefore, in determining Signature whether to grant bail, both the seriousness of the Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 27 of 35 PS to HMJ ANU MALHOTRA.

charge and the severity of the punishment should be taken into consideration.

40. The grant or refusal to grant bail lies within the discretion of the court. The grant or denial is regulated, to a large extent, by the facts and circumstances of each particular case. But at the same time, right to bail is not to be denied merely because of the sentiments of the community against the accused. The primary purposes of bail in a criminal case are to relieve the accused of imprisonment, to relieve the State of the burden of keeping him, pending the trial, and at the same time, to keep the accused constructively in the custody of the court, whether before or after conviction, to assure that he will submit to the jurisdiction of the court and be in attendance thereon whenever his presence is required.

xxx xxx xxx

46. We are conscious of the fact that the accused are charged with economic offences of huge magnitude. We are also conscious of the fact that the offences alleged, if proved, may jeopardise the economy of the country. At the same time, we cannot lose sight of the fact that the investigating agency has already completed investigation and the charge-sheet is already filed before the Special Judge, CBI, New Delhi. Therefore, their presence in the custody may not be necessary for further investigation. We are of the view that the appellants are entitled to the grant of bail pending trial on stringent conditions in order to ally the apprehension expressed by CBI."

(emphasis supplied) ROLE OF THE COURT Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 28 of 35 PS to HMJ ANU MALHOTRA.

67. The rate of conviction in criminal cases in India is abysmally low. It appears to us that this factor weighs on the mind of the Court while deciding the bail applications in a negative sense. Courts tend to think that the possibility of a conviction being nearer to rarity, bail applications will have to be decided strictly, contrary to legal principles. We cannot mix up consideration of a bail application, which is not punitive in nature with that of a possible adjudication by way of trial. On the contrary, an ultimate acquittal with continued custody would be a case of grave injustice."

to contend to the effect that economic offences cannot be classified as a category of one group to deny bail on that basis to further submit to the effect that in view of the factum that the Investigating Agency has completed the investigation and the charge sheet has been filed, the continued incarceration of the applicants in custody is no longer required and they be released on bail pending trial on stringent conditions in order to ally the apprehension expressed by the CBI. Reliance was also placed on behalf of the applicant Dinesh Dua on the verdict of the Hon‟ble Supreme Court in "State (NCT of Delhi v Navjot Sandhu @ Afsan Guru" (2005) 11 SCC 600 to canvas the extent of culpability for a conspiracy and to submit that there is nothing to indicate that the applicant Dinesh Dua was in any manner culpable of commission of any conspiracy with the other co-accused.

38. During the course of submissions that were put forth on behalf of the CBI it has also been brought forth that the voice samples of the accused persons have also been taken.

39. On a consideration of the entire available record taking into account the factum that the charge sheet in the matter has been filed and the investigation in the matter has also been completed and voice samples of the accused persons have been taken, though undoubtedly the offence alleged to have been committed (if proved) by the applicants is grave, the trial in the matter would take ample time.

40. The applicants through the record appear to have roots in society. Further there is nothing to indicate that despite the recommendation made by the Special Expert Committee for waiver of Phase-III clinical trial in the country to M/s Biocon Biologics to import and market Insulin Aspart Injection for the treatment of the diabetic condition subject to the condition that the Phase-IV clinical trial in India would be conducted which also includes a sub-set population to generate pharmacokinetic/ pharmacodynamic (PK/PD) and immunogenicity and to submit the protocol to CDSCO before placing the drug in the market as per guidelines in the country that the said recommendation of the SEC has so far been approved and given effect to by the Drug Controller General of India of the Central Drugs Standard Control Organization. The contention raised by Dr.S.Eswara Reddy (applicant of Bail Appln. No. 2262/2022) that he is neither the part of the Subject Expert Committee nor the final authority to approve the content of the minutes of the meeting of the Subject Expert Committee and that the Subject Expert Committee consists of various outside experts of the field from various government medical colleges and hospitals which are approved by the Ministry of Health & Family Welfare, Government of Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 30 of 35 PS to HMJ ANU MALHOTRA.

India, and that the SEC after duly deliberating over the formulation and data provided by the manufacturer independently decides whether to grant the recommendation for the approval of the drug or not and the proceedings of which meeting are then reduced to draft minutes and sent to the Drugs Controller of India to the Licensing Authority for in principle checking and thereafter sending it to the members of the SEC for their approval of the minutes of the meeting, cannot be overlooked. The submission of the said applicant that it is only after the approval of the minutes of the SEC members that the minutes are published on the CDSCO website by the concerned authority has also to be taken into account for as has already been observed herein above there is nothing on the record to indicate that the approval of the recommendation of the SEC has been approved by the Drugs Controller General of India.

41. Likewise, a similar contention is raised by the applicant Dr.L.Praveen Kumar (applicant of Bail Appln. No.2202/2022) to the effect that no decision has been taken by the SEC till date and a mere recommendation was made pursuant to which multiple stages ought to follow based upon which decisions taken in these stages only an approval can be granted as thus at this stage to be taken into account for consideration of the grant or non-grant of the bail to the applicants.

