Two months have passed since the new Govt under the Prime Ministership of Dr. Manmohan Singh took over the reins in India. The United Progressive Alliance (UPA), finds itself in a position in which no previous Indian Govt since the Narasimha Rao govt. of 1999 has been - a position from which it can consolidate the policies it embarked upon in 2004. It has the right majority in the Parliament to ensure it does not need to make as many compromises as coalition Govts usually do. Unlike last time, there are no constraints of common minimum programme. The congress has the manifesto to follow. Quick reading of the election manifesto shows that it emphasizes continuity and the kind of radical reforms that the market likes. The Indian pharma industry welcomed the UPA's return to power with a decisive mandate reflecting formation of a stable Govt to carry forward economic reforms, with expectations that the Govt would frame policies that will support the sector.
Health is one of the directive principles enshrined in the Indian Constitution. Although Article 21 of the Constitution requires the State to ensure the health and nutritional well being of all people, the Govt has a substantial technical and financial role in it.
The Indian healthcare sector constitutes:
• Medical care providers: physicians, specialist clinics, nursing homes and hospitals
• Diagnostic service centers and pathology laboratories,
• Medical equipment manufacturers,
• Contract research organizations (CRO's),
• Pharmaceutical manufacturers, distributors and dealers
• Third party support service providers (catering, laundry)
Before independence of India, the health care sector was in dismal condition with high morbidity and mortality rates and prevalence of infectious diseases. Since then India has worked continuously to improve Primary Health Care and its health care system. Considerable progress has been made in expanding the public system and reducing the burden of disease. But the Govt funded facilities are not matching the growing population demand in primary, secondary or tertiary care. Post Liberalization, in the 1980's the entry norms for private players in the health services industry were relaxed and now the private healthcare facilities are owned and run by for profit companies, non-profit or charitable organizations.
The healthcare industry has emerged as one of the most challenging sector in India with estimated revenue of about $ 30 billion (FY 2005) constituting 5% of the GDP. The Indian health services sector is estimated to be around Rs. 750 billion with hospitals accounting for more than half of this. The sector had a growth of over 12% p.a. in the past four years and is estimated to grow by 170% by 2012. Though the private sector has also been equally responsible in bringing about the desired changes in the health industry, the health sector performance requires much improvement in comparison with other emerging economies. Deficiencies persist with respect to access, affordability, efficiency, quality and effectiveness, despite the high level of overall private and public expenditure on health. More than 26% of population living below the poverty line still finds it difficult to have an affordable access to quality medicines and healthcare facilities. A senior official of the Department of Pharmaceuticals, GOI quoting WHO figures disclosed that only 35% of our population has access to healthcare, mostly from private doctors and hospitals and about 80% our total health spending is on medicines.
In 1978, India pledged along with other WHO member Nations, 'Health for All by the Year 2000' at Alma-Ata; and in the same year signed the International Covenant for Economic, Social and Cultural Rights, under which the State is obliged to achieve the highest attainable standard of health. However the health scenario in India despite growth continues to be abysmal. Alarming and appalling healthcare scenario in India is depicted by the facts that annually 22 lakh infants and children die from preventable illnesses; 1 lakh mothers die during child birth, 5 lakh people die of Tuberculosis. Diarrhea and Malaria continue to be killers while 5 million people are suffering from HIV/AIDS. Many self-help groups believe that since 1990s, the public health system has been collapsing and the private health sector has flourished at the cost of the public health sector because health policy in India has shifted its focus from being a comprehensive universal healthcare system as defined by the Bhore Committee (1946) to a selective and targeted programme based healthcare policy with the public domain being confined to family planning, immunization, selected disease surveillance, medical education and research. The larger outpatient care is almost a private health sector monopoly and the hospital sector is increasingly being surrendered to the market. Reforms of the 90s have created a trajectory of public health spending that shows a downward trend both in terms of share of the Govt's budget as well as a proportion of the Gross Domestic Product.
