A six-year-old from Kharsia village in Bilaspur district of Chhattisgarh died of diphtheria on July 11 at the government CIMS hospital in the district. The hospital did not have the diphtheria antitoxin (DAT)/anti-diphtheria serum (ADS) available for treatment. A day earlier, on July 10, a 13-year-old girl from Ghonghadih village was admitted to the Jan Swasthya Sahyog (JSS) clinic in Ganiyari village with fever and bull neck swelling, and was unable to swallow any fluids – clear indications of diphtheria. The symptoms also pointed to the girl’s serious condition and the urgent need for the serum for her survival.
We (the doctors at JSS) attempted to procure the drug from different sources – from the district and the state health authorities, from pharmaceutical manufacturers in other cities of Chhattisgarh, West Bengal, Maharashtra and Delhi as well as from institutes that manufacture ADS such as the Haffkine Institute in Mumbai and the Premium Serums and Vaccines Pvt. Ltd in Pune. This attempt to urgently access ADS was met with a common response of an acute shortage of the serum nationwide.
The Haffkine Institute informed us that they did not have the drug and that they could not reveal the contacts of those who stocked their product. Two hospitals in Delhi and Mumbai informed us that they had the drug but the patient would have to get admitted in those hospitals to access the serum. Such a response, which required a patient in a critical condition to travel from rural Chhattisgarh to Delhi or Mumbai was unfathomable. After a stressful 60 hours, we finally managed to acquire the ADS from a private retailer.
We hope that this delay will not have an adverse impact on the young patient’s recovery and that she will pull through soon. Unfortunately, in the past two years, three of four patients with diphtheria in Chhattisgarh have died because of the non-availability of ADS.
These recent episodes have once again placed a spotlight on the abysmal state of healthcare in the country, raising questions on the affordability and availability of life-saving medicines. This shortage – and the resulting premiums demanded by unscrupulous retailers – are putting many patients suffering from diphtheria at severe risk and even resulting in their deaths, which are very much preventable.
Resurgence of diphtheria in India
There have been a number of reports of re-emergence or persistence of diphtheria in several Indian states, including Andhra Pradesh, Delhi, Maharashtra, Chandigarh, Gujarat, Assam, West Bengal, Madhya Pradesh, Uttar Pradesh, Rajasthan and Haryana, during the past two decades. Despite the Universal Immunisation Programme (UIP), there has been a resurgence in diphtheria cases in India. In 2005, the incidence of diphtheria increased to 5,725 cases, despite the reduced incidence from 39,231 in 1980 to 3,094 cases in 2000. According to the World Health Organization, 3,380 cases have been reported in India in 2016.
These incidences point towards certain neglected and emerging facts regarding the epidemiology of diphtheria which ought to be considered by the UIP. Firstly, in the past, diphtheria was commonly found among children under five. However, now it is seen affecting older children (5-19 years) and adults. Secondly, the occurrence of diphtheria also reflects inadequate immunisation in early childhood – either these children were not immunised or were only partially immunised. In our experience, cases occurring even in the immunised individuals highlight the defect in the entire process of immunisation: poor cold chain maintenance which causes compromised efficacy of the DPT vaccine (against diphtheria) if it is not stored between 2-8ºC. Therefore, booster doses of diphtheria toxoid beyond infancy and early school age is essential to maintain immunity against diphtheria.
Presently, the UIP in India offers three doses of the diphtheria, pertussis and tetanus vaccine starting at six weeks of age followed by two booster doses at 18 months and between 54 and 72 months. Moreover, some epidemiological studies point to the lack of routine collection of data about the coverage of the first and second boosters under the UIP as well as National Health Surveys.
Achieving and maintaining high levels of immunity, especially among infants and children by high coverage of primary and booster immunisation against diphtheria, is necessary to control the disease in India. If vaccination rates fall or health systems break down for some reason – as has happened in many countries such as Russia in recent years when there has been conflict – diseases like diphtheria can make a comeback.
Lack of medicines and treatment
The mainstay of treatment in diphtheria is DAT or ADS. During the first half of the 20th century, many companies produced DAT for their countries’ national use, however, with the scaling up of immunisation programmes, market for DAT collapsed, reducing the number of manufacturers. In India, DAT is manufactured by VINS Bioproducts Ltd in Hyderabad apart from the Haffkine Institute and Premium Serums and Vaccines Pvt. Ltd. However, it seems that the medicines are not regularly manufactured due to paucity of demand. The shortage of DAT calls for serious consideration about our understanding of success of the national immunisation programme. Given the low incidence of diphtheria and the insufficient inducement for pharmaceutical companies to develop improved versions of DAT or to continue producing the earlier forms, the supply of this lifesaving therapeutic will continue to be scarce.
As in the case of diphtheria, there are other illnesses for which drugs may not be required frequently but may be lifesaving. Further, the economics of drug production, pricing and availability act as barriers for the poor to easy accessibility of these drugs. Examples include anti-rabies antiserum for bad potentially rabid animal bites, anti-snake venom, anti-scorpion antivenom, anti-tetanus serum, crystalline penicillin and codeine tablets.
Providing access to essential medicines
It is well known that access to life-saving medicines is critical to protecting and promoting the right to health. The central and state governments have a legal obligation to ensure access to life-saving drugs to patients under Article 21. India being a signatory to International Covenant on Economic, Social and Cultural Rights (ICESCR), is duty bound to fulfill its international legal obligations under this treaty. Under the ICESCR, providing access to essential medicines is considered to be a core and non-derogable obligation. In furtherance of its responsibility, the states ought to adopt and implement a public health strategy and a plan of action that reflects the region-wise epidemiological burden of disease and take steps to make medicines available for even such neglected yet life threatening diseases.
The fact that a disease affects only a small percentage of a population or the medicines for it are required infrequently or that the stocks may expire before they are needed are unacceptable reasons for non-availability of life-saving medicines at public institutes and hospitals. The government must, at a minimum, ensure that individuals have access to essential medicines – the drugs controller should ensure that the stock of life-saving medicines are available at all times in some volumes at the state level.
To address the issue of manufacturing and supply of medicines of such neglected yet important diseases, pharmaceutical companies should be commissioned to produce them for national use.
Yogesh Jain is a public health physician at Jan Swasthya Sahyog, Chhattisgarh.