India launches nationwide audit of blood banks after children test HIV-positive post-transfusion

The Central Drugs Standard Control Organization (CDSCO) has started risk-based inspections of all blood centres and any facility not compliant with the standards will be closed down, the officials said. Risk-based inspections prioritize surveillance of facilities based on potential risk to patients instead of random checks.

The health ministry has asked all states and Union Territories to conduct a comprehensive audit of blood centres on priority and shift to advanced methods of testing blood for infections.

“Ensure testing of all blood units for mandatory transfusion-transmitted infections, namely HIV, Hepatitis B, Hepatitis C, Malaria and Syphilis. Strengthen the mandatory testing for HIV, Hepatitis B, and Hepatitis C with the use of fourth-generation CLIA/ELISA," secretary Punya Salila Srivastava said in a statement issued last month.

The step comes in the backdrop of children being tested positive for HIV after blood transfusions during treatment for thalassemia in Satna (Madhya Pradesh), West Singhbhum (Jharkhand), Jaipur (Rajasthan) and Kamrup (Assam) due to a suspected breach in screening protocols. India requires 14.6 million units of blood annually to meet transfusion requirements.

The Centre wants states to shift to the fourth-generation enzyme-linked immunosorbent assay (ELISA) method from rapid card tests, which can miss low-level viral loads. The ministry also plans to enforce biometric linkages for all donors to curb "professional donors." State regulators have been directed to prioritize the removal of such "replacement" donations in favour of a 100% voluntary system.

Blood bank network

Facilities that fail to meet standards and those operating without digitized tracking via e-Raktkosh (a government digital portal) now face immediate shutdown. e-Raktkosh is an integrated Blood Bank Management Information System that connects all blood banks.

Queries sent to the health ministry spokesperson and the Drug Controller General of India, which heads the CDSCO, on 3 February remained unanswered.

Experts said rigorous blood testing is the bare minimum, given the many instances of avoidable HIV and other blood-borne infections spreading through blood transfusions.

“Being stricter with blood banks and insisting on the use of fourth-generation ELISAs is good. While PCR (polymerase chain reaction) testing is now the standard of care in many places and has become more affordable, at least fourth-generation ELISA testing 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 a virus rather than just its antibodies. The Indian Council of Medical Research views PCR testing as the gold standard, though it currently recommends 4th-generation ELISA as the mandatory baseline 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) might not be possible in all blood banks immediately, the current measures are the absolute minimum that should be insisted upon," she said.

This regulatory overhaul aims to replace professional donors with a voluntary, non-remunerated donation system. Professional donors sell their blood for money, often hiding high-risk behavior and donating too frequently, which compromises blood safety.

Ethical blood supply

Voluntary donors have the lowest prevalence of transfusion-transmitted infections and ensure a safer, more ethical blood supply. The UK, the US and Japan have long transitioned to 100% voluntary donation models.

“Mandate adherence to standard SOPs for all processes, especially donor selection and counselling before blood donation and recall/referral of reactive blood donors, permanently removing them from the donor pool," the ministry said in its statement. “Discourage continued reliance on replacement blood donation – instead promote voluntary, non-remunerated regular blood donors."

Replacement donors give blood when needed by a member of their family or community. They are not paid by the blood transfusion service or hospital but may be rewarded with cash or other forms by the families of patients.

Since the landmark 1996 Supreme Court judgment that 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 of epidemiology and communicable diseases at ICMR, India has been trying to ban professional donors, who often have risky lifestyles, since 1989. By mandating fourth-generation ELISA testing, the 'window period'—the time between viral entry and detection—will be reduced to two weeks from three, he said.

Integrating biometric data via the e-Raktkosh platform is important to dismantle the professional donor system and ensure donors are truly voluntary, Gangakhedkar said.

“While lapses have occurred globally and locally due to greed or shortcuts in rural areas, our goal remains a camp-based, voluntary approach to reach zero transmission of infections. Use of risk-based screening of all the blood banks is a welcome step that will weed out the blood banks that do not follow the prescribed standards," Gangakhedkar said.