Affordable Drugs for Hepatitis C



Affordable Drugs for Hepatitis C 


The figures of Hepatitis C affected Indians who could not afford medical treatment are not collected centrally. However, the cost of treatment for Hepatitis C is high for the cases which require treatment. The Government of India has launched a National Programme for prevention and control of viral Hepatitis during 12th Five Year Plan period under which the activities undertaken, inter alia, are: 


1.      Laboratory network for laboratory based surveillance of viral hepatitis in different geographical locations of India, in a phased manner.
2.      Setting up of one Reference Laboratory at National Centre for Disease Control (NCDC), Delhi.
3.      Training and capacity building of professionals in relevant sectors, like Microbiologists, Laboratory Technicians, data Managers and Field Workers.
4.      Laboratory support for outbreak investigation of hepatitis through established network of laboratories.
5.      Development of guidelines and creating awareness for prevention and control and treatment of blood borne and water borne hepatitis.
6.      Information Education and communications (IEC) for dissemination of information about prevention and control of viral hepatitis.

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

Subsequently, CDSCO has also granted permission to manufacture and market Sofosubuvir 400 mg tablet in March, 2015 to Indian manufacturers namely, M/s Hetero Labs. and Natco Pharma.  CDSCO has no information about cost of the drug.

The Minister for Health & Family Welfare, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today.

 *****
Measures Taken to Eradicate AIDS Disease 


The National AIDS Control Organization (NACO) has taken following key steps to prevent and control the HIV epidemic in the country:-
¡        Revised Migrant Strategy with focus at Destination, Transit & Source and Employer-led Model to address vulnerabilities of migrant labour.

¡        Scale up of Opioid Substitution Therapy at Public Health settings to control HIV among IDU & sensitization of law enforcement agencies.

¡        For elimination of HIV infections among children, lifelong ARV to HIV positive pregnant women for prevention of Parent to Child Transmission of HIV has been rolled out.

¡        In certain pockets of high prevalence states where HIV prevalence among FSW and MSM continues to be high, emphasis is given to sustain the higher coverage of targeted interventions and improve the quality of outreach.

¡        Scale-up of free 1st line and 2nd line Anti retroviral Treatment for People living with HIV and strengthening supply chain management of drugs.

¡        National Helpline was launched to facilitate easy dissemination of information related to HIV/AIDS to general public, People Living with HIV/AIDS (PLHIV), High Risk Groups (HRG) and vulnerable population in 8 Indian languages.

¡        Considering the fact that combination of multi-drug in a single pill is very effective, well tolerated, so once a-daily fixed dose regimen (FDC) has been rolled out in a single pill ARV drug among the 1st line treatment patients.

¡        Mainstreaming and partnerships is recognized as a key approach in National AIDS Control Programme to facilitate multi-sectoral response engaging a wide range of stakeholders and optimally utilize the resource available from other Ministries and Department. In this regard the NACO has identified 31 key Departments/ Ministries of Government of India for mainstreaming. 12 such Memoranda of Understanding (MoU) has already been signed.

The Minister of State, Ministry of Health and Family Welfare, Shri Shripad Yesso Naik stated this in a written reply in the Rajya Sabha here today.

*****

Emergency Facilities in CGHS Dispensaries 

The CGHS dispensaries have all the medicines required in emergency. As per the CGHS guidelines, a provision is there to keep medicines available to counter any medical emergency that might arise within the Wellness Centre. There is an Emergency Tray available with the nursing staff which contains most of the medicines required under emergency situation. The availability of the medicines with their valid date of expiry in this Emergency Tray is checked on a regular basis and also during surprise checks. 

A complaint was received on 07.09.2013 from Sh. R. C. Khuntia, the then Member of Parliament in respect of pensioner beneficiary, Sh. B. K. Joshi regarding non-supply of life saving drugs on time by CGHS Bhubaneswar. The delay in supply was due to non availability of cancer medicine with the authorized stockiest. 

In case the medicines are not available at the Wellness Centre, they are procured through local purchase. If any medicine is prescribed by the treating doctor that is required to be used immediately and if that medicine is not available in the Wellness Centre, authority slip is issued to the patient to collect the medicine from the authorized local chemist free of cost. 

The Minister for Health and Family Welfare, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today. 

