ANSWER
THE MINISTER OF HEALTH AND FAMILY WELFARE
(SHRI JAGAT PRAKASH NADDA)
(a) to (e): A statement is laid on the Table of the House
STATEMENT REFERRED TO IN REPLY TO LOK SABHA
STARRED QUESTION NO. 285* FOR 18TH DECEMBER, 2015
(a) to (c) 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 I. Separate figures for various types of Hepatitis are not collected at present.
The main cause of Hepatitis A & E is consumption of contaminated water and provision of safe drinking water is the main strategy to control diseases caused by drinking of contaminated water. Rural water supply is a State subject. Government of India supplements the efforts of the States by providing technical and financial assistance under the centrally sponsored National Rural Drinking Water Programme (NRDWP) for providing safe and adequate drinking water supply facilities in rural areas of the country.
Hepatitis B vaccination is included under the Universal Immunization Programme (UIP) of Government of India. Government is using auto-disabled (AD) syringes for all vaccinations under the UIP in all States. AD syringes are single use, self-locking syringes that cannot be used more than once. This prevents misuse and contamination/cross infection through repeated use of unsterile injection/equipment. The funds released to the States for implementation of UIP in last three years and current year are placed at Annexure II.
Screening of blood reduces the risk of transmission of Hepatitis B and C by blood transfusion. Therefore, blood banks mandatorily screen for Hepatitis B & C as per Drug & Cosmetics Act 1940 and rules thereof.
A National Programme on Surveillance of Viral Hepatitis under the 12th Five Year Plan has been launched by the Government. National Centre for Disease Control (NCDC), Delhi has been identified for coordinating the various activities under this programme.
NCDC, under the Ministry of Health and Family Welfare, provides technical guidance to State Governments on prevention and control of water borne diseases including Hepatitis, and helps them in carrying out investigation of outbreaks of such diseases under Integrated Disease Surveillance Programme (IDSP). NCDC also provides laboratory support for outbreak investigations and etiological diagnosis besides conducting 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 to
outbreaks of epidemic-prone diseases. The details of funds released to States/UTs during last three years and current year are at Annexure- III.
(d) The following three antiviral drugs have been approved in 2015 considering waiver of local clinical trial for Import/Manufacturing and marketing in the country.
S. No Name of the Drug Date of Approval
01 Sofosbuvir 400 mg Tablet 13.01.2015
02 FDC of Ledipasvir (90 mg) + Sofosbuvir 400 mg) Tablet 08.12.2015
03 Daclatasvir Tablet (30 mg/ 60 mg) 11.12.2015
The issue of considering waiver of local clinical trial in above cases were deliberated in the expert committees and, based on their recommendation, waiver of local clinical trial was granted.
Grant of waiver of local clinical trial has resulted in early launch of the drug Sofosbuvir indicated for “in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults”.
These antiviral drugs have been approved for Import/ Manufacturing and marketing in the country subject to certain conditions. One of the conditions is that the applicant shall conduct a time bound Post Marketing Trial (Phase-IV) as per the protocol approved by DCG (I).
(e) Drugs including anti-hepatitis are regulated under the provisions of Drugs and Cosmetics Act, 1940 and Rules 1945 made thereunder.
1. Under the Act and Rules, the regulatory control over the drugs imported into the country is exercised by the Central Government through the Central Drugs Standard Control Organization (CDSCO). For import and marketing of drugs, the overseas manufacturing premises and the drugs are required to be registered and license is required to be obtained from CDSCO.
2. New drugs are approved in accordance with provision of the Drugs and Cosmetics Act, 1940 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 country are specified under Rule 122A, 122B, 122D, 122E and Schedule Y of Drugs and Cosmetics Act, 1940 and Rules, 1945.
4. However, for manufacture/Import and marketing of any new drug, prior permission from CDSCO is required to be obtained.
5. The manufacture, sale and distribution of drug is regulated under the said Act & Rules by the State Drugs Control Authorities appointed by the State Governments. The regulatory control over the manufacture and sale of the drugs is exercised through a system of licensing and inspection.
Government has launched Pharmacovigilance Programme of India for monitoring the safety of the marketed drug. Indian Pharmacopoeia Commission, Ghaziabad, is the national co-coordinator of the programme.
