MUMBAI: When you last visited your doctor for a stomach infection, did he caution you about the possible side-effects of the prescribed antibiotic, or were you alerted about these through a `medication guide’ inserted in the pack? Probably not. Neither did the doctor who treated 10-year-old Ruchi inform her parents about the complications, nor was a medication guide available. The pharma company which manufactures the antibiotic too abdicated its responsibility of highlighting the side-effects.So when Ruchi popped the widely-sold antibiotic, ciprofloxacin, for her ENT infection for 15 days, she developed serious skeletal deformities. The antibiotic, which was meant to cure her, nearly crippled her, causing dangerous side-effects.Ruchi is not alone. There are many such examples where patients suffered serious side-effects by taking popular pills as they were not aware of the drug’s adverse impact. In some instances, they may have been plain unlucky, but in most cases it’s because of scanty information about the medicine, safety risks which are neither communicated by doctors who are extremely busy, nor by pharma companies themselves.So are patients here being given the short shrift? It appears so, as companies are not communicating safety risks and adverse reactions associated with certain medicines on packs in India. This is even as global regulatory agencies like the US Food and Drug Administration recommend companies to educate patients about routine side-effects and alert them with additional warnings.The problem is on several fronts. “The lax system of approval of drugs in India, profit-oriented pharmaceutical companies who care two hoots (about patients), and doctors who are nearly all-dependent on field force do not convey clearly to the patient about the possible side-effects of a prescribed drug,” says CM Gulhati editor of medical journal, MIMS, who has championed the cause of safe drugs, for decades.Awareness about safety risks and side-effects is critical among children and pregnant women. This is because certain medicines, like some antibiotics and painkillers, are not recommended for use during pregnancy, while some have been banned for lactating women. Moreover, doctors have been advised not to prescribe drugs like antibacterials, acid suppressants, codeine (cold and cough remedies), anti-diarrhoeal to children below 12 years (see graphic). Most doctors do not ask their female patients if they are pregnant or breast-feeding. Hence, if certain drugs not permitted during these situations are administered, it may lead to serious side-effects to both —patients and their breast-fed babies.Companies feel that communicating safety information to patients is akin to advertising, and hence would be in violation of the Drugs and Magic Remedies Act. But, drugs controller general GN Singh told TOI, “It is the responsibility of companies to communicate about the side-effects and adverse events of medicines to ensure patient safety.”TOI contacted several companies with queries on the need to educate patients through “clear and efficient labels”, detailing safety risks and precautions. Most pharma companies did not wish to be quoted on the issue. “Since it’s not mandatory to provide package insert or a patient medication guide, individual medicine strips do not carry it. Only certain medicines carry these inserts in a pack of 5 to 10 strips,” an executive with a leading company said. He added that inputs costs have been rising for the industry, and packaging is perhaps one way where they can cut costs.“When using any drug, it is important that doctors explain common drug reactions to the patient. Also, patient should read ‘contraindications and warnings and precautions’ sections carefully,” says Dr Anoop Misra, chairman of Delhi-based Fortis-C-DOC. According to him, it is the duty of pharmaceutical companies to update the package insert in the event of a newly-described adverse effect — which should be disseminated to both doctors and patients.Domestic companies, however, take refuge in laws which do not make it binding on them to provide a “medication guide” which will make patients alert about adverse events, drug reactions or precautions.While Indian pharma companies have adopted several global practices voluntarily, why they have chosen to ignore an important aspect of patient safety? More importantly, why hasn’t the law been tightened?In fact, 5% of all emergency hospital admissions in the US are due to side-effects of the drugs administered to them. According to experts, in India the situation is worse as there is no registry of adverse events available.Very few companies are adding the package insert. “Package inserts by 5-10% companies are practically useless as they are microscopic, and hence cannot be read. The language used is also technical, and hence it may not be comprehensible for patients. In any case, these are meant for use only by medical practitioners as they clearly state,” an industry expert said.At the same time, pharmacovigilance for every new and old drug prescribed needs to be monitored, and all adverse events reported by the company, and communicated by drug regulator, says endocrinologist Dr Shashank Joshi. These studies, particularly for new drugs, need to be conducted and ratified by independent authorities.Keeping in mind the challenge of literacy here, some feel that it’s the responsibility of the doctor to counsel patients regarding side-effects. “They also need to be available for patients’ queries,” says Leena Menghaney, a lawyer and activist working on public health.