Have adequate measures been taken to stop rampant sale of schedule H1 drugs?
The Schedule H1 notification of the Government of India on Aug 30, 2013, as an amendment to the Drugs and Cosmetics Rules of 1945, came into force from Mar 1, 2014 with 46 drugs placed under this restricted category which mainly comprised of third and fourth generation antibiotics, anti-TB and some other habit-forming drugs with the aim of putting a check on their indiscriminate use by patients/ consumers.
In brief, Schedule H1, following drug substances and their salts excluding those intended for topical or external use (Except ophthalmic and ear or nose preparations) Alprazolam, Balofloxacin, Buprenorphine, Capreomycin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefexime, Cefoperazone, Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Chlordiazepoxide, Clofazimine, Codeine, Cycloserine, Diazepam, Diphenoxylate, Doripenem, Ertapenem, Etambutol HCl, Ethinamide, Feropenem, Gemifloxacin, Imipenem, Isoniazid, Levofloxacin, Meropenem, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Prulifloxacin, Pyrazinamide, Ribabutin, Rafampicin, Sodium Para-aminosalicylate, Sparfloxacin, Thiacetazone, Tramadol and Zolpidem were covered.
To know more on the gazette notification, follow at http://www.cdsco.nic.in/writereaddata/588E30thAug2013.pdf
The packaging of these drugs was proposed to have a mandatory warning printed on them in a box with a red border on the label and sold by chemists on production of a prescription.
The chemist was made responsible of retaining a copy of the prescription and maintain a separate register for these 46 drugs where the name of the patient and the details of the doctor who prescribed the drugs, dispensed drug amount were noted for future investigation or queries. This register was advised to be kept for three years before being destroyed.
The Central Drugs Standard Control Organization (CDSCO) had the responsibility to enforce the order. Violation of this provision was decided to be prosecuted. State Drug Inspectors were instructed to conduct surprise inspections at the pharmacies and chemist shops to check the registers and sale of these 46 drugs under Schedule H1.
The move to establish the Schedule was primarily intended to control the rampant use (that probably includes a large component of misuse through over-the-counter (OTC) dispensing) of antibiotics in India. This intention was laudable. But, lack of proper regulation and stringent action has resulted in rapid rise of anti-microbial resistance all cross India. Inappropriate and irrational use of medicines provide favorable conditions for resistant micro-organisms to emerge and spread. Administration of broad spectrum antibiotics as a first-hand therapy to the outpatients is another factor that leads to emergence of resistant strains. Compounding this problem, consumers and public have lack of knowledge regarding appropriate use of antibiotics. Self-medication and poor compliance are the other factors responsible for antimicrobial resistance among consumers. And today it is feared that in coming years, antimicrobial resistant diseases shall be the largest health daemons causing increased health ailments, prolonged suffering, confusion amongst prescribers, damages, mortality and other miserable conditions in patients.
It is a saddening fact that Over-the-Counter (OTC) Drugs in India can be procured in small or large quantities from various medical shops at any time. Though this is a punishable offence for the dispensers, but such retailers and distributors without any fear of stringent action follow their deadly dispensing method to unaware consumers who are totally ignorant of upcoming side-effects and anti-microbial resistance. People who are below the poverty line, and even those who are not so, prefer to approach friendly neighbourhood retailers for minor symptoms, who in good faith are more than ready to oblige by handing over small quantities of various drugs, including supply of antibiotics for 2-3 days, for immediate symptom relief. Easy availability coupled with irrational prescribing of antibiotics by doctors at all levels is contributing to increasing resistance to antibiotics and increasing drug resistant TB cases in India.
The problem of antibiotic resistance runs deep and is multifactorial. At present we are standing at a short span of time, were a mammoth task of curbing the antibiotic resistance remains unaccomplished. In addition to curbing OTC sale, improving microbiology research, continuous surveillance of antimicrobial sensitivity-resistance patterns, implementation of antibiotic policy at all levels of healthcare, continuous awareness generation among medical students, educated consumers regarding rational use of antibiotics are some of the widely recommended measures which are significantly lacking in India. Though the Government has taken the first step by amending the law, regular monitoring in medicine shops, prescription audits, doctors’ active participation is absent. Recently, Health Ministry has launched “Medicines with the Red Line” media campaign which creates awareness regarding rational usage of medicines which carry a red line on their strip.
Therefore, we need to create a nationwide antibiotic surveillance program coupled with capacity building in antibiotic policy. Medical teaching institutions and other hospitals now need to do their bit by implementing the other measures in a strenuous and sustained manner. In every nook and corner, propaganda of rampant, irregular and indiscriminate use of Schedule H1 Drugs should be spread.
We know that a very difficult task can be achieved with hard work and awareness. Therefore, we should all try our level best to curb the menace. PSM-India is also looking forward in doing its bit, today’s article is an eye –opener for all readers, so that next time before consumption of such medicine, proper details and prescribing information together with doctor’s recommendation should be followed for speedy recovery and to avoid further complications!!