Making prescription of generic drugs mandatory

In a widely publicised speech on April 17, Prime Minister Narendra Modi indicated that the government may bring in a legal framework under which doctors will have to prescribe generic medicines.

Why this law needed:

• A major hurdle faced is that doctors don’t prescribe generic medicines supplied through Jan Aushadistores, so patients find it tough to ask for the correct generic equivalents.

Why generics:

• Access to quality medicines at affordable prices is a key challenge for the Government. In this connection the prices of branded medicines are generally higher than generic medicines due to various reasons inter-alia including branded drugs having patent protection and a number of drugs having limited regulation through the Drug Prices Control Order, 1995 etc In comparison to branded medicines generics have low cost and poor could afford.

What is Jan Aushadhi Scheme:

• Scheme was initially launched in 2008 with the aim to make quality medicines available at affordable prices for all, particularly the poor and disadvantaged through specialized outlets called Jan Aushadhi stores.
• In 2016-17 budget government announced to open 3,000 Jan Aushadhi stores in 2016-17 across the country .
• Scheme was launched to make available quality generic medicines at affordable prices to all, especially the poor, throughout the country, through outlets known as Jan Aushadhi Stores (JASs).
• Under the Jan Aushadhi Scheme, the State Governments are required to provide space in Government Hospital premises or any other suitable locations for the running of the Jan Aushadhi Stores (JAS)

Generic drug

• The generics are medicines on which patents have expired. They are sold either as branded products or as unbranded products under their generic names.
• These drugs are equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use. The generic names are internationally agreed short names called International

Non-Proprietary Names.

• For example, paracetamol is the name for a pain relieving and fever reducing medication and Crocin is one brand name of paracetamol.
• The Indian Medical Council (Professional Conduct Etiquette and Ethics) Regulations, 2002 says: “Every physician should prescribe drugs with generic names legibly (can be read easily) and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs.”
• The move proposed by the government will make it illegal for Indian doctors to write out a prescription for the trademark of the drug, forcing them to mention the chemical name instead.

What is the proposed move?

• The proposed legislation has the potential of offering the patient a greater say in the choice of a medicine.
• Making it obligatory on the doctor to prescribe a generic drug would mean that the prescription will detail the medicine’s composition.
• It would leave the choice of the brand on the patient.

What should be done?

• For this to be effective, the proposed law needs to go beyond the doctor-patient binary and target each link in the pharma industry’s chain of corruption.
• E.g. there are more than 500 generic versions for the anti-bronchial pneumonia formula, amoxycillin and potassium clavulanate, that cost between Rs 70 to Rs 300 for a packet of 10 tablets.
• A patient with a prescription detailing the composition of the medicine could still be dependent on a pharmacist to make the most suitable drug choice.
• Also a pharmacist is less likely to be sensitive to a patient’s medical and financial condition than the doctor.
• Therefore the pharmacists should also be brought under its ambit.
• The generic medicine industry should also be revamped. Last year, 27 commonly-used medicines in the country failed quality tests.
• Currently in most cases, failure to comply with standards results only in a short-term suspension of a manufacturer’s production licence. Effective deterrents should be formulated.
• Adequate regulations, ample drug inspectors and lab facilities to check drug quality should be provided to ensure quality.
• The move needs to be backed by adequate regulatory and legal provision

Benefits of making prescription of generic drugs mandatory:

• Branded medicines are more expensive. The generic drug does not have to undergo a complete clinical trial to be proved equivalent, the bioequivalence test is much cheaper than clinical trials making generic drugs cheaper.
• While generic medicines are good quality low-cost drugs with equal efficacy as that of branded drugs, in the absence of proper knowledge consumers often tend to go by what doctors and chemists decide for them.
• The government’s move assumes significance as medicines account for 70-75% of a household’s out of pocket expenditure on health
• The move will result into affordable access to quality medicines which is a part of free universal access to healthcare services.
• India being a world leader in generics, the dependency on imports of patent drugs will reduce improving our trade of balance.

Example:

• The US in 1984 introduced “the Drug Price Competition and Patent Term Restoration Act”, it transformed the drug market by allowing a generic medicine, that has demonstrated mere bioequivalence with the branded drug, to be dispensed as a substitute for a prescription of the branded drug. Subsequently, this model has been followed in other countries and today most OECD and other developing countries accept the substitution of a branded medicine with a generic equivalent.

Analysis

• At least 90% of the Indian domestic pharmaceutical market, of 1,00,000 crore and more, comprises drugs sold under brand names. There simply are not enough generic name equivalents of branded medicines sold.
• About half the market—50,000 crore and more—is for fixed-dose combinations (FDCs) of drugs, a further half of them irrational.
• Many FDC drugs contain even eight or nine medicines. To write, and remember, the constituents of FDC drugs in generic names is impractical, considering that there would be thousands of FDC brands.
• A combination drug is a fixed-dose combination (FDC) that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.
• Even if the doctor manages to write a prescription in generic names for single-ingredient drugs, pharmacists will sell the brand that maximises their commission and will in all likelihood not stock the less costlier but equivalent brand or generic medicine that is as good. This defeats the basic intention of making medicines affordable for consumers.
• Prescription by generic names merely shifts the focus of the pharmaceutical industry’s unethical drug promotion to the pharmacist; away from the prescriber, and resulting in business as usual.
• Medicines will continue to account for anything from 50% to 80% of treatment costs.