Think It Over
A Peep into The Irrational & Unethical Pharma Practices
Petrol available all over the country is of uniform quality. One may buy from Hindustan Petroleum, Bharat Petroleum or Indian Oil outlet. Petroleum authorities take care of it, so that no damage occurs to the engines of vehicles. In the year 2012 I had stated: “A doctor prescribes or administers drugs to a patient and is expected to follow ‘cause no harm’ principle. Safety and Welfare of a patient is a main concern of the medical profession, which includes medical and paramedical personnel and even drug industry. While pharmaceutical companies make legitimate profits from the sale of drugs, but at the same time they should take necessary steps to ensure the wellbeing of the people" (1).
It is being said that Pharmaceutical industry has commercialized. We have to remember that drug manufacturers are commercial houses and not charitable NGOs. What should be the margin of profit is for the government and other agencies to deliberate upon? The drugs should be safe and rational products. Unfortunately, these issues are not being taken up by the concerned authorities (2). In the year 2013 I had stated: “The most important point is that drug formulations should be appropriate, safe and uniform (3).
In our country we the doctors face following problems regarding medicines:
1. Spurious drugs: Where ingredients mentioned do not exist or in very low quantity, thus provide no benefit to the patients.
2. Substandard medicines: Where quantity of ingredients is less than 90% of required quantity. Such medicines may not provide full benefit, on the other hand in case of antibiotics may result in resistant microbes.
3. Problematic formulations: Varying concentrations of different constituents in combination formulations can pose problems for doctors and risks for patients (4). Anticold formulations having Chlorphenaramine Maleate and Phenylephrine Hydrochloride as the main ingredients have sometimes other molecules like Cetirizine or Levocotirizine and Paracetamol also. Cetirizine and Levocetirizine are to be administered once in 24 hrs while other ingredients are to be administered 3 to 4 times in a day. Different pharmaceutical houses make products with different quantities of different ingredients. There are 32 formulations in tablet forms, 16 in syrup forms and 6 in drop forms (5).
4. Irrational formulations: Clavulanic Acid is approved in combination with Amoxicillin and Sulbactum for combination with Cefoperezone. Presently many antibiotics in combination with Clavulanic Acid or Sulbactum are available in the market. These formulations add tremendously to the cost of therapy without providing any additional benefit to the patients. I checked a Therapeutic Index and noted the number of brands apart from the approved combinations as following :
A. Clavulanic Acid : Cefpodoxime 48, Cefexime 38, Cefuroxime 18, and Cefadroxyl 2.
B. Sulbactum: Ceftriaxone 47, Meropenen 7, Cefexime 6, Cefotaxime 4, Cefuroxime 4, Cefpodoxime 1, Cefepime 1, Ceftriaxone 1, Cefpirome 1, Ampicillin 1, and Amoxicillin 1.
5. Combinations of antagonistic ingredients : Iron and Zinc have many similar absorption and transport mechanisms, and may therefore compete for absorption (6, 7). Iron may interfere with absorption of Zinc when ingested together. Many drug manufacturers market formulations havine Iron and Zinc.
6. Funny combinations :
A. Paracetamol syrups. Paracetamol syrups containing 120 mg, 125 mg, 156.25 mg and 250 mg paracetamol per 5 ml are available. Manufacturer marketing the brand having 156.25 mg per 5 ml must be using very advanced technology to make drugs of such accurate quantity. Doctors would need calculators to calculate the accurate dose for a child.
B. Some time back a reputed manufacturer introduced a Multivitamin, Multimineral, and Axtioxidant with addition of Amino Acids, which no other similar product contained. Print on the packing provides information regarding the percentage of RDA (Recommended Daily Allowance) of Amino Acids which are : L-Valine 0.16%, and rest between 0.19 and 0.59% of RDA, i.e. none of Amino Acid ingredient is even 0.6% of required RDA. Prescribing such product amounts to be fooling oneself and cheating the parents. C. Addition of Probiotics to Antibiotics. The rationale for the use of Probiotics is based on the assumption that the use of Antibiotics leads to a disturbance in the normal intestinal microflora leading to Antibiotic Associated Diarrhea. Can probiotic in combination with antibiotic survive while similar microflora in gut is destroyed by antibiotics. Probiotic provides benefit in the gut when the antibiotic has been absorbed.
