TEAM HERALD
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PANJIM: Medical Council of India’s directive to doctors, hospitals and medical colleges to move towards generic medicines has been met with opposition, as the medical fraternity feels that it is impracticable to implement these directives.
Similarly, the Union ministry of health and family welfare has issued a directive to the food and drug administrations of all states to grant licences for drug formulation in its generic name instead of a trade name.
The doctors are not too happy with the medical council guidelines saying that there is no way to keep check on the quality of generic medicines that are sold.
“If we write medicines by the generic name as opposed to the trade name, the pharmacist can give whatever medicine is available and he will give one that has the most profit margins for him. In that sense the patient is at the mercy of the pharmacist,” Dr Shekhar Salkar the chairperson of the Goa State Medical Council said adding that the patient was safer in the hands of the doctor, than in the hands of the pharmacist.
Dr Salkar said that he has already written to the Medical Council of India expressing that instead of advising the doctors to prescribe medicines by medical name, the council should develop a mobile software that could give the doctor access to the various brands of the compound he wants to prescribe so he can give a list of good options to the patient, who could then choose whichever medicine he/she wants based on pricing, repute and other factors.
Given the lack of effective regulation of medicines and that bioavailability and bioequivalence tests are not carried out on pharmaceutical products, there is no way to guarantee that the medicines that are sold have the same quality and subsequently the same effect as they are supposed to. For this specific reason doctors prefer to prescribe medicines of reputed brands rather than have the pharmacist decide which brand the patient should use.
The Medical Council of India had issued the guidelines in a bid to both, reduce the financial burden that medicines are on patients, as well as to break the nexus between pharmaceutical companies and doctors. The direction of the MoHFW to issue licences according to trade names are also difficult to implement.
Director of FDA, Salim Valjee said that it will be difficult to monitor if they give licences based on the generic name rather than on the trade name in which it is produced.
“It will be very difficult to monitor each brand if we are to be giving licences only based on generic names,” Dr Veljee said. In the US and other developed nations, the term generic medicine is used for a pharmaceutical drug which is produced by a manufacturer other than the discoverer after the discoverer’s patent period has expired. This is irrespective of whether the medicine is sold under a trade name or the name of the compound.
In India however, almost 99.9% of the medicines produced have not been developed here but are sold under various trade names and are technically speaking ‘generics’. However the term generic is used to refer to medicines that are not sold under any brand name or trade name but by the drug or the salt that they contain.
Neither branded nor generic medicines can offer quality assurance given that bioavailability and bioequivalence tests are not mandatory.
