Generic Drugs: Making Healthcare Affordable
As the largest provider of generic drugs globally - with Indian generics accounting for 20 percent of global exports in terms of volume – India can be the real game-changer.
Recently, the World Health Organization (WHO) invited pharmaceutical companies to submit proposals to manufacture affordable versions of newer medicines for the treatment of drug-resistant tuberculosis (DR-TB). Although India has the maximum number of DR-TB patients worldwide – around 1.3 lakh, say official figures - the Government gets only about 10,400 doses of medication as a donation from US- and Japan-based manufacturers.
In a country of 1.34 billion people, where the majority pays out of pocket for healthcare, generic drugs are a smart way to make healthcare more affordable. Unfortunately, there are a lot of misconceptions and misinformation about generic drugs - from its efficacy and safety to cost and accessibility. Simply put, generic drugs have the exact same chemical composition, with similar performance characteristics, as its branded variants. However, unlike brand-named drugs, generics are marketed under its chemical name, without any marketing titles.
In the United States, the Food and Drug Administration (FDA) notes that the cost of a generic drug, on an average, is 80-85 percent lower than the brand-name product. This is possible because of the substantial amount of money saved on research, development, marketing and promotion of the generic drug.
After the expiry of the patent period of a brand-named drug (usually 20 years), other companies can launch generics of the drug at a hugely discounted price. For instance, a branded cholesterol-lowering drug, which costs over Rs 100 (for a strip of 10 tablets), is available for less than three rupees in its generic form. Similarly, a much-in-demand branded diabetes drug, which costs over Rs 115, is available for less than two rupees as a generic.
India needs to encourage the substitution of inexpensive bioequivalent generic versions of drugs to deal with the problem of rising healthcare costs. According to the National Health Policy, 63 million Indians are pushed into poverty annually owing to healthcare expenses. Generic drugs can be the most potent weapons in our battle against the dual forces of infectious and lifestyle diseases.
Safety & efficacy
Contrary to popular perception, generic drugs are as safe and effective as the original patent-protected drugs. As the FDA puts it, “A generic drug is approved only after it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs. The generic drug manufacturer must prove its drug is the same as (bioequivalent) to the brand name drug.”
A scientific review of 47 studies (published between 1984 and 2008) that compared cardiovascular drugs found no evidence that brand-name drugs were superior with respect to clinical outcomes. Similarly, a randomized controlled trial comparing a brand antibiotic versus a generic antibiotic found no differences in clinical effects.
However, unlike most developed countries, where the science of bioequivalence evaluations for generics has been in place for more than two decades, India is yet to establish a track record of generic therapeutic equivalence. In India, ‘branded generics’ - generics manufactured by known brand names – are changing the rules of the game. In fact, generic drugs manufactured by Indian companies are commonly used to treat diseases, such as HIV/AIDS, TB, Malaria, and a wide range of infectious diseases, by leading international organizations like Doctors Without Borders (or the MSF), UNITAID, UNICEF and the like.
That apart, Indian pharmaceutical companies received more than 300 approvals in 2017 - up by nearly 43 percent from 211 in 2016 - to launch generic drugs in the US. The clearances came despite regulatory pressure from the US FDA.
These are exciting times for the industry, as in the next couple of years, quite a few cardiovascular, diabetic and oncology molecules will be going off-patent in the Indian market. This is expected to prompt launches of generic versions in a highly competitive market space, slashing down the drug prices significantly.
Under the Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP), efforts are already being made to ensure easy availability of generic medicines. The Medical Council of India (MCI) is also pushing for prescription of generic drugs bearing names of salts (active ingredients) by doctors.
However, unlike in the West, in India we don’t have the concept of community pharmacists, who can act as the vital link between patients and doctors, when it comes to concerns regarding medicines. Online pharmacies have the potential to fill that gap – by educating patients and addressing their concerns. For “Make in India” to be truly successful, we need to ensure that Indians are ready for the change.
As the largest provider of generic drugs globally - with Indian generics accounting for 20 percent of global exports in terms of volume – India can be the real game-changer. Like it did with the success of addressing the HIV epidemic. Competition among Indian drug producers, as a WHO official noted recently, had brought down the price of HIV medicines by 99 percent from $15,000 per patient per year to less than a dollar a day!
Disclaimer: The views expressed in the article above are those of the authors' and do not necessarily represent or reflect the views of this publishing house
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