Three-member panel to oversee Tocilizumab distribution in Delhi
New Delhi: In order to streamline and systematize the supply of Tocilizumab, the Delhi government has issued an order specifying measures for appropriate drug distribution and establishing a three-member Technical Expert Committee (TEC) comprising of physicians involved in COVID patient care, stipulating that only members of the TEC can recommend the use of Tocilizumab or Immunomodulator therapy.
The move aims to prevent the indiscriminate use of the drug and to establish the transparent, efficient and time-bound system of distribution of the formulation to the needy and hospitalized COVID-19 patients on clinically approved evidence-based grounds and the ethical principle of distributive justice across Delhi.
This comes after the Delhi High Court directed the Union of India and the GNCTD to take urgent measures to ensure that the drugs are allocated to States/UTs and distributed transparently, efficiently, and in a timely manner so that they can be immediately administered to patients who are in need and have been duly prescribed with the same.
The Court was dealing with a petition filed by the kin of a COVID patient currently admitted in Malik Radix Health Care Hospital, Nirman Vihar, New Delhi. The petition was concerned with the supply and availability of the drug Tocilizumab 400 MG for COVID-19 patients who are prescribed the same.
In compliance with the court order, the Delhi government has constituted a three-member Technical Expert Committee (TEC) consisting of physicians engaged in COVID patient treatment, with the direction that only committee members should recommend the use of Tocilizumab/lmmunomodulator therapy.
The committee consists of Dr . M. K. Daga (Pulmonologist), as Chairman, Dr. Manisha Aggarwal (Anesthes ia Branch, MAMC), and Dr. S. Anuradha (Medicine Branch, MAMC).
In addition, the Delhi Government has developed a step-by-step mechanism for approving the distribution/supply of Tocilizumab to notify COVID Hospitals (both public and private) for the care of COVID-19 patients as;
i. Application: All the COVID Hospitals requiring Injection Tocilizumab for treatment of COVID-19 patients shall apply to the Technical Experts Committee.
ii. The application will be the Proforma (Annexure-A) to be sent to the TEC through notified e-mail or physical copy. No application without filled proforma or incomplete Proforma will be entertained.
iii. The TEC will meet twice every day (preferably 10-11am in the morning and -5 PM in the evening) to scrutinize the applications received and facilitate rapid decision making, as time is of the essence in such cases. The meetings can be held on a virtual/digital platform. The guiding principles for TEC shall be evidence based clinically approved parameters as well as principles of equity, distributive justice and transparency.
vi . DGHS shall coordinate with the TEC and facilitate rapid decision making and also monitor the overall management of drug from approval till delivery to the hospital concerned.
v. The decision of daily meetings will be conveyed to all the stakeholders through e mail and reasons for refusal will be written and informed to the requisitioning Hospitals. A copy of the decision shall also be displayed on the website of DGHS/Health Department.
vi. On recommendation of the TEC, the o/o DGHS shall issue the drug to the authorized representative of the Government Hospital/institution concerned or the CFA/Stockiest shall release to the authorized representative of the private Hospital concerned( in this case, on payment basis) as the case may be.
vii. DGHS and all the CFAs/Stockists will ensure the issuance of drug on same day to the Government and private Hospital concerned. Respectively All relevant records shall be maintained by o/oDGHS.
viii. The concerned Govt/Private hospital will submit report regarding usage of drug for the approval patient only.
ix. It shall be the personal responsibility of the Hospital Administration of the institutes requisitioning Tocilizumab to ensure appropriate use of prescription medicine, prevent any misuse/pilferage, coordination with health authorities and to keep proper records so that they are available for audit purpose later.
x. The distribution of Tocilizumab Injections will be made up till the stock remains as per the allocation of Government of India. No waiting list shall be made.
xi For arrival of fresh stocks applications will be called afresh after notifying all hospitals for arrival of stocks.
xii. In exceptional circumstances Pr Secretary (H&FW) may allocate injections to any Government Hospitals/ Hospitals run by Government Agencies on special recommendation by the treating doctor.
When deciding whether or not to recommend Tocilizumab/lmmunomodulator therapy, the following factors will be considered and recorded :-
Condition | Yes/No | Condition | Yes /No | |
Rapid deterioration | Coexistent infection other than COVID-19 | |||
RR>30 bpm | PaO2/FiO2> 300 mm Hg; chronic Qlucocorticoid use | |||
SaO2<93% on room air &CRP> =75 mg/L. | H/o another ILG inhibitor in present admission. | |||
PaO2/FiO2< 300 mm Hg in room air, and | H/O severe allergic reactions to monoclonal antibodies | |||
Lung infiltrates > 50% within 24-48 h | ANC | |||
Invasion or noninvasive mechanical ventilation, including through HFNC with flow> 30 L/min & FiO2>0.4 | Active diverticulitis, IBD, or another symptomatic gastrointestinal tract condition that might predispose patients to bowel perforation | |||
Vasopressor or inotrope | Severe hematological, renal, or liver function impairment. | |||
Investigations | Result | Result | ||
CRP | s Creatinine | |||
SGOT/SGPT | CT severity score (if available | |||
Blood culture (if available | s Procalcitonin (if available) | |||
To view the official order, click the below link-
