BUSINESS ETHICS in PHARMACEUITIAL INDUSTRY

The Pharmaceutical Industry: An Introduction

Pharmaceuticals has an ethical side that is they're a commodity that you may be forced to take to save your life which deeper significance. The Pharmaceutical Industry comprises of manufacture and sale of pharmaceutical drugs which can be loosely defined as any chemical substances intended for use in the medical diagnosis, cure, treatment, or prevention of a disease Industry is the world's third largest by volume. The domestic market was worth US$ 12.26 billion. In the Indian market, Cipla retains its leadership position with 5.27 per cent share followed by Ranbaxy and Dr.

Importance Of Ethics In Pharma

The rules of behavior and ethics that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on.

Despite the pharmaceutical industrys notable contributions to human progress, including the development of miracle drugs for treating cancer, AIDS, and heart disease, there is a growing tension between the industry and the public.
There is a duty and responsibility of care to the Life, health and safety of all and this is what makes the Pharmaceutical Industry different from any other business or industry.

Ethics and Pharmaceutical Clinical Trials

Clinical trials are a set of procedures in medical research conducted to allow safety and collect information about adverse drug reactions and adverse effects of other treatment for health interventions India along with Pakistan and Bangladesh - destination for clinical trials (WHO) Clinical Trial industry in India is worth Rs 5000 crore. (3 yrs ago was 800 Cr.)

 TWO PHASES: Animal testing,(around tens of millions to more than 100 million animals are used annually) Eg: 1. Between 1976 and 1985, 52% animal tested drugs were found more dangerous to humans than previously indicated. Drugs like Thalidomide, Zomax and DES were all tested on animals and judged safe but had devastating consequences for the humans. ALTERNATIVES: sophisticated non-animal research methods like computer simulators and imaging techniques, studies of human population, in vitro research (in a test tube) and replacing animals with human cells in safety tests.

 HUMAN TESTING: 670 Indians lost their lives in medical experiments, Only 8 got the insurance amount from the pharmaceutical companies. In developing countries Cost is 60%-100% less. Eg: 1. In Andra Pradesh, 14,000 scheduled tribe girls were used for an Oral Cancer medical experiment.6 girls died during the experiment. 2. Apex medical research institution of India AIIMS(All India Institute of Medical Science) conducted a experiment in which 49 babies died. 4142 babies were used, in that, 2728 were under the age of 1.

 Ethical Conduct Closely supervised by appropriate regulatory authorities Consent of participating human subjects. Ensure the "rights, safety and well being of trial subjects are protected". Ethical concerns are present when conducting clinical trials on children (paediatrics)

Ethics and Pharmaceutical Pricing

Reasons for high price medicines, Branded vs. generic drugs Big brands vs. small player Price control Poor quality or lure of lucre

Branded Name Generic Name

Branded Price

Generic Price(Rs) 3.6 66 2,800 18 78 69 4.75 240.67

Price Inflation 1861.11% 365.15% 496.42 477.77% 1307.69% 594.20% 4154.94% 264.67%

Entac Augmentin(GS K)

Lantac 67 Moxikind(Mankin 241 d) 13,900

Zometa(Novarti Zoldria(Cipla) s)

Eltroxin(GSK) Roxin(Zydus) 86 Plavix(Sanofi) Noklot(Zydus) 1020 Diovan(Novarti Starval(Ranbaxy) 410 s) Rintid(Kopran Pharma) Zoran(Dr Reddys) 197.36

OvutriqChoriomon5000( 637 HP(GenBiotech Panacea Biotech) )

Eltroxin(GSK)

Roxin(Zydus)

86

18

477.77%

 What should a patient do to ensure not being victimized by this kind of unethicality, Check the Internet Ask the doctor/chemist SMS facility Verbatim

Ethics and Pharmaceutical Advertising

In 1997, the Food and Drug Administration relaxed regulations on advertising side-effects, and since direct-to-consumer (D2C) advertising in the pharmaceutical industry has exploded more as television commercials. That advertising directly to the consumer actually creates a need. Usually the patients put immense pressure on doctors to prescribe after they have been exposed to a pharmaceutical advertisement. he medication may not be right for the patient

 Condition branding is a technique of pharmaceutical companies to market medical conditions far beyond their natural incidence The industry takes a health risk and markets it in such a way that the public perceives the risk as a viable threat to their well being. Example of condition branding is the case of osteoporosis suffering from bone density loss following menopause. In pharmaceuticals, a market can simply be created by exploiting a potential health risk. A real danger exists to the patient when all the complexities of a medication are not adequately assessed. In 2005, Pfizer was forced to withdraw its drug Bextra from all markets and pay out $2.3 billion in damages It is evident that pharmaceutical companies consider the consequences of their actions less and less as they seek profitable investments

Ethics and Pharmaceutical Marketing

Became a part of everyday life for most physicians Marketing practices include indirect bribing For instance Piramal healthcare Dr. reddys lab Wanbury

As pharmaceutical business is very profitable, it is hardly any wonder that pharmaceutical companies spend at least 2025 % of their sales revenue on promoting their products. Drug promotion is carried out by means of, frequent visits to private medical practitioners by the medical representatives.

Cont.

Factors for unethical marketing include: 1. Increased competition and unethical practices adopted by some of the propaganda base companies. 2. Low level of customer knowledge. 3. Increased greed for gifts and money within the Doctors.
A case:Dr. Rudy Mueller: "It's very tempting and they just keep anteing it up. And it's getting harder to say no. ABC news. No free lunch

Ethics In Pharmaceutical Sales

Internationally banned drugs, which are banned in some developed countries and are known to have serious side-effects, are readily available in the Indian market. It is not the chemists pushing the drug; it is the doctors prescribing it to their patients. Delhi appears to be a hub of illegal drug manufacturing trade.
DRUG Analgin Lomofen Nimesulide Dcold,Vicks Action 500 Entroquinol USE Painkiller Anti-diarroheal Fever,Painkiller Cold & cough Anti diarroheal REASON FOR BAN Bone marrow depression Cancer Liver failure Stroke Blindness

Indian Ayurvedic medicines: Panacea or Poison Ban of ayurvedic medicines like Maha Sudarshan Churna Powder, Yograj Guggul tablets and Sudarshan tablets; Dabur Indias Maha Sudarshan Churna and Shilajit capsules; Karela Capsules manufactured by Himalaya Drug Company; and Safi Liquid from Hamdard Wakf-India by Canadian Government. Vicks Action 500 been banned by European and North American countries due to phenylpropanolamine (PPA) which causes stroke. Sale of expired drugs latest medical scam hit Tamil Nadu, a drug racket on 10th March 2010

Ethics and Pharmaceutical TRIPS

Priorities given to profit rather then health. Reduces the availability and affordability of essential drugs. Patent means monopoly ?

Cont.. Why TRIPS brought in? Thanks to the virtue absence of patent protection in India. To dominate the market with much higher prices. Deliberate act.

Conclusion
What are the regulatory bodies doing ???? An investors point of view. An ethical point of view.

 Project by.. NAME Roll.no Grace Galsurkar 13 Saurabh Vora 58 Purvi Chaudhary 07 Ruchi D. Goyal 16 Viancia Almeida 02 Ravi Gupta 18 Ayush Khaitan 59