Lok Sabha Question No. 336 (UNSTARRED), answered on 2017-02-03
Subject: Increase in Hepatitis Cases
Ministry: HEALTH AND FAMILY WELFARE
Asked by: RAJESH KUMAR DIWAKAR

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 336 TO BE ANSWERED ON 03 RD FEBRUARY , 201 7

## INCREASE IN HEPATITI S CASES

## 336. SHRI RAJESH KUMAR DIWAKER:

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

- (a) whether cases of hepatitis infections are on the rise in the country, if so, the details thereof and the reasons therefor;
- (b) the number of cases of various types of hepatitis infec tions reported during each of the last three years and the current year, type and State/UT - wise;
- (c) the measures taken/proposed to be taken by the Government for prevention and control of hepatitis  along  with  the funds  allocated  and  utilised  for  the purposeduring  the  said  period, State/UT - wise;
- (d) whether the Government has recently given licence to manufacture drug for hepatitis, if so, the details thereof; and
- (e)  the  steps  taken/proposed  to  be  taken by  th Government  to  eliminate  hepatitis incl uding immunization and ensure the quality and safety of the anti - hepatitis drugs?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SMT. ANUPRIYA PATEL )

(a)to (d): The  number  of  cases due  to  Viral  Hepatitis  as  reported  by  the  States/UTs  to Central  Bureau  of  Health  Intelligence  (CBHI)  in  the  last  three  years  is  given  at Annexure . Separate figures for various types of Hepatitis are not collected at present.

The main cause of Hepatitis A & E is co nsumption of contaminated water and providing provision f or safe drinking water is the main strategy to control it . Rural water supply is a State subject. Government of India supplements the efforts of the States by providing technic financ ial assistance under the centrally sponsored National Rural Drinking Water Progra (NRDWP) for providing safe and adequate drinking water supply facilities in rural areas country.

Hepatitis B vaccination is included u nder the Univers al Immunizati on Programme (UIP) of Government of India .Government is using auto - disabled (AD) syringes for all vac cinations under the UIP in all S tates. There is no vaccine available for Hepatitis C.

Screening of blood reduces the risk of transmission of Hepatitis B and C by b transfusion.  Therefore,  blood  banks mandatorily  screen for  Hepatitis  B  &  C  as  per  Drug s & Cosme tics Act 1940 and R ulesthereunder.

The Government of India has recently insti tuted a 'National Viral hepatitis Surveillance Programme' under the 12th five year plan (2012 - 17) with an estimated budget of Rs.30 crore. The  initial  funds  have  been  released  to  N ational  Centre  for  Disease  Control  (N CDC ) in  this current financial year an d the surveillance activities have been initiated.

NCDC  also provides  technical  guidance  to  State  Governments , laboratory  support  for outbreak investigations and etiological diagnosis besides conduct ng regular training courses for development of trained manpower. Funds are released to States/UTs under Integrated Disease Surveillance  Programme  (IDSP)  to  strengthen  surveillance  and  to  detect  and  respond outbreaks of epidemic - prone diseases .

Many antiviral  drugs likeLamivudine, Adefovir  Dipivoxil , Ente cavir , Telbivudine , Tenofovir etc., for treatment of Hepatitis B and Sofosbuvir ,FDC of Ledipasvir and Sofosbuvir 400 mg,Daclatasvir etc., for the treatment of Hepatitis C have been approved in the country.

Central  Drugs  Standard  Control  Organization (CDSCO)  has  granted  import  and marketing  permission  on  13 th January,  2015  for  Sofosubuvir  400  mg  tablet  (brand  name Sovaldi)manufactured  by  M/s  Gilead  Science  Ltd.  for  treatment  of  chronic  Hepatitis  C adults.

Subsequently, since March 2015, CDSCO h as also granted permission to manufacture and market Sofosubuvir 400 mg tablet to a few Indian manufacturers.

(e): Drugs including anti - hepatitis are regulated under the provisions of Drugs and Cosmetic Act, 1940 and Rules 1945 made thereunder.

