News

Dt.11/06/2023

News reports say the government plans to make it mandatory for doctors to write prescriptions in generic names in private hospitals, a significant departure from the existing practice of prescribing brand names of medicines. This may have serious implications, from the quality of medicines that reach patients to how doctors are informed about new inventions. (Economic Times)

When a doctor prescribes a medicine — a cough syrup for example — it is the name of the brand.

But if the government has its way, that may change soon.

A recent news report says the union health ministry plans to make it mandatory for doctors in private hospitals to start prescribing generic medicines instead of “expensive branded drugs”, starting with those taking the benefits of the central government health schemes.

To make it simple to understand, for a common tablet to bring down fever, the doctor will now write Paracetamol on the prescription instead of brands like Dolo or Crocin or any tablet that has paracetamol as its active ingredient.

Now let’s take a tougher one — Olmezest CH20 is a brand used to treat high blood pressure.

It has three ingredients — Olmesartan, medoxomil and chlorthalidone. If the government decision comes through, the doctor is expected to write the names of all three ingredients instead of just the brand name.

For the patient, the next step is to hand the prescription to the chemist, who now acquires the power to decide the brand to sell to the patient. The patient has no clue about the producer of the drug or its quality records.

With the power to judge those parameters, slipping away from the doctor to the retail chemist, many feel traders will do everything to push medicines that fetch them high-profit margins.

The patient has a few other problems to deal with.

For example, names of chemicals can be overwhelming. For a simple cough syrup, the prescription may read like this: Levosalbutamol suplhate + ambroxol hydrochloride + guaiphenesin. The brand name for this is Ascoril LS, sold by Glenmark.

Puzzle of branded generics
India’s roughly USD42 billion market for medicines comprises what is known as branded generic drugs — an oxymoron that essentially means multiple copies of an original drug mostly researched by multinational companies but sold as distinct brands after its patent term expires.

This stands in contrast to most developed markets like the US or Europe where drugs are sold only under generic names after their patents expire while the innovator brand continues to retain its identity.

What makes the idea of writing prescriptions of generic drugs complex, if not impractical, is that India has a large share of combination drugs — an ingenious method to combine two or more drugs for better efficacy and higher compliance for patients. That also saves cost since the patient is not needed to buy two or more different drugs.

Also, by having a simple brand name, the patient, who at best has peripheral knowledge about medicines — is saved from the confusion to pick one brand from over a hundred similar products that claim to give the same benefits.

So, if you had shuddered at the chemistry classes in school, brace up. Also, think of the millions of people who may not be familiar with English and must make an informed decision.

Besides, spare a thought for the ever-busy doctors who must put in more time in writing long and complex chemical names. Making sense of the illegible handwriting of most doctors anyway ends in a guessing game for families.

Write generic names or else….
The buzz to switch prescriptions from brand names to generic names in private hospitals has intensified. It is already being enforced in government hospitals. A May 12 circular by Atul Goel, directorate general of health services to Safdarjung Hospital, RM Lohia Hospital and Lady Hardinge Medical College, all based in Delhi said doctors, including residents, in some instances are observed to continue to prescribe branded medicines.

“This has been viewed strictly by the competent authority,” the note said, adding the heads of these institutions may ensure strict compliance by the doctors working under them. Doctors in government hospitals or CGHS (Central Government Health Scheme) settings or polyclinics, it said, have been instructed time and again to prescribe generic medicines only.

While such notifications have been issued in states like Rajasthan as far back as 2010, their on-ground implementation has posed a critical challenge. Doctors, both in government and private practices, have been reluctant to write generic drug names, mostly citing poor quality of products that may not benefit the patients. Besides, intermittent reports of regulatory oversights have led to deeply ingrained doubts about the effectiveness of such medicines.

Quality question
Dr Lancelot Pinto, consultant respirologist, PD Hinduja Hospital is candid about the adverse implications of moving ahead with making generic prescriptions mandatory. He says as a respiratory physician, when he prescribes medications, he tends to trust some pharma companies more than others.

“This is a perception based on my knowledge of their track record when it comes to safety, their dedication to academic research and knowledge translation efforts. This is, of course, a perception, but as in any other field of life, perceptions drive practice and need to be addressed if practice is to be changed,” he adds.

Pinto says he is principally fine to prescribe generic drugs, but his apprehensions are based on studies that show a patchy history of poor quality of generic medicines. He says that has led to an inherent distrust in generics from little-known companies, and the government needs to address this mistrust.

Copycats don’t always work
India is estimated to have over 3,000 drug manufacturing units that supply thousands of brands in the local market. Of these, many have arrangements with small third-party manufacturing units that may not be periodically inspected by regulatory agencies for stringent quality controls.