There have of course been reservations about the Govt budget's outlay on health being only 15% higher than last year. A steady annual increase of 35% is needed over several years to raise public health spending from the present paltry 0.9% of GDP to the National Common Minimum Plans target of 2 to 3%. Another requirement is greater decentralization of the public health delivery system. Health infrastructure is marked by great disparity between rural and urban areas. Most secondary and tertiary health facilities are available in urban and tier-II cities. There is a need to incentivise building up health infrastructure in rural areas.
Recommendations for the UPA Govt.
1. New UPA Govt must fulfill its promise of amending the Drugs and Cosmetics Act so as to award exemplary and deterrent punishments to those dealing with counterfeit medicines.
2. Proposal for constitution of National Drug Authority was first mooted in the Drug Policy of 1994, then came the idea of "Central Drug Authority" (CDA) and then in recent draft of National Pharmaceutical Policy of 2005 there was talk of "National Authority for Drugs and Therapeutics" which sought integration of NPPA, DCGI and CDSCO into one body. Govt. must establish CDA now as early as possible.
3. Govt. must frame a comprehensive, patient-friendly National Pharmaceutical Policy in consensus with the recommendations of various expert committees / commissions without any further dilly-dallying and meaningless meetings.
4. It is high time that the new Govt tightens its noose in regard to price regulation and control of medicines. Erring companies need to be taken to task and overcharged dues need to be recovered, which should be spent on healthcare schemes for poor and downtrodden. All essential medicines should be brought under Price Control commensurate to the ruling of Supreme Court in 2003 and any overcharging by pharmaceutical companies in future should be viewed very seriously.
5. Sale of medicines as food/dietary supplements should not be allowed because not only do the companies in question manage to sell the same product > five times higher price but also manage to escape from attracting legal and penal provisions as provided under Drugs and Cosmetics Act. Present Govt. at the centre needs to bring a tough legislative provision to curb this malpractice and besides punishing the guilty, it should also recover the dues on account of such dubious sale by them in the past. Govt. must seriously think about enacting Criminal Profiteering Act in India to curb such kind of malpractices. This way crores of rupees can be recovered from such erring companies that can be utilized for welfare and healthcare measures of poor sects of the society.
6. NPPA must vigorously monitor the prices of medicines and take serious cognizance of any undue hike. 10% monitoring window should be effectively started. Price monitoring window should be commensurate to the current inflation index of the country.
7. For making available anti-cancer and anti-HIV/AIDS medicines at reasonable prices, Govt. must evolve the public-private partnership programme with the concerned manufacturers and cancer hospitals in the country.
8. Commitments made by previous UPA regime towards Pharmaceutical Research and Development in the country need to be fulfilled. It had established a Pharmaceutical Research and Development Support Fund (PRDSF) having a corpus of Rs. 150 crores (where only interest income is available for spending) and is utilized for funding R&D projects of research institutions and industry in the country. Govt. had duly acknowledged that this amount is by no measures adequate to meet the present day and the emerging requirements of this sector and that this fund would be sufficiently augmented. It was also decided to convert it into an annual grant of Rs. 150 crores, so that thereafter it could be suitably increased further in a phased manner over a period of next five years. Under this fund priority had to be given for R&D in case of diseases which are endemic to India like malaria, tuberculosis, hepatitis-B, leishmania, HIV/AIDS etc. The programme has stagnated at where it was in 2005 and no substantial headway has been made. New dispensation should take up this matter on priority so as to boost pharmaceutical and disease research activities in the country.
9. There is need for a strong first-level care with strong secondary- and tertiary-level care linked to it. New UPA Govt. must take bold initiatives for an integration of preventive, promotive, curative and rehabilitative health services which have to be made accessible and available to the people. Healthcare delivery has to be guided by the principles of universality, comprehensiveness and equity.
10. It is truly a very sad fact that wherever our National Health Policy makes a mention of the health personnel, it mentions only about doctors and nurses, very blissfully and unfortunately ignoring the Pharmacists, who otherwise are an integral and important component of the medical team and whose significant role in healthcare delivery can be ignored only by the ignorant.
