The Indian drugs regulator is keen on tighter controls on the retail of antibiotics. This is to curb abuse and drug resistance, a menace of ever-growing proportions. A just cause, of course. But the method that it seeks to employ for the purpose is questionable.
The Times of India reported this week that the regulator has proposed the introduction of a new “schedule H1”, in the Drugs and Cosmetics Act which will contain a list of antibiotics and anti-tuberculosis drugs currently on market.
“These drugs will only be sold against a prescription that the chemist will have to retain. The label of these drugs will have to carry a special warning. I am instructing the state drug controller generals to be ready to conduct surprise checks on compliance of retailers once H1 is notified,” the newspaper quoted the drugs regulator G N Singh as saying (italics mine).
Letter but not spirit
Antibiotics are legally prescription-only medicines as per Indian laws. Yet they are known to be retailed without or against dated prescriptions, much like other such drugs. A situation analysis by the Global Antibiotic Resistance Partnership (GARP) and the Public Health Foundation of India (PHFI) in 2011 found that “in Delhi no prescription was presented for one-fifth of the antibiotics purchased recently.”
Changing the behaviour of pharmacists is “pivotal for the success of any campaign against misuse or abuse of antibiotics,” it said. “They need to feel that they are part of the health system, rather than simply another business.”
Fair enough. But how?
Wheels within wheels
Firstly, in the absence of enough evidence to suggest that the root cause of antibiotic abuse and resistance is, indeed, indiscriminate consumption by patients without medical advice, chemist shops are bound to ask why they are being singled out for special treatment.
Says Jagannath Shinde, president, All Indian Organisation of Chemists and Druggists (AIOCD), “there is no machinery to check if antibiotics are being correctly prescribed by doctors or not.” Chemists undergo all sorts of checks and inspections all the time, he claims. “Who’s checking the private practitioner?”
Indeed, the GARP-PHFI analysis points out that Indian studies have uncovered a host of reasons for overuse. These include the lack of microbiology facilities to test for the bugs, and doctors prescribing antibiotics to any patient with a fever taking it as a sign of bacterial infection. Even, patient expectations.
Secondly, assuming even that a chemist does keep records, a prescription audit (assuming there will be one) will likely throw up a sizeable number of scrips from medical professionals who might technically not be allowed to prescribe allopathic medicines, such as Ayurveda and Homeopathy doctors. Given the shortage of allopathy doctors, many alternative medicine doctors practice modern medicine.
This is legal in some states while in others, the local government only winks at the practice knowing, perhaps, that the shortage of M.B.B.S/M.D doctors has to be made up somehow. This is particularly true in rural and semi-urban areas and in the lower middle-class and poorer pockets of a city like Mumbai.
However, can such states continue to do so when the evidence rubs this fact in their face? Especially when there might even be a link between the irrational use of antibiotics and doctor qualification. In Maharashtra the state drugs regulator recently attempted to prevent chemists from filling prescriptions of such doctors but relented after chemists went on strike.
However, it continued to maintain that such doctors would have to pass a one-year pharmacology course in order to practice allopathy, a move that was opposed by the association of allopathy doctors as not being nearly enough. Shoudn’t this issue be concurrently resolved for good?
Lastly, why are Indian patient buying prescription medicines over-the-counter? This behaviour is motivated, at least to some extent, by the state of healthcare delivery in India. In cities, given the abysmal doctor-patient ratio, the long queues outside a doctor’s cabin and the blink-and-miss consultation inside do not seem worth the time or cost when the ailment is seen to be minor (cold, cough, low-grade fever, bearable aches and pains). See my earlier post on this here. In villages, there are hardly any doctors. And India has, ironically, been very slow in switching drugs from Rx-to-OTC legally.
Play softball instead
The GAAR-PHFI analysis admits that “despite laws and regulations on the books, restricting antibiotic treatment to people with a prescription may not
be enforceable in many countries, including India.”
It does however suggest that giving incentives to chemists to keep records might help.
The regulator seems more inclined to an “all stick-no carrot” approach (note the words “surprise checks” that conjure up images of raids and potential scope for harassment).
That can end in one of two ways. One, this rule – like others before it – will be implemented patchily. In the hands of some unscrupulous officials, it could become a potential tool for harassment and corruption.
Or two, there will be shortages as chemists either strike in protest or stop storing these medicines. In the past, this last has been known to flare up with drugs that double up as narcotics and have greater documentation requirements.
According to a paper by GARP’s India Working Group, India’s National Policy for Containment of Antimicrobial Resistance covers a range of topics, including curbing antibiotic use in animals, particularly those raised for human consumption; conducting infection surveillance in hospitals; improving hospital surveillance for monitoring antibiotic resistance; promoting rational drug use through education, monitoring, and supervision; researching new drugs; and developing and implementing a standard and more restrictive antibiotic policy. All this in addition to schedule H1.
Perhaps it makes more sense to take an integrated approach that encompasses doctors, pharmaceutical companies (who push these drugs aggressively), chemists and patients in parallel, each of whom have a role to play. Each should be made clearly aware that they are not being singled out and told of progress made with other groups.
An approach that emphasises co-operation (and has many carrots) is likely to work far better than throwing the rule book at people.
Pic courtesy superamit’s photostream on Flickr.