“We need to have the reassurance that a generic (drug) is as good as any innovator’s molecule (medicine), it can be safely prescribed and not really bother about the quality. Independent audits by third parties would help foster an environment of transparency and accountability,” Pinto told ET Prime.

Other doctors agree with Pinto’s assertions and with good reasons. Ravi Wankhedkar, former president, Indian Medical Association says a decision to switch to generic prescription has serious flaws and will throw more challenges than solutions. It needs a serious review and similar moves had been opposed in the past.

“Thousands of medical representatives who are working hard to promote their brands. What happens to them? How are doctors expected to know about new drugs that are launched in the market,” asked another doctor.

Most medical professionals see the quality of the drug as a big worry and forcing a decision with a narrow view of just cutting the prices of medicine brands is moving in the wrong direction.

A recent study published in Mycoses - a scientific journal - showed anti-fungal drug itraconazole capsules had variable and unpredictable bioavailability in the treatment of patients with chronic pulmonary aspergillosis. The study tested generic brands in 94 patients against the innovator brand that was given to 99 patients.

The study found a higher proportion of subjects (patients) achieved therapeutic levels with the innovator drug than with generic brands. At two weeks, the study showed only 29% patients on generic drugs achieved therapeutic levels, as compared to 73% in innovator drug’s arm. You can read the study by following this link.

That poses serious questions on the strong push given to generic drugs by the government.

Prices and pharma’s unscrupulous promotions
Senior industry executives told ET Prime slashing prices of medicines, particularly those that are rampantly promoted to doctors is the priority for the government. The government sees the unbridled push of medicines by pharmaceutical companies to doctors as a significant addition to the final price of medicines.

In its defense, the government holds that wide variation exists between prices of drugs sold by pharmaceutical companies while the same drugs sold through its own Jan Aushadhi Scheme or fair price outlets are much cheaper to the patients.

Take for example atorvastatin, a popular drug to treat cardiac issues, for which scores of brands are available. On online pharmacy Netmeds, Sun Pharma’s Aztor 10 mg strip of 15 tablets is available at INR74 at maximum retail price.

In comparison, Hetero’s Genxvast is sold at INR14.35 for a strip of 10. The price gap is wider at the government-run Jan Aushadhi stores. The price of generic atorvastatin drops to INR8.80 for a strip of 10 tablets. For most other commonly used drugs, the price difference is in a similar range.

This is where the government and industry are at loggerheads.

Sources say the government feels the pharmaceutical industry is pricing the drugs at a significantly higher margin and fleecing the patient while the industry says medicine prices in India are among the lowest in the world and cutting it beyond the current levels may compromise their quality and may lead the industry to collapse.

A senior industry executive says if the decision to choose a generic drug is made by the channel partners, they may dispense drugs with a higher profit margin, regardless of the drug's quality. This can result in spurious generic drugs being dispensed putting patient care and human life at risk.

A senior representative from the All India Organization of Chemists and Druggists, the group that represents chemists, proposed a single price for medicines across the country. In his view, the price wars have no end and if every medicine is at the same price level, the best brands can anyways stand as of exceptional quality.

Jan Aushadhi: Cheap but is it the best?
But the government seems unrelenting. Lately, a renewed push is being given to Jan Aushadhi scheme, an ambitious project that has seen tardy acceptance for its 15 years of existence. According to the 2021-22 annual report of the department of pharmaceuticals, roughly 8640 Jan Aushadhi stores are operational that sell 1451 drugs and 240 surgical equipment. The report says the stores collectively achieved sales of INR652.67 crore which led to savings of approximately INR3,800 crore for the citizens.

The government says its procurements stand on firm principles of highest quality standards of drugs. This claim is disputed by industry. Officials say the tenders for supplies to Jan Aushadhi go to those units that offer the cheapest rates but that may not be at the best quality.

The two sides are clear about their priorities — the government is inclined on making drugs affordable, but the industry says it will lead to a deterioration in the quality of the drugs and may even jeopardise the industry. Critics say health is an emotive subject and the noises echoing from Delhi are part of the build-up to prepare for the general elections next year.

In all this, Pinto makes a sanguine point.

He says doctors are easy targets for criticism, and every allegation of malpractice is often directed towards them. “At the end of the day, if I prescribe something and my patient does not get better, the liability is mine. I feel responsible,” he adds.

Pinto has strong reasons In hospitals, doctors have been attacked by angry families of patients. If a drug is not of high quality and shows no benefits, the patient does not go after the company or get the chemical analysis done. “The liability will be on me and if that is the case, I need to be reassured about the quality and that I am not causing any harm,” he says.