After capping the prices of stents, the Ministry Health and Family Welfare is mulling legal routes to make prescription for generic drugs a must. The ministry has also taken a number of measures to promote clinical trials in the country in a scientific and ethical manner, Minister of Health and Family Welfare JP Nadda tells TEHELKA
Edited Excerpts from an interview •
Why only 1.5 per cent clinical trials take place in India, which is very less in comparision to other countries?
India continues to be an attractive destination to conduct trials keeping in view the availability of a large patient pool with genetic diversities, state of the art facilities in numerous medical institutions, hospitals, well-qualified Good Clinical Practices (GCP) and trained medical professionals. It offers an opportunity for generating a large number of jobs for scientific and technical manpower.
Currently, the number of clinical trials being conducted in the country is very small when seen in the context of the disease burden in the country and availability of scientific and technical manpower. The dip in the number of clinical trials conducted in India in the recent past was due to concerns raised on various issues including unpredictability in regulatory practices, procedure for review and approval of clinical trials, functioning of Ethics Committees, Subject Expert Committees, examination of reports of Serious Adverse Events and payment of compensation, number of trials allowed per investigator, number of beds required in hospitals to qualify as clinical trial sites, academic clinical trials for repurposing of existing medicines, and provisions relating to audio visual recording of informed consent, etc.
Realising the importance of clinical trial in development of new drugs to cope up with the disease burden, the Ministry of Health and Family Welfare has taken a number of measures to promote conduct of clinical trials in the country in a scientific and ethical manner. To ensure expeditious evaluation of applications without compromising the quality of review, twenty-five panels comprising experts from Government Medical Colleges and other reputed Institutions across the country have been set up for evaluation of applications for conduct of Clinical Trials and New Drugs. Within the overall mandate of ensuring patient safety, a number of changes have been made in the Drugs and Cosmetics, Rules, 1945 to expedite decision making. Thus for example, the requirement of audio-visual (AV) recording of Informed Consent Process (ICP) of all subjects in clinical trials has been revised. Recording of such consent is now mandatory only in case of vulnerable subjects in clinical trials. In case of clinical trial of anti-HIV and anti-Leprosy drugs, only audio recording of consent is required. Similarly, no permission is required for conduct of clinical trials of approved drug formulations for new indication, route of administration, etc. for Academic/Research purposes subject to the condition that the trial has been approved by the Ethics Committee and the data generated will not be submitted to the regulatory Authority for new drug approval purposes.
The restriction of not more than three clinical trials by an Investigator has been removed and, now, the respective Ethics Committees have been empowered to take a call considering the risk and complexity and quantum of work involved in a particular clinical trial. The requirement of at least 50 bedded hospitals across the board for all kinds of clinical trials has been revised. Since different kinds of trials requires distinct facilities, the Ethics Committees have been empowered to take a decision keeping in view the suitability and availability of adequate investigational and treatment facilities at such sites.
No NoC is now required for addition of new clinical trial sites or investigators. The respective Ethics Committee, after due diligence, can approve such proposals for addition of site(s) and investigator(s). Obligation of sponsor is now be limited to informing the CDSCO about any such addition/deletion and if, no objection is received from DCG(I), it would be deemed to have the concurrence of CDSCO. IT enabled system for online submission and processing of clinical trial application has been developed.
It is also pointed out that a new separate and comprehensive New Drugs and Clinical Trials Rules are under preparation and these will be finalized after detailed consultations with all stakeholders. The new rules will bring the highest degree of clarity and convergence with international practices.
Are there any financial commitments in tackling non-communicable diseases in India?
While the financial allocations are being finalized (work-plan being finalized), it has been clearly stated by us and spelled out in the NHP 2017 that the overall focus of the Ministry of Health will be on ‘wellness’ in addition to sick-care and thereby NCDs become our prime focus.
We are going to carry out phased transformation of our 1.5 lakh Sub centers to ‘wellness centers’ to screen the NCDs including screening for 3 cancers viz. cervix, breast and oral cancer.
Currently we are managing NCDs through National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) wherein 356 District NCD Clinics, 103 Cardiac Care Units, 71 Day Care Centres and 1,871 CHC-NCD Clinics for management of common NCDs have been established.
For tertiary care, Tertiary care cancer centers (TCCC) scheme, 20 state cancer institutes (SCI) and 50 TCCCS have been envisaged of which so far, 8 TCCC and 9 SCI have been supported with financial assistance under the programme.
