The Health Ministry’s heart is in the right place when it bats for generic medicines as opposed to branded ones, and insists on doctors prescribing only the former. The government on its part has thrown its weight behind the initiative by setting up Jan Aushadhi drug shops in urban centres. The rationale behind the twin initiatives is that patients should get cheaper substitutes with the bio-equivalents not compromised. So far so good.
But are we really ready for generic drugs? Consider cough syrups the market is flooded with thanks to the drug being OTC or over the counter. The death of young children in Gambia taking cough syrup imported from an Indian generic manufacturer not only shook the global conscience but also brought shame and ignominy on the Indian drug industry. To be sure, generic drugs do not ipso facto mean spurious drugs, a western worldview fostered by their drug companies whose monopolies or market share is threatened. That happened when our Pharma companies led by Ranbaxy and Cipla ruled the roost in the world market in a milieu of process patents which had to yield to product patents in 2005 at the strident insistence of the World Trade Organization (WTO), obviously at the behest of the western drug monopolies. They tarred all Indian drugs with the same brush and went to the extent of impounding shipments in transit centres at ports at the Netherlands.
But at the same time, we cannot turn a blind eye to or be oblivious of the western and WHO charges of lack of perfect adherence to phytosanitary stipulations in our drug manufacturing facilities. Cleanliness and hygiene are key as much to the drug industry as they are to the semi-conductor industry. Small wonder that Glycodin is still the byword for cough syrup amongst the cognoscenti in India despite its high price vis-à-vis the competition mainly from the generic manufacturers. A drug should both be efficacious and unharmful. The quality of ingredients and salts used matter as much as phytosanitary conditions. A few decades ago, our soft-drink manufacturers were in the doghouse for allowing chemicals to seep through into the bottles. Given the mammoth quantities of water required by them, ground water was a first choice.
Are our drug manufacturing facilities paying full and complete heed to exacting quality including phytosanitary stipulations laid down by the WHO? Are our inspection and certification regimes sound and of unimpeachable integrity? The answer sadly to both these questions is in the negative. Federal Drug Agency (FDA) of the United States of America has the reputation for meticulous examination of quality and potency standards besides insisting on comprehensive labelling before drugs are allowed to enter the market.
Unless we are satisfied that such a regime is in place, we should not insist on doctors prescribing only generic medicines without mentioning the brand names. And that is clearly at least a decade off if not longer. When it comes to drugs, especially to lifesaving drugs, cheapness cannot be the only counter and obsession. Cheapness in any case is being ensured by the market and disruptive delivery apps that have sprung up offering to deliver medicines in a jiffy to the doorsteps of the patients at 20% discount and more. In their wake, the mushrooming drug and cosmetics shops our urbanscape is chock a bloc with are also slowly falling in line though kicking and screaming. It is common knowledge that the mean retail margin on medicines is around 40%. Till recently, retailers saw wisdom in hogging everything for themselves. But their dovecotes have been fluttered by the delivery apps. So, the government need not obsess over cheapness and on that ground alone bar prescription of branded drugs.
In this context, the recent Delhi High Court verdict that medicines should be clearly distinguishable and there should not be even slightest confusion in Mankind Pharma Limited vs Novakind Bio Sciences Private Limited is bound to strike a chord. The test of deceptive similarity applied in trademark case needs to be applied even more rigorously and assiduously to drugs said their Lordships. Phonetically, Mankind and Novakind may not be on all fours but the test of deception in the minds of common folks must be applied strictly without any latitude. Likewise, dictionary terms cannot be monopolised by anybody through registration as trademarks except through uniquely stylised letters. But the Court in this case read the word ‘kind” in association with the prefix Man and gave a permanent injunction against its use in favor of Mankind. The point is drugs are a class apart as they affect the wellbeing of consumers. So, no amount of precaution is too much.
Parenthetically, the authorities also have a beef against big pharma corrupting the medical community with lavish gifts and junkets to idyllic places. Small wonder their drugs enjoy top-of-mind recall among such pampered doctors when writing out the prescriptions. While such corrupt practices need to be tamed, they should not blind the government to the need for quality drugs. While branded goods do not ipso facto become quality goods, the truth is that a brand is alive to the need for quality lest its image is besmirched.
So, let the consumer decide whether she wants branded or unbranded drugs, but given the nature of the product, she is going to go by the doctor’s advice. Prescription of generic drugs then is not the panacea for our drug-related ills! That can wait till we spruce up our regulatory, inspection and certification regimes for drugs.
S Murlidharan is a freelance columnist and writes on economics, business, legal and taxation issues
