Date: 01/09/2022

Relevance: GS-2: Important aspects of governance, transparency and accountability, Issues relating to development and management of Services relating to Health, Education, Human Resources.

Relevance: GS-4: Medical ethics, ethical concerns and dilemmas in government and private institutions; laws, rules, regulations and conscience as sources of ethical guidance; accountability and ethical governance.

Key Phrases: Unethical Practices in Pharma Industry, Medical and Professional Ethics, National Pharmaceutical Pricing Authority (NPPA), Ethical marketing, Drug Prices Control Order (DPCO)

Context:

• Recently controversy erupted when Income Tax (IT) department officials raided premises of a pharma firm and declared that the firm was pursuing unethical business practices to promote a specific painkiller drug in its product line.

Background:

• It is believed that there is a huge prevalence of unethical marketing tactics in the pharmaceutical industry in India.
• Such practices take place in the name of marketing through gold coins, holidays for doctors and their families, sponsorship of ‘scientific’ conferences, and poorly designed clinical trials organized in medical colleges with munificent honorariums.
• In the current case such gifts and freebies were given to doctors and medical professionals for promoting the group’s products and the cost is estimated to the tune of ₹ 1000 crores which is masked through fake expenditure heads.

What is the legal status of gifts/ benefits to medical practitioners?

• In the Finance Bill of 2022 there is a provision that prohibits favours and benefits to medical practitioners under Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002
• Indian Medical Council (IMC) regulations prohibit doctors from accepting any gifts or benefits in the form of travel and hospitality, etc., from pharmaceutical companies.
• The problem lies in the fact that the Finance Bill, 2022 explanatory memorandum misses the point that the IMC regulations apply to doctors and not to pharmaceutical companies.
• Also, the IMC regulations prohibit doctors from taking gifts and freebies but allow professional associations of doctors to accept them.

How does the Pharma industry and medical practitioner nexus work?

• Despite government agencies curbing unethical practices, marketing medicines through prescribers is the most sought after route with the idea of increasing prescriptions of a particular company’s products in exchange for inducements.
• The patient has no choice when a particular brand usually priced higher than a less costly equivalent is prescribed by the doctor.
• Incidentally, the Indian law does not allow retail pharmacists to do brand substitution or sell an unbranded generic instead of a branded one which magnifies the issue and people are forced to buy the same product.

Different ways of Unethical pharma practices:

• There are numerous brands of a particular medicine in India and a variety of prices so every manufacturer has to claim some unique feature to push its product.
• Hence, to project a unique feature among several equally good qualities; manufacturers resort to marketing inducements often bordering on the unethical. Inducements, monetary and non-monetary, are proportional to the number of prescriptions.
• Pharma companies spread the belief, and prescribers and patients accept the narrative, that a higher-priced brand of the same medicine works better.
• Creative features are added over time by making a regular tablet into a sustained/extended/controlled/prolonged release and claiming better results.
• Promotion of FDCs (fixed dose combinations) which uses combinations of different chemical salts; they claim such FDCs to be more efficient and price them way higher.

Common people will pay the price

• Sometimes patients need only one salt but are forced to take FDCs so the chances of the patient consuming irrational and/or unnecessary medicines are quite high.
• Use of antibiotics when they are unnecessary poses a risk of developing resistance to one or both of the antibiotics in the combination.
• Such antimicrobial resistance deprives people of vital tools to fight life-threatening infections.
• Some fixed-dose combinations of potent topical corticosteroids (clobetasol, mometasone etc.) not only cause huge monetary investment but also result in irreversible lifetime skin damage.

Faulty Price control methods need a re-fix

• Currently, all drugs in the National List of Essential Medicines (NLEM) 2015 are under price control, per DPCO 2013 which accounts for a maximum of 18 percent of the total annual domestic sales and remaining 82 per cent are overpriced.
• The faulty methodology of fixing ceiling prices in DPCO 2013, using simple average methods, shows that many of the ceiling prices of NLEM medicines are overpriced.
• Price control is on only the specific presentations and strengths mentioned in the NLEM, therefore in the NLEM 2011 that was tagged with the DPCO 2013 few medicines (e.g.500mg paracetamol) came under price control and left out the majority of drugs.
• The manufacturers have exploited such loopholes as increasing the dose by small percent which falls beyond price control limit and then increasing the prices to a greater extent thus expanding the scope of profits (as far as 2000%)
  • For e.g. as per DPCO 2013 ,500mg paracetamol cannot be priced beyond ₹10.10 per strip of 10 tablets, but 650 mg paracetamol(not regulated) is sold at ₹20.40 per 10 tablets. i.e an increase of production cost by about 30% has led to selling price being more than doubled thus expanding the scope of larger profits.
• The extra margin probably helps undertake more marketing expenditures by transitioning to an unnecessary FDC and Such marketing, mostly unethical, is routine for most medicine manufacturers in India and for most brands.

A Code for ethical marketing with teeth is the way forward:

• Over the years the government, civil society has come out with several versions of a Uniform Code of Pharmaceuticals Marketing Practices (UCPMP).
• Although the drug industry is one of the stakeholders, any such code remains, and has remained, toothless and voluntary, and not mandatory.
• There is no law to deter unethical marketing of medicines but a government with a political will can fix the issue by regulating the pharma industry through a mandatory code for ethical pharmaceutical marketing with teeth.

Conclusion:

• There is an imminent need to minimize market failure in India’s pharmaceutical industry by rationalizing prices and regulating medicine strengths and unscientific content.
• Professional associations of doctors can take this forward by refusing gifts and inducements in short by being good, ethical human beings to preserve the sanctity of the medical profession for a larger good.

Source: The Hindu BL

Mains Question:

Q. “The increased unethical practices in the Indian pharmaceutical industry demand a mandatory, enforceable code for ethical pharmaceutical marketing for a larger good”. Comment on the relevance of the statement and support it through appropriate facts. (250 words).