Hyderabad: The CBI has registered a corruption case against a senior Central Drugs Standard Control Organisation (CDSCO) official and the managing director of a pharmaceutical company over allegations that bribes were sought and offered to secure clearances for applications linked to World Health Organisation (WHO) certification standards.A Hyderabad-based regulatory consultant is also mentioned in the FIR as an alleged intermediary in the dealings. The FIR, registered by the CBI’s anti-corruption branch, Visakhapatnam, on Aug 6, names Bikash Roy, assistant drug controller (India) at the CDSCO sub-zonal office in Visakhapatnam, and H Vikram, MD of Chennai-based Artura Pharmaceuticals Private Limited, which operates a manufacturing unit at Sri City in Andhra Pradesh. Unknown public servants and private individuals have also been named.The case was registered based on source information received by the CBI, which nominated deputy superintendent of police Pramod Kumar Tanwar as the trap laying officer.3 pharma applications pendingAccording to the FIR, Roy was responsible for handling applications related to certificate of pharmaceutical product (CPP) and WHO-good manufacturing practices (GMP) certifications for pharmaceutical companies under his jurisdiction. He was overseeing both the CDSCO sub-zonal office and sea port office in Visakhapatnam, with jurisdiction across Andhra Pradesh.The CBI alleged that three applications submitted by Artura Pharmaceuticals were pending with Roy, including two WHO-CPP applications and one application relating to an additional product.The CBI further alleged that Roy expected an “undue advantage” for processing and clearing the applications. He allegedly asked Vikram to meet him in Visakhapatnam to settle the matter and indicated that the files could be cleared without a physical inspection of the company’s premises if the payment was made.According to the source information cited in the FIR, Roy allegedly collected between Rs 30,000 and Rs 40,000 per ‘WHO file.’ He was also allegedly expecting an annual payment of Rs 50,000 for applications relating to Artura Pharmaceuticals.For the applications pending at the time, Vikram allegedly intended to pay Rs 50,000 to Roy on August 6.Hyd consultant mentionedThe FIR also refers to Sirimisetty Prasad, a Hyderabad-based consultant who handled regulatory compliance and govt-related work for pharmaceutical companies in Andhra Pradesh and Telangana.According to the CBI’s source information, Prasad allegedly informed Vikram that Roy expected an undue advantage for clearing the pending applications. However, Prasad has not been named as an accused in the case. The consultant also allegedly advised Vikram to negotiate the proposed payment for the pending applications from Rs 50,000 to Rs 30,000.The CBI alleged that the circumstances pointed to a criminal conspiracy involving the payment of bribes in return for official favours in processing pharmaceutical regulatory applications. The allegations contained in the FIR are subject to investigation.