11. The national health policy was framed in 2002 and unfortunately no revision or modification has been carried out since then even after seven years after its promulgation. Considering the outbreak of newer diseases, ever changing population characteristics, morbidity and mortality and demography, our National Health Policy direly requires a prompt revision by our new Govt.
12. UPA Govt announced several schemes for making medical and healthcare facilities accessible and affordable to poor people living in far flung areas of the country like National Rural Health Mission, National Illness Assistance Fund, Rashtriya Swasthya Bima Yojana etc. Mute question staring in the face of the Govt is whether these schemes are implemented in letter and spirit and whether their benefits are reaching to the target group or going into the fat bellies of huge armies of sarkari babus and politicians. Union Health Minister recently pledged to ensure full implementation of these schemes by reviewing their progress every six months in every state, by visiting every state twice a year and by holding review meetings with Chief Ministers and Health Ministers. But will these measures suffice to check age old pilferage and diversion tactics of corrupt officials? Whole system has to be shaken up vigorously to ensure their implementation in true sense of the word and accountability has to be monitored, recorded, ensured and legally enforced at every level in the supply chain.
13. Erstwhile Health Minister Ambumani Ramados had made a promise to launch National Urban Health Mission in the country that was supposed to provide insurance cover to the millions of slum dwellers in urban areas with an aim of giving them basic medical facilities. The new Health Minister must take steps to launch this scheme on priority.
14. In respect of Promotion of Generics, Task Force set up by the Govt has strongly recommended that the public procurement and distribution of medicines through the public health system should mainly be for generic drugs, Quality certification may be provided free to dedicated generic manufacturers and there should be no control on price or distribution margins specified for generics. Four years have passed since the Task Force submitted its report but unfortunately no ground change is noticeable in terms of implementation of its recommendations. It is time for Govt. to shun inaction and indecisiveness and implement recommendations of various expert groups.
15. The much hyped plan to extend health care facilities by Employees State Insurance Corporation (ESIC) hospitals to BPL families covered under the Rashtriya Swasthya Bima Yojana is yet to be implemented. An ordinance by the labour ministry amending the Employees State Insurance Act has lapsed. The ordinance issued in July last year has expired as it could not be ratified by the Parliament. Challenge for new Govt. is to bring the ordinance back into force and ensure medical and healthcare facilities to BPL families at 144 ESIC hospitals of the country free of cost.
16. In India, > 53% children (67 million) under five years, live without basic healthcare facilities. This means that India alone accounts for about one-third of all children in the world aged below five who do not get basic healthcare. It also means that poor children in India, along with those in Brazil and Egypt, are three times more likely to die before their fifth birthday than children in other parts of the world. 66% of the poorest children in India receive no or minimal healthcare, the number stands at 31% of well-off children, who are not covered. While India has cut its overall child mortality rate by 34% since 1990, the survival gap between girls and boys has widened. New dispensation at the centre must take adequate measures to rectify this dismal scenario.
17. The RCH programme emphasizes improving access to skilled care and emergency obstetric care, as also coverage and quality of antenatal care and increasing the coverage of post partum care. The Govt has introduced the “Janani Suraksha Yojana”, which is a modification of the National Maternity Benefit Scheme that provides comprehensive medical care during pregnancy, child birth and post natal care and thereby improve the level of institutional deliveries in low performing States to reduce maternal mortality. Effective implementation of this scheme is required.
18. Under the Capacity Building Project through World Bank, assistance has been provided to upgrade testing facilities and to establish new drug testing laboratories so as to enhance the capacity of the laboratories to test large number of samples. Under this project 23 States and 6 Central Drug Laboratories had to be strengthened through renovations, extensions and equipments. However the present status of progress made in this World Bank assisted project is not well known. Therefore GOI must take up the up gradation of state and central drug testing laboratories on priority to enhance the capacity to test drugs which shall in turn help in detection of spurious drugs.
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