7. Misinformations by Pharma Houses : Chlorpheniramine Maleate is not recommended for children below 1 year of age and Phenylephrine HCl is not recommended for children below two years of age. Anticold drug Flucold AF drops marketed by Wallace contains phenylephrine HCl 5 mg and Chlorpheniramine Maleate 2 mg per 1 ml. On the packing printed is dosage schedule which is 0.1 ml for children 1 – 6 months, 0.1 – 0.2 ml for 7 – 12 month, age group, 0.2 – 0.4 ml for 1 – 3 year age group and 0.3 – 1.0 ml for children 3 – 6 years. Hatric 3 Drops marketed by Aristo Pharma contains Phenylephrine HCl 2.5 mg and Chlorpheniramine Molecte 1 mg per 1 ml. Recommended dose is 0.5 ml three times daily for children below 6 months and 0.5 ml three to four times for children aged 7 months to 2 years. It is important to note that this drug contains Paracetamol 125 mg per ml. This means that dose of Paracetamol remains same for 1 month old baby and 2 years old child. Two months old babies weigh between 4 and 6 kg. 0.5 ml of Hatric 3 contains 62.5 mg of paracetamol which would be appropriate dose for a baby weighing 4 kg, would be under dose for babies above 3 months and grossly under dose for children above 1 year of age. Now a days one can check the facts on internet. Parents may know from the internet that Chlorpheniramine Maleate is not recommended for children below 1 year of age and Phenylephrine HCl is not recommended for children below 2 years of age. Parents will have very poor opinion about the doctor who prescribes such drugs for children below 2 years of age.
In 1961 when I qualified as a doctor there were about a dozen or so pharmaceutical companies both Indian and foreign. Presently their number is in three digits and so there is tough competition. Business philosophy dictates that competitors must strive not only to maintain the quality of the product, but, to provide better product at competitive price or even at lower price to attract more clients. It appears that the pharmaceutical industry has turned upside down all the principles of business.
Price of petrol available at different petrol pumps in an area is same. But, prices of products having same drug formulations produced by different manufacturers are some times different. I would like to mention lowest and highest MRP of some products. Cefpodoxime 200 mg tablets. Podomox (Torrent) Rs. 10.20 and Bactiloc (Intralife) Rs. 22; Cefexime 200 mg tablets – Milixim (Glenmark) Rs. 7.24, Crinux (Pax Healthcare) Rs. 21.00, Amoxicillin 500 mg + Clavulanic Acid 125 mg tablets – Aculav (Macleods) Rs. 14.80, Adentin (Aden Healthcare) Rs. 25.00, Azithromycin 100 mg / 5 ml in 15 ml bottle – Zathrin (FDC Ltd.) Rs. 26.10, Azibact (IPCA) Rs. 35.87.
What could be the reason for such difference in prices of same drugs by different manufacturers? It could be due to some special overhead expenditures incurred by different pharma houses. A study by Support for Advocacy and Training to Health Initiative (SATHI) reported by The Times of India dated November 29, 2019 captioned ‘Bribes to Doctors by Pharmaceutical Industry’ states: “Medical Representatives have revealed wide spread use of bribes including foreign trips, microwave ovens, expensive smart phones, jewellery and even women, by pharmaceutical companies. According to medical representatives, hardly 10 – 20% doctors follow the MCI code of ethics, while the rest accept or even demand ‘incentives’ to prescribe products of a company. The most common inducement is the sponsoring of doctors for conferences”. Naturally the burden is passed on to the consumers.
This study is based on interviews of 50 Medical Representatives from six cities. It states that ‘hardly 10 – 20% of doctors follow the MCI code of ethics, while rest accept or even demand’ incentives’ to prescribe products of a company. It means 80 – 90% of doctors prescribe unnecessary, irrational and more expensive drugs for their own benefits. I would not like to comment on the purpose and outcome of this study by SATHI. But, it has rendered great service to the pharmaceutical industry as it has projected doctors as villains and drug manufacturers as hapless victims.
One would take this study with a pinch of salt. Perhaps the truth about this phenomenon is other way around. Some pharmaceutical houses produce irrational, substandard and even potentially harmful drugs and then they look for some greedy and gullible doctors with carrots of incentives (bribes) to prescribe their products.
It seems that in race for one-upmanship the pharma industry has turned blind eye to the science of pharmacy and safety of people. Issue of concern is that irrational drugs are manufactured after obtaining licenses from appropriate authorities and prices which are different for same drug by different manufacturers must have been fixed after approval of pricing authorities.
- -Dr. Yash Paul, G-1, Kumkum Apartment-II, 48, Vinoba Nagar, Malviya Nagar, Jaipur 302017. dryashpaul2003@yahoo.com
REFERENCES
1. Paul Y. Drug formulations: Safety of patient remains the main concern. Express Pharma, 2012; 7: 34.
2. Paul Y. Onus of Parients’ Safety is on the Doctors. J Indian Medico Legal and Ethical Association. 2017; 5: 65 – 66.
3. Paul Y. Need for Safe and doctor friendly formulations. Pharma Times. 2013; 45: 31 – 32.
4. Paul Y. Dextromethorphan: Problem with Formulations. Indian Pediatr. 2014; 51: 1019.
5. Paul Y. Problems Associated with Anti-cold Drugs. J Indian Medico Legal and Ethical Association. 2019; 7: 17 – 20.
6. Sandstrom B. Micronutrient interaction: Effect on absorption and bioavailability. British J Nutr. 2001; 85: 5181 – 5185.
