In global AIDS response, the Indian pharmaceutical Industry has immensely contributed by supplying low-price and high-quality medicines especially across the African continent. Over the last 40 years, India has transformed from net importer to net exporter of medicines. According to Annual Report (2014-15) of the Department of Pharmaceuticals, Government of India, more than 80 per cent anti-retroviral (ARV) drugs for the treatment of HIV in Africa are sourced from India. Export-Import Bank of India (EXIM Bank) cites that pharmaceutical exports from India were globally pegged at US$ 11.6 billion in 2014-15. Pharmaceutical Export Promotion Council of India (Pharmexcil) ranks Africa the third prime importer of medicines from India. Thus, India has a growing role as the ‘pharmacy of the world’.
Medicines made in India comply with global regulatory standards and India accounts for more than 65-70 per cent of medicines in the WHO Prequalified List of Medicinal Products for HIV, tuberculosis, malaria, reproductive health,and other categories.
HIV/AIDS snapshot
On the World AIDS Day, observed on Dec 1 every year, the National AIDS Control Organisation (NACO) under the Ministry of Health and Family Welfare, Government of India released current figures on status of HIV/AIDS. The total number of persons living with HIV (PLHIV) in India is estimated at around 21.17 lakhs. This makes India home to the third largest population of PLHIV in the world, and remains the largest in Asia. As per UNAIDS - the joint United Nations programme on AIDS, as of June 2015, globally, there are 36.9 million PLHIV, out of which 15.8 million PLHIV were accessing antiretroviral therapy.
Unlike a decade back, today, testing HIV positive is no more a death sentence rather it has become a chronic manageable medical condition. The PLHIVs are leading a very normal and productive life with regular use of ART medications and healthy lifestyle. Thanks to contemporary treatments and antiretroviral drugs that have improved suppression of the virus in PLHIVs and thus, there is a far longer period of clinically "non-diseased" state before a PLHIV may develop AIDS.
It is estimated that around 13.45 lakhs PLHIV needed ART in India in 2015, including 12.71 lakhs adults (15+years) and 75 000 children (<15 years). Approximately 8 lakhs PLHIVs are currently receiving ART. This means 2/3rdof the estimated population still needs to be initiated on treatment and around 1/3rdof the estimated population is not even aware that it is infected with the virus.
Policy advances and commitments
The Government of India has taken proactive steps to navigate global policy discourse and agreements especially in the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) for enabling locally produced affordable medicines. For establishment of such a vibrant pharmaceutical industry over the years India has made investment in human resource, research and development (R&D) infrastructure, supportive legislation, conducive industrial policies, drug regulatory mechanism, and international collaborations.
In context of HIV/AIDS there are certain policy advances and commitments that are pertinent for pharma industry, as summarized below:
- The government has recently announced adoption and implementation of World Health Organization’s (WHO) early treatment initiation recommendation at CD4 500 and introduction of third line treatment. According to Government’s estimate one lakh additional PLHIVs qualify for early treatment initiation and immediately need to be put on treatment. While this had already been announced in February 2014 during the launch of NACP IV, yet pending for implementation.
- Government has taken positive policy and programmatic decisions despite administrative transitional challenges such as; early initiation and roll out of test and treat approaches for; HIV-TB co-infection and positive pregnant mothers, to meet the commitment for test and treat for key populations for HIV & TB and to achieve the goal of eliminating mother-to-child transmission of HIV (eMTCT) respectively.
- The legislation process for the HIV/AIDS (Prevention and Control) Bill, 2014 is advancing. The Bill intends to provide Legal protection for PLHIVs against discrimination—with guarantee to free HIV and health treatment, social protection and other provisions. Therefore, once the HIV/AIDS legislation is enacted, the life-long treatment will be guaranteed.
- The government is committed to provide Universal Health Coverage, health assurance and insurance. The ruling party in its manifesto had expressed health insurance and reduction in out-of-pocket spending on health care. Health insurance is very important for the PLHIVs and TB patients because, although treatment is provided by the government but a large number of people choose to receive treatment from the private sector due to convenience, medical emergency and/or confidentiality related concerns. This is important for India’s realization of Universal Health Coverage. There have been some developments at the Insurance Regulatory and Development Authority of India (IRDAI) and NACO levels however, needs further advocacy and advances.
The global outlook
The global response to the AIDS epidemic has highlighted the urgency of ensuring immediate as well as long-term equitable access to medicines for all. Thus, supply of affordable and accessible diagnosis and treatment is an integral part of reaching this target as well as essential to impact the broader health system in order to ensure Universal Health Coverage (UHC) under the Sustainable Development Goals (SDG).
