The drug trade is governed by special legislations, devised for inspiring public confidence in the quality of drugs they consume. Drugs & Cosmetics Act and Pharmacy Act are basically devised to ensure such confidence and quality of medicines.
Can the regulatory authority viz. Drugs Control Administration, merely enforcing the laws, guarantee the quality of drugs? We must go beyond the legislation. Here ethics become relevant. Can there be ethics in trade? - trade is primarily to make money. Can ethics make money? Pharmacy is not merely a trade but a profession. There are clearly laid down professional ethics. These professional ethics require a competitive mind set in quality and not competition in price.
To infuse those professional ethics there are rules of ethics enforced by professional institutions and good business practices by trade associations.
Code of ethics for pharmacists
The pharmaceutical society in United Kingdom had evolved the following code of ethics for pharmacists:
■ A pharmacist's prime concern shall be for the welfare of both patients and public
■ A pharmacist shall uphold the honour and dignity of the profession and not engage in any activity which may bring the profession into disrepute
■ A pharmacist shall at all times have regard to the laws and regulations applicable to pharmaceutical practice and maintain a high standard of professional conduct. A pharmacist shall avoid any act or omission, which would impair confidence in the pharmaceutical profession. When a pharmaceutical service is provided, a pharmacist shall ensure that it is efficient.
■ A pharmacist shall keep abreast of the progress of pharmaceutical knowledge in order to maintain a high standard of professional competence relative to his sphere of activity.
■ A pharmacist shall neither agree to practice under any conditions of service, which prevent his professional independence nor impose such conditions on other pharmacists. .
In order to maintain the required level of standards and quality, efficiency and competency, pharmacist is entitled for certain level of protection from professional and trade associations. The trade associations enforce business practices to ensure there is no competition in prices, regulate the distribution channels to enhance the level of standards. When such professional activities are considered as restrictive trade practices, there is a clash between Rule of Law and Rule of Ethics.
What are ethics? Websters' new world dictionary defines 'ethics' as:
Morals, standards, system of morals. How do morals become relevant under legislation? Drugs & Cosmetics Act, a special legislation has a social purpose behind it, the social purpose being a public purpose. Public interest being supreme, there should be no clash between professional interests and public interest.
In this context, it is relevant to quote a judgment in United Kingdom, (in a similar one to that of present MRTP's) where it was pronounced that pharmaceutical society of Great Britain could make rules affecting the non-professional as well as professional activities of pharmacists, but only if the rules could be shown to be in the interest of public and the profession.
"I have no doubt that it would be within the competence of the society, as a body concerned for the honour and well being of those engaged in the profession of pharmacy, to lay down rules concerning non-professional (as well as professional) activities to professional standards and behaviour. But, that would have to be proved in agreement with the Court of Appeal. I do not think it was proved in this case. It will normally be for a profession itself to decide in regard to its standards and its codes of behaviour and the mere fact that certain rules are laid down which are severely restrictive will not warrant attack upon them in the interests of members and in the public interest such rules are reasonable - Lord Morris.
'Rules of law and rules of ethics are commonly held to differ because law is enforced by the State while ethical rules are only morally binding. But law and ethics are not opposite. The law itself has a basis in ethics - in general, it reflects the moral standards of the community'
It will augur well, if MRTP Commission in India recognize the synergistic value of law and ethics acting together to enhance the value of ethical drug trade in India.
Ethical drug trade in India
Having discussed that Law & Ethics are not opposite - we now analyze how the quality of drugs is proposed to be guaranteed under D&C Act: The legislation envisages licensing of manufacturers, all sales establishments (institutions, hospitals, nursing homes wherever drugs are sold) and distribution channels, even government institutions manufacturing and selling drugs. While the manufacturers are required to test the raw materials and finished products before they are sold and used, Trade is required by law to buy these drugs from licensed manufacturers/dealers. Store them in the condition in which they received it, and exercise reasonable diligence.
Often we hear that professional competence and standards in pharmaceutical trade in India are lacking while in most of the countries professional ethics are better observed. It is also said that medicines are not as easily available in western countries as they are in India. Where exactly we fail? Is it failure of the legislation or is it the failure of individuals or is it the failure of enforcing machinery?
In this context, while evaluating the level of regulatory measures, we should also study the prevailing distribution policies of the manufacturers, trade practices, role of the trade associations in enforcing certain conditions and restrictions.
Whether professional standards enforced by Pharmacy Council of India, (PCI) professional qualities and ethics introduced by Indian Pharmaceutical Association or trade practices adopted by All India Organisation of Chemists and Druggists (AIOCD) are proved to be in the interest of the profession, its members and public.
(The author is Trustee of AIOCD Educational Trust, Chennai)