The Government of Maharashtra has passed an order asking doctors both in private and public sectors to prescribe medicines by generic names along with the brand names. They have been given two months notice to comply with the order.
The reactions to the order have been illogical as the order itself. The order gives a model format called the Maharashtra Model Prescription Format. Medicines are to be prescribed on a minimum A 5 size paper (14 x 21 cms). The operative part of the format asks the prescriber to give the name of the medicine or “any other cheaper generic medicine as per choice of patient.” The generic name is to be given in capital letters. In other words along with business as usual of prescribing the branded medicine, the generic name of the medicine is to be mentioned. It is not mandatory – but only “as far as possible.” It assumes that the patient will know the difference between generic and branded medicine and he/she has a “choice” when in distress.
It also assumes that these generic name medicines will be available in retail shops. Chances are that practically no retailer will keep medicines with only the generic name because they generally tend to be cheaper and have therefore lesser margins. So, I go to the retail pharmacy, ask for the generic named rosuvastatin but it is not available. Then the pharmacist will say take this branded equivalent and this is from a well known company. Chances are that he will give the more expensive or popular brand as it will have more margin. And if it is a drug like rosuvastatin (unlike its chemical analogue atorvastatin), the brand will be high priced and out of price control. If it is a fixed dose combination (FDC), say norflaxacin plus tinidazole or say Aluminium hydroxide + Magnesium hydrochloride + Methylpolysiloxane (brand Gelusil), it will take a consumer with familiarity with English and chemistry to confidently negotiate the purchase.
One even doubts how many pharmacists will be familiar – that is as and when pharmacists are present in the retail shop. At least 70 per cent of the medicines in the market, by value, are fixed dose combinations (FDCs) with a longer list of generic name constituents.
Somewhere it also relies on the ability and the competency of the pharmacist (I am loosely using the term for the boy who will deal with the prescription) to substitute brands for generic and generic for brands or generics of different companies. Such powers are not granted them as per the law. That is the pharmacist cannot substitute at will.
With this kind of discouraging experience, most patients will tell their doctors please prescribe the brand and be done with it. The format also requires the prescriber to record the patient’s name, age and weight with the complete address of the patient (name of the owner of the animal in case of veterinary drug – how thoughtful). It is impractical to ask a busy GP to write the complete address.
However, this is required says the government format in case of prescription errors of various kind and for recall of medicines. When and where such recalls were done last in the history of retail prescriptions in India?
Indeed if the purpose of the government in implementing the model prescription format was to encourage generic name drugs, it is likely to end up as a case of the baby of generics being thrown with bathtub and bathwater.
Which is unfortunate because in keeping with the practice of countries with good pharmaceutical regulation, we need to encourage generic names as contrasted to brand names and as far as possible single ingredient formulations (that is fixed dose combinations should be the exception than the rule). Brand names confuse for various reasons. There are at least a lakh brands of medicines in India, and often sharing common brand names with underwear and cars and common salt. A branded drug, manufactured by small/big company gives the impression of being of “better quality” than the generic version. When in reality branded medicines from even the “top companies” are routinely hauled up for quality (out of the media gaze).
Quality is not a function of size of the company nor because it is a brand or a generic. Every licensed medicine in India is to be made as per procedure specified and every medicine made in India is required to be of quality as per pharmacopeial standards prescribed. It is a culpable crime if a medicine is not as per prescribed quality. Punishments vary from fine to 10 year imprisonments. If penalty provisions are implemented uniformly and fairly, the noise about
brand and generic being of different quality will vanish. Prices will also come down as companies with same identical generic names will find it difficult to claim special virtues.
The long term solution is to allow marketing of medicines only under their generic (or international non proprietary) names, remove unnecessary and unscientific combinations from the market, and regulate prices of the remaining essentials in the market. The current move is a confused move paved with good intentions.
(The author works with Locost Vadodara and is a regular commentator on the public health aspects of generic medicines).