Arun Mishra, C.J.@mdashHeard finally with the consent of learned counsel appearing for the parties. C.W.P. No. 3031/2007 has been filed by Mr. Vijay Mehta in which prayer has been made to direct the State of Rajasthan to ensure that he doctors prescribe medicines in their generic name and the doctors who fail to do so be appropriately dealt with by the Indian Medical Council and Rajasthan Medical Council. The Council be directed to take stern action against those doctors who act contrary to the provisions of the Indian Medical Council (Professional Conduct, Etiquette & Ethics) Regulation, 2002. Other prayers made in the writ application have not been pressed as such they are not being referred.
2. The petitioner is District President of All India Trade Union Congress. The writ application has been filed considering high rocketing unreasonable price of medicines. The medicines are becoming beyond the reach of the people living below the poverty line. The medicines are not available at reasonable cost. The medicines are not being prescribed by their generic name but by their brand names whereas the doctors cannot do so. They are bound by the Regulations framed by the Medical Council of India to prescribe the medicines by their generic names. The doctors are trying to adopt different mechanism to sidetrack and justify their action of not prescribing medicines by their generic names. Reliance has been placed by the petitioner on Rajasthan State Standard Treatment Guidelines, 2006 which have been prepared by the Medical, Health and Family Welfare Department of the Government of Rajasthan with the help of outstanding doctors of Rajasthan in different specialties. It has been mentioned with respect to the prescription form in the Guidelines of 2006 thus.
The International Non-proprietary name of the drug should always be used. If there is a specific reason to prescribe a special brand, the trade name can be added. The Pharmaceutical form (for example ''tablet'', ''oral solution'', ''eye ointment'') should also be stated.
3. The petitioner has also relied upon a Booklet containing Orders for Purchase of Stores (Drugs & Medicines) issued by the Directorate of Medical & Health Services, Government of Rajasthan in which generic names of medicines have been used.
4. The Medical Council of India with the previous approval of the Central Government and in exercise of the powers conferred u/s 20A read with Section 33(m) of the Indian Medical Council Act, 1956 (referred to hereinafter as ''the Act of 1956'') has framed Indian medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 herein after referred to as ''the Regulations of 2002'') which have been notified on 11.3.2002. Chapter-I of the Regulations of 2002 pertains to Code of Medical Ethics. Regulation 1.5 deals with the use of generic name of drugs and provides that every practitioner should as far as possible prescribe the drugs by their generic names. Regulations have been filed as Annex. 3 to the writ application.
5. It is further averred in the writ application that strange mechanism is being resorted to frustrate the policy of Government of Rajasthan. Some doctors have resorted to the mechanism of making a patient write that he does not want medicines to be prescribed in generic name. Photocopies of two prescriptions (P/7 & P/8) have been filed. In one of them, patient Nand Kishore was asked to write "GENERIC DAVAI NAHI LAGWANI HAI". These types of declarations are obtained in ignorance and pressure. The action amounts to violation of professional ethics framed by the Medical Council of India with the approval of the Central Government.
6. There is no different sets of standard for same drugs. Sections 21, 22 and 23 of the Drugs and Cosmetics Act, 1940 (referred to herein after as ''the Act of 1940'') have also been referred to. The Government is bound to keep the price control of drugs so that they are available at affordable prices. Prayer has also been made to direct the Central Government to bring more drugs under the price control. It is contended that to ensure that the people of Rajasthan get the drugs at reasonable price, the Government of Rajasthan be directed to set up large number of outlets wherefrom the citizens of Rajasthan can get drugs at affordable price.
7. In the reply filed by the Union of India, it is contended that the manner of labeling and packaging of drugs has been prescribed and penal action has to be taken against the violator. Under the amendment made in the Act of 1940 by Drugs and Cosmetics (Amendment) Act, 2008, the penal provision with respect to spurious, adulterated, misbranded, non-standard drugs, cosmetics, ayurvedic, siddha and unani drugs has been suitably enhanced to deter the delinquents from indulging in such anti social activities. The maximum punishment is that of life term imprisonment and fine of Rs. 10 lakhs.
