Central Organization for the Control of Drug Standards (CDSCO) has started risk-based inspections at all blood centers and any facility not complying with norms will be closed, officials said. Risk-based inspections prioritize surveillance of facilities based on potential risk to patients rather than random inspections.
The Health Ministry has asked all states and Union Territories to conduct a comprehensive audit of blood centers on priority and switch to advanced methods of testing blood for infections.
“Ensure testing of all units of blood for mandatory transfusion-transmitted infections, specifically HIV, hepatitis B, hepatitis C, malaria and syphilis. Strengthen mandatory testing for HIV, Hepatitis B and Hepatitis C using fourth-generation CLIA/ELISA,” Punya Minister Salila Srivastava said in a statement issued last month.
The move comes in the backdrop of children testing positive for HIV after blood transfusions during thalassemia treatment in Satna (Madhya Pradesh), West Singhbhum (Jharkhand), Jaipur (Rajasthan) and Kamrup (Assam) due to suspected violation of screening protocols. India requires 14.6 million units of blood annually to meet its transfusion requirements.
The center wants states to switch to a fourth-generation enzyme-linked immunosorbent assay (ELISA) method from rapid card tests that can miss low viral loads. The ministry also plans to enforce biometric linkages for all donors to curb “professional donors”. State regulators were ordered to prioritize the elimination of such “replacement” donations in favor of a 100% voluntary system.
Blood Bank Network
Non-compliant facilities that operate without digitized tracking through e-Raktkosh (government digital portal) now face immediate shutdown. e-Raktkosh is an integrated blood bank management information system that connects all blood banks.
Inquiries sent to a spokesperson for the health ministry and the Drug Controller General of India, who heads the CDSCO, remained unanswered on February 3.
Experts said strict blood tests are the bare minimum, given the many avoidable cases of HIV and other blood-borne infections spread through blood transfusions.
“Being stricter on blood banks and insisting on fourth-generation ELISA is good. While PCR (polymerase chain reaction) testing is now standard of care in many places and has become more affordable, at least fourth-generation ELISA must be the bare minimum,” said Dr Soumya Swaminathan, former chief scientist at the World Health Organization.
The PCR method detects the genetic material (DNA/RNA) of the virus rather than just its antibodies. The Indian Council of Medical Research considers PCR testing to be the gold standard, although it currently recommends the 4th generation ELISA as a mandatory basis for national screening.
Dr Swaminathan said the advantage of PCR is its ability to detect infection even during the “silent phase” or incubation period due to its high sensitivity.
“ELISA tests only detect infection after antibodies have formed in the blood. While molecular testing (PCR) may not be possible in all blood banks immediately, current measures are the absolute minimum that should be insisted on,” she said.
The aim of this revision of the regulations is to replace professional donors with a voluntary, unpaid donation system. Professional donors sell their blood for money, often hide high-risk behavior and donate too often, compromising blood safety.
Ethical blood supply
Voluntary donors have the lowest prevalence of transfusion-transmitted infections and ensure a safer and more ethical blood supply. The UK, US and Japan have long since moved to 100% voluntary donation models.
“Order adherence to standard SOPs for all processes, particularly donor selection and pre-donation counseling and recall/recommendation of reactive blood donors, their permanent removal from the donor pool,” the ministry said in a statement. “Discourage continued reliance on replacement blood donation – promote voluntary, unpaid regular blood donors instead.”
Replacement donors give blood when a member of their family or community needs it. They are not paid by the transfusion service or the hospital, but patients’ families may reward them in cash or in another form.
Since the Supreme Court’s landmark judgment in 1996, which banned professional blood donation, the government has been trying to ensure safe and adequate blood transfusions in the country.
According to Raman Gangakhedkar, former chief scientist for epidemiology and communicable diseases at India’s ICMR has been trying to ban professional donors, who often lead risky lifestyles, since 1989. By mandating fourth-generation ELISA testing, the “window time” — the time between virus entry and detection — will be reduced to two weeks from three, he said.
The integration of biometric data through the e-Raktkosh platform is important to break the system of professional donors and ensure that donors are truly voluntary, Gangakhedkar said.
“While there have been failures globally and locally due to greed or short-circuits in rural areas, our goal remains a camp-based, voluntary approach to achieving zero transmission of infections. The use of risk-based screening of all blood banks is a welcome step that will weed out blood banks that do not adhere to prescribed standards,” Gangakhedkar said.
