With the law enforcement agency having finally managed to nab Rishikesh-based Neeraj Clinic's R K Gupta, his much-hyped but bogus cure for epilepsy may now be out of harm's way. The medical bodies may be rejoicing at what may be the ending chapter to the phony saga. But is it time to sleep over things for good? Expert opinions tend to disagree. It seems the whole episode has opened a Pandora's box, and exposed some vital lose ends in the drug laws.
The case highlighted how a fraud doctor managed to dupe thousands of patients by offering a sure-shot cure for epilepsy, under the garb of allopathic medicines. People also refer to the tall claims the doctor made in jumbo-sized advertisements, and photos showing him receiving awards from eminent dignitaries. It may take some time before the actual extent of this 'scam' may be gauged, but imminently, it sure is surprising how such impressive advertisements were allowed to be carried at all when they are prohibited ab initio! The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, in its Schedule given with Section 3(d) and 14), clearly restricts advertisement for treatment of certain diseases including epilepsy (see Serial No. 17 of the aforesaid schedule).
Drug authorities are the most qualified personnel to comment on how such an unambiguous and clear-cut provision in the law was allowed to be openly flouted for long. The larger concern is this is not an isolated case and malpractices in Indian drug-related advertising is not uncommon. Take another example. Wings Pharmaceuticals, a Delhi-based company, suddenly floods leading news channels with its advertisement campaign - "Hari panni waali goli". The campaign positions its flagship pain-reliever, Diclowin Plus, as an effective medicine for pain relief and prompts consumers to take it for body pain, headache, etc.
The key ingredient in Diclowin Plus is Diclofenac Sodium, which falls under the Schedule 'H', (commonly known as prescription drugs), of Drug & Cosmetics Act, 1940, and the corresponding Drug and Cosmetic Rules, 1945, which mandates that the drug is 'to be sold by retail on the prescription of a registered medical practitioner only'.
The Central Drug Controller's statement clarifying that the issue is under the purview of the state drug controller has also added fuel to the raging fire over the controversy. When the advertisements are being aired on India's leading news channel, and the audiences are being targeted nationally, is it not amusing to hear that the matter is to be dealt with at a state level?
There are quite a number of schedule H drugs in India, being manufactured by companies spread across the country. Taking a cue from the precedent set by the 'Hari Panni' campaign, the consequent steep rise in the sales volumes of Diclowin Plus, and the callous and lethargic action from the drug authorities, it is feared that several other drug companies may be tempted to follow suit and make money the easy way. Would, then, each of the state drug controllers be summoned to follow-up the cases individually?
But why this fuss over advertising Schedule 'H' drug? A drug is put under this restrictive Schedule 'H' category only when the Indian drug authorities consider that the side-effects of the drug may be possibly-harmful to the patient, and only a qualified medical practitioner is capable of evaluating how frequently and in what dosage will the medicine benefit the patient, without causing much harm to his health. The rationale is that since the patient - a lay man - is not expected to be fully aware of its possible side-effects and/or contra-indications that have been reported - it should not be bought by the patient without a prescription from a qualified doctor.
The 'Hari Panni' television advertisement, however, encourages just that - an over-the-counter purchase by the patient himself. In addition, it also associates the use of the medicine in common pains thus making the drug seem like an equally common "household commodity" - thus undermining the gravity and purpose of the restrictive Schedule 'H'.
Experts fear that such blatantly sinful advertisements of the drug should immediately be stopped, as they are already leading consumers to buy the medicine over-the-counter, by-passing the registered medical practitioners, thus exposing them to possibly grave side-effects.
Side effects of diclofenac sodium include headache, rash, flatulence (excess gas in the stomach and intestines), heart failure, blood disorders, diarrhoea, constipation, nausea, vomiting or abdominal pain, indigestion, ulcers in stomach or intestine, decreased kidney function, inflammation of the liver, severe blistering skin reaction affecting the tissues of the eyes, mouth, throat and genitals (Stevens-Johnson Syndrome), alteration in results of liver function tests, bleeding from the stomach or intestine, dizziness or loss of balance, and anal itching and burning.
Being an NSAID, it is not recommended in asthmatics, pregnant women, patients allergic to aspirin, and those with a history or suspected risk of peptic ulcer, or of gastro-intestinal bleeding. Further, diclofenac may have serious interactions with other drugs. There may be an increased risk of bleeding from the gut if diclofenac is taken with blood thinning or anti-clotting medicines such as warfarin. If diclofenac is taken together with antibiotics like ciprofloxacin, convulsions may occur in patients with or without previous history of epilepsy or convulsions.
Alas, a drug with so many side-effects, contra-indications and drug interactions is being positioned as a medicine of choice for the commoner! And that too when the law has ample clauses to keep these in abeyance. Just as in Neeraj Clinic's case, on the legal front here again, provisions in the law debar Schedule 'H' drugs from being advertised.
Section 2 (2.1.9) of the Government of India's Final Model Guidelines - Code of Ethics For Advertisement Of Drugs, published in IDMA Bulletin XXX (10), 14 March 1999, clearly states, "(An advertisement of drug shall not) include products which are required to be sold only against prescriptions written by a registered medical practitioner."
The same code also states, under Section 2 (2.1.2), that "(An advertisement of drug shall not) be designed to arouse unwarranted expectations of product effectiveness", and under Section 2 (2.1.3), "(An advertisement of drug shall not) mislead with regard to safety, usage or immediacy of relief". Section 2 (2.1.7) of this code cautions that "(An advertisement of drug shall not) give an impression that a medical consultation or surgical operation is unnecessary."
Diclowin Plus advertisement is a breach of law in all these aspects, since it arouses unwarranted expectations among consumers regarding its non-permitted OTC usage, misleads public about its safety by not prominently highlighting the fact that it may cause serious side-effects if not taken without doctor's prescription, and gives an impression that the medicine may be by the consumer himself and attempts to obviate the need for medical advise, whereas according to the law, it MUST not be taken without requisite doctor prescription.
Similarly, there are guidelines in the ASCI's (Advertising Standards Council Of India) Code on Advertisement (Clause 4 and 6) and in OPPI's General Principles of the Model Guidelines of the Code of Ethics for Advertisement of Drugs (CLAUSE 2 (2.1.9)) which disapprove such advertisements.
Despite such detailed provisions under various Guidelines and Statutory Acts, advertisements like cures for epilepsy and Diclowin Plus continue to mock at the lacunae in Indian Legal System, albeit at the cost of endangering human health.
Is the government machinery sleeping? If so, it seems the aware citizens, experts on ethics in advertising, voluntary forums, and the media will have to take a collective initiative to wake them up to rectify this convenient "error of omission." Ambiguous loopholes in law that encourage companies to use it to their advantage should be amended more stringently, and that should give some food for thought to the drug authorities.