Generic vs. branded medicine: Doctor’s stake : just stringent check on quality of medicine.

Doctors should have no issues to what Honourable Prime Minister Mr Narender Modi himself has spoken, for putting in place a legal frame work to ensure that doctors prescribe only generic drugs. This practice can be easily followed if apprehensions about quality of medicines are allayed.

There have always been concerns regarding quality of generic drugs sold under various trade names since the control over their quality is not foolproof. Implementation has to come along with stringent laws regarding drug testing and quality assurance, otherwise it may be dangerous to patients and in turn to doctors, in the present scenario.

   Generic drug are low cost version of a formulation that should ideally be equivalent to a branded product as far as its production quality, dosage, strength, route of administration and efficacy is concerned. Most generic products are allowed to enter the market only after expiry of the patent protection duration granted to the drug’s original developer.

   Branded drugs are expensive and there is a huge price variation between different branded drugs containing same molecule which is inexplicable. How can doctors interpret the price variation which can be sometimes many times for the different brands of same molecule. Is this price variation because of some difference in efficacy? How to interpret this much price gap and how to keep track of newer names launched at lower prices? Doctors do not manufacture drugs nor are they responsible for printed high retail prices variation in drug prices. I feel the biggest problem is the lack of documentation on efficacy of different brands of same molecule, which if done could guide the doctor. Some regulatory agency needs to be responsible for guiding doctors and patients regarding relationship of quality of drugs and prices. Therefore it is actually not correct to hold doctors responsible for these cost variations.

Huge price variation:  But all said and done, none of the arguments can explain the huge price variation for the different brand of same molecule. This malpractice of pharmaceutical industry has gone on for years without any check and this needs a solution which cannot be found at the door of doctors alone.

The quality control mechanism need to be strengthened and made more stringent. Before using a generic drug, the doctor or patient has to be well assured about  consistent quality of various drugs of same molecule and their pharmacological properties and also the fact that they have been manufactured using the standard practices  and meet the quality controls as per the regulations laid down. Concerned agency should check, verify and certify each and every drug.

 Bioavailability equivalence: There has to be a stringent legal mechanism to guarantee the bio equivalency of the compound for the drug made available in the market. Even a bioequivalent drug can fail efficacy test because of factors like heat, humidity and stability issues. There should be a strict quality control with best manufacturing and packing practices followed for generic and branded medicines alike.

Quality assurance of every drug is a patient’s right and a doctor’s too. They both have a right to know about relationship of quality, efficacy and price. It is of paramount importance to the patient who is ultimately    the consumer.

 Doctors can be victim of this anomaly in a bigger way: They can be in big trouble if quality of the drug prescribed by them is lacking in its quality and efficacy. Major adverse effects and even deaths have been reported due to poor quality of drugs or contaminated drugs. For example deaths in a sterilization camp in Chhattisgarh (FIR 11.11.14) have been attributed to use of contaminated drugs. Think of the plight and suffering of the doctor who was then portrayed as a criminal. He was lucky that court ultimately found out about the poor quality drugs as the cause. But in a day to day routine practice, it is very difficult even to think of such possibilities and prove it and consequently doctor has to suffer the blame of being negligent. Most of the time, it is taken as incompetency and failure of the doctor while the actual problem lies with the drug. If a doctor makes a correct diagnosis and advises medicines correctly but the patient still does not get well, it is the doctor who is blamed for the lack of improvement. Sometimes, if patient does not get well or if a life is lost, doctor may be abused, assaulted or dragged to court. Consequently most doctors try to play safe and prescribe drugs of pharmaceutical companies of sound background. So doctor’s concern should be to ensure and demand strict quality control of medicines because it has a real bearing on the ultimate practice of the doctor. It is really unfortunate that for the lack of poor regulatory mechanisms and greed of pharmacy industry, doctors suffer.

 Doctors just need stringent quality control, law and mechanisms to guarantee effective medicine be it generic or branded. 

It is not a problem to a doctor whether patient gets a generic or branded medicine, as long as it is effective.  Nor does it concern them whether a drug company or chemist make 100% or 1000% of profit out of medicine. The latter should be regulated by government agencies.

It needs a sincere effort by the Government to maintain stringent quality of drugs so as to ensure that both generic as well as branded drugs have same quality and efficacy. The recent initiative by our prime minister can usher in a new era and can be path breaking if strict measure are in place for quality control and standard manufacturing practices are followed.