Annexure I
State-wise Cases due to Viral Hepatitis (All Causes) during 2012 – 2015
Sl. No. State / U.T. 2012 2013 2014(Prov.) 2015(Prov.)
Cases Cases Cases Cases Reference Period Jan 15 up to
1 Andhra Prad. 7955 8739 3716 1867 August,15
2 Arun. Prad. 1520 588 378 218 September,15
3 Assam 419 466 1994 456 September,15
4 Bihar 3094 6736 20670 20361 October,15
5 Chhattisgarh 914 670 533 437 October,15
6 Goa 92 173 182 102 July, 15
7 Gujarat 4763 3676 4808 2870 October,15
8 Haryana 2686 1307 2717 4076 October,15
9 HP 1310 2023 2808 1440 September,15
10 J & K 5967 6307 5110 3172 October,15
11 Jharkhand 983 1444 972 457 October,15
12 Karnataka 10789 5415 6613 5001 October,15
13 Kerala 8212 7034 5567 2961 October,15
14 Madhya Prad. 12325 14055 16141 8802 October,15
15 Maharashtra 6175 5851 5985 5776 October,15
16 Manipur 229 258 443 68 September,15
17 Meghalaya 221 518 609 253 June, 15
18 Mizoram 914 419 194 155 October,15
19 Nagaland 284 119 88 27 October,15
20 Orissa 5372 3743 4910 3040 October,15
21 Punjab 3323 3099 4525 7551 October,15
22 Rajasthan 1595 2384 9719 2194 October,15
23 Sikkim 667 692 554 18 September,15
24 Tamil Nadu 10628 1868 2671 858 October,15
25 Tripura 272 205 177 85 September,15
26 Uttarakhand 6499 8619 9243 7529 September,15
27 Uttar Pradesh 6345 9079 16026 8783 October,15
28 West Bengal 4097 4967 4444 2951 October,15
29 A & N Islands 172 231 262 37 August,15 exc Feb, May
30 Chandigarh 1751 424 766 862 August,15
31 D & N Haveli 159 90 32 43 October, 15 exc Aug
32 Daman & Diu 192 184 65 51 October,15 exc Mar, Apr
33 Delhi 8184 8290 6425 4872 August,15
34 Lakshadweep 17 5 16 4 September,15
35 Puducherry 755 447 299 435 September,15
Total 118880 110125 139662 97812
Source: National Health Profile brought out by CBHI, DGHS
Note :
1. 2014 & 2015 : Andhra Pradesh excludes data of 10 districts of Telangana from July 2014 Onwards.
2. 2014: Data for Assam till September
3. 2014 : Data from Meghalaya does not contain figures for October
Annexure II
Allocation ,Release & Expenditure under Routine Immunization for the12th Plan
Rs. In crore
S.N. States 2012-13 2013-14 2014-15 2015-16
Allocation Release Exp Allocation Release Exp Allocation Release Exp Allocation Release Exp
1 Andaman & Nicobar Islands 0.06 0.04 0.06 0.06 0.03 0.03 0.07 0.06 0.02 0.06 0.04 0.02
2 Andhra Pradesh 12.66 10.00 19.67 14.06 6.22 7.17 9.54 0.00 4.49 7.63 0 4.92
3 Arunachal Pradesh 0.68 0.61 1.54 0.76 1.76 1.87 0.76 0.57 0.47 0.61 0.45 0.44
4 Assam 15.38 12.38 24.99 17.09 12.82 18.56 17.09 12.82 13.36 13.67 10.25 8.41
5 Bihar 20.17 37.21 28.05 22.41 28.87 48.18 20.05 15.04 59.12 16.04 12.03 7.21
6 Chandigarh 0.16 0.00 0.03 0.18 0.03 0.12 0.20 0.15 0.07 0.16 0.16 0.11
