India cracks down on professional blood donor rackets with tougher new rules

The rules restrict eligibility to registered voluntary and charitable organizations, barring family societies and trusts, and mandate social accountability evaluation, among other measures, according to two government officials and documents reviewed by Mint.

Both new and existing blood centres must adhere to rigorous operational and ethical benchmarks to secure and maintain their licences, including establishing their own component separation and storage facility within two years of receiving the permit.

India requires 14.6 million units for blood transfusion annually. The regulatory overhaul of India’s blood transfusion infrastructure aims to promote 100% voluntary donations without any payment and focuses on prioritizing public health over commercial interests. The majority of blood is needed for medicine (41.2%), surgery (27.9%) and obstetrics/gynaecology (22.4%) patients. Type O-negative blood and AB-positive plasma are in high demand.

The Union government earlier ordered an immediate nationwide audit of all 4,153 licensed blood banks and centres by the country’ top drug regulator, the Central Drugs Standard Control Organisation (CDSCO), following children being tested positive for HIV after blood transfusions in Satna (Madhya Pradesh), West Singhbhum (Jharkhand), Jaipur (Rajasthan) and Kamrup (Assam) due to breaches in screening protocols.

“Secure availability of blood to whoever needs it is an essential public health need. It is also absolutely essential that we ensure safety of the transfused blood, which must be free from infectious pathogens or toxic chemicals,” said Dr K. Srinath Reddy, former president of the Public Health Foundation of India, a non-profit and public-private initiative. “Voluntarily donated blood, which is adequately tested, provides greater assurance of blood safety compared to paid donor blood.”

These new regulations now govern the issuance of no-objection certificates (NOCs) by state blood transfusion councils (SBTC), according to a communication from India’s apex drug regulator, the Drug Controller General of India (DCGI), to all licensing authorities of states and Union territories reviewed by Mint.

This was approved in the 34th governing body of the National Blood Transfusion Council (NBTC). The council is the apex policy-making body under the ministry of health and family welfare, responsible for ensuring the supply of safe, sufficient and high-quality blood and blood components.

Queries emailed to the spokespersons of the health ministry and the DCGI on Wednesday remained unanswered till press time.

Push for 100% voluntary donation

The “professional donor” racket involves individuals who sell their blood for money, often hiding high-risk behaviour and donating too frequently, which compromises blood safety. Replacing this with a 100% voluntary system is essential because voluntary, non-remunerated donors have the lowest prevalence of transfusion-transmitted infections and ensure a safer, more ethical blood supply. Countries including the UK, the US and Japan have long transitioned to 100% voluntary donation models, ensuring safer and more efficient blood banking networks.

The government’s directive says the organization should submit an undertaking to ensure annual blood collection of more than 2,000 units a year, with nearly 100% contribution from voluntary blood donors, preferably from outdoor camps. It should submit an undertaking to appoint a medical social worker and a counsellor with the blood bank for arranging voluntary blood donation camps and pre- and post-test counselling.

Mint earlier reported that the CDSCO had earlier warned that a facility not compliant with the risk-based inspections standards would be closed down. It required mandatory testing of all blood units for infections including HIV, hepatitis B and C, malaria and syphilis.

Higher entry barriers

Under the new guidelines, every district should have at least one blood bank, but clustering of blood banks in urban and semi-urban areas should be avoided. New blood banks need to be set up based on geographic location and population demand only, the communication said.

“Regulation of blood banks is a highly desirable public health measure. Geographical maldistribution of blood banks must also be addressed while licensing new blood banks,” Dr Reddy said. “The new regulatory framework addresses these challenges.”

Among non-governmental and private entities, eligibility is now restricted to registered voluntary or charitable organizations that have been operational for at least two years. To prevent the entry of “family-run” commercial ventures, the guidelines specify that applicants must not be a “family society” or trust.

An organization’s social accountability will now be examined. “The objectives in the Memorandum of Association must include activities related to the healthcare delivery system or blood transfusion services,” the communication said. “The activities must showcase social accountability, reflected in the annual Audited Statement of accounts of the last two years.”

Easier compliance for some areas

This initiative aims to ensure that no centre operates—whether for a new license or a renewal—without meeting these stringent safety, ethical and technological benchmarks, said one of the two government officials cited above, requesting anonymity.

Recognizing the logistical challenges, the NBTC has allowed for relaxations in rural, tribal, hilly, and desert regions, as well as for the armed forces, to ensure accessibility in difficult terrains.

To avoid compliance gaps, the government has aligned licence renewal requirements with the stringent “New Blood Bank License” norms, compelling existing centres to demonstrate their long-term efficacy and commitment to non-commercial practices. Also, financial transparency remains a priority.

“Applications for a new licence or renewal of license will not be processed by the DCGI in the absence of a written NOC from the SBTC,” the communication said. “The organisation should submit details of processing charges collected by the blood bank after 12 Feb, 2014. The SBTC should verify if the collected charges are subsidized or at par with guidelines issued by the NBTC.”

The Centre is also mandating a shift to the fourth-generation enzyme-linked immunosorbent assay (ELISA) method for screening donated blood rather than the rapid card tests, which can miss low-level viral loads.