Also AYUSH facilities and methodologies and yoga integrated with NPCDCS services
Criticism is always easier than real action. I will lay down some facts and let you decide. Besides sustaining India’s Polio free status, India is the first country to be officially acknowledged as being Yaws-free (much before the WHO global target year of 2020.). Also India was validated for Maternal and Neonatal Tetanus Elimination (MNTE) in April 2015, much ahead of the global target date of December 2015.
What is perhaps noteworthy is that India’s Under five Mortality Rate and Maternal Mortality Ratio declined at a higher pace than global average. The percentage annual compound rate of decline in IMR during the period of the Mission also accelerated from 2.1 per cent to 4.5 per cent.
There has been a significant decline in Total Fertility Rate (TFR). The TFR in India declined from 3.8 in 1990 to 2.9 in 2005 to 2.3 in the year 2013. 24 States/UTs have already achieved replacement level of less than 2.1.
This has been possible due to improve health systems, on which the Ministry has been focussing. Furthermore, we are tirelessly working towards health system strengthening through our flagship programme the National Health Mission. It caters to not only reproductive health issues but also Communicable diseases (all vector borne diseases & TB) and NCDs, Blindness et all. Under NHM:
During the last 2 years (2014-2016), 4343 new constructions and 7498 renovations of health facilities including SC, PHC, CHC, SDH and DH were sanctioned, whereas 6908 constructions and 6423 renovations have been completed.
Accredited Social Health Activists (ASHAs): 43,726 ASHAs have been selected in the entire country and 62,047 provided with health kits.
8205 additional health human resources have been added under NRHM.
8048 AYUSH doctors have been engaged under NHM.
Emergency Response Service (ERS): 2924 vehicles supporting Dial 102/104 services and 923 vehicles supporting Dial 108 services were operationalized.
1122 MMU are operational in the country across 335 districts. A whole range of health care services ranging from treatment of minor ailments, communicable & non communicable diseases, Reproductive & Child Health, Family Planning and in some cases, diagnostics services free of cost to the population in the target area through these mobile units.
Community participation: 2.85 Crore Village Health and Nutrition Days (VHND) were held under NRHM.
3.34 Crore beneficiaries were added under Janani Suraksha Yojana (JSY).
Through NHM we are giving high salaries, hard area allowances etc to attract & retain the HR NCD program wherein there are efforts for providing early diagnosis and management of common NCDs, build capacity at various levels of health care facilities for prevention, diagnosis and treatment of common NCDs through 356 district NCD cells and 356 district NCD clinics, 103 cardiac care units, 71 day care centres and 1871 CHC level NCD clinics. Further as part of the tertiary care cancer centers (TCCC) scheme, 20 state cancer institutes (SCI) and 50 TCCCS are envisaged out of which 5 TCCC and 6 SCI have been supported with financial assistance under the scheme so far.
Malaria, Dengue, Chikungunya, Kala-Azar are being taken care through National Framework for Malaria Elimination (NFME) which comprises preventive measures by source reduction, engineering methods, use of Long Lasting Insecticidal Nets (LLIN), Indoor Residual Spray (IRS), repellents, early case detection, complete treatment as part of the strategy. Accredited Social Health Activists (ASHAs) are being involved in source reduction activities (emptying containers to prevent breeding of vector mosquitoes) for Dengue prevention and control.
Besides the above mentioned, we also have to tackle Tuberculosis (TB) and HIV/AIDS. As concerns TB, until 2015, 128 CBNAAT sites are functional in the country largely providing decentralized testing for detection of DR TB and now additional 500 machines have been provided for ensuring access to rapid quality assured diagnosis of DR TB and in all the districts of the country. Additionally, Bedaquiline was launched as part of the RNTCP as a conditional access programme. The drug is a new anti-TB drug for treatment of MDR-TB.
As concerns HIV/AIDS we have launched Third line free ART programme for People Living with HIV which brings India’s ART programme at par with programmes in the developed countries. Also recently Ministry launched the ‘Test and Treat’ policy wherein any person tested positive for HIV will be put on free ART irrespective of the CD4 count or clinical stage. India has nearly 1600 ART and Link ART sites where treatment is provided across the country and recently we crossed the 1 million people on ART.
Other initiatives for provisioning tertiary level care while keeping in mind the load of Out of Pocket (OOP) expenditure is the Pradhan Mantri National Dialysis Programme. Under this, every facility will have 6 dialysis machines and will be extended up to 10 machines per facility.
