A generic drug is a medication that is produced to be identical to an already marketed branded drug. It is, in fact, the same in terms of dosage, safety, way to administer, strength, the way it performs, and purpose of use. The generic medicine works the same way, providing the same benefit clinically as its brand-name counterpart. Generic drugs are available in the Indian marketplace, and in 2019, the Central Drugs Standard Control Organization or CDSCO made plans to regulate generic medicine, by stating that manufacturers were required to provide test results validating their drugs.
CDSCO insists that generic medicines should be biologically equivalent to branded patented counterparts. This mandate was a must in order for generic drugs to be sold on the Indian market. As these drugs are more affordable (because they are “copies”), Indians, especially from the poorer sections of society stand to benefit. While generic drugs have been created to a large extent in India, no regulation has ever been adhered to stringently.
The Latest Laws
Reports suggest that most cancer medicines remain expensive and unaffordable by a majority of cancer patients in India. As there is no curb on profits earned by pharmaceutical companies, prices of drugs that are patented and branded are high, and they only rise higher. In India, there are laws in place that clearly specify that medical prescriptions should offer generic medicine to patients. In turn, chemists and druggists should make these readily available to people.
Still, the widespread use of generic drugs isn’t prevalent in the Indian health sphere, as large pharma companies aggressively market branded medication. There are other reasons for this too. Patients are ill-informed about generic medication, and “rely” on branded products more, as this somehow ensures efficacy for them. Doctors too prescribe these, because though generic drugs are identical to branded ones, there is no strict regulation that proves they are. Doctors may be apprehensive (and with reason) about prescribing medication, even with the slightest doubt in mind.
A Need for Stringent Regulation
There are a few doctors who prescribe generic medication, especially when branded counterparts aren’t readily available. During the pandemic, some doctors have consulted with patients via telemedicine and prescribed generic drugs. The majority of physicians, however, do not. Around 85% of expenditure for health is financed by the household income of Indian families. Medication is an out-of-pocket expense, and for most Indians, the cost of ill health can mean spending a whole month’s income. On the common man, the strain is tantamount to getting ill itself.
The government has taken initiatives to compel makers of generic medicine to market products aggressively, but the mindset against them still stays with patients and doctors alike. Pharmacies are apprehensive about selling them, as the profit margins on these are low. Generic drugs are not good for business. Doctors also state that Indian consumers have a predisposed idea that medication “has to be costly to ensure quality”. This prompts them to prescribe branded medicines more, while pharmacies confirm this point of view.
Non-availability of Drugs
Another pertinent reason why physicians may not prescribe generic medicine is that generic drugs are scarce in the market. Many a time, they are not available as chemists don’t wish to stock them. There is no assurance that generic drugs will be available to patients even if the doctor does prescribe them. Senior health ministry officials state that poor and middle-income groups in India are the hardest hit by lack of affordability for medication. Since there is no strict regulation for generic medication, doctors state that at times, generic medication may have slight differences in composition relating to its efficacy.
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