8. Reply has been filed by the Medical Council of India contending that the Medical Council of India is a statutory authority constituted by the Central Government under the Medical Council of India Act, 1956. It is an expert body constituted under the provisions of the Act of 1956. It is an expert body constituted under the provisions of the Act of 1956. The Regulations of the Medical Council of India are binding and mandatory as held by the Hon''ble Apex Court in
Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that thee is a rational prescription and use of drugs.
9. Section 15(2) of the Act of 1956 provides that no person who is not qualified in the system of modern medicines can be registered in the State Register. The person must have requisite qualification and bound to observe the ethics. The Government of Rajasthan has issued orders from time to time to the doctors to prescribe the medicines by their generic names. However, the doctors are not giving effect to the same. They have resorted to different mechanism to side-track and justify their action of not prescribing medicines by generic name. The Medical Council of India has amended the Regulations by Indian Medical Council (Professional Conduct, Etiquette and Ethics (sic) Regulations, 2004 (referred to hereinafter as the Regulations of 2004''). Chapter 6 of the Regulations of 2004 deals with ''unethical acts'' and Chapter 7 deals with ''misconduct''. Chapter-7 Regulation 7 defines misconduct, professional misconduct. Regulation 7.1 provides that violation of the regulation is also misconduct. Chapter-8 contains the provision with respect to disciplinary proceedings. Regulations stipulate that every practitioner should prescribe as far as possible medicines with generic name and he/she shall ensure that there is a rational prescription and use of drugs. In case of violation being brought to its knowledge, the Medical Council of India has to take action in accordance with the Regulations. The doctors are bound to prescribe, as far as possible, drugs with generic names and they shall ensure that there is a rational prescription and use of drugs.
10. The State of Rajasthan in its reply has submitted that it has already taken decision and issued orders time to time for prescribing medicines by generic name by the medical practitioner. The State Government has issued various directives requiring the doctors to prescribe generic medicines keeping in view the larger public interest. Prescribing the medicines in their brand names is nothing but to advance commercial activities of the pharmaceutical companies. The circulars have been issued on 23.12.2006 and 9.4.2007. It has been mentioned in he circulars that the medical practitioners working in the Government hospital should prescribe the medicines in their generic names and also prescribe the names quoted in essential medicine list (EML, 2005). Every practitioner is bound to observe and act in accordance with the Regulations of 2002 otherwise he is liable to be punished under Chapter-8 of the Regulations of 2002 and the Medical Council of India has to take disciplinary action. One public interest litigation being D.B. Civil Writ Petition (PIL) No. 3504/2007 was filed challenging the circulars issued by the State Government. The same has been dismissed with costs of Rs. 25,000/- vide order dated 30.4.2008 filed as Annex. R. 1/9 to the return filed by the State. The State is supporting the case of the petitioner.
11. This Court considering the question whether combination of drugs and life saving drugs can also be prescribed in generic names, has passed the following order on 29.3.2011 in C.W.P. No. 3031/2007:
In this petition, the question involved is whether the medicines have to be prescribed in their generic name or by brand name Regulation 1.5 framed by he Medical Council of India provides that every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs. The violation of the prescription made under the Regulations is punishable one. The State Government, Department of Medical, Health and Family Welfare has issued instructions by notification dated 23.12.2006 requiring the doctors to prescribe the medicines by generic name. The Standard Treatment Guidelines have been issued. The Rajasthan State Essential Medicine List has also been issued. The State Government has directed that Essential Medicine List be used for prescribing the medicines to the patients and the Life Line Fluid Store and other Medical Stores shall ensure that generic medicines are available. Other necessary instructions have also been issued. In case, the instructions are violated, it would entail the disciplinary proceedings.
However, Mr. J.P. Joshi, appearing on behalf of Raj. Medical College Teachers Association, has relied upon he Minutes of Meeting on Prescription of Drugs by Generic Names. A meeting was held by various authorities at the State level on 17th April, 2007 in which it has been decided thus:
As far as possible, prescription of drugs by doctors in hospitals should be by generic names. This shall be binding to all doctors with the exception of two categories of drugs - (i) Combination Drugs and (ii) Life Saving Drugs. Barring these two broad categories of exceptions (which may be prescribed by brand names), the doctors should prescribe all other drugs by generic names.
