Lok Sabha Question No. 478 (UNSTARRED), answered on 2022-12-09
Subject: Rabies Vaccine
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Dean Kuriakose, E. T. Mohammed Basheer, Adoor Prakash

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE

## DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK  SABHA UNSTARRED QUESTION NO. - 478 TO BE ANSWERED ON 09.12.2022

## RABIES VACCINE

## 478. ADV. DEAN KURIAKOSE: SHRI E.T. MOHAMMED BASHEER: ADV. ADOOR PRAKASH:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether the Government has taken note of the diseases and side effects caused due to dog bites and if so, necessary steps taken in this regard;
- (b) the number of deaths due to rabies, despite taking rabies vaccine in the country, State/UT-wise including Kerala;
- (c) the  monitoring  mechanism  in  place  to  ensure  quality  testing  of  samples  and production of quality vaccines in the country;
- (d) the  details  of  the  process  with  respect  to  the  testing  of  sample  and  quality  of vaccines that lead to deaths in Kerala, despite being administered to the victims; and
- (e) the  necessary  steps  taken  by  the  Government  to  ensure  the  availability  of  antirabies vaccine in the country?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

(a) to (e):

Ministry  of  Health  and  Family  Welfare  (MoHFW)  has  launched  the  National  Rabies Control since 12th Five-Year Plan for prevention & control of rabies .National Rabies

Control Program has been  implemented in the entire country (Except UTs of Andaman &Nicobar Islands and Lakshadweep).

State-level activities of the program have been implemented through the National Health Mission since FY 2019-20 and financial assistance is also provided to states for:

-  Provision  of  procurement  of  Anti-Rabies  Vaccine  for  animal  bite  victims through the National Free Drug Initiative
-  Capacity  building  through  training  of  Medical  Officers  and  Health  Workers under NRCP
-  IEC/BCC under NRCP: Rabies Awareness and Do's and Don'ts in the event of Animal Bites
-  Strengthening Surveillance of Human Rabies & Dog bite cases.

States/UT wise number of deaths due to rabies till October 2022 is placed at Annexure.

As per the provisions of Drugs and Cosmetics Act, 1940 & Rules thereunder 1945 and New Drugs and Clinical Trials Rules, 2019, the manufacturing license for production of vaccine  is  granted  on  the  basis  of  joint  inspection  of  manufacturer  conducted  by  State Drugs  Control  Department  and  Central  Drugs  Standard  Control  Organization  (Central Licensing  Approving  Authority)  and  all  the  Vaccine  batches  are  tested  for  standard quality and lot released by Central Drugs Laboratory, Kasauli.

As  per information provided by State Government  of Kerala, all vaccines and immunoglobulin batches have been tested for quality prior to delivery.  However, some deaths have occurred in persons who had been administered post exposure prophylaxis, corresponding batches were sent for repeat quality testing at Central Drugs Laboratory, Kasauli. All the tested batches have been reported to be conforming to requisite quality standards.

Union Health Ministry has asked State/UTs to include the Anti Rabies Vaccine (ARV) in the  essential  drug  list  and  procure  it  under  the  National  Free  Drug  Initiatives  of  the National Health Mission (NHM).

Drug General Controller of India vide letter dated 26.04.2019 had asked all manufacturers  to  furnish  monthly  details  of  the  quantities  of  ARV  manufactured, exported, sold in the domestic market and supplied to the institutions. Subsequently, on 19.07.2019 another letter was issued by CDSCO  to all Anti-Rabies Vaccine manufacturers to ensure that the manufacturing of ARV is carried out with full capacity and  the  first  preference  may  be  accorded  to  meet  domestic  requirements  including government institution supplies in the country.

Union  Health  Ministry  provides  financial  assistance  to  State  Governments  through National Health Mission for procurement of ARV to ensure the availability of ARV  at health facilities.

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## Annexure

State wise Human Rabies Cases reported in Year 2022 (till October 2022)

|   S.No | State Name       |   Total Number of Death in State |
|--------|------------------|----------------------------------|
|      1 | Andhra Pradesh   |                               19 |
|      2 | Assam            |                               12 |
|      3 | Bihar            |                               18 |
|      4 | Chhattisgarh     |                                2 |
|      5 | Gujarat          |                                5 |
|      6 | Haryana          |                                4 |
|      7 | Himachal Pradesh |                                1 |
|      8 | Jammu& Kashmir   |                                2 |
|      9 | Karnataka        |                               32 |
|     10 | Kerala           |                               21 |
|     11 | Maharashtra      |                               24 |
|     12 | Manipur          |                                2 |
|     13 | NCT of Delhi     |                               18 |
|     14 | Tamil Nadu       |                               22 |
|     15 | Telangana        |                               21 |
|     16 | Uttar Pradesh    |                               19 |
|     17 | Uttrakhand       |                                2 |
|     18 | West Bengal      |                               24 |