The world political leaders and global community acknowledges Indian pharmaceutical industry’s contribution to AIDS response. Voices are raised at international fora in great expectation and in favour of India’s continued role as the pharmacy of the world.
For instance, strong statements were delivered by President of Kenya and many other ministers from African continent at a sideline session ‘End AIDS Epidemic by 2030’ during the recently concluded India Africa Forum Summit 2015 in New Delhi. The African leaders stated that India can support the African countries through its knowledge and expertise in manufacturing of life saving drugs so as to enhance their domestic drug manufacturing capacity. The Indian Health Minister reiterated for sustained contribution of Indian pharma industry and expressed willingness to partner with Africa in providing safe, affordable and accessible antiretroviral medicines. The Indian Health Minister also committed to ensuring that the TRIPS flexibilities will be fully harnessed to provide sustained and uninterrupted access to Lifesaving medicines. Such statements were made at the UN General Assembly, BRICS Forum and others.
The United Nations Secretary-General has recently constituted a high-level panel on access to medicines. The panel will also consider infectious diseases such as HIV and Hepatitis C, the rising burden of non-communicable diseases, and the affordability of health technologies, new and old. India has the opportunity to take full advantage of the panel to put forth the topical issues concerning access to medicine.
Recently, the World Trade Organisation (WTO) has granted extension of TRIPS exemption to the Least Developed Countries (LDC) till 2033. India has been exporting generic medicines to the LDCs therefore; it is an important development for Indian companies to continue to supply generics medicines.
Public health concerns Essential Medicines and Drug pricing
The National List of Essential Medicines 2011 (NLEM) is put under the Drug Price Control Order. There is no control on prices of medicines, which are not listed, patented medicines and indigenously developed medicines. The opportunities and challenges posed by such market driven policy needs to be evaluated.
India’s National Pharmaceutical Pricing Authority (NPPA) canceled government price caps on 108 expensive and widely prescribed medicines for HIV, diabetes, cancer tuberculosis and cardiac conditions, making lifesaving medicines less affordable, especially for the estimated 30 per cent of India’s population that lives below the poverty line.
The NLEM 2011 is currently under review for amendment. Advocacy efforts are on to amend the list to include contemporary HIV/AIDS and tuberculosis drugs used in national programme. This amendment needs to be well-balanced to ensure access to medicines at the same time to ensure that manufacturers remain motivated to produce essential drugs.
Legal, regulatory and programmatic challenges
Pharma patenting poses a major challenge that often needs to be countered by use of TRIPS flexibilities such as patent oppositions and compulsory Licenses. Indian generic pharmaceutical companies have been innovative in formulation development. Companies have improved ARV formulations such as; pediatrics dosage forms, dispersible tablets/syrups/ sprinkles/Heat stable tablets and fixed-dose combination ARVs (FDC - whereby two or more ARVs are combined into one tablet. FDCs have made dose regimen simpler, drastically reduced the pill burdens which is as low as 1 pill per day. Today, the Least Developed Country's (LDC) have achieved access to simpler medicines like FDC which are not even available in most developed markets due to patent issues etc.
Hepatitis C Virus (HCV), a major cause of cirrhosis and liver cancer, is another major emerging public health challenge. Although it is curable, the treatment is expensive and is still out of reach for most people suffering from the disease. New drugs like Sofosbuvir drugs may be produced locally at much cheaper prices. Few multi-national pharmaceuticals companies are making strategic alliances with Indian companies for licensing arrangements. However, the regulatory approval processes and patenting issues slows-down the pace for access to medicine.
Reliance on external sources
India pharma not only caters to the global markets but there is a huge domestic demand base for good quality medicines. Pharma sector is one of the focus areas for government’s “Make in India”. However, the increased reliance on countries like China and others for raw materials and intermediate ingredients used in pharmaceutical manufacturing is seen as an area of concern.
ConclusionGovernment of India claims to have successfully achieved the 6th Millennium Development Goal (MDG 6) of halting and reversing the HIV epidemic. However, still there remains the unfinished agenda. Post-2015, after the adoption of Sustainable Development Goals (SDGs), new targets have been set for end of AIDS.
There is need to push for HIV Bill, health insurance, early roll-out of CD4 500 and third line treatment. The entire supply-chain management of medicines needs to be made more efficient and effective. There is dire need for a roll-out of a national programme on HCV and government procurement to leverage high volumes and procurement in bulk to further reduce the purchase price of nee generation medicines.
Government need to encourage the pharmaceutical industry to focus on locally produced newer medicine formulations for treating HIV, co-infections and co-morbidities and diagnostics. Reinforce links with national leadership, including with relevant ministries such as health, drug regulator, external affairs, commerce and chemicals and fertilisers.
(The author is Bureau Chief, AIDS Healthcare Foundation)