7 Chattisgarh 5.73 0.00 7.33 6.36 3.50 10.24 4.93 3.70 8.95 3.95 2.96 5.02
8 Dadra & Nagar Haveli 0.05 0.02 0.06 0.06 0.06 0.07 0.07 0.00 0.13 0.05 0.04 0.07
9 Daman & Diu 0.04 0.00 0.03 0.04 0.04 0.07 0.05 0.04 0.07 0.04 0.03 0.01
10 Delhi 2.50 2.05 0.46 2.78 0.69 1.21 3.24 3.24 2.68 2.59 1.94 4.00
11 Goa 0.22 0.00 0.10 0.24 0.07 0.07 0.28 0.21 0.10 0.23 0.12 0.04
12 Gujarat 9.03 24.90 23.75 10.03 14.37 24.42 11.67 11.67 26.27 9.33 7.00 12.27
13 Haryana 3.79 6.79 7.49 4.21 3.16 12.74 4.90 3.67 10.57 3.92 2.94 8.74
14 Himachal Pradesh 1.54 0.85 1.77 1.71 1.28 0.89 1.32 0.99 1.14 1.06 0 1.86
15 Jammu & Kashmir 2.81 0.00 1.68 3.13 0.94 1.63 2.42 0.00 0.90 1.94 1.46 0.84
16 Jharkhand 7.39 0.00 10.54 8.21 6.16 14.70 6.37 4.78 17.18 5.10 3.83 9.85
17 Karnataka 9.14 6.85 8.39 10.15 3.89 10.53 11.81 11.81 11.30 9.45 7.09 5.55
18 Kerala 4.99 3.74 6.95 5.55 4.16 7.80 6.45 4.84 8.13 5.16 3.87 3.43
19 Lakshadweep 0.01 0.09 0.04 0.01 0.05 0.06 0.01 0.01 0.01 0.01 0.01 -
20 Madhya Pradesh 14.11 14.11 43.97 15.68 11.76 44.01 14.03 10.52 37.28 11.22 10.10 17.99
21 Maharashtra 16.80 12.60 30.47 18.67 16.06 32.86 21.71 16.28 31.21 17.37 13.03 10.61
22 Manipur 1.34 1.34 0.72 1.49 0.86 0.71 1.49 1.12 0.66 1.19 0.90 0.42
23 Meghalaya 1.46 1.28 0.57 1.63 0.04 0.31 1.63 0.00 0.73 1.30 0.98 0.46
24 Mizoram 0.55 0.51 0.59 0.60 0.61 0.55 0.60 0.14 0.30 0.48 0.36 0.30
25 Nagaland 0.98 0.76 1.23 1.09 0.73 1.30 1.09 0.81 0.19 0.87 0 0.68
26 Orissa 8.15 0.00 12.89 9.06 9.06 18.66 8.10 8.10 17.36 6.48 4.86 6.65
27 Pondicherry 0.18 0.14 0.12 0.21 0.09 0.12 0.24 0.24 0.11 0.19 0 0.07
28 Punjab 4.14 2.68 4.27 4.60 3.45 6.93 5.35 4.01 7.75 4.28 3.21 6.65
29 Rajasthan 13.34 20.92 19.90 14.82 11.11 23.71 13.26 9.94 28.10 10.61 7.96 12.12
30 Sikkim 0.30 0.19 0.26 0.33 0.26 0.45 0.33 0.25 0.53 0.27 0.20 0.18
32 Tamil Nadu 10.78 0.00 2.18 11.98 12.75 6.32 13.94 13.94 8.01 11.15 0 4.33
33 Tripura 1.81 0.00 1.05 2.01 1.33 1.53 2.01 1.51 3.09 1.61 1.21 0.56
34 Uttar Pradesh 38.79 60.40 78.82 43.10 0.00 112.85 38.56 28.92 93.16 30.85 23.14 43.07
35 Uttarakhand 2.27 0.00 3.47 2.52 1.88 5.36 1.95 1.47 5.18 1.56 1.17 4.17
36 West Bengal 13.65 1.25 17.14 15.17 30.80 25.96 17.65 13.24 26.98 14.12 10.59 17.68
37 Telangana 6.82 5.11 4.46 5.45 0 4.76
Grand total 225.00 221.70 360.57 250.00 188.91 441.94 250.00 189.19 430.05 200.00 131.93 203.52
38 Others 0.00 0.00 2.85 0.00
Grand total 225.00 221.70 363.42 250.00 188.91 441.94 250.00 189.19 430.05 200.00 131.93 203.52
Note:
1). Expenditure includes expenditure against central Release, state release & unspent balances at the beginning of the year. Expenditure for the F.Y. 2015-16 (upto 30.09.2015 as per FMR) are provisional.
