Indian Medical Industry – “Swindling Silently & Swiftly !”

Recently I was walking around the shop to purchase the medicine, which was prescribed by my doctor. It’s been a while since finding that medicine has become a tough row to hoe for me both in walk in pharmacies & online portals. At last when I couldn’t find it, the pharmacist offered me its alternative within same price range and same salt.

Although I’ve been his familiar & old patient and I trust him by all means, but there’s something about this incident that I can’t ignore, i.e.: Partisanship.

One can visualise the drastic impacts of partisanship in Indian medical profession just by the fact that now it’s being labelled as ‘Indian Medical Industry’, or at least this is what it has been made. The mere word Industry instead of Profession imparts the sense of business replacing what used to be a practice. Hadn’t it been for 2nd wave of Covid-19, led by Wuhan Virus, it’d have been still left unnoticed. But not anymore, let’s dwell into its ins & outs.

MEDICINES – A MIRAGE FOR POOR !

When a doctor prescribes a specific drug to you, it actually refers to the Brand Name of that drug. There’s no mention of its components (Primary Salt, Adjuvant, etc) and these medicines under a specific Brand Name costs manifolds than their corresponding Generic Versions that serves the same purpose with same primary salt(s), with same effects. Due to these high costs, a simple 3 day drug course for Gastroenteritis, i.e., Stomach Infection becomes unaffordable for people with lower incomes. In extreme circumstances, this necessitation costs us lives that could’ve been prevented if acted preemptively.

For example : Consider three salesmen of different companies approaching a newly practicing doctor – Dr. Jaiswal. These three salesmen bring three respective medicines having common function(s).

• Salesman 1 offers Dr. Jaiswal his company’s product (medicine A) in which the doctor gets 20% incentive and the rest goes to the company.

• Salesman 2 offers Dr. Jaiswal his company’s product (medicine B), which is same as medicine A, but has no incentive for him.

• Salesman 3 offers Dr. Jaiswal his company’s product (medicine C), which is an innovative model of the previous ones, having 5% incentive for him.

Now what do you think which offer a doctor’s common sense would ask him to opt for?

Second offer is a straight ‘NO’ as company retains all the profit in it, leaving no choice but to go for first option in which the doctor makes his profit as well. For the sake of moral grounds, third offer seems ‘NO WIN - NO LOSS’ but this is an extremely rare condition in today’s scenario, where money is the ultimate king !

WHAT ARE GENERIC MEDICINES ?

A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents may or may not be produced via ‘Reverse Engineering (Application of Biotechnology)’. A generic drug has the same Active Pharmaceutical Ingredient or API (a biologically active ingredient in a pharmaceutical drug or pesticide) as the original, but it may differ in some characteristics such as the manufacturing process, formulation (Process in which different chemical substances, including the active drug, are combined to produce a final medicinal product), excipients (Substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts, or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility.), colour, taste, and packaging.

DIFFERENCE BETWEEN BRANDED DRUG & IT'S GENERIC VERSION :-

According to the United States Food & Drug Administration (USFDA), a federal agency of the Department of Health & Human Services, Branded Drug is a prescribed drug marketed under a proprietary, trademark-protected name and Generic Drug as the drug product that is comparable to branded drug product in dosage form, strength, route of administration, quality & performance and intended use.

In USA, there’s a crystal clear distinction between Branded & Generic drugs, i.e.: Once the patent for a particular drug is expired, other companies are eligible to make profit out of it and will be considered as ‘generic drug’. But in India, all pharmaceutical companies make generic salts and give their brand names to it. The price of an unbranded generic version of a medicine is generally lower than the price of a corresponding branded medicine because in case of generic version, the pharmaceutical company does not spend money on research & development (R&D), testing & trials, advertising, promotion of its brand. The sale of a generic version is incentivized by a pharmaceutical company by keeping a high trade margin for wholesalers and retailers.

Two drugs will only be considered as generic drugs if they’re having same :

• Dosage to be consumed – concentration should be same (eg : both 10 mg)

• Medium of consumption – both either should be intravenous, swallowable pills, etc.

• Function(s) – either both should cure high temperature or both should reduce bacterial infection.

• Composition – encompassing salt(s) should be same.

• Tangible attributes – taste, colour, etc.

