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, cumbersome record keeping, lenient regulatory enforcement and the cost to set up a robust electronic system. Maharashtra Food and Drug Administration (FDA) officials, however, say that they have issued circular to all the retailers mandating them to follow the rules and also are educating them on the same. Repeat offenders for non-compliance of Schedule H1, a senior FDA official says will be penalised 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.
Maharashtra FDA Commissioner convened meetings in Nagpur, Nashik earlier and in Mumbai at Ghatkopar recently to sensitise retailers about the Schedule H1 compliance. While some retailers argue that it is not stringently implemented, others are finding it difficult to maintain a separate register mandated by the law. According to a retailer based in Mumbai, "Around 70 per cent of over 7000 retailers in Mumbai are following an electronic billing system for compliance to Schedule H1 but rest of them are still not able to comply with Schedule H1 prescription." A meeting to sensitise retailers on Schedule H1 compliance is scheduled to be convened by the state FDA on 28 April, 2014 at Goregaon in Mumbai.
Pharmacists at the same time feel that a proper healthcare infrastructure should be in place to implement Schedule H1 in the true spirit of the law with onus not only on pharmacists but also on physicians. "Pharmacists are being harassed in the name of record keeping and around 5000 drug licenses were cancelled across Maharashtra in 2013 alone as compared to 3000 the previous year. We want Schedule H1 to be amended to include the clause that physicians should also maintain records of Schedule H1 drugs as it includes anti TB drug and habit forming drugs like codeine. The state government should take a serious view of the fact that physicians from other traditional systems of medicine should not be allowed to prescribe Schedule H1 drugs as they lack the required knowledge on the same,"says Maharashtra State Chemists and Druggists Association (MSCDA), secretary, Anil Navandar.
Government had amended the D&C Rules to insert Schedule H1 to regulate the use of antibiotics in the country, but placing 46 antibiotics under category instead of original proposal to include 91 drugs.
Echoing similar views, All India Organisation of Chemists and Druggists (AIOCD) general secretary Suresh Gupta says, "Pharmacists are being harassed in the name of record keeping. They are being mandated to maintain a separate register for Schedule H1 drugs as it includes anti TB drug and habit forming drugs. The onus of implementing Schedule H1 lies as much with the physicians as it is with the pharmacists. It defies all logic when the Act mandates only pharmacists to maintain records and not physicians considering the fact that over 65 per cent prescribers or medical practitioners are unqualified.
The government made it compulsory for these listed antibiotics to carry warning also. “If it contains a drug substance specified in Schedule H1, the drug formulation shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label,” according to the official notification by the health ministry.
Antibiotics falling under third and fourth generation and several habit forming drugs are in the list. Alprazolam, Balofloxacin, Buprenorphine, Capreomycin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefixime, Cefoperozone, Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Chlordiazepoxide, Clofazimine, Codein, Cycloserine, Diazepam, Diphenoxylate, Doripenem, Ertapenem, Ethambutol Hydrochloride, Ethionamide, Feropenem, Gemifloxacin, Imipenem, Isoniazid, Levofloxacin, Meropenem, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Prulifloxacin, Pyrazinamide, Rifabutin, Rifampicin, Sodium Para-aminosalicylate, Sparfloxacin, Thiacetazone, Tramadol and Zolpidem are the drugs included in the list.