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Is A Law for Prescription of Generic Drugs An Answer to High-Priced Branded Drugs?

The debate on Generic Vs Branded drugs has attracted headlines and is being discussed in various forums since the Prime Minister spoke last month about legislation for prescribing generic drugs by doctors in India.

The low-price advantage of generic drugs appears to be the main driver for such a step in a country where 72 per cent of healthcare expenses in rural areas consist of money spent on medicines. Concerns have also been raised from certain quarters about the efficacy, availability and regulation of such drugs.

Benefits of generic drugs and risks and challenges associated with them in comparison to branded medicine:

A generic drug is one that is the bio-equivalent of a branded drug, generally not under patent protection. E.g. Paracetamol is the generic name of Calpol, the commonly used branded drug for treatment of pain relief and fever.

The factor that favours generic is affordability for the common man without compromising on the active ingredients in comparison to the branded version. As a proactive step, last year, the Medical Council of India (MCI) amended Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, which now says:

“Every physician should, as far as possible, prescribe drugs with generic names and he/ she shall ensure that there is a rational prescription and use of drugs.”

Though the above amendment is discretionary, if a law is in place, medical practitioners will have no choice but to prescribe only the generic name.

So, while the rationale behind generic drugs is socio-economically justified, it is commonly argued that the prescription of generic will be effective if the following concerns are addressed.

Concerns with Prescription of Generic Drugs

The whole country has just around 1,800 drug inspectors, making the regulation of generic drugs a major challenge. The companies producing branded drugs exercise self-regulation and ensure high standards, keeping their brand equity in mind. The same does not apply in the case of generic drugs.

The availability of generic medicine is limited to around 10,000 Jan Aushadhi stores run by the government. Since many drugs are not available there all the time, people have no choice but to buy their branded alternatives from chemists.

The consistency in the quality of generic drugs is a major concern. On many occasions, generic drugs have been found to contain less than the required amount of active pharmaceutical ingredient (API), thus making them ineffective.

Testing & Documentation
Despite government regulations, few drugs undergo quality testing in India. Without proper testing and documentation of test results and their audit, which may apply to many generic drugs, it is not fair to expect doctors to prescribe such drugs.

Prescribing Fixed Dose Combination
The market share for fixed dose combination is 45 per cent. Many fixed dose combinations have as many as 10 ingredients. While prescribing, it will be tedious for doctors to write each of the ingredients down and will be equally confounding for chemists when it comes to providing such medicine.

The Shift of Power to Chemists
If a law is passed for doctors to only prescribe the generic name of a drug, chemists will be the ultimate decision makers at the sales point. In such a case, he may sell the brands, which offer him the highest profit margin, negating the sole benefit for which the law is enacted.

If the above-mentioned issues are addressed, this step by the government will prove to be a boon to the citizens of India, where pharmaceutical companies widely use unethical means to promote their products, which are priced much higher.