Reconsider order choosing generic drugs over branded drugs, doctors urge Centre

Hyderabad: The Centre’s sudden move to ban doctors from prescribing branded drugs in favour of generic medicines without taking all aspects into consideration, has received a thumbs down from almost all private and government doctors.

As per the new regulations of the National Medical Council (NMC), doctors must prescribe generic drugs. In case of failure to do so, they will be penalised and even their license to practice may be suspended for a period.

Doctors from the Indian Medical Association (IMA), Telangana chapter and IMA headquarters pointed out that this move, taken without any consultation with medical practitioners, will be detrimental to patient care and safety mainly because the quality and safety aspects of manufacturing the drugs will be compromised in case of low-priced generic medicines. They said there are chances of malpractices being committed to making generic drugs. They asked the government to defer the regulation for wider consultation and demanded a foolproof system of quality assurance before switching to generic drugs.

What is a generic drug?

A generic drug is a medication with the same active ingredient and clinical benefit as its branded counterpart. Branded drugs reflect the names given to them by the manufacturing company while the generic drug refers to a drug produced and named after the active ingredient. For example, while paracetamol is the generic name, drugs like Calpol, Crocin, Lemolate, and Tylenol are the brand names.

Efficiency of generic drugs is questionable

Dr BN Rao, president of the Indian Medical Association of Telangana State, said, “Even though the move is intended to reduce the expenses for patients, the decision is not practically feasible. We, doctors, are not against prescribing generic medicines but we doubt their bioavailability (a measure of how much a drug is able to access the circulation and reach the target/action area depending on its absorption and secretion), efficiency and endpoint efficacy (targeted outcome of a drug after clinical trial), which are vital for controlling and curing diseases. So, cost alone should not be the criteria but side effects of such generic drugs also need to be considered. For adverse reactions, one can sue the branded companies but there is no such accountability for generic drugs.”

“Instead of making it mandatory to prescribe generic medicines, the government should try to reduce the price of drugs from branded companies by slashing the taxes and providing infrastructure and power at a lower cost,” suggested Dr Rao.

Doctors should handle the decision over type of drugs

“NMC insisting on writing prescriptions only in generic names is just shifting the choice from a medical practitioner who is primarily concerned, trained and responsible for the patient’s health to a chemist or a person sitting in a chemist shop, selling drugs. The onus of exercising the choice shifts from the doctor or a qualified professional to the medical shop or market forces. This would not be in the best interest of the patient. We should refrain from just cost cutting irrespective of quality treatment. The government, if serious about implementing generic drugs should give license only to the generics and not to any branded drugs while ensuring the quality of generic drugs,” said Dr Sharad Kumar Agarwal, national president of IMA.

The IMA president further added, “The highest impediment to generic drugs is the uncertainty about its quality. Less the 0.1 per cent of the drugs manufactured in India are tested for quality.”

Dr Anilkumar J Nayak, honorary secretary general of IMA, said, “IMA has been demanding that only good quality drugs should be made available and prices should be uniform and affordable. IMA urges the government to have a ‘one drug, one quality, one price’ system ensuring the highest quality for generic drugs and banning all manufacturing of branded drugs. The notification is an injustice to the doctors.”

Stringent quality checks needed

Dr M Kiran, an anaesthesiologist at Nizamabad Government Hospital said, “Unless the quality of the generic medicines is ensured, the move to ban prescribing branded drugs will not be a fool-proof mechanism and can rather backfire doing more harm than good for patients. As per the Lok Sabha data, 3.4 per cent of the drugs analysed in the country are substandard. Such moves can be encouraged when the quality is maintained and there is a stringent quality check on whether all good manufacturing practices are followed or not.”

According to Dr S Vijay Mohan, general physician at Care Hospital, Hyderabad, it is difficult to implement this in India with such a huge population and a huge number of quacks. “Anybody can write any major antibiotic or even anti-cancer drug even without holding a degree in our country. This can be implemented only if all pharma companies are taken over by the government and they start producing only ‘generic’ drugs. We also have so many unqualified people and small pharma companies who are capable of producing even duplicate ‘generic’ drugs.”

“In the West and Gulf countries, for each level of qualification, a limited group of drugs are allowed. When it comes to high-end antibiotics, the pharmacist will issue the drugs only on producing three prescriptions written by three equally qualified doctors. When it comes to sleep medicines and narcotic drugs, there is a special rule of ‘Red Prescription,’ again advised by three different doctors. We don’t have this mechanism except in hospitalised patients,” adds Dr Vijay Mohan.