CHANGING PRESCRIPTION DRUGS TO OTC MAY BE DANGEROUS INDIA’S LITTLE REGULATED DRUG INDUSTRY DOES IT AT WILL

Otrivin Oxy, a fast relief adult nasal spray over-the-counter (OTC) drug marketed in India by GlaxoSmithK line (GSK), the world’s sixth largest pharmaceutical companyby revenue, seems to have become very popular among those suffering from severe nasal congestion. Its 10-second TV ad is quite compelling. The ad features a young man with clipped red nose struggling to sleep in his bed before inhaling the miracle nasal solution Otrivin Oxy which “acts in 25 seconds” to provide “relief up to 12 hours”. The young man inhales the drug to get a fast relief. Otrivin Oxy, claims GSK, helps in opening up the nasal passages by reducing excessive nasal secretions and returns the swollen blood vessels to their normal size.

The dosage is simple: for adults and adolescents (12 years and above), one spray in each nostril, 1-2 times a day. Further, it says “do not exceed two applications daily into each nostril.” The digital ad featuring Otrivin Oxy is certainly one of the best among the fast growing ‘OTC’ drug ads in the county. The market is flooded with OTC drugs. More and more patients are visiting pharmacists instead of a doctor for medicines to treat ailments such as cough, cold, allergies, pain, fever,
acidity, diarrhea, and skin-related conditions.

Nothing may appear to be wrong with GSK’s short and easy instructions on the use of Otrivin Oxy. However, the drug’s side effect or reactions part, written in extremely small font size on a thin leaflet inside the pack carrying well over 100 words, could be a matter of real big concern, raising the question if such a drug should be allowed to sell without medical prescription from a registered doctor. One such warning says ‘check your doctor before using Otrivin Oxy if you suffer from high blood pressure, overactive thyroid, glaucoma, prostatic hypertrophy, diabetes or phaeocromocytoma.’

The latter is a rare tumour that can form in cells in the middle of the adrenal glands. The tumour can
cause the adrenal glands to make too much of the hormones norepinephrine (noradrenaline) and epinephrine (adrenaline). Together these hormones control heart rate, metabolism, blood pressure, and the body’s stress response. Increased levels of these hormones can put the body into a stress-response state, causing blood pressure to increase. The questions are: how many of the cheap ad- attracted Otrivin Oxy users are fully aware of their complex medical conditions, should such a drug be branded ‘OTC’ by a pharmaceutical firm and, more pertinently, should such practices be regulated?

Unfortunately, there is nothing in India’s 80- year- old Drugs and Cosmetics Act that strictly specifies the nature and description of drugs that can be sold by pharmacies over the counter. Originally known as the Drug Act, the law followed the recommendations of the Chopra Committee of 1930. The drug rules were first passed in 1945. It is true that the Act had undergone several amendments over the years. TheAct defines the term ‘drug’ as a combination of variety of substance and includes diagnostic and medical devices. ‘Cosmetic’ is defined asany product (excluding soaps) for application to the human body for beautifyingor cleansing. In 1964, the Act was amended to include Ayurvedic and Unani drugs. Under Section 17 of the Act, a drug is considered misbranded if it claims to be of more therapeutic value than it actually is. The term OTC does not havea legaldefinition in India, asyet. Technically, all drugs are OTC unless they are specifically stated as ‘prescription only’ drugs. OTC medicines are legally allowed to be sold by pharmacists without a doctor ’s prescription. N ormally, OTC drugs are supposed to allow faster and cheaper access to healthcare. However, their misuse and adverse healtheffects should be a matter of concern.

Not long ago, a decision to have a separate provision for OTC drugs under the Drugs and Cosmetics Act was taken by the drugs consultative committee, which is part India’s health ministry. Asub-committee was formed to examine the OTC drug issue in particular and make suitable recommendations. Though the sub- committee felt that there is an urgent need for definingOTC drugs and for
laying down specific provisions for the regulation of OTC drugs in the country, it is not clear what is holding the authorities back.

The government was supposed to come up with a list of OTC drugs under a separate schedule by making changes inthe drug law withstringent regulations on quality, advertisement and pricing of such products. Could the delay in the government’s decision in this regard be influenced under pressure from the pharmaceutical industry? It is anybody’s guess. But, the“urgency” on the part of the authorities seems to be somehow lacking. That is hardlybe regarded as a healthy state of affair. In several countries, OTC drugs are bunched under a separate category having established regulations for their use. However, India does not provide either any guideline for licensing OTC medicines or allot a separate category for these drugs.

Going by the World Health Organisation perspective, for a product to be an OTC medicine, it should be marketed on prescription for at least five years. Thetime period for change of category from
prescription drugs to OTC seems to vary from country to country. However, all agree that it is important to ensure that the OTC category medicines must not cause serious adverse drug reactions with increasing frequency during their conversion period — from prescriptiondrugs to OTC. In China, OTC medicines carryingspecial logo marks are regulated since 1999.

All advertisements of OTC drugs in China require prior government approval. Unfortunately, India’s drug market — represented mostly by millions of private pharmacies in urban and rural areas — faces little interference from regulatory authorities. Few drug dispensers are even qualified pharmacists. For them, all drugs appear to be OTC drugs. Very few care for doctor’s prescriptions. The health ministry is little concerned. Nor are the industry ministry and its department of drugs and pharmaceuticals. The issue is rarely debated in legislative assemblies and Parliament. Paradoxically, the drug industry and pharmacies seem to be in control of health of the public.