As per the Resolution dated 17th April, 2007, it has been decided to make exception of Combination Drugs and Life Saving Drugs and they need not be prescribed by generic names. It was submitted by Mr. Marudhar Mridul, Sr. Advocate, assisted by Mr. P.S. Chundawat that Combination Drugs can also be prescribed by generic name as well as there was no necessity to make an exception with respect to Life Saving Drugs and they can be prescribed by generic names.
In the circumstances, we direct Mr. Saluja appearing on behalf of Medical Council of India, to place on record he considered opinion of the M.C.I. in this regard, particularly with respect to Combination Drugs and Life Saving Drugs required by the patients. The considered and reasoned decision be taken by the Medical Council of India and this Court be apprised of the same. We give six weeks'' time Mr. Saluka to submit the decision taken by the M.C.I. in this regard.
List in July 2011. A copy of this order be furnished to Mr. Saluja representing the M.C.I.
12. The Medical Council of India was asked by this Court to give an opinion with respect to the question whether exception from prescribing generic names of medicines can be given to Combination Drugs and Life Saving Drugs. Thereafter, the Medical Council of India has filed the additional affidavit of Mr. Shikhar Ranjan, Law Officer, Medical Council of India as to whether branded name of drugs can be prescribed in respect of combination and life saving drugs or not. The Ethics Committee of the Medical Council of India at its meeting held on 10.5.2011 considered the matter and following decision has been taken:
The Ethics Committee considered the letter received from Ravinder Singh Saluja, Advocate dated nil and the order of the Hon''ble High Court of Rajasthan dated 29.3.2011 and directions contained therein was placed before the Ethics Committee. The issued posed in the said judgment/order is as to whether branded name of drugs can be permitted in respect of combination and life saving drugs or not. The Ethics Committee deliberated and discussed on the issue in threadbare manner. The Ethics Committee relied on the provisions of Ethics Regulations namely the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 contained in regulation 1.5 and the same is reproduced herein as under:
Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs.
The Ethics Committee also cited the example that generic drugs are much cheaper to the branded drugs. The Ethics Committee also noted a provision is already there is in the Ethics Regulations which says that as far as possible, generic name of drugs should be used and there should not be any exception for combination drugs or life saving drugs. The generic name should be prescribed as it is beneficial to the society.
13. Thereafter, the State Government was asked to consider the decision taken by Ethics Committee of the Medical council of India in its meeting dated 10.5.2011. The State Government has filed an affidavit of Mr. B.N. Sharma, Principal Secretary, Medical and Health Services, Government of Rajasthan, Jaipur. It has been pointed out in affidavit that in compliance of the decision taken by the Ethics Committee of Medical Council of India, circulars have been issued on 7.10.2011 mentioning that every physician, whether serving privately or in government service, should, as far as possible, prescribe drugs with generic names and shall ensure that there is a rational prescription and use of drugs, it is also pointed out in the affidavit that the State Govt. has launched Free Medicine Distribution Scheme in the Govt. Hospitals throughout Rajasthan where the medicines are being supplied in their generic names.
14. In C.W.P. No. 2991/2007, Mr. Ashok Changani, learned counsel appearing on behalf of the petitioner, has confined the prayer only to the extent that the State Government may be directed to prescribe some more medicines by generic names to be prescribed by the doctors. The other reliefs prayed for in the writ petition have not been pressed by him.
15. Mr. M. Mridul, learned senior counsel appearing on behalf of the petitioner in C.W.P. No. 3031/2007 has submitted that the direction be issued to comply with the directives issued by the Medical Council of India and the State Government and any violation be ordered to be dealt with sternly in accordance with the Regulations of 2002.
16. Sarva Shri R.S. Saluja, V.K. Mathur and Y.P. Khileree, learned counsels appearing on behalf of Medical Council of India, Union of India and State Government respectively have supported the submissions raised by Mr. M. Mridul, learned senior counsel.