So far, 1,069 Dialysis Units, 2,319 Dialysis Machines have been made operational. Nearly 1.1 lakhs patients have availed of services and almost 12 lakh dialysis sessions have been held. We have 83 AMRIT stores which have served more than 17.97 lakhs patients and made them a saving of 103.55 Crores The MoHFW and Ministry of Drinking Water & Sanitation, launched a joint initiative – Swachh Swasth Sarvatra on 29 December, 2016. In those blocks, where, through efforts of the MDWS and local community, Open defecation has been eliminated, the MOHFW will provide their Community Health Centre (CHC) a grant of Rs. 10 lakhs to ensure that the facility achieves High Quality benchmarks of sanitation, hygiene and infection control (minimum score of 70 under the Kayakalp assessment). Better community behaviour and a clean facility is envisaged to complement each other by reducing the disease burden related to water borne disease. Simultaneously, MDWS will undertake ODF activities in the Gram Panchayat of Kayakalp award winning PHCs. Ministry of Drinking Water & Sanitation will also provide WASH training to a nominee of those CHCs and PHCs. This complementarity will enable stakeholders to work together for a joint vision and become accountable for common goals.
Besides NHM, overall at the central level A total of 22 Medical Colleges with 1715 MBBS seats have been approved. Total approved cost 2058 Crore with Central Share 1234.80 Crore.
205 Crore has been released for 22 Medical Colleges during 2015-16 & 2016-17. New medical colleges attached with existing District/ Referral hospitals: MoUs received from all States/UT; 53 proposals approved so far at a total cost of 10017 Crore (Central Share is 6860.70 Crore). 5300 new MBBS seats to be created. 1953.42 Crore released for 51 medical colleges. Five new Medical Colleges i.e. at Port Blair (A&N Islands); Rajnandgaon (Chhattisgarh); Sarguja (Chhattisgarh); Gondia (Maharashtra); and Nahan (Himachal Pradesh) are functional.
The DNB seats, which are equivalent to MD/MS, have increased by 2147 in the last one year. Since July 2014, 1675 hospital beds added in the six functional AIIMS (including 850 beds added in the last one year). Basket of services in six AIIMS expanded and presently, on an average, about 1663 major surgeries are getting performed every month.
Construction of Super Specialty Block in four GMCs completed, adding up to 902 hospital beds, six Super Specialty Departments and three Trauma Centres.
About 1.4 per cent of GDP is spent on healthcare in India, which is one of the lowest percentages in the world. Is the government planning to increase this percentage?
The NHP 2017 has COMMITTED to 2.5 per cent of GDP for health in a phased manner and how we intend to do so is also laid out in the policy.
In 2014 the health ministry had started a program for immunization “INDRADHANUSH”. What success has been achieved in this regard as the goverment aims to complete its target by 2020.
I need to clarify that Mission Indradhanush was not a separates and parallel program to MoHFWs Universal Immunization Program (UIP)/Routine Immunization (RI). To supplement the efforts of RI we conceived of a special targeted intervention to reach out to all those children who have been left out of the RI drives or are partially-immunized. This was called ‘Mission Indradhanush’. It is a sub part of the overall UIP of the country, designed and implemented to increase the coverage of UIP itself.
During the three phases of Mission Indradhanush, 497 districts across 35 states/UTs were covered. During these phases, more than 2.1 crore children were reached of which 55 lakh children were fully immunized. In addition, 55.9 lakh pregnant women were also vaccinated with Tetanus toxoid. The platform of Mission Indradhanush was also utilized for distributing 52.2 lakh ORS packets and 183.1 lakh Zinc tablets to children. 4th phase of Mission Indradhanush commenced on 7th February 2017 in 8 North eastern states and in 180 districts across 18 states from 7th April in rest of the country. As on date, more than 2.7 crore pregnant women and children have been immunized. The annual rate of immunization which was earlier 1 per cent has grown to 6.7 per cent.
You announced in 2015 to include vaccination for rubella, rotavirus and encephalitis also. Any progess on that front?
Yes, all the vaccines you are mentioning have been rolled out:
Rotavirus Vaccine: launched on 26th March 2016 and has been introduced in four states i.e. Andhra Pradesh, Odisha, Haryana and Himachal Pradesh. Rotavirus vaccine expansion to four more States (Madhya Pradesh, Assam, Rajasthan and Tripura) has been done on 18th February 2017 and planned in Tamil Nadu and Uttar Pradesh in 2017-18.
