Schedule H1: Hope or hype?

The Schedule H1 notification of the Government of India on Aug 30, 2013, as an amendment to the Drugs and Cosmetics Rules of 1945, has now come into force from Mar 1, 2014. This schedule imposes certain conditions in the dispensing of listed medicines, which are somewhat midway between Schedule H (that stipulates retail dispensing only against a valid prescription) and Schedule X (that stipulates prescription in duplicate, separate license requirement and meticulous storage and dispensing records). This schedule has been anticipated for some time but now that it is in force, needs wide publicity and a critical look, from all physicians and healthcare providers in general and the community of pharmacologists and pharmacists in particular.

The schedule is 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 is laudable. It is an open secret that practically any drug is OTC in India and can be procured in small or large quantities if one knows the right retailers and distributors. People who are below the poverty line, and even those who are not so, prefer to approach friendly neighborhood retailers for minor symptoms, who 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. This, we assume, is done in good faith but the long-term consequences are anybody's guess. 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.

What are the immediate implications of the Schedule H1 restriction? Currently, 46 drugs have been placed under this restricted category, which mainly comprises third and fourth generation cephalosporins, carbapenems, newer fluoroquinolones and first- and second-line antitubercular drugs. The packaging of these drugs will have mandatory Schedule H1 warning printed on the label in a box with red border and the Rx symbol in red. They can be sold by pharmaceutical chemists only on production of a valid prescription. The chemist will maintain a separate register where identity of the patient, contact details of the prescribing doctor and the name and dispensed quantity of the drug will be recorded. This register has to be retained for at least three years. The drugs control authority has the responsibility to enforce the order. Government drug inspectors can conduct surprise checks on these registers and monitor sale of these 46 drugs under Schedule H1.

Will this restriction work in dampening rampant OTC sale of antibiotics? Let us hope that the awareness, which this legal provision generates will have a deterrent effect in itself. Schedule X has worked, possibly because the need for duplicate prescription and stringent records makes both prescribers and dispensers wary. But, then Schedule X includes only a handful of drugs that are either obsolete or seldom needed anyway. Schedule H has been there for ages but has not worked efficiently, necessitating a schedule H1 now. What about its enforceability? Inspectors can only check what is recorded. How will they check sales that are not recorded in the H1 register, including sales against ‘prescriptions’ made out by unqualified ‘doctors’ and ‘alternative medicine’ practitioners. To do this would mean more elaborate and time consuming cross-checking of the inventory. It is not clear whether the chemist will retain a copy of the prescription that is served. The penal provisions for violation are also not clear.

What are the broader implications of Schedule H1? Will it have any impact on antibiotic resistance? It is still too early to say. The list of 46 items includes 11 that are non-antimicrobials. Therefore, the focus on antibiotics is somewhat diluted. With antibiotics, there are notable exclusions like gentamicin, piperacillin-tazobactam, linezolid and tigecycline. We do not know the reasons for these exceptions – whether the technical advisory committee has not recommended their inclusion or whether market data suggests that their OTC use is non-existent. The older fluoroquinolones, like ciprofloxacin and ofloxacin, have not been restricted, which can be a lacuna because cross-resistance is so common among the bacteria resistant to fluoroquinolones. Older beta-lactams (e.g. co-amoxiclav, cephalexin, cefadroxil) and macrolides (e.g. azithromycin, roxithromycin) have not been included. While this will come as a relief to scrupulous chemists who intend to follow these regulations, their misuse, which is already probably high, may increase. The non-antimicrobial items include opioids, benzodiazepines and zolpidem. Notable exclusions here are lorazepam, zopiclone, eszopiclone and zaleplon. Further, will prescribers heed the spirit of schedule H1 restrictions? Unfortunately, the schedule provides no disincentives for prescribers in selecting the listed drugs without due care.

The problem of antibiotic resistance runs deep and is multifactorial. In addition to curbing OTC sale, improving microbiology support, continuous surveillance of antimicrobial sensitivity-resistance patterns, implementation of antibiotic policy at all levels of healthcare, continuous awareness generation among medical students regarding rational use of antibiotics and regular prescription audits are some of the other widely recommended measures; all of which are seriously lacking in India. The government has taken a first step by amending the law. There are indications that the Indian Council of Medical Research will commence a nationwide antibiotic surveillance program coupled with capacity building in antibiotic policy making and stewardship. Medical teaching institutions and other hospitals now need to do their bit by implementing the other measures in a concerted and sustained manner.

Monitoring the impact of Schedule H1 is a challenge. This opens up new research possibilities for Indian pharmacologists and pharmacists and other readers of this journal. Such research will not just be good academic exercise but will have major societal relevance. The Indian Journal of Pharmacology will be looking forward to report the results of these challenging studies in its pages.