Govt to amend D&C Rules: Blood bank / centre

There are around 2,760 registered blood banks / centres in the country as of today.

Govt India
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In the wake of technical manpower crunch across blood banks / centres in the country, the Union health ministry will soon amend Drugs and Cosmetics (D&C) Rules, 1945 regarding the qualification of ex-serviceman to be recognized as technicians in blood banks / centres.

Qualification of ex-serviceman to be recognized as technicians in blood banks / centres

There are around 2,760 registered blood banks / centres in the country as of today.

Although having technical knowledge and experience, on many occasions, ex-servicemen are facing difficulty to prove that their qualifications are at par with a Diploma in Medical Laboratory Technology (DMLT) / Bachelor in Medical Laboratory Technology (BMLT). Also, it was not included in recent GSR 166(E) dated 11 March 2020, where qualification of the technician and technical supervisor and experience is mentioned.

To download notification No. GSR 166(E) dated 11 March 2020, click here

In this regard it was proposed to amend the Rule 122G or Schedule F XIIB of D&C Rules, 1945. Drugs Consultative Committee (DCC) under the union health ministry after detailed deliberation agreed on the proposal.

In its joint inspections, Drug Controller General India (DCGI) and State Licensing Authorities (SLAs) have also taken cognizance of the absence of requisite number of Blood Transfusion Officers (BTOs) at the blood banks / centres, besides other technical deficiencies such as non-calibration of equipment.

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As per D&C Rules, a 24/7 blood bank / centres is required to have at least three BTOs working in shifts. It is also mandatory that collecting and transfusing of blood and its components be done in the presence of a BTO to avoid fatal mistakes.

The blood centre technicians and technical supervisors serving in Defence Services have done Blood Transfusion Associate (BTA) class I to III course. There are large number of technicians in the Defence Services, those have done BTA class III/II/I, Diploma in Blood Transfusion Techniques (DBTT) courses in accordance with Defence Services Qualification Regulation, 1958 and have adequate experience of working in military hospitals.

However, the qualification viz. BTA class III/II/l and Diploma in Blood Transfusion Technology (in accordance with defence services qualification regulation 1958) is not mentioned in Schedule F part XIIB of Drugs and Cosmetics Act, neither in Rule 122G (where qualification of Medical officer is mentioned).

As per official reports, blood banks / centres in the past have failed to operate efficiently due to lack of monitoring by technically qualified staff and have exhibited non- compliance in terms of staff strength and instrumentation which is a violation of Schedule F of Drugs and Cosmetics Act, 1940.

Schedule ‘F’, Part XII-B and/or XII-C provisions that the applicant is supposed to provide adequate space, plant and equipment for any or all the operations of blood collection or blood processing. It also mandates to provide and maintain adequate technical staff as specified in the law.

A letter has also been issued by Central Drugs Standard Control Organisation (CDSCO) to all SLAs on the subject “Qualification of ex-serviceman to be recognized as technician in blood banks / centres”.

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