17. Shri J.P. Joshi, learned senior counsel appearing on behalf of association of doctors has submitted that directives of the medical Council of India and the State Government have to be ultimately followed by the doctors.
18. It is imperative as per the Regulations of 2002 framed by the Medical Council of India which have the statutory force, that the doctors should prescribe the medicines, as far as possible, in generic names. The State of Rajasthan has issued directions from time to time. However, the directions are being flouted as pointed out by the petitioner by obtaining declarations from the patients that they don''t want prescription of medicines under generic names. Obtaining of such declaration, in our opinion, tantamount to violation of Regulations framed by the Medical Council of India and is unethical practice. Any doctor who obtains such declaration renders himself liable to disciplinary action. Medical practitioners cannot leave it to the choice of patients which medicine is suitable for him and cannot be permitted to commit violation of code of conduct on the shelter of such declaration. The prescriptions (P/7 & P/8) filed with the writ application go to indicate that the concerned medical practitioner has evolved a device of obtaining a declaration which itself amounts to breach of professional ethics as contained in the Regulations of 2002. The action amounts to breach of Regulation 1.5 contained in Chapter 1 of the Regulations of 2002. No such action can be resorted to by the doctor as the doctor is bound by the professional ethics. The Regulations of 2002 provide declaration to be furnished by each applicant at the time of making applications for registration under the provisions of the Act of 1956 as provided in Appendix-I. Code of Medical Ethics - Regulation 1 contained in Chapter 1 reads thus,
Declaration: Each applicant at the time of making a application for registration under the provisions of the Act, shall be provided a copy of the declaration and shall submit a duly signed declaration as provided in Appendix I. The applicant shall also certify that he/she had read and agreed to abide by the same.
19. Thus, Regulations are to be observed by every medical practitioners which have been framed by the Medical Council of India in exercise of the powers conferred u/s 20A of the Act. The Medical Council of India has to prescribe the standards and code of ethics for medical practitioners. The Hon''ble Apex Court in M.C.I. vs. State of Karnataka (supra) has laid down that the Regulations are binding and mandatory. The Medical Council of India is an expert body constituted under the provisions of the Act of 1956. Its duty is to ensure highest standard of medical education and ethics to be followed by the medical practitioners. Every doctor while practicing is bound to obey the ethics framed by the Medical Council of India.
20. It cannot be ignored that it has become a common practice to find out several ways to flout the ethics. The prescriptions (P/7 to P/8) filed along with the petition are such circuitous attempts made by the medical practitioner. The doctors are bound to comply with the Regulations as they stand and cannot evolve such circuitous methods to commit breach of the ethics. They cannot escape the rigour of the Regulations by resorting to aforesaid methods. When generic medicine is available and it is possible to prescribe it, obtaining of such a declaration, is illegal and cannot be adopted. Let disciplinary action be initiated by Medical Council of India against such doctors as per the Regulations framed by it.
21. At National Level, provision has been made to prescribe medicines in generic names in National Health Policy, 2002. Para 4.11.1 of the Policy provides that prescribing medicines by their generic names is a pre-requisite for cost-effective public health care and in the public health system and this would be enforced by prohibiting the use of proprietary drugs except in special circumstances. The petitioner has rightly relied upon the publication ''Basic and Clinical Pharmacology'' edited by Bertram G. Katzjung, Professor Emeritus, Department of Cellular and Molecular Pharmacology, University of California, San Francisco in which it has been observed that, "for some drugs in common use, the difference in cost between the trade-named product and generic product varies from less than two fold to more than 100 folds." The petitioner had also relied upon Harrison''s 15th Edition Principles of Internal Medicine by six eminent doctors of America which also mentions the names of medicines in generic terms. The substance of the aforesaid publications is that the medicines should be prescribed by their generic names and it is internationally accepted practice.
