Mumbai : Severe shortage of dolutegravir along with other antiretroviral (ART) drugs at government-run ART centres in parts of the country has put scores of indigent HIV patients in trouble.
Dolutegravir, termed as a miracle drug in HIV treatment, drastically reduces viral load in patients. The National AIDS Control Organisation national programme in 2020. The treatment regimen of several patients was replaced with dolutegravir.
Besides dolutegravir, ART centres in several states including Maharashtra, Assam, Manipur, Meghalaya, Nagaland are facing short supply of nevirapine, lopinavir-ritonavir combination, zidovudine-lamivudine combination etc.
Due to short supply of these drugs at ART centres, HIV patients have been put on different drug regimens. States like Assam and Manipur have instructed patients to purchase drugs from the market which will be reimbursed on producing receipts.
Confirming the shortage of ART drugs at government run centres, Dr Ishwar Gilada, consultant in HIV, STDs and Infectious Diseases as well as president of AIDS Society of India said “It is true that these drugs have been out of stock for a while. But it is only a temporary thing, the supply of drugs will soon be normalised. There are a slew of factors leading to shortage of drugs in the National AIDS Control Programme. The first problem is in the supply chain which needs to be resolved. And second, the drug is manufactured by only a few companies. The authorities buy it at a much lower price, which can also hinder the supply of the drug.”
Over 17 lakh people contracted HIV in the country in the last 10 years due to unprotected intercourse, according to the data provided by NACO.
Dolutegravir along with several other ART medicines is procured by NACO and supplied to ART centres pan India for free. A single tablet of dolutegravir costs NACO Rs. 6.67 (excluding Goods and Services Tax). The same tablet costs Rs. 117 in the market.
It is learnt that the Central Medicine Services Society (CMSS), a central procurement agency which is responsible for streamlining drug procurement and distribution system of the Union health and family welfare ministry, had floated tenders for supply of ART drugs eight months back. The CMSS did not finalize the tender due to lack of eligible bidders. It floated a second tender three months back but bidders are yet to be finalized. Meanwhile, NACO has urged state governments to conduct their own procurement of ART drugs for needy patients. According to sources, states are facing challenges while procuring ART drugs in small quantities.
“Launched on April 1, 2004, ART programme has been the “tipping point” in India’s fight against HIV/AIDS and has changed the face of the National AIDS Control Programme. It has provided significant impetus and evidence that public health programmes can effectively deliver the “chronic care” concept as well as preventive strategies and aspects. Studies show that a person living with HIV has a similar life expectancy to an HIV-negative person – provided they are diagnosed in good time, have good access to medical care and are able to adhere to their HIV treatment,” said Dr Gilada.
HIV was first detected in India in 1986. The government launched the National AIDS Control Programme (NACP) in 1992. The government implemented the NACP in phases. The first phase of NACP (1992-1999) focussed on awareness generation and blood safety. The second phase witnessed launch of direct interventions across the prevention-detection-treatment continuum with capacity building of States on programme management. The third phase (2007-2012) was a story of scale-up with programme management decentralised up to the district level. The fourth phase (2012-2017) was a period of consolidation and enhanced Government funding. The NACP phase-IV (Extension) was first approved for the period of 2017-2020 and then further extended for one more year i.e., 2020-21. Currently the fifth phase (2021-26) is being implemented with an aim to reduce annual new HIV infections by 80 per cent, AIDS-related mortalities by 80 per cent, eliminate vertical transmission of HIV and Syphilis and promote universal access to quality STI/RTI services to at-risk and vulnerable population.
Based on the World Health Organization’s (WHO) recommendation, currently India uses dolutegravir based regimen, he said.
Based on new evidence assessing benefits and risks, WHO recommended the use of dolutegravir as the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential in 2019. The WHO recommended dolutegravir in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) for first-line treatment of all adults and adolescents and Efavirenz 400mg plus two NRTIs as an alternative first-line regimen for adults and adolescents.
Whereas WHO previously recommended Efavirenz 600mg, it now supports the lower dose of 400mg which has benefits in terms of side-effects and cost.
Dolutegravir is a drug that is more effective, easier to take and has fewer side effects than alternative drugs that are currently used. The HIV drug also has a high genetic barrier to developing drug resistance, which is important given the rising trend of resistance to Efavirenz and nevirapine-based regimens (NACO) introduced the ART drug in the, stated a communication issued by WHO.