Pharma manufacturer Reliance Life Sciences (RLS) is under the scanner of the Food and Drugs Administration (FDA) in Maharashtra. The company has been served a show-cause notice by the FDA, after gross contraventions were detected by the regulatory authority in the company’s drug manufacturing set-up in Navi Mumbai.
A three-member FDA team found as many as 11 contraventions at the company's factory premises in the TTC Industrial Area in Rabale, Navi Mumbai. The FDA notice stated that RLS has been grossly and repeatedly contravening the law and proposed to cancel or suspend the manufacturing licence of the unit, pending explanation from the company.
The FDA swung into action after the arrest of four accused, including Dilbagh Singh, who duped RLS into buying a phony mix of egg yolk, soyabean and vegetable oil, under the name of Fresh Frozen Plasma (FFP), used by the company as a raw material to make AlbuRel, a life-saving injection. Also, Zahir Vohra, zonal in-charge of the Plasma Procurement Cell of RLS, was arrested by the Punjab police.
“The Punjab police had sought our help as the manufacturing plant is in Maharashtra. The plant was inspected to check whether it was following protocols while manufacturing drugs,” said an FDA official, requesting anonymity.
The FDA notice observes that the plasma-sourcing team of RLS has not provided training to the logistics and courier companies that it employs for collecting FFP from licensed blood banks.
“Adequate training is a must for persons who collect FFP. Also, there was an absence of separate temperature dataloggers in the cold chain facilities storing FFP, to determine the response of the package to the test condition,” explained the official.
In June this year, RLS had sent 370 empty crates for transporting 21,700 bags, containing 5,000 litres of FFP, to Dilbagh Singh at Adesh University and Hospital, Barnala Road, Bhatinda, Punjab through Bhoruka Logistics Pvt Ltd, Mumbai by Lorry No. MH-04-GR-6094.
RLS has also made an advance payment of Rs 62.5 lakh to Dilbagh Singh, Satinder Pal Singh, and Sunita & Jai Peevan Di Enterprises. Dilbagh Singh had allegedly posed as the head of the licensed blood bank at the hospital. Sources said that he had provided blank cheques to RLS as a surety against the acceptance of the payments. When RLS realised that they were duped, they tried to encash the cheques, but they were dishonoured.
FDA rapped RLS on the count that the pharma company had no Standard Operating Procedures (SOPs) or written procedures for procuring FFP from authentic licensed blood banks.
The notice states: “You have not carried out vendor approval of licensed blood banks from whom FFP is collected. You have not provided written SOPs for vendor qualification for procuring human plasma.”
The notice also observes that there were no sufficient premises in the plant for cleaning and dusting incoming raw materials. “The thermocol boxes or gunny bags containing FFP have to be de-dusted and vaccum-cleaned to maintain sterility,” said the official.
The officials observed that most FFP packets did not bear the labels of the original blood bank. “It was found that on receipt of FFP, no procedure was followed by the company for checking the label of the blood bank. It was also found that some FFP bags did not bear the name of the product,” the official said.
RLS is one of three pharmaceutical manufacturers which produce albumin injections for domestic supply in India. Albumin is administered intravenously to patients in critical-care situations. RLS makes albumin available to hospitals, trade and small nursing homes.
An RLS spokesperson said: “Reliance Life Sciences has been manufacturing plasma proteins since 2005, maintains high quality standards and has been regularly audited successfully by several national and international regulatory authorities. Reliance Life Sciences has not received any plasma from Dilbagh Singh and has appropriately responded to the regulatory authorities.”