7. Solomons NW, Ruz M. Zinc and iron interaction: concepts and perspectives in developing world. Nutri Res. 1997; 17: 177 – 185.
ADEH Appeal:
Make Code on Pharma Firms Mandatory!
The Alliance of Doctors for Ethical Healthcare (ADEH) has demanded that the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) be made mandatory. It is unfortunate that even after 5 years the code remains voluntary. This is despite the fact that several medical organizations have demanded this repeatedly from the government. The global experience also shows that voluntary code does not work.
The Prime Minister, as published in a section of the media has warned pharmaceutical companies not to indulge in unethical practices and stop giving freebies to the doctors with a purpose to procure business. However, that any such deliberations occurred in the meeting with the Prime Minister has been denied by the pharmaceutical companies. It may be pointed out here that the companies spend crores of rupees through associations by sponsoring the medical conferences. They spend huge amount on travel, accommodation and other expenditures on the doctors for lavish arrangements of the conferences.
As per the clause 7.2 of the UCPMP “companies or their associations/representatives shall not extend any hospitality like hotel accommodation to healthcare practitioners and their family members under any pretext”. The implied meaning of this is that even extending benefits to the doctors through associations is unethical. But this is being flouted with impunity.
Unfortunately, the Medical Council of India (MCI) had amended THE INDIAN MEDICAL COUNCIL (PROFESSIONAL CONDUCT, ETIQUETTE & ETHICS) REGULATIONS, 2002 in its meeting on 18 February 2014 and exempted the "Professional Associations of Doctors" from the purview of Medical Ethics. There is urgent need to take steps to reverse this amendment of the MCI and make the UCPMP mandatory.
Since the corporate hospitals are not covered under this ethics, they take advantage and openly flout the ethics. They should also be brought under the MCI regulations on ethics. It is also equally important that the any freebies from the Pharmaceutical companies be made taxable. These were taxable earlier but the decision was reversed later by the Pune Bench of the Income Tax Appellate Tribunal.
Without these steps the Prime Minister’s statement will remain only a rhetoric, particularly when the PMO has not clarified its position over the denial by the pharmaceutical companies about prime minister's warning.
Signatories:
Dr G. S. Grewal (Former President- Punjab Medical Council, Ludhiana) - 9876098393
Dr Vipin Vashishtha (Paediatrican, Bijnor, Utter Pradesh) - 9759641900
Dr J. Amalorpavanthan (Vascular Surgeon, Chennal, Tamil Nadu) – 9841060598
Dr Abhay Shukla (Public health expert, Co-author of the book published by Penguin: Dissenting Diagnosis, Pune, Maharashtra.) -9822246327
Dr Anant Phadke (Public health expert, Pune, Maharashtra) 9423531478
Dr Arun Mitra (ENT specialist and former Chairperson, Ethics Committee, Punjab Medical Council, Ludhiana) -9417000360
Dr Monica Thomas (Neuro physician, Delhi) – 9811912026
Alliance of Doctors for Ethical Healthcare (ADEH) (www.ethicaldoctors.org)
Dr K.V. Babu (Ophthalmologist, Health Activist, Kannur, Kerala) - 9446565615
Dr Shakeel Ur Rehman (Physician, member of Indian doctors for Peace and Development, Patna, Bihar) -9431493870
Dr Sanjeeb Mukhopadhyay (Gynaecologist, Kolkata, W.Bengal) - 9831031015
Dr Zaibunissa (Opthalmologist, Chennail, Tamil Nadu) - 9884060159
Dr Mussadik Mirajkar (Surgeon, Freelance HR activist, Mumbai)- 9821024314
Dr George Thomas (Orthopaedic surgeon, Chennai, Tamil Nadu) - 9840212287
Dr Sharada Bapat (Family physician, Pune, Maharashtra) 9921009370
Dr Jamila Koshi (Psychiatrist, Chennai, Tamil Nadu) – 9810336620
Dr Muralidhar (Professor of surgery, Chettinad medical college, Chennai, Tamil Nadu) - 9176987697
Dr Jacob John (Neurosurgeon, Kollam, Kerala) - 9847077656
Dr Vinay Kulkarni (Skin specialist, Pune, Maharashtra) - 9822300532
Dr Sanjay Nagral (Gastrointenstinal Surgeon, Mumbai, Publisher, Indian Journal of Medical Ethics (IJME) - 9820285458
Dr Saiju Hameed (Public health expert, Kolam, Kerala) - 9447120487
Contact persons:
Dr G.S. Grewal - 9876098393
Dr K.V. Babu – 9446565615
Dr Vipin Vashishtha (Paediatrican, Bijnor, Utter Pradesh) - 9759641900
Dr Shakeel Ur Rehman - 9431493870
Dr Arun Mitra -9417000360,
Dr Anant Phadke - 9423531478
Dr George Thomas - 9840212287