Indian pharmaceutical market comprises of basic drugs to finished products valued at 15 billion US dollar is the third largest in the world in terms of volume of trade. Recently the US Department of Justice had imposition of criminal and civil fines totalling 500 million dollars on India's largest pharmaceutical company, Ranbaxy Laboratories, is jolt and shock for Indian pharma sector. Having achieved niche position, it has to face the humiliation of den of poor quality and unethical practices. The US Department of Justice stated the company acknowledged that US Food and Drug Administration's (US FDA) 2006 and 2008 inspections of the Dewas facility found incomplete testing records, inadequate stability programme and manufacturing practices that didn't follow regulations. The company also pleaded guilty to making false statements to the US Food and Drug Administration about how it tested drugs at two of its Indian plants. The major evidence is the slap for Ranbaxy by the US FDA which convicted that Indian pharma giant has some serious lapses not only in manufacture but also in practice of ethics. This is the beginning of downfall of pharma industry of India. This has raised serious questions regarding the good manufacturing practices (GMP) followed by the industry and eroded the trust of public in abroad and India as well. There is almost need to bring transparency and establish the code for practice for pharmaceutical industry on the lines of Association of British Pharmaceutical Industry. The standards of practice are the first requirements and be based on patient interests, as it is universally acceptable. No where pharmaceutical industry can be privileged above patients. Hence, the standards of practice need to be regulated by the industry as such as it involves the ethical practice which is essential to reclaim the trust and put back the industry on right track of progress.
The industry is fragmented into different organizations and trusts. For example the OPPI, Indian Drug Manufacturers’ Association (IDMA) and Indian Pharmaceutical Association. There are various state wise associations also. It is time for industry to consolidate into a single agency and project itself single national entity for the benefit of themselves and the pharma sector. The code of ethics involves a comprehensive guidelines of professional practice starting from manufacture of basic drugs to dispensing of products to final consumer the patients. Unless the system is established ,it is very difficult to identify who is right and wrong and chaos are in place instead of orders. It is no surprise that it has given scope for the criminals to play with law as Industry has no control or discipline in place.
After having been said this, the industry should look around the globe, how the standards of practice are implemented in other countries. For Example, in UK, they have established a not for profit trust, whose main objective is to ensure the ethical practice by its members. Identify the wrong practices and bring it to the notice of law enforcing agency and see that the guilty get punished. This has resulted among the members to be aware alert for any unethical practice by themselves and take a corrective actions. Such a continuous practice with transparency has won the public trust and confidence.
However in our country, we have Indian Drug Manufacturers’ Association, OPPI and several others who are focused on representing there members safeguard rather than professional conduct. All though they have guidelines, there is no mechanism to check and identify the fraudulent practices and punish the wrong doing. This has led a widespread practice of profit oriented practices leading to fall in standards and erosion of reputation of the industry in the eye of the health care consumer. The public trust is quintessential need of functioning of Industry. The chaos would lead to fall of health care services. In the interest of the health care sector and also in the interest of industry proper mechanism of operational of code of practice starts functioning under single banner. This trust should co ordinate with stake holders like national and international regulators, governments, health care professionals, marketing people and medical representatives to establish a code of practice to which everyone becomes abiding by it. This is the requirement for the survival of the industry. All though it is time consuming and difficult task to make every one agree and cooperate, as there is no other alternative, sooner or later, everybody (pharma industry) starts contributing to the cause.
We can observe such system is functional and successfully operative in developed counties. In UK, the prescription medicines code of practice authority administers the association of British Pharmaceutical Industry‘s code of practice is self administered by Association of British Pharmaceutical Industry. Any of the members found not abiding the code, shall be decreed and slapped penalty for wrong doing. In doing so, they have successfully made the ethical practice a gold standard for marketing the pharmaceuticals. It has earned respect for industry in the eye of stake holders and service providers. To maintain high standards of ethical practice a reality, they have started training of medical representative. These exams are mandatory for continuing the job of medical representative. This ensures quality and uniformity of promotional practices in the country.
To summarise, there is a need to unify all pharmaceutical industry, to establish a trust and academy through which the wrong ethical practices are identified, and brought to the notice of regulator, who can take up the matter with the concerned industry, control them by mode of punishment. The need for professional training of medical representative is a long felt need, which can be fulfilled by the trust taking the initiative. This would pave way to clear the smoke and doubts about the pharmaceutical industry practice in years to come.
(Author is with Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka 576104).