The Parliamentary Standing Committee on Health and Family Welfare tabled a Report in Parliament on May 8, 2012, on the functioning of the Central Drugs Standard Control Organization (CDSCO).  CDSCO is the agency mandated with the regulation of drugs and cosmetics in India.  The Report covers various aspects of drug regulation including organizational structure and strength of CDSCO, approval of new drugs, and banning of drugs, among others. Following the Report, the Minister of Health and Family Welfare has constituted a Committee to look into the procedure for drug regulation.  The Committee is expected to make its submissions within a period of two months. This post focuses on irregularities in the approval of new drugs by CDSCO.  It discusses the regulations relating to drug approval and the Standing Committee's observations on the working of CDSCO. Approval of new drugs Drugs are regulated by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945 [Rules].  The CDSCO, under the Ministry of Health and Family Welfare, is the authority that approves new drugs for manufacture and import.  State Drug Authorities are the licensing authorities for marketing drugs. New Drugs are defined as:

  • drugs that have not been used in the country before,
  • drugs that have been approved by a Licensing Authority but are now being marketed for different purposes, and
  • fixed dose combinations of two or more drugs that have been individually approved before but are proposed to be combined in a fixed ratio that has not been approved.

The Rules require an applicant for a new drug to conduct clinical trials in India to determine the drug’s safety and efficacy.  These trials are necessary for both domestically manufactured and imported drugs.  However, the authority can exempt a drug from the requirement of local and clinical trials in the public interest based on data available in other countries. Observations and recommendations of the Committee The Committee found that a total of 31 new drugs were approved between January 2008 and October 2010 without conducting clinical trials on Indian patients.  The Report mentioned that drug manufacturers, CDSCO officials and medical experts colluded to approve drugs in violation of laws.  Following are some of the Report’s findings:

  • Under the Rules, the Drugs Controller General (India) (DCGI), the head of CDSCO, can clear sites of clinical trials after ensuring that major ethnic groups are enrolled in these trials to have a truly representative sample.  This rule was violated by the DCGI when sites for clinical trials were approved without ensuring diversity.  The Committee recommended that the DCGI approve sites for trials only if they cover patients from major ethnic backgrounds.
  •  The Report found that certain actions by experts were in violation of the Code of Ethics of the Medical Council of India.  A review of expert opinions revealed that several medical expert recommendations had been given as personal opinions rather than on the basis of scientific data.  Additionally, many expert opinions were written by what the Report calls ‘the invisible hands’ of drug manufacturers.  The Committee recommended that CDSCO formulate a clear set of written guidelines on the selection process of experts with emphasis on expertise in the area of drugs.
  •  The Rules ban the import and marketing of any drug whose use is prohibited in the country of origin.  CDSCO violated this rule by approving certain Fixed Dose Combination drugs for clinical trials without considering the drugs’ regulatory status in their respective country of origin.  Drugs such as Deanxit and Buclizine, which have been prohibited for sale and use in their countries of origin, Denmark and Belgium, respectively, were approved for clinical trials.  The Committee recommended an inquiry into the unlawful approval of these drugs.
  • The Rules require animal studies to be conducted for approval of a drug for use by women of reproductive age.  CDSCO violated this rule in approving Letrozole for treating female infertility.  Globally the drug has only been used as an anti-cancer drug for use among post-menopausal women.  The drug has not been permitted for use among women of reproductive age because of side effects.  The Committee recommended that responsibility be fixed for unlawfully approving Letrozole.
  •  Rules require Post-marketing Safety Update Reports (PSURs) on drugs to be submitted to CDSCO.  PSURs are used to collect information on adverse effects of drugs on Indian patients as a result of ethnic differences.  When asked by the Committee to furnish PSURs on 42 randomly selected new drugs, the Ministry was able to submit PSURs for only 8 drugs.  The Report contended that this action reflected a poor follow-up of side effects on Indian patients.  The Committee recommended that manufacturers of new drugs be warned about suspension of marketing approval unless they comply with mandatory rules on PSURs.

The National Medical Commission (NMC) Bill, 2017 was introduced in Lok Sabha in December, 2017.  It was examined by the Standing Committee on Health, which submitted its report during Budget Session 2018.  The Bill seeks to regulate medical education and practice in India.  In this post, we analyse the Bill in its current form.

How is medical education and practice regulated currently?

The Medical Council of India (MCI) is responsible for regulating medical education and practice.  Over the years, there have been several issues with the functioning of the MCI with respect to its regulatory role, composition, allegations of corruption, and lack of accountability.   For example, MCI is an elected body where its members are elected by medical practitioners themselves, i.e. the regulator is elected by the regulated.  In light of such issues, experts recommended nomination based constitution of the MCI instead of election, and separating the regulation of medical education and medical practice.  They suggested that legislative changes should be brought in to overhaul the functioning of the MCI.

To meet this objective, the Bill repeals the Indian Medical Council Act, 1956 and dissolves the current Medical Council of India (MCI) which regulates medical education and practice.

Who will be a part of the NMC?