*****
Laboratories for Testing Medical Devices 

Medical devices are currently tested in the following laboratories: 

(i). National Institute of Biologicals, Noida - For testing diagnostic devices viz. HIV, HBsAg and HCV; 

(ii). Central Drugs Testing Laboratories, Mumbai – For testing of Intra Uterine Devices viz Cu-T & Tubular Rings which are included in Schedule R to the Drugs and Cosmetics Rules,1945; and 

(iii). Central Drugs Testing Laboratories, Chennai - For testing of Condoms. 

The current emphasis of the Department of Health and Family Welfare is on strengthening the existing laboratories. However, when required, the Department of Commerce also supports establishments of common testing laboratories for medical devices and diagnostic equipment under Central Assistance to States for Infrastructure Development of Export Scheme to support the growth of the industry. 

The Minister for Health and Family Welfare, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today. 

*****

Monitoring of Medical Devices and Clinical Trials 

After extensive consultations with all stakeholders including the States, the Central Ministries/Departments, Industry and Consumer Associations and after placing the proposed charges in public domain and due consideration of all the suggestions/comments received, a draft Bill has been prepared and sent to the Ministry of Law and Justice for vetting. 

The Bill is proposed to be introduced in the next session of Parliament. The Minister for Health & Family Welfare, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today. 

*****

Implemention of Rashtriya Arogya Nidhi (RAN) 


The Rashtriya Arogya Nidhi (RAN) is under implementation in the country. Details of scheme and salient features are given below:-

The Rashtriya Arogya Nidhi (RAN) has been set up vide Resolution No. F-7-2/96-Fin-II dated 13/1/1997 and registered under the Societies Registration Act, 1860, as a Society. The RAN was set up to provide financial assistance to patients, living below poverty line and who are suffering from major life threatening diseases, to receive medical treatment at any of the super speciality Hospitals/Institutes or other Government hospitals. The financial assistance to such patients is released in the form of ‘one-time grant’, which is released to the Medical Superintendent of the Hospital in which the treatment has been/is being received.

            The RAN is operationalized through four windows, detailed below:

(i)                  Revolving Funds have been set up in 12 Central Government Hospitals/Institutions located all over India for providing financial assistance for treatment upto Rs. 2 lakh.       
(ii)                Financial assistance is provided from RAN Headquarters for cases referred by Government hospitals/institutions, which do not have a Revolving Fund and for cases referred by 12 Government hospitals/institutions with Revolving Funds for assistance exceeding Rs. 2 lakh.
(iii)               State Illness Assistance Fund set up in all States/UTs (with Legislature) except Meghalaya and Nagaland. Grants-in-aid to States/UTs is released to the extent of 50% of the contributions made by the State Governments/UTs to the State Fund/Society subject to a maximum of Rs. 5 crore to States with larger number and percentage of population below poverty line viz. Andhra Pradesh, Bihar, Madhya Pradesh, Karnataka, Maharashtra, Odisha, Rajasthan, Tamil Nadu, Uttar Pradesh and West Bengal and Rs. 2 crore to other States/UTs. Funds to the States/UTs are released on submission of utilization certificate and list of beneficiaries in respect of funds released to them earlier.

(iv)              Health Minister’s Cancer Patient Fund (HMCPF) within RAN which has been established as a separate Corpus Fund, and is also managed by the Managing Committee and Technical Committee of RAN. An amount of Rs. 100.00 crore has been placed in the Corpus Fund and the earning from the Corpus Fund accrued out of interest is utilized for providing financial assistance to cancer patients through 27 Regional Cancer Centres (RCC) located all over India. Revolving Funds have been set up in  these RCCs by placing an amount upto Rs. 50 lakh for providing financial assistance for treatment upto Rs. 2 lakh. Cases involving expenditure over and above Rs. 2 lakh, are referred to the Ministry. Funds to the RCCs are released on submission of utilization certificate and list of beneficiaries in respect of funds released to them earlier.

(v)                An illustrative list of categories of treatment to be provided from the Fund is given below:-

An illustrative list of categories of treatment to be provided from the fund is as  follows : (This list is reviewed by the Technical Committee from time to time ):

1. Cardiology & Cardiac Surgery:
         1. Pacemakers
         2. CRT/Biventricular pacemaker
         3. Automatic Implantable Cardioverter defibrillator (AICD)
         4. Combo devices
         5. Diagnostic Cardiac Catheterization including Coronary Angiography
         6. Interventional procedure including Angioplasty, Rota-ablation,
             Balloon Valvuloplasty e.g. PTMC, BPV etc.
         7. ASD, VSD and PDA device closure
         8. Peripheral Vascular Angioplasty, Carotid Angioplasty, Renal
             Angioplasty
         9. Coil Embolization and Vascular plugs
         10. Stents including Drug Eluting Stents
         11. Electrophysiological Studies (EPS) and Radio Frequency (RF)
               Ablation
         12. Heart surgery for Congenital and Acquired conditions including
               C.A.B.G
         13. Vascular Surgery
         14. Cardiac Transplantation etc.
2. Cancer :
1.      Radiation treatment of all kinds including Radio Therapy and
         Gama Knife Surgery.