The drug product doesn’t need to be the same even if the two share Brand-Generic Drug Relationship. e.g.: Ibuprofen is the generic version of ‘Advil’ (Pfizer) but the pill itself is different with regards to taste and colour. Anyone can sell and make profits out of Ibuprofen but not Advil.

ACTIONS SPEAK LOUDER THAN WORDS !

In 2017, in one of his many speeches, PM Modi asked doctors to prescribe generic salts instead of branded drugs to their patients.

• ‘Pradhan Mantri Bhartiya Janaushadhi Pariyojana’ (PMBJP) was launched by the Department of Pharmaceuticals, under the aegis of Ministry of Chemicals & Fertilizers, in which quality generic medicines are sold across the country via dedicated outlets called ‘Pradhan Mantri Bharitya Janaushadhi Kendra’ (PMBJK).

• An IOS & android application of the same was launched as well by ‘Sadanand Gowda’ on April 08, 2020. As on March 10, 2021, 7507 PMBJKs has been opened across the country.

• The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India, whose primary objective is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.

• Clause 1.5 of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations - 2002 prescribes that every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drug.

• The MCI or the appropriate State Medical Councils have been empowered to take disciplinary actions against a doctor for violation of the provision of the aforesaid Regulations. As and when complaints are received against the violation of code of ethics for doctors, such complaints are referred by MCI to the concerned State Medical Councils where the doctors/medical practitioners are registered.

• Tele-Medicine Guidelines 2020 issued on May 22, 2020, do direct all the Registered Medical Practioners (RMPs) to use Generic Names of the drugs in capital letters on the prescription format as appended with the document.

There are lone crusaders like Dr H. S. Bawaskar, the physician from Raigad who filed a complaint with the Medical Council of India (MCI) in 2013 when a diagnostic centre sent him a commission. But the MCI and the larger medical community seems to ignore such efforts and even suppress them.

In 1996, a Chennai-based nephrologist, Dr M. K. Mani filed a complaint with the MCI and even his reproduced correspondence with the diagnostic centre that had offered him a commission. It looks like the MCI hadn't resolved the issue when The Lancet checked in November 2013.

Further, the Ministry of Health & Family Welfare (MoH&FW) has taken various regulatory measures to promote and ensure the quality of generic medicines. These include :

• Instructions to Licensing Authorities to grant / renew licenses to manufacture for sale or for distribution of drugs in proper / generic names only.

• Amendment in the Drugs and Cosmetics Rules, 1945 for making it mandatory to grant license for a drug formulation containing single active ingredient in proper name only.

• Inclusion of provision in the Rules, 1945 for submission of the result of bioequivalence study along with application for grant of manufacturing license in the case of certain drugs.

• Provision for joint inspection of manufacturing establishment by the Drugs Inspectors of Central Government and State Government.

The Republic of India, despite of having the third cheapest healthcare services, still needs to go a long way in order to be at par with WHO’s standards (if not a role model).

This is something which has been profoundly highlighted during the second Covid-19 wave – Shortages of oxygen, medicines, hospital beds, etc. Considering Branded & Generic Drugs, both have their own significances – without branded drugs there will be no drugs at all as they are the ones who conduct extensive researches, trials, feedback, advertising, which generates additional employment. On the other hand generic drugs are more accessible for the low income population.

These Indian generic drugs are the reason why :

• African population is still surviving against malaria, dengue, typhoid and what not.

• India is called Pharmacy of the World. (India tops in the world in exporting generic medicines worth of Rs 50,000 crores and currently, the Indian pharmaceutical industry is one of the world's largest and most developed, according to Union Minister of state for chemicals and fertilizers Srikanta Jena.)

• Vaccine diplomacy (Vaccine Maitri) was a major success amid Covid-19 pandemic.

There are a few simple steps that the doctors / medical practioners can take to start with:

• Refuse to give or accept commissions from or to other doctors and/or diagnostic centres.

 

• Keep the patient’s interest topmost in all the decisions and the advice they give them.

• Be honest and transparent with patients.

A constructive solution towards this swindling would be a minor change in prescription writing pattern of the medical practioners, i.e.: If the doctors mention both branded as well as generic drugs to the patient, then, it’ll be a double edged sword – the doctor would still be enjoying their incentives and the patient can look out for alternatives instead of wasting time on a single brand name in case of scarcity.

A Random Brainstorming initiative in collaboration with Beingafauji .