The NMC will consist of 25 members, of which at least 17 (68%) will be medical practitioners.  The Standing Committee has noted that the current MCI is non-diverse and consists mostly of doctors who look out for their own self-interest over larger public interest.   In order to reduce the monopoly of doctors, it recommended that the MCI should include diverse stakeholders such as public health experts, social scientists, and health economists.  In other countries, such as the United Kingdom, the General Medical Council (GMC) responsible for regulating medical education and practice consists of 12 medical practitioners and 12 lay members (such as community health members, and administrators from the local government).

How will the issues of medical misconduct be addressed?

The State Medical Council will receive complaints relating to professional or ethical misconduct against a registered doctor.  If the doctor is aggrieved by the decision of the State Medical Council, he may appeal to the Ethics and Medical Registration Board, and further before the NMC.  Appeals against the decision of the NMC will lie before the central government.  It is unclear why the central government is an appellate authority with regard to such matters.

It may be argued that disputes related to ethics and misconduct in medical practice may require judicial expertise.  For example, in the UK, the GMC receives complaints with regard to ethical misconduct and is required to do an initial documentary investigation.  It then forwards the complaint to a Tribunal, which is a judicial body independent of the GMC.  The adjudication and final disciplinary action is decided by the Tribunal.

What will the NMC’s role be in fee regulation of private medical colleges?

In India, the Supreme Court has held that private providers of education have to operate as charitable and not for profit institutions.   Despite this, many private education institutions continue to charge exorbitant fees which makes medical education unaffordable and inaccessible to meritorious students.  Currently, for private unaided medical colleges, the fee structure is decided by a committee set up by state governments under the chairmanship of a retired High Court judge.  The Bill allows the NMC to frame guidelines for determination of fees for up to 40% of seats in private medical colleges and deemed universities.  The question is whether the NMC as a regulator should regulate fees charged by private medical colleges.

NITI Aayog Committee (2016) was of the opinion that a fee cap would discourage the entry of private colleges, therefore, limiting the expansion of medical education.  It also observed that it is difficult to enforce such a fee cap and could lead medical colleges to continue charging high fees under other pretexts.

Note that the Parliamentary Standing Committee (2018) which examined the Bill has recommended continuing the current system of fee structures being decided by the Committee under the chairmanship of a retired High Court judge.  However, for those private medical colleges and deemed universities, unregulated under the existing mechanism, fee must be regulated for at least 50% of the seats.  The Union Cabinet has approved an Amendment to increase the regulation of fees to 50% of seats.

How will doctors become eligible to practice?

The Bill introduces a National Licentiate Examination for students graduating from medical institutions in order to obtain a licence to practice as a medical professional.

However, the NMC may permit a medical practitioner to perform surgery or practice medicine without qualifying the National Licentiate Examination, in such circumstances and for such period as may be specified by regulations.  The Ministry of Health and Family Welfare has clarified that this exemption is not meant to allow doctors failing the National Licentiate Examination to practice but is intended to allow medical professionals like nurse practitioners and dentists to practice.  It is unclear from the Bill that the term ‘medical practitioner’ includes medical professionals (like nurses) other than MBBS doctors.

Further, the Bill does not specify the validity period of this licence to practice.  In other countries such as the United Kingdom and Australia, a licence to practice needs to be periodically renewed.  For example, in the UK the licence has to be renewed every five years, and in Australia it has to renewed annually.

What are the issues around the bridge course for AYUSH practitioners to prescribe modern medicine?

The debate around AYUSH practitioners prescribing modern medicine

There is a provision in the Bill which states that there may be a bridge course which AYUSH practitioners (practicing Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) can undertake in order to prescribe certain kinds of modern medicine.  There are differing views on whether AYUSH practitioners should prescribe modern medicines.

Over the years, various committees have recommended a functional integration among various systems of medicine i.e. Ayurveda, modern medicine, and others.  On the other hand, experts state that the bridge course may promote the positioning of AYUSH practitioners as stand-ins for allopathic doctors owing to the shortage of doctors across the country.  This in turn may affect the development of AYUSH systems of medicine as independent systems of medicine.

Moreover, AYUSH doctors do not have to go through any licentiate examination to be registered by the NMC, unlike the other doctors.  Recently, the Union Cabinet has approved an Amendment to remove the provision of the bridge course.

Status of other kinds of medical personnel

As of January 2018, the doctor to population ratio in India was 1:1655 compared to the World Health Organisation standard of 1:1000.  The Ministry of Health and Family Welfare stated that the introduction of the bridge course for AYUSH practitioners under the Bill will help fill in the gaps of availability of medical professionals.

If the purpose of the bridge course is to address shortage of medical professionals, it is unclear why the option to take the bridge course does not apply to other cadres of allopathic medical professionals such as nurses, and dentists.  There are other countries where medical professionals other than doctors are allowed to prescribe allopathic medicine.  For example, Nurse Practitioners in the USA provide a full range of primary, acute, and specialty health care services, including ordering and performing diagnostic tests, and prescribing medications.  For this purpose, Nurse Practitioners must complete a master’s or doctoral degree program, advanced clinical training, and obtain a national certification.