Taking into account the WHO's latest report on antimicrobial resistance, which reveals antibiotic resistance as a burgeoning problem in South East Asia, Maharashtra Food and Drug Administration (FDA) commissioner Mahesh Zagade has appealed to the chemists to comply with Schedule H1 on an urgent basis.
The FDA has made it clear to the chemists about compliance to Schedule H1 in the wake of the findings that there is irrational usage of around 65 per cent antibiotics. It has therefore been mandated that the prescription should compulsorily bear the doctor's name and correct dosage regimen in accordance with the law of the land.
Explains Zagade, "Schedule H1 compliance is very much necessary as Maharashtra accounts for Rs. 1500 per capita consumption of drugs as compared to the national average of Rs. 694. While talking about the existing scenario, he pinpoints that the country is currently facing a scarcity regime as no new drug class has been launched since 1987 to tackle infections caused by multi-resistant bacteria."
Daptomycin was the last one launched in late 1980s. Daptomycin is a lipopeptide antibiotic used in the treatment of systemic and life threatening infections caused by Gram positive organisms. Citing the WHO report, which focuses on antibiotic resistance in seven different bacteria responsible for common and serious diseases such as bloodstream infections (sepsis), pneumonia, urinary tract infections and gonorrhoea, Zagade informs that it also includes diarrhoea. That is why, it becomes imperative that right kind of dosage regimen needs to be adhered to. Echoing similar views, pharmacology expert Dr R P Agarwal has also recommended strict and exact adherence to dosage regimen of prescription medicines to tackle antibiotic resistance.
The recently conducted study by Indore based MY Hospital under its head of microbiology division Dr Anita Mutha on 400 patients suffering from infectious diseases has revealed that one third of the patients have shown antibiotic resistance. Findings and conclusion was based on 1100 samples drawn during the study.
Argues Ashok Khandelwal from Healthcare Advocacy group Chikitsasansar, "Today non-compliance to Schedule H1 compliance will have serious implications as drug wholesalers are promoting irrational usage of drugs in the name of new antibiotics by illegally selling it to quacks. Drug Controller General of India (DCGI) needs to take appropriate action as it has been found that medical representatives appointed by drug companies in order to meet their targets promote antibiotics to unqualified allopaths and these in turn prescribe medicines to patients irrationally with the motive of getting hefty commissions. This has led to rampant quackery on one hand and disillusioned healthcare practitioners and patients on the other hand as drug usage most of the times is not backed by valid information on pharmacology."
WHO’s report results show high levels of E. coli resistance to third generation cephalosporins and fluoroquinolones—two important and commonly used types of antibacterial medicine– in the South East Asian region. Resistance to third generation cephalosporins in K. pneumoniae is also high and widespread. In some parts of the region, more than one quarter of Staphylococcus aureus infections are reported to be methicillin-resistant (MRSA), meaning that treatment with standard antibiotics does not work.
Most of the chemists across Maharashtra have yet to follow the newly amended Schedule H1 effective from March 1, 2014 due to lack of awareness and cumbersome record keeping. Non-compliance of Schedule H1, a senior FDA official says, will attract penalty ranging from lodging FIRs and cancellation of licenses based on the merit of the case.
The Central government in September 2013 had amended the Drugs and Cosmetics (D&C) Rules to insert Schedule H1 to curb the indiscriminate use of antibiotics and some other vital drugs, by placing 46 antibiotics under this category.