2.      Anti-Cancer Chemotherapy supportive medication and antibiotic,
         Growth factor,

3.            Bone Marrow Transplantation- Allogenic & Autologous
4.            Diagonostic Procedures- Flow cytometry/cytogenetics /IHC Tumour
         Markers etc.

5.      Surgery for cancer patients
6.      Catheters, central lines and venous access devices.


3. Urology/Nephrology/Gastroenterology :

1.Dialysis and its consumable (Both haemodialysis as well as Peritoneal)
2.Plasmalpheresis in acute renal failure
3.Continuous renal replacement therapy in acute renal failure in ICU sick
    patient.

4.Vascular access consumables (Shunts, catheters) for Dialysis
5.Renal transplant-cost of renal transplant varies from 2.5 to 4.0 lakh
   Depending upon type of drug used as per patient need.

6.PCN and PCNL Kits
7.Lithotripsy ( for Stones)
8.Disposables & Stents for endoscopic surgical procedures in Urology &
   Gastroenterology.

9.  Liver Transplantation and Surgery for portal hypertension.


4. Orthopedics:

1.                  Artificial prosthesis for limbs
2.                  Implants and total hip and knee replacement
3.                  External fixaters
4.                  AO implants, used in the treatment of bone diseases and
                      fractures

5.                  Spiral fixation Implant- Pedicle Screws (Traumatic,
                        Paraplegic, Quadriplegic)

6.                  Implant for Fracture fixation (locking plates & modular)
7.                  Replacement Hip –Bipolar /fixed
8.                  Bone Substitutes
5.  Neurosurgery – Neurology :
1                    Brain Tumors
2                    Head injuries
3                    Intracranial aneurysm
4                    AVMs
5                    Spinal tumors
6                    Degenerative /Demyelinating diseases of brain/spinal cord
7                 Stroke
8                    Epilepsy
9                    Movement disorders
10                Neurological infections
6. Endocrinology :

1.                  Hormonal replacement for lifelong therapy :
-   Cases of complicated diabetes which require one time treatment
     e.g. amputation or renal transplant
-    Hypo pituitarism
-    Hypo thyrodism
-    GH deficiency
-    Cushings Syndrome
-    Adrenal insufficiency
-    Endocrine surgery
7.       Mental Illness :
1.                  Organic Psychosis acute and chronic
2.                  Functional psychosis including Schizophrenia, Bio-polar
Disorders, delusional disorders and other acute polymorphic psychosis

3          Severe OCD, Somatoform disorders, eating disorders

4.         Developmental disorders including autisms spectrum disorders and        Severe behavioural disorders during childhood.                                                                                                            
                                                                   
8.      Drugs :
1.                  Immunosuppressive drugs
2.                  Anti D
3.                  Anti Haemophilic Globulin
4.                  Erythropoietin
5.                  Blood & Blood products/Plasma for patients of Burns
6.                  Liposomal Amphotericin
7.                  Peg Interferon
8.                  Ribavarin
9.                  CMV treatment (IV Gancyclovir, Valganciclovir)
10.              Voriconazole
11.              Anti-rejection treatment (ATG, OKT 3)
12.              Treatment for Post –transplant viral infection
13.              Any life supporting drugs.         
9.                    Investigations:

Ultra-sound, Doppler studies, Radio-nucleotide scans, CT Scan, Mammography, Angiography for all organs, M.R.I, E.E.G, E.M.G, Uro-dynamic studies, Cardiac Imaging- Stress Thallium & PET, Cardiac MRI, Investigation for CMV, BK Virus, TMT, Echocardiography.
Psycho diagnostics, neuropsychological assessments, IQ assessments, blood tests like serum lithium and drug level of carbamazepine, valporate, phenytoin and any other similar medications: CSF studies screening for substances or abuse/toxicology.

10.               Others :


1.                  Immunoglobulin for AIDP (GB Syndrome) and Myasthenia Gravis.
2.                  Anti viral
3.                  Anti Fungal
4.                  Wilson disease : Penicillamine A
5.                  Botulinum A toxin injection for spasticity
6.                  Baclofen for spasticity


11.               Miscellaneous :


Shunts for Hydrocephalus.

