The Central Bureau of Investigation (CBI) said that senior officials of the Central Drugs Standards Control Organisation (CDSCO) not only colluded with Bengaluru-based pharma company Biocon Biologics to favourably approve their proposals, but also ‘manipulated’ the minutes of the subject expert committee (SEC) meeting causing ‘substantial wrongful gain’ to Biocon Biologics.
India’s joint drugs controller Eswara Reddy was arrested on Tuesday by the investigating agency along with L Praveen Kumar, associate vice president and head, national regulatory affairs (NRA), Biocon Biologics by the CBI. Guljit Sethi (alias Guljit Chaudhary), Bioinnovat Research Services and Dinesh Dua, director, Synergy Network – both of whom acted as ‘conduits’ on behalf of pharma companies – were arrested along with assistant drug inspector, CDSCO Animesh Kumar.
CBI sources informed that all five will be presented in court on Tuesday afternoon and that the agency will seek police custody.
In a statement Biocon Biologics said, “We strongly deny the allegations of bribery against the Company and its officials associated with the approval process of one of our products in India.”
The CBI has alleged that Sethi, who has been handling government regulatory work for Biocon Biologics, conspired with Praveen Kumar and some other senior executives of the company to pay a sum of Rs 9 lakh as bribe to Reddy. The money was offered to favourably recommend the file of insulin Aspart injection to the SEC meeting on May 18, for waiving off the phase 3 clinical trials, the agency has said.
Insulin Aspart is already approved in the EU. While drug regulators of various countries at times approve drugs based on approvals already received in regulated markets, at times they also seek local clinical trial data. Local trials are usually conducted to evaluate and understand the tolerability and effectiveness of the drug on the local demographic.
In its FIR, the CBI has said that Reddy had attended the SEC meeting on May 18, and had also supported the waiver. Not only that, the agency goes on to add that Reddy ‘manipulated’ the minutes of the SEC meeting held that day by changing some key-words like replacing ‘data’ with ‘protocol’, thereby giving ‘substantial wrongful gain’ to the company.
Three files of Biocon Biologics, including one related to waiver of phase 3 clinical trials, was referred to him for processing and approval. The agency was acting on inputs it received that Reddy has been dealing and processing files related to applications for drug approvals and vaccines by various pharmaceutical companies.
In fact, Sethi was acting on behalf of several pharmaceutical companies and delivering bribes to various senior CDSCO officials through Dua on various occasions.
In the case of Biocon, Sethi conspired with Kumar and other CDSCO officials to include the Biocon Biologics file for the SEC meeting held on June 15, and Kumar received a bribe of Rs 30,000 for the same, the CBI FIR noted.
It added that Reddy met Dua in the CDSCO office on June 15 in connection with the approval of the third file that was during the SEC meeting that day. CBI said that Reddy assured Dua of a favourable outcome. Later in the day, Kumar informed Sethi that the file had been approved in the SEC meeting.
The FIR further states that Reddy shared his ‘new’ residential address at Chanakyapuri with Dua and asked him to meet over the weekend. Kumar agreed to pay Rs 9 lakh to Reddy, and Sethi arranged for part of the agreed bribe amount to be delivered to Reddy at his residence on June 20.
The CBI said that these acts by the people named above prima facie disclose criminal conspiracy, cheating and forgery and thus a case has been registered against them.
BOX: Biocon Biologics says SEC recommendation according to Regulatory guidelines
Biocon Biologics not only denied allegations of bribery, but said that the rationale for waiver of Phase 3 clinical trials was based on Indian regulatory guidance.
The company said that its product approvals are backed by science and clinical data. The rationale for waiver of phase 3 trials was based on Similar Biologics Guidelines 2016 & New Drugs and Clinical Trials 2019.
“The guidelines provide a framework for waiver of Phase 3 clinical trials to be conducted in India based on a commitment to undertake a Phase 4 trial, the design of which should be approved by the Central Licencing Authority. In line with the above regulations, Biocon Biologics presented a proposal for import and marketing of Insulin Aspart with a waiver of Phase 3 clinical trial in India,” the company said.
It added that it presented a detailed proposal along with pre-clinical and clinical trial data.
The Subject Expert Committee (Endocrinology and Metabolism) in its meeting held on May 18, at CDSCO, New Delhi, noted that Biocon Biologics has conducted Phase 1 and Phase 3 trials with Aspart in Germany and USA, respectively, and based on the results of this global trial, Biocon Biologics’ product, Aspart, has been granted marketing authorization by EMA and Health Canada, Biocon Biologics claimed.
“Due regulatory process followed for all our product approvals Biocon Biologics follows due regulatory process for all our product approvals by the DCGI. The entire application process in India is online and all meeting minutes can be found on the website of the Central Drugs Standard Control Organization (CDSCO),” it added.
The company said that it condemns all acts of corruption and bribery and is cooperating with the investigating agency.