Japanese encephalitis: JE vaccination program started in 2006 in JE endemic areas with strategy to cover all children of 1-15 years of age in mass vaccination drive (campaign mode) and subsequent integration into routine immunization. Out of total 215 identified JE endemic districts, campaign activity has been completed in 206 districts. JE vaccine has been introduced as a part of RI in these 206 districts (two doses, first at 9-12 months and second at 16-24 months).
Adult JE vaccination: NVBDCP has identified 31 high burden districts from Assam, Uttar Pradesh and West Bengal for adult JE vaccination. Adult vaccination campaign (15-65 years age group) with JE has been carried out in all the identified districts.
Rubella vaccine initiated as Measles Rubella (MR) campaign targeting children aged 9 months to 15 years of age and was launched on 5th February 2017 in five states/UTs (Karnataka, Tamil Nadu, Goa, Lakshadweep & Puducherry). All the states will be covered in a phased manner over a period of 3 years. Subsequent to the completion of the campaign, the Rubella vaccine will be introduced as MR vaccine as two doses in the place of measles containing vaccine 1 & 2 at 9-12 months and 16-24 months as part of Routine Immunization (RI).
We are also going to launch PCV (Pneumococcal Conjugate Vaccine) on the upcoming 13th May.
Organ donation is one of the important issue Ministry of Health data indicates that annually one to two lakh organ transplant required, but only 5,000 transplants takes place. What steps Ministry is taking to increase the percentage?
The government has launched National Organ Transplant Programme (NOTP) for carrying out the activities as per Transplantation of Human Organs and Tissues Act, 1994 training of manpower and promotion of organ donation from deceased persons. Under the said programme, an apex level organization, National Organ and Tissue Transplant Organization (NOTTO) has been set-up at Safdarjung Hospital, New Delhi for National networking, National Registry, to provide an online system for procurement and distribution of Organs & Tissues and to promote Deceased Organ and Tissue Donation More than 1 lakh pledges for organ donation have been received.
A 24×7 call centre with toll free helpline number (1800114770) has been established for providing information on organ donation and coordinating matters relating to retrieval and allocation of organs recovered from cadaver donors.
National Organ and Tissue Donation and Transplant Registry (NOTTR) have been launched. NOTTO has launched National Registry for maintaining National Waiting list of patients who require organs/ tissue.
The networking of transplant and/or retrieval hospitals has been started initially in Delhi and NCR. Five regional level organizations called Regional Organ and Tissue Transplant Organization (ROTTO) have been identified in the States of Tamil Nadu, Maharashtra, Assam, West Bengal and UT of Chandigarh for networking and coordinating procurement and distribution of organs. Operational Guidelines for National Organ transplant Programme has been released.
Policy and criteria for organ allocation in case of Kidney, Liver, Heart & Lung and Cornea have been approved. Standard Operating Procedures for various vital organs has been approved and uploaded on NOTTO website.
What are the priorities of the ministry in coming years to improve healthcare system in India?
The demographics of our country is my biggest challenge because not only does my ministry has to ensure services for reproductive health but the double burden of both communicable and non-communicable diseases. Hence the priority is universal health i.e. wellness along with sick-care.
With this priority in mind the required system strengthening will take place as laid out in the NHP 2017 i.e. we are going to carry out phased transformation of our 1.5 lakh Sub centers to ‘wellness centers’ to screen the NCDs including screening for 3 cancers viz. cervix, breast and oral cancer. In the first phase, the population based screening component will be rolled out in 100 districts in 32 states and UTs with about 1000 sub-centres undertaking screening this year. In subsequent phases, Chronic Obstructive Respiratory diseases will be included and the programme will be scaled up to cover other districts. Support to states will also be provided for community health promotion and prevention efforts, and referral and treatment.
Like fixing the cost of stents, what other measures is the government planning?
Stents was a step towards bringing affordability and reducing the out of pocket expenditure (OOPE). Next as is all over the news i.e. push towards generic medicines. In this regard MoHFW recently issued a draft gazette notification making it mandatory for pharma companies to carry generic name of drugs on packs that is at least two fonts larger than the brand name. This clause will be a legal provision as a rule under the existing Drugs and Cosmetics Act and any violation will be punishable under the provisions of the law. The ministry has sought public comments on the draft, after which it is likely to become part of the drug law. Issued orders to the Medical Council of India (MCI), state governments and all central government hospitals asking them to ensure that doctors write prescriptions with generic names of medicines in legible hand writing.
In last three years, the government has capped prices of around 700 essential medicines. It has also capped prices of stents and is working to make drugs for critical diseases like cancer and heart disorders available through various schemes. It has also launched several programmes to make free drugs and diagnostics available under the National Health Mission.