The recent kerfuffle over a particular brand of the painkiller paracetamol 650 mg tablet is not really over the particular brand as much as about the unethical marketing tactics of the pharmaceutical industry in India.
Gone are the days when a mere ball-point pen or a diary from a medical representative was sufficient. Now, the norm is gold coins, holidays for doctors and their families, sponsorship to ‘scientific’ conferences, and poorly designed clinical trials organised in medical colleges with munificent honorariums — all of which are basically unethical marketing efforts in disguise.
The press release issued after the recent ‘raid’ on a well-known pharma group by the I-T Department has these lines: “The initial gleaning of the evidence has revealed that the group has been debiting in its books of account unallowable expenses on account of distribution of freebies to the medical professionals under the head ‘Sales and Promotion’.
These freebies included travel expenses, perquisites, gifts, etc., to doctors and medical professionals for promoting the group’s products under the heads ‘Promotion and Propaganda’, ‘Seminars and Symposiums’, ‘Medical Advisories’, etc. The evidence indicates that the group has adopted unethical practices to promote its products/brands. The quantum of such freebies detected is estimated to be around ₹1,000 crore.”
The company has rejected the allegations.
In the Finance Bill of 2022, an explanatory memorandum on the changes introduced says: “... any expense incurred in providing various benefits in violation of the provisions of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 shall be inadmissible under section 37(1) for being prohibited by the law.”
Indian Medical Council regulations prohibit doctors from accepting any gifts or benefits in the form of travel and hospitality, etc., from pharmaceutical companies. But the Finance Bill, 2022 explanatory memorandum seems to miss the point that the IMC regulations apply to doctors and not to pharmaceutical companies. Also, paradoxically, the IMC regulations prohibit doctors from taking gifts and freebies but allows professional associations of doctors to accept them!
There have been sporadic efforts over the years by government bodies to curb the unethical marketing efforts of pharma companies. Marketing of medicines is unethical when prescribers are offered inducements with an idea of increasing prescriptions of a particular company’s products. Prescribers claim they are not influenced by such marketing efforts.
But it is hard to believe except in the case of a select minority in the medical profession. The patient has no choice when a particular brand — usually priced higher than a less costly equivalent — is prescribed by the doctor. Incidentally, the law does not allow retail pharmacists to do brand substitution or sell an unbranded generic instead of a branded one — notwithstanding the Prime Minister’s exhortation to use unbranded generics some time back.
In India, the same medicine is sold at a variety of prices. There are probably more than a hundred paracetamol brands. Every manufacturer has to claim some unique feature to push his/her product. But how do you claim a unique feature among several equally good quality (assuming so for the time being) brands of, say, a paracetamol tablet?
Hence, the need for marketing inducements often bordering on the unethical. Inducements, monetary and non-monetary, are proportional to the number of prescriptions and, therefore, the chances of the patient consuming irrational and/or unnecessary medicines are also quite high.
Pharma companies spread the belief, and prescribers and patients accept the narrative, that a higher priced brand of the same medicine works better. From the manufacturer’s side, creative features are added over time by making a regular tablet into a sustained/extended/controlled/prolonged release when it is not really called for.
Sometimes FDCs (fixed dose combinations) are invented. You may mix paracetamol plus say cetirizine or ibuprofen. In fact, an FDC of paracetamol plus ibuprofen sells a lot. Many patients take both when they probably need only one. Antibiotic combinations are misused when not really necessary, and they are rarely needed, and, worse, cause resistance to one or both of the antibiotics in the combination. Such antimicrobial resistance deprives us of vital tools to fight life-threatening infections.
Only a few FDCs are rational. Fixed dose combinations of potent topical corticosteroids (clobetasol, mometasone, for instance) apart from costing an arm and a leg, result in irreversible lifetime skin damage.
In the case of paracetamol, the DCGI notified in September 2011 that in all FDCs containing paracetamol, the strength of the paracetamol should not be more than the safety dose of 325 mg because of the risk of liver damage and allergic reactions. One does not understand why the same safety concerns do not apply to single ingredient paracetamol tablets of 500 mg, 650 mg and 1000 mg (as in Crocin Plus). Subsequently, the DCGI confined the 2011 order to FDCs of paracetamol and analgesics/anti-inflammatory drugs only.
NLEM and price regulation
Currently, all drugs in the National List of Essential Medicines (NLEM) 2015 are under price control, per DPCO 2013. But this accounts for a maximum of 18 per cent of the total annual domestic sales of ₹1.6-lakh crore and more. The rest 82 per cent are overpriced, and many are irrational too.
In fact, because of the faulty methodology of fixing ceiling prices in DPCO 2013, the so called simple average method, many of the ceiling prices of NLEM medicines are overpriced.
This has been documented in PILs by the authors and their affiliates in the Supreme Court. Also, price control is on only the specific presentations and strengths mentioned in the NLEM. Thus, in the NLEM 2011 that was tagged with the DPCO 2013, paracetamol 500 mg tablet was listed, and therefore came under price control. One can escape price control by making strengths not mentioned in the NLEM. The 650 mg version of paracetamol, of which Dolo 650 is the most well-known brand, was not in NLEM 2011.
The 650 mg version of the paracetamol tablet subsequently found mention in the revised NLEM 2015. Therefore from 2015, paracetamol 650 mg, and Dolo, came under price control. Paracetamol 500 mg tablets (brands Crocin, Calpol, etc.) have as of writing a ceiling price – the MRP cannot be more than the ceiling price – of ₹10.10 per strip of 10 tablets. The cost price is about ₹6 per 10 tablets. The ceiling price of the 650 mg version of the paracetamol tablet should be, common sense says, at the most 30 per cent more. But it is ₹20.40 per 10 tablets, 100 per cent more.
So much for the simple, rather simplistic, average methodology of fixing ceiling prices. Add caffeine to paracetamol 650 mg, you are out of price control and you can sell it at ₹57 per 15 tablets — as does a well-known brand. The extra margin probably helps mere paracetamol 650 mg manufacturers undertake more generous marketing expenditures by transitioning to an unnecessary FDC.
Such marketing, mostly unethical, is routine for most medicine manufacturers in India and for most brands. The margins can go up to 2,000 per cent.
Code for ethical marketing
Over the years, government, civil society and other stakeholders have had desultory meetings, and have come out with several versions of a Uniform Code of Pharmaceuticals Marketing Practices (UCPMP). With drug industry as 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. The unethical is not illegal.
A government with political will can do much on the supply side to prevent gifts and inducements given to doctors. A mandatory code for ethical pharmaceutical marketing with teeth is required. Much more can be done to minimise market failure in India’s pharmaceutical industry by rationalising prices, and regulating medicine strengths and unscientific content.
Professional associations of doctors can do even more by refusing gifts and inducements — in short by being good, ethical human beings.
The writers are affiliated with Low Cost Standard Therapeutics (LOCOST), Vadodara and All-India Drug Action Network (AIDAN)