How feasible is pharmaceutical regulation in India?
Authors: Sachin Atre
Journal: The Lancet Global Health (2018)

Patricia McGettigan and colleagues1McGettigan P Roderick P Kadam A Pollock AM Access, Watch, and Reserve antibiotics in India: challenges for WHO stewardship.Lancet Glob Health. 2017; 5: e1075-e1076Summary Full Text Full Text PDF PubMed Scopus (33) Google Scholar (November 2017, e1075–76) draw attention to one of the most pressing pharmaceutical regulation issues in India, especially relevant as WHO adopts the Global Antimicrobial Resistance Action Plan.2WHO, Global action plan on antimicrobial resistance. Geneva: World Health Organization. http://www.wpro.who.int/entity/drug_resistance/resources/global_action_plan_eng.pdf (accessed Nov 4, 2017).Google Scholar Through a careful analysis, the authors showed that not only are overall sales of antibiotics rapidly increasing, but so too are the sales of Watch Group and Reserve Group antibiotics as well as unapproved fixed dose combination antibiotics. In my opinion, to understand the problem of overuse of antibiotics and emerging resistance we need to view it through an anthropological lens. India has a population of 1·3 billion and a complex health-care system comprising the public sector and a vast, weakly regulated private sector that includes many formal and informal providers. There are several autonomous, private medical colleges across the country, which are widely known to charge huge capitation fees3D'Silva J India's private medical colleges and capitation fees.BMJ. 2015; 350: h106Crossref PubMed Scopus (4) Google Scholar from students who sometimes have no merit to become clinicians. Although the Government of India took a positive step in 2016 to remove huge capitation fees in private medical colleges and promote merit based admissions, the cost of regular tuition fees remains exorbitant. The clinicians who graduate from such expensive medical colleges might initially be motivated by trying to recover the money invested in their education. Furthermore, many practitioners from alternative systems of medicines such as Ayurveda, Unani, and homoeopathy, who prescribe antibiotics, unfortunately have little knowledge or training of antibiotic use. Whether from licensed clinicians or otherwise, the appropriateness and requirement of prescriptions remain questionable. If a pharmacist knows the patient in his or her locality, it is quite possible to get antibiotics even without prescriptions. Generally, there is one licensed pharmacist per pharmacy, but often in busy pharmacies, untrained supporting staff also attend patients. In India prescription-based medicine dispensing has little meaning from a regulatory viewpoint because pharmacies do not have systems to monitor parameters such as the prescription's time validity, who has been prescribed medicines and for which health condition. Also, prescriptions are always returned to patients with hardly any evidence left with pharmacists except drug quantity record. Thus, tracking antibiotic use becomes practically impossible. The misuse of antibiotics is inevitable considering all the above circumstances. Ironically, a country with a population as large as India's does not have adequate human resource for drug inspections nor to cater for many of the national disease control programmes—eg, tuberculosis.4Kadam A Maigetter K Jeffery R Mistry N Weiss M Pollock A Correcting India's chronic shortage of drug inspectors to ensure the production and distribution of safe, high-quality medicines.Int J Health Policy Manag. 2016; 5: 535-542Crossref PubMed Scopus (5) Google Scholar, 5Atre S Murray M Management and control of multidrug-resistant tuberculosis (MDR-TB): Addressing policy needs for India.J Public Health Policy. 2016; 37: 277-299Crossref PubMed Scopus (13) Google Scholar One of the root causes for this state of affairs is the Indian Government's poor investment in the health sector.6Bloom BR Rethinking how to address the world's largest infectious killer in the world's largest country.J Public Health Policy. 2016; 37: 300-303Crossref PubMed Scopus (3) Google Scholar When I asked pharmacists in rural India about visits by drug inspectors, the frequent answer was "once in a year or two", which might explain the grim regulatory control situation there. Moreover, India has wholesale drug markets, such as Bhagirath palace in Delhi, which are known for illegal drug sales.7Jain SK The spurious drug menace and remedy.Health Administrator. 2006; 19: 29-40Google Scholar, 8Sharma P Health ministry's surgical strike at Delhi market reveals dark side of medicine hub. June 14, 2017http://indiatoday.intoday.in/story/health-ministrys-surgical-strike-at-delhi-market/1/978228.htmlGoogle Scholar Unless these fundamental issues are dealt with, implementing WHO's Global Antimicrobial Resistance Action Plan remains unrealistic in India. I declare no competing interests. Access, Watch, and Reserve antibiotics in India: challenges for WHO stewardshipIn its most recent Model List of Essential Medicines,1 WHO adopted a new classification for antibiotics. This new model comprises three categories: Key Access antibiotics (eg, β-lactam, aminoglycoside, and first-generation or second-generation cephalosporin antibiotics) that "should be widely available, affordable and quality-assured";1 Watch Group antibiotics (including most of the highest priority critically important antimicrobials for human medicine—eg, macrolides, quinolones, glycopeptides, penems, and third-generation cephalosporins)2 recommended only for specific, limited indications; and Reserve Group antibiotics (eg, fourth-generation and fifth-generation cephalosporins, aztreonam, polymixins) for situations when all alternative antibiotics have failed. Full-Text PDF Open Access