22. Even in the case of combination and life saving drugs, the Medical Council of India has taken a decision that as far as possible, the medicines should be prescribed in generic names and not in the brand names, which decision has been followed by the State Government and accordingly, appropriate orders have been issued. All medical practitioners are bound to comply with the directives issued by the Medical Council of India and the State Government in this regard. General rule is of prescription of medicine by generic names and combination of drugs and life saving drugs are not in excepted categories, thus decision dated 17.4.2007 referred in order dated 29.3.2011 stands superseded by the subsequent decision of the Medical Council of India which has been rightly followed by State Government being binding on it. It would not be appropriate for the doctors to avoid the prescription of medicines names by prescribing combination of drugs or in the guise of life saving drugs.
23. Doctors prescribe the medicine by writing first word ''Rx''. The nobility of profession cannot be destroyed by bringing commercial element and making it a business activity to cater to commercial interest of pharmaceuticals by prescribing medicines in brand names. Such tendency to violate the code of ethics is against the spirit of dignified profession dealing with general life. In case, the doctors prescribe a medicine in branded name even in the cases where it is possible to prescribe the medicines in generic name, it would amount to violation of Code of Ethics framed by the Medical Council of India and required to be dealt with sternly. We direct the Medical Council of India to take cognizance of such cases whenever reported and to deal with such medical practitioners sternly.
24. It is rightly contended in the reply that medicines are prescribed in branded name as there is a commercial element and these branded medicines are sometimes prescribed in order to benefit the pharmaceutical companies and there is unholy link between doctor and pharmaceutical company and ultimate sufferer is poor ailing person who has to purchase the medicines at much higher rates than he can afford. Otherwise also, there is right with every person to obtain irrespective of financial status the prescription of medicines in generic names as mandated in the statutory Regulations framed by Medical Council of India. It is common ground that branded medicines are offered at exorbitant prices, there is duty cast to ensure that the medicines are available at affordable prices in furtherance of which, the Government issues price control order. However, the fact remains that generic medicines are available at much lower rate as compared to branded medicines. No person and particularly, they have not cannot be made to suffer as they cannot afford the luxury of purchasing the branded medicines at much more cost than generic medicines. The right to obtain treatment is fact of Article 21 of the Constitution of India and right to obtain treatment at affordable prices of medicines is one of the concomitant of the same. Not prescribing the medicines in generic names may in given facts tantamount to violation of Article 21 of the Constitution of India. The combination of drugs and life saving drugs which are available in generic names, have to be prescribed in generic names otherwise the action would amount to violation to right to life itself. The Ethics Committee of the Medical Council of India has rightly taken the decision that as far as possible, generic name of drugs should be used and there should not be any exception of combination drugs or life saving drugs. The generic name should be prescribed as it is beneficial to the society. It has also been noted by the Ethics Committee that the generic drugs are much cheaper than the branded drugs. Let medical profession follow the ethics and not resort to various unscrupulous methods of violation.
25. Let every effort be made by the State Government and Medical Council of India to ensure that the decision of Ethics Committee and the directives issued by the State of Rajasthan in compliance to the decision of the Medical Council of India are taken to a logical end and the nexus of pharmaceutical company and some of medical practitioners is broken who indulge in prescribing the medicines in branded names in order to cater to commercial interest.
26. For all the medical practitioners, the decision of the Medical Council of India and the State Government holds good. The ethical standards are to be complied with by all medical practitioners whether they are serving in government hospitals or privately.
27. Coming to the submission raised by Mr. Ashok Changani, learned counsel appearing on behalf of the petitioner in C.W.P. No. 2991/2007 that the State Government may specify the names of more generic medicines to be prescribed.
28. To this, the Government Counsel has no objection. He further submits that from time to time, the list is revised and nothing prevents the State government to revise it further. In our opinion even in the absence of specification of the names by the State government of other generic medicines, the decision of Ethics Committee of Medical Council of India holds good. Let it be complied with. Even the non-mention of generic medicines in EML-2005 would not be a shelter to avoid prescribing the medicines in generic names as decided by the ethics committee of the Medical Council of India and no exception can be made in case of combination and life saving drugs and the circular issued by the State government in compliance thereof on 7.10.2011. With the aforesaid directions, these two writ applications (C.W.P. No. 3031/2007 and C.W.P. No. 2991/2007) are disposed of.