2). Release for the F.Y. 2015-16 is updated upto 30.10.2015 and is provisional
3). The above Releases relate to Central Govt. Grants & do not include state share contribution.
Annexure III
INTEGRATED DISEASE SURVEILLANCE PROGRAMME
SUMMARY OF FINANCIAL STATUS OF STATE SOCIETIES (Rs in Lacs)
As on 05.11.2015
Sl. No. States/UTs GIA Released to States Expenditure
2012 - 13 2013-14 2014-15 2015-16 2012 - 13 2013-14 2014-15 2015-16
1 Andhra Pradesh 104.29 198.31 122.48 181.84 229.84 167.45 40.37
2 Gujarat 205.4 270 400 243.75 311.27 490.55 509.78 64.44
3 Karnataka 214.22 124 270.5 180 214.65 298.58 367.91 175.35
4 Maharashtra 100 183.5 280 210.43 210.2 195.21 55.01
5 Punjab 198.96 120.2 168.75 115 173.2 223.18 282.1 124.93
6 Rajasthan 231.77 195.32 325 225 214.92 293.04 471.03 121.25
7 Tamil Nadu 60 98.26 325 213.75 143.29 287.2 350.6 156.87
8 Uttarakhand 90.87 60.93 45 115.33 160.97 177.72 26.54
9 West Bengal 151.67 120.11 250 100 200.83 221.81 181.73 44.91
10 Andaman & Nic. Islands 19.87 9 5.25 11.27 6.43 6.06 3.31
11 Bihar 147.35 164.69 200 167.56 190.84 200.94 11.5
12 Chandigarh 7.03 19.92 40 23.25 14.66 28.31 30.53 18
13 Chhattisgarh 96.74 29.67 60 100 65.86 89.49 130.22 20.88
14 Dadra & N. Haveli 22.36 21 13.5 15.04033 23.96 27.79 18.38
15 Daman & Diu 31.32 6.01 22.5 15.59 31.41 24.7433 9.11
16 Delhi 34.9 56.25 63.75 33.22 56.51 90.6 36.28
17 Goa 18.02 28.23 45 20 21.94 33.62 43.78 21.35
18 Haryana 220.35 71.32 150 135 134 169.1 181.25
19 Himachal Pradesh 28.34 73.06 70 52.5 46.56 56.98 63.2 10.67
20 J&K 50 82.22 127.5 150 94.71 119.09 129.72 11.79
21 Jharkhand 119.25 112.5 100 91.05 137.49 157.54 23.01
22 Kerala 23.84 106.21 101.25 112.5 106.44 147.61 131.19 47.7
23 Lakshadweep 1.13 0.82 3.13 0.39
24 Madhya Pr. 120.65 246.51 350 225 245.12 340.66 359.59 167.53
25 Orissa 118.3 92.72 350 150 146.48 247.08 310.14
26 Puducherry 30 43.6 70 48.75 45.17 60.07 61.26 28.76
27 Uttar Pradesh 203.88 300 225 344.89 178.35 478.01
28 Telangana 0 0 87.53 93.75 0 0 98.23 71.73
29 Arunachal Pr. 94.21 181.69 152.24 107.87 201.23 131.03 114.84
30 Assam 170.41 129.91 206.25 262.5 176.92 220.37 296.54 63.72
31 Manipur 42.6 25.69 96.25 50 55.26 41.88 84.07 4.95
32 Meghalaya 59.54 20.25 45 50 34.01 56.96 47.84
33 Mizoram 36.53 70.44 97.5 75 66.01 84.07 80.23 13.44
34 Nagaland 60.3 115.84 120 112.5 113.47 127.01 112.57 38.89
35 Sikkim 20.87 30 50 30 28.81 38.12 48.42 9.61
36 Tripura 15.32 50 30 16.38 23.61 44.94 7.12
Sub Total OTNE
2217.8 2760.36 4342.77 2618.25 3366.45033 4333.19 5231.4533 1310.06
Sub Total NE
484.46 589.14 817.24 610 598.73 793.25 845.64 252.57
Grand Total 2702.26 3349.5 5160.01 3228.25 3965.18033 5126.44 6077.0933 1562.63
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