42. Furthermore, the contention of the applicant Dr.S.Eswara Reddy (applicant of Bail Appln. No.2262/2022) that Rule 101 of the New Drugs and Clinical Trial Rules, 2019, which reads to the effect:

"101. Name of countries for purpose of new drug approval- The Central Licencing Authority, with the Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 31 of 35 PS to HMJ ANU MALHOTRA.

approval of the Central Government, may specify, by an order, the name of the countries, from time to time, for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V."

have essentially to be considered and that the medicine in question has already been launched by the BBL and had undergone Phase I clinical trial in Germany and Phase III trial in USA and the drug had been approved and granted marketing authorization by European Medicine Agency (EMA) and Health Canada, after enquiring its quality, safety and efficacy was only 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", are aspects which merit consideration.

43. Another aspect that cannot be overlooked is that the alleged recovery in the instant case is not pursuant to any usual trap proceedings and the consideration of credibility of circumstantial evidence would have to be assessed.

44. Another aspect which cannot be overlooked is that the alleged intercepted calls between the accused persons have to be weighed at the altar of admissibility and legality of evidence. It can also not be overlooked as laid down by the Co-ordinate Bench of this Court in Jatinder Pal Singh V. Central Bureau of Investigation; Crl.M.C. 3118/2012 a verdict dated 17.1.2022, admissibility of such evidence with mandatory requirements of compliance of Section 5 of the Indian Telegraph Act, 1885, is essential for interception of messages for the exercise of powers under Sub-Section (2) of Section 5 of the Indian Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 32 of 35 PS to HMJ ANU MALHOTRA.

Telegraph Act,1885, in the event of the occurrence of any public emergency/existence of public safety interest which are the sine qua non. Though the public health would undoubtedly amount to an issue in relation to the public emergency or the existence of a public safety interest, there is nothing presently placed on record to indicate the invocation of Section5(2) of the Indian Telegraph Act, 1885 by the CBI.

45. Section 5(2) of the Indian Telegaph Act, 1885, is as under:

" 5. Power of government to take possession of licensed telegraphs and to order interception of messages.-

(1) xxx (2) On the occurrence of any public emergency, or in the interest of the public safety, the Central Government or a State Government or any officer specially authorised in this behalf by the Central Government or a State Government may, if satisfied that it is necessary or expedient so to do in the interests of the sovereignty and integrity of India, the security of the State, friendly relations with foreign states or public order or for preventing incitement to the commission of an offence, for reasons to be recorded in writing, by order, direct that any message or class of messages to or from any person or class of persons, or relating to any particular subject, brought for transmission by or transmitted or received by any telegraph, shall not be transmitted, or shall be intercepted or detained, or shall be disclosed to the Government making the order or an officer thereof mentioned in the order:

Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 33 of 35 PS to HMJ ANU MALHOTRA.

Provided that the press messages intended to be published in India of correspondents accredited to the Central Government or a State Government shall not be intercepted or detained, unless their transmission has been prohibited under this sub-section.]

46. Furthermore, the offences alleged to have been committed by the applicants are punishable with imprisonment to a maximum of seven years of imprisonment.

47. The applicants, i.e., Dr. L. Praveen Kumar (applicant of Bail Appln. No. 2202/2022), Dinesh Dua (applicant of Bail Appln. No. 2290/2022) and S. Eswara Reddy (applicant of Bail Appln. No. 2262/2022) apparently are not flight risks and are thus allowed to be released on bail on their furnishing a personal bond in the sum of Rs.1,00,000/- each with two sureties of the like amount to the satisfaction of the Trial Court with directions:

 the applicants shall surrender their passports before the Trial Court at the time of submission of the bail bonds and surety bonds;

 the applicants shall under no circumstances leave the country,  the applicants shall appear before the Trial Court as and when directed;

 that the applicants shall keep their mobile phone on at all times and drop a pin on the Google map to ensure that their location is available to the Investigating Officer;  that the applicants shall commit no offence whatsoever during the period that they are on bail in the instant case and;  that the applicants shall make no attempt to influence the prosecution witnesses.

Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 34 of 35 PS to HMJ ANU MALHOTRA.

48. Nothing stated herein above shall however amount to any expression on the merits or demerits of the trial that may take place.

49. The Bail Appln. No. 2202/2022 along with Crl.M.(Bail) No. 885/2022, Bail Appln. No.2290/2022 with CRL.M.(BAIL) 915/2022 and Bail Appln. No.2262/2022 are disposed of accordingly.

50. The date 08.09.2022 in CRL.M.(BAIL) 915/2022 is thus, cancelled.

ANU MALHOTRA, J.

SEPTEMBER 06, 2022 Nc/sv Signature Not Verified Digitally Signed By:SUMIT GHAI Signing Date:06.09.2022 11:02:42 This file is digitally signed by Bail.Appl.No.2202/2022, 2290/2022 & 2262/2022 Page 35 of 35 PS to HMJ ANU MALHOTRA.

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Delhi High Court