Over-the-counter drug distribution and tuberculosis control in India
Authors: Rajpal S Kashyap, Aliabbas A Husain
Journal: The Lancet Infectious Diseases (2016)

Tuberculosis caused by Mycobacterium tuberculosis has been catastrophic with one third of world's population infected with tuberculosis bacilli.1Husain AA Daginawala HF Singh L Kashyap RS Current perspective in tuberculosis vaccine development for high TB endemic regions.Tuberculosis. 2016; 98: 149-158Summary Full Text Full Text PDF PubMed Scopus (9) Google Scholar The incidence and prevalence of tuberculosis is much higher in high-burden countries like India, which accounts for 26% of all cases of tuberculosis worldwide.2Verma R Khanna P Mehta B Revised national tuberculosis control program in India: the need to strengthen.Int J Prev Med. 2013; 4: 1-5PubMed Google Scholar The implementation of directly observed, treatment-short course (DOTS) under the Revised National Tuberculosis Control Programme (RNTCP) has been instrumental in tuberculosis control in India. In 2015, 1·28 billion people were covered under RNTCP with cure rate success of more than 85%. Despite high success rates, every year almost 2·2 million people develop tuberculosis in India and 220 000 people die from the disease.3Government of IndiaRevised national tuberculosis programme annual status report 2015.http://www.tbcindia.nic.in/showfile.php?lid=3180Google Scholar An increase in the number of drug-resistant cases has added a big blow to tuberculosis control programme in India. According to WHO, India is home to almost 73 000 drug-resistant cases of tuberculosis.4Kashyap RS Nayak AR Husain AA et al.Tuberculosis in India: the continuing challenge.Current Sci. 2013; 105: 597-606Google Scholar Irrational over-the-counter drug distribution by private pharmacists has been one of the key factors affecting tuberculosis control programmes in the country. In India, any drugs not included in the list of prescription-only drugs are regarded as non-prescribed or over-the-counter drugs. In recent years, over-the-counter drug distribution has increased substantially, which is mainly the result of exponential growth of pharmaceutical markets in India. In 2011, Indian pharmaceutical markets recorded turnover of international $ (INR$) 538 million, mostly because of increasing investments by domestic and international companies in rural markets and through sale of over-the-counter drugs.5Gupta S Emerging Indian OTC Markets.AJMST. 2013; 1: 24-29Google Scholar Despite high over-the-counter drug prevalence in India, few studies have been done of their effect on tuberculosis control. In The Lancet Infectious Diseases, Madhukar Pai and colleagues6Satyanarayana S Kwan A Daniels B et al.Use of standardised patients to assess antibiotic dispensing for tuberculosis by pharmacies in urban India: a cross-sectional study.Lancet Infect Dis. 2016; (published online Aug 24.)http://dx.doi.org/10.1016/S1473-3099(16)30215-8PubMed Google Scholar used the standardised patient method to access over-the-counter antibiotic distribution by pharmacists in urban India. The two categories of standardised patients, which included both symptomatic and microbiology confirmed tuberculosis cases, visited 623 different pharmaceutical settings in urban areas of the cities Delhi, Mumbai, and Patna. These patients were used to screen quality of ideal management along with over-the-counter drug distribution. The results of the study suggested better management of confirmed cases than suspected cases, by urban pharmacies, wherein 372 (62%) of 601 cases (95% CI 58–66) were ideally managed and referred to health-care centres without any drug dispensing. On the contrary, only 99 (15%) of 599 pharmacies ideally managed presumptive cases, and only 80 (13%) of 599 (95% CI 11–16) cases underwent referrals. The results showed a substantial effect on tuberculosis management, based on referral rates of patients to health centres. Low referral rates of suspected cases only show high over-the-counter drug abuse in these patients, thereby increasing the risk of drug resistance before initiation of treatment. Our experience of working in high tuberculosis endemic settings and other studies in high-burden countries7Bell CA Ilomäki J Pichenda K Duncan GJ Saini B Referral of tuberculosis symptomatic clients from private pharmacies to public sector clinics for diagnosis and treatment in Cambodia.J Eval Clin Pract. 2015; 21: 285-291Crossref PubMed Scopus (15) Google Scholar, 8Vu DH van Rein N Cobelens FG Nguyen TT Le VH Brouwers JR Suspected tuberculosis case detection and referral in private pharmacies in Viet Nam.Int J Tuberc Lung Dis. 2012; 16: 1625-1629Crossref PubMed Scopus (17) Google Scholar, 9Sabde YD Diwan V Saraf VS Mahadik VK Diwan VK De Costa A Mapping private pharmacies and their characteristics in Ujjain district, Central India.BMC Health Serv Res. 2011; 11: 351Crossref PubMed Scopus (29) Google Scholar support the above conclusion made by Pai and colleagues, when over-the-counter drug distribution is commonly encountered. India has many pockets of tuberculosis endemics inhabited mainly by rural population. High illiteracy further compounds the problem because most people without any knowledge of tuberculosis infection directly approach private pharmacies for medicines. Most pharmacies do not have any trained staff and pharmacists often leave the shop in care of subordinates to distribute drugs. Therefore treatment and reporting practices often do not meet national or international standards for tuberculosis. Because of these reasons, only 58% of total tuberculosis cases are notified in India every year, with one third of cases being either not diagnosed or diagnosed but not treated properly.10TBFACTS.org. TB in India: TB burden, NSP, private TB care. 2016. http://www.tbfacts.org/tb-india/ (accessed July 2, 2016).Google Scholar Although the studies by Pai and colleagues are admirable and project need of antimicrobial stewardship in tuberculosis control in India, we feel that additional studies, especially in rural and underdeveloped regions targeting local pharmaceuticals, would further bolster our understanding of over-the-counter drug abuse in this population. Private pharmacies play a crucial part in tuberculosis control. In 2003, India launched nationwide public– private mix DOTS programme to boost private pharmacies in treatment and observation along with increased referral rates to health centres.11Dewan PK Lal SS Lonnroth K et al.Improving tuberculosis control through public-private collaboration in India: literature review.BMJ. 2006; 332: 574-578Crossref PubMed Scopus (134) Google Scholar In 2013, the Cosmetic and Drug Act launched by the Indian union health ministry prohibited the sale of any antibiotics or anti-tuberculosis drug without a referral from a medical practioner.12Azad GN The drugs and cosmetics (amendment) bill 2013.http://www.prsindia.org/uploads/media/Drugs%20and%20Cosmetics/drugs%20and%20cosmetics%20bill.pdfGoogle Scholar Despite sustainable efforts, the link between the public sector and private pharmacies remains underdeveloped. A legislative and educational strategy is required in underdeveloped regions to prevent the misuse of antibiotics and to reduce cases of drug resistance. In the near future, increased advocacy in non-referring pharmacies is needed to boost the DOTS programme in India. We declare no competing interests. Use of standardised patients to assess antibiotic dispensing for tuberculosis by pharmacies in urban India: a cross-sectional studyOnly some urban Indian pharmacies correctly managed patients with presumed tuberculosis, but most correctly managed a case of confirmed tuberculosis. No pharmacy dispensed anti-tuberculosis drugs for either case. Absence of a confirmed diagnosis is a key driver of antibiotic misuse and could inform antimicrobial stewardship interventions. Full-Text PDF Open Access