- 1.Under the Act and Rules, the regulatory control over the drugs imported into the coun exercised  by  the  Central  Government  through  the  Central  Drugs  Standard  Contro Organization  (CDSCO).  For  import  and  marketing  of  drugs,  the  overseas  manufacturin premises and the drugs are required to be registered and license is required to be from CDSCO.
- 2.New drugs are approved in accordance with provision of the Drugs and Cosmetics Act, 19 and Rules, 1945 made thereunder after being satisfied that the drug permitted to be imported/ manufactured shall be effective and safe for use in the country
- 3.Detailed requirements and guidelines for manufacture/import of new drugs in the countr specified under Rule 122A, 122B, 122D, 122E and Schedule Y of Drugs a nd Cosmetics Act, 1940 and Rules, 1945.
- 4.However,  for  manufacture/Import  and  marketing  of  any  new  drug,  prior  permission  fro CDSCO is required to be obtained.
5. The manufacture, sale and distribution of drug is regulated under the said Act & Rules the State Drugs Control Authorities appointed by the State Governments. The regulatory con over the manufacture and sale of the drugs is exercised through a system of licensi inspection.

Annexure - 16 (Provisional)

State/UT - wise Cases due to Viral Hepatitis (Al l Causes) reported during the year 2014

| S.No.   | State /U.T        | 2014   |   2015 |   2016 |
|---------|-------------------|--------|--------|--------|
| 1       | Andhra Pradesh    | 3716   |   2531 |   1736 |
| 2       | Arunachal Pradesh | 378    |    267 |    237 |
| 3       | Assam             | 2033   |    917 |   1858 |
| 4       | Bihar             | 20670  |  25808 |  22308 |
| 5       | Chhattisgarh      | 548    |    532 |    423 |
| 6       | Goa               | 182    |    156 |    104 |
| 7       | Gujarat           | 4808   |   3736 |   2598 |
| 8       | Haryana           | 1934   |   5020 |   3612 |
| 9       | Himachal Pradesh  | 2808   |   1739 |   2350 |
| 10      | Jammu & Kashmir   | 5110   |   4028 |   2974 |
| 11      | Jharkhand         | 1052   |   1230 |   1088 |
| 12      | Karnataka         | 6402   |   6478 |   4149 |
| 13      | Kerala            | 5567   |   3894 |   3929 |
| 14      | Madhya Pradesh    | 16145  |  12938 |   8580 |
| 15      | Maharashtra       | 6753   |   8386 |   7774 |
| 16      | Manipur           | 443    |     88 |    116 |
| 17      | Meghalaya         | 643    |    253 |     73 |
| 18      | Mizoram           | 194    |    138 |    216 |
| 19      | Nagaland          | 113    |     57 |     84 |
| 20      | Odisha            | 5069   |   4309 |   2262 |
| 21      | Punjab            | 4525   |   9330 |   5906 |
| 22      | Rajasthan         | 9719   |   3305 |   1468 |
| 23      | Sikkim            | 556    |     43 |    384 |
| 24      | Tamil Nadu        | 880    |   1066 |    510 |
| 25      | Telangana         | *NA    |   1735 |   2183 |
| 26      | Tripura           | 177    |    130 |    141 |
| 27      | Uttarakhand       | 9243   |  10242 |   7725 |
| 28      | Uttar Pradesh     | 16037  |  11088 |   8898 |
| 29      | West Bengal       | 4444   |   3865 |   2121 |
| 30      | A & N Islands     | 262    |     80 |    102 |
| 31      | Chandigarh        | 766    |   1249 |    793 |
| 32      | D & N Haveli      | 32     |     48 |      3 |
| 33      | Daman & Diu       | 65     |     64 |     20 |
| 34      | Delhi             | 6965   |   8362 |   6081 |
| 35      | Lakshadweep       | 16     |     10 |      6 |
| 36      | Puducherry        | 299    |    503 |    350 |
| Total   |                   | 138554 | 133625 | 103162 |

Source: *NA stands for Not Available

Monthly Health Condition Reports from Directorate of Health Services of States/UTs