12.   Other major illness/treatment/intervention considered appropriate  for financial assistance by Medical Superintendent/Committee ofDoctors could be considered for grant.



The Minister for Health and Family Welfare, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today.

                                                          *****

Adulteration of Milk and Milk Products 

The Food Safety and Standards Authority of India (FSSAI) had conducted a nationwide survey on milk adulteration in 2011 through its five regional offices. A total of 1791 samples were drawn from 33 states and were tested in the Government laboratories. 68.4% of the samples were found to be non-conforming to the prescribed standards. Out of these samples, in 46.8% samples, milk found to be sub-standard in respect of Fat and Solid Not Fat (SNF) contents. Another 44.69% of the samples (548) in respect of skim milk powder were found to be non-conforming to the prescribed standards where presence of glucose was detected in 477 samples. A total of 103 samples (5.75%) were found to be adulterated with detergents. 

The Food Safety and Standards Act, 2006 provides for graded penalties including life imprisonment. However, implementation and enforcement of the Food Safety and Standards Act, 2006 and Rules & Regulations made thereunder primarily rests with State/UT Governments. Random samples of food items are drawn by the State Food Safety Officers and are sent to the laboratories recognized by the Food Safety and Standards Authority of India (FSSAI) for analysis. In cases, where samples are found to be not conforming to the provisions of the Act and the Rules and Regulations made thereunder, penal action is initiated against the offender. The State/UT Governments have been requested by the Department of Health and Family Welfare on 07.01.2015 to finalize State wide Action Plan to draw and test samples of milk products at regular intervals. 

The Minister for Health & Family Welfare, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today. 

*********

International Co-Operation on Health Sector 

To scale up international cooperation in the health sector, various Memorandum of Understanding (MoUs)/Agreements have been signed by the Ministry of Health and Family Welfare/Ministry of AYUSH with foreign countries. The list of countries with whom the MoUs/Agreements have been signed is given below:-
List of Countries
with whom Ministry of Health & Family Welfare / Ministry of AYUSH has signed
Agreements / Memorandum of Understanding (MoUs) /
 Memorandum of Cooperation (MoC) / Statement of Intent (SoI)

Department of Health & Family Welfare:

Sl.No
Name of country
Date of signing
Subject
1.       
Afghanistan
28-08-2005 (Agreement)
Healthcare & Medical Science
2.       
Austria
17-02-2004 (Agreement)
Health
3.       
Bangladesh
12-02-2013  (MoU)
Health & Medical Science
4.       
Brazil
05-05-1998 (Agreement)
Health & Medicine
5.       
Bulgaria
28-11-2011 (Agreement)
Health & Medicine
6.       
Burundi
18-09-2012  (MoU)
Health & Medicine
7.       
Cyprus
08-10-2002 (Agreement)
Public Health & Medical Sciences
8.       
China
03-09-1994 (Agreement)
Health & Medicine
9.       
Columbia
19-01-2010 (Agreement)
Health
10.  
Croatia
09-06-2010 (Agreement)
Health & Medicine
11.  
Egypt
18-11-2008  (MoU)
Health & Medicine
12.  
Fiji Islands
10-10-2005 (Agreement)
Health & Medicine
13.  
Japan
01-09-2014  (MoC)
Healthcare
14.  
Hungary
18-01-2008 (Plan of Cooperation)
Public Health
15.  
India-Brazil-South Africa (IBSA)
17-10-2007 (MoU)
Health & Medicine
16.  
Indonesia
11-10-2013  (MoU)
Health
17.  
Israel
09-09-2003 (Agreement)
Health & Medicine
18.  
Kazakhstan
16-04-2011 (Agreement)
Healthcare
19.  
Kuwait
23-04-2012  (MoU)
Medical cooperation
20.  
Latvia
28-02-2012 (Agreement)
Healthcare & Medical Science
21.  
Malawi
03-11-2010  (MoU)
Health & Medicine
22.  
Maldives
02-01-2014  (MoU)
Health
23.  
Mauritius
12-03-2013  (MoU)
Health & Medicine
24.  
Mongolia
14-09-2009 (Agreement)
Health & Medical Science
25.  
Mozambique
22-02-2004 (Agreement)
Health & Medicine
26.  
The Netherlands
30-01-2014  (MoU)
Health Care & Public Health
27.  
Philippines
05-10-2007  (MoU)
Health & Medicine
28.  
Poland
24-04-2009 (Agreement)
Health & Medicine
29.  
Russia
16-12-2011  (MoU)
Drug quality & safety standards
30.  
Rwanda
12-11-2010  (MoU)
Health & Medicine
31.  
Saudi Arabia
20-11-2006 (Executive Programme)
Health & Family Welfare
32.  
Seychelles
10-09-2003  (MoU)
Health
33.  
Sweden
24-02-2009  (MoU)
Health Care and Public Health
34.  
Tajikistan
03-09-2012 (Agreement)
Health & Medicine
35.  
United Kingdom
19-05-2013  (MoU)
Health
36.  
Yemen
09-06-2013 (Agreement)
Health & Medicine
37.  
US-FDA
10-02-2014  (SoI)
Medical Products
38.  
Among – India, Bangladesh, Bhutan, Nepal and Thailand [facilitated by WHO]
09-09-2014  (MoU)
Kala-azar

