The Delhi high court on Tuesday granted bail to S Eswara Reddy, the top officer at the drug regulatory agency of India, more than two months after his arrest in a bribery case.
Reddy, the joint drug controller who is now suspended, was arrested on June 21 after the Central Bureau of Investigation (CBI) caught him with a middleman while allegedly receiving Rs 4 lakh of the total promised bribe of Rs 9 lakh for waiving clinical trials of Biocon Biologics’ Insulin Aspart, an injection which is at the centre of the controversy.
Reddy was arrested along with the associate vice-president of Biocon Biologics L. Praveen Kumar and three others.
A bench of Justice Anu Malhotra noted that the charge sheet was already filed and an investigation into the matter was completed. According to the judgment copy, seen by News18.com, the bail has been granted on the basis of no “flight risks”. It noted that although the offence alleged is grave, the trial in the matter would take ample time.
The court noted that “the applicants through the record appear to have roots in society”.
It also said that despite the allegation that Reddy took the bribe to pass an order in favour of Biocon Biologics to waive the phase 3 clinical trial of the insulin injection, the waiver hasn’t been granted yet.
“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)… 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 ARGUMENTS
The argument raised by Reddy, mentioned in the judgment copy, was that “he is neither the part of the SEC nor the final authority to approve the content of the minutes of the meeting of the SEC…”
The court held that it cannot be “overlooked” that “the SEC 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 India…”
“…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…”
The argument submitted by Reddy further added 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.
And so far, the court observed that “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.”
The court also took notice of Rule 101 of the New Drugs and Clinical Trial Rules, 2019.
The rule says: “The Central Licencing Authority, with the approval of the Central Government, may specify, by an order, the name of the countries, from time to time, for considering waiver of the local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V.”
Reddy has argued that this rule is essential to be considered. He said that “the medicine in question has already been launched by Biocon and had undergone Phase I clinical trial in Germany and Phase III trial in the 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…”
Hence, he mentions that “ the aspects which merit consideration” are that it was the 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” as alleged.
Reddy, who has served as a drug controller general of India for almost a year at the CDSCO, has been suspended by the ministry of health and family welfare until further orders. He has also served as the drug controller general of India (DCGI) — the chief of CDSCO — from February 2018 to August 2019.
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