Department of Health Research:

Sl. No
Organization / Country
Date of signing
Subject
1.       
Department of Health Research and National Institute of Health & Care (NICE), UK
14-06-2013
Strengthen evidence based clinical policy making in healthcare system through Medical Technology Assessment Board.
2.       
Indian Council of Medical Research (ICMR) and Research Council of Norway on Health Research
14-10-2014
Encourage research in a range of health areas of mutual interest, including human vaccine, infectious diseases and anti-microbial resistance.
3.       
ICMR and International AIDS Vaccine Initiative (IAVI), USA
10-11-2014 
Cooperation in AIDS vaccine development.
4.       
ICMR and the Russian Foundation for Basic Research
11-12-2014
Cooperation in specific areas of health research, such as, oncology, bioinformatics, neurosciences, new generation vaccines and HIV/AIDS.

Ministry of AYUSH:

Sl. No
Country
Date of signing
Subject
1.       
Hungary
17-10-2013
Strengthen, promote and develop cooperation in the field of traditional systems of medicines.
2.       
Bangladesh
09-09-2014
Strengthen, promote and develop cooperation in the field of Traditional Systems of Medicines and Homoeopathy.
3.       
Nepal
25-11-2014
Strengthen, promote and develop Cooperation in the field of Traditional Systems of Medicines.

The international cooperation facilitates capacity building, training, exchange of information, exchange of experts, health manpower development, and technical support in establishing laboratories / hospitals and research in mutually identified areas, on the basis of equality, reciprocity and mutual benefit.  It provides opportunities for sharing and emulating best practices and learning from each other, to address the health challenges faced by the country.
The Minister for Health and Family Welfare, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today.
                                                          *****
  Childeren Vaccinated Under Pulse Polio Programme 
                                                                             
A nationwide pulse polio programme was launched by Government of India in year 1995. The state wise details of number of children who got the benefit of this programme since inception in 1995 till 2015 are given below:

Total number of children vaccinated from 1995-96 to 2014-15 (up to Jan-2015) under Pulse Polio Programme
 (figures in crore)

Sl. No.
STATE/UTs Name
Number of children vaccinated
1
Andaman and Nicobar Islands
0.16
2
Andhra Pradesh
51.21
3
Arunachal Pradesh
0.77
4
Assam
23.36
5
Bihar
228.34
6
Chandigarh
0.85
7
Chhattisgarh
11.41
8
Dadar and Nagar Haveli
0.16
9
Daman and Diu
0.09
10
Delhi
28.08
11
Goa
0.57
12
Gujarat
44.51
13
Haryana
31.27
14
Himachal Pradesh
3.26
15
Jammu and Kashmir
7.67
16
Jharkhand
25.55
17
Karnataka
33.25
18
Kerala
12.44
19
Lakshadweep
0.03
20
Madhya Pradesh
63.89
21
Maharashtra
71.26
22
Manipur
1.48
23
Meghalaya
1.94
24
Mizoram
0.52
25
Nagaland
1.05
26
Odisha
23.14
27
Puducherry
0.46
28
Punjab
21.41
29
Rajasthan
62.13
30
Sikkim
0.29
31
Tamil Nadu
31.83
32
Telangana
0.44
33
Tripura
1.87
34
Uttar Pradesh
394.08
35
Uttarakhand
10.43
36
West Bengal
71.83

 Total
1261.01

The Minister for Health & Family Welfare, Shri J P Nadda stated this in a written reply in the Rajya Sabha here today.

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