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:
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:
The National Medical Commission Bill, 2017 was introduced in Lok Sabha recently and is listed for consideration and passage today.[1] The Bill seeks to regulate medical education and practice in India. To meet this objective, the Bill repeals the Indian Medical Council Act, 1956 and dissolves the current Medical Council of India (MCI). The MCI was established under the 1956 Act, to establish uniform standards of higher education qualifications in medicine and regulating its practice.[2]
A Committee was set up in 2016, under the NITI Aayog with Dr. Arvind Panagariya as its chair, to review the 1956 Act and recommend changes to improve medical education and the quality of doctors in India.[3] The Committee proposed that the Act be replaced by a new law, and also proposed a draft Bill in August 2016.
This post looks at the key provisions of the National Medical Commission Bill, 2017 introduced in Lok Sabha recently, and some issues which have been raised over the years regarding the regulation of medical education and practice in the country.
What are the key issues regarding the regulation of medical education and practice?
Several experts have examined the functioning of the MCI and suggested a different structure and governance system for its regulatory powers.3,[4] Some of the issues raised by them include:
Separation of regulatory powers
Over the years, the MCI has been criticised for its slow and unwieldy functioning owing to the concentration and centralisation of all regulatory functions in one single body. This is because the Council regulates medical education as well as medical practice. In this context, there have been recommendations that all professional councils like the MCI, should be divested of their academic functions, which should be subsumed under an apex body for higher education to be called the National Commission for Higher Education and Research.[5] This way there would be a separation between the regulation of medical education from regulation of medical practice.
An Expert Committee led by Prof. Ranjit Roy Chaudhury (2015), recommended structurally reconfiguring the MCI’s functions and suggested the formation of a National Medical Commission through a new Act.3 Here, the National Medical Commission would be an umbrella body for supervision of medical education and oversight of medial practice. It will have four segregated verticals under it to look at: (i) under-graduate medical education, (ii) post-graduate medical education, (iii) accreditation of medical institutions, and (iv) the registration of doctors. The 2017 Bill also creates four separate autonomous bodies for similar functions.
Composition of MCI
With most members of the MCI being elected, the NITI Aayog Committee (2016) noted the conflict of interest where the regulated elect the regulators, preventing the entry of skilled professionals for the job. The Committee recommended that a framework must be set up under which regulators are appointed through an independent selection process instead.
Fee Regulation
The NITI Aayog Committee (2016) recommended that a medical regulatory authority, such as the MCI, should not engage in fee regulation of private colleges. Such regulation of fee by regulatory authorities may encourage an underground economy for medical education seats with capitation fees (any payment in excess of the regular fee), in regulated private colleges. Further, the Committee stated that having a fee cap may discourage the entry of private colleges limiting the expansion of medical education in the country.
Professional conduct
The Standing Committee on Health (2016) observed that the present focus of the MCI is only on licensing of medical colleges.4 There is no emphasis given to the enforcement of medical ethics in education and on instances of corruption noted within the MCI. In light of this, the Committee recommended that the areas of medical education and medical practice should be separated in terms of enforcement of the appropriate ethics for each of these stages.
What does the National Medical Commission, 2017 Bill seek do to?
The 2017 Bill sets up the National Medical Commission (NMC) as an umbrella regulatory body with certain other bodies under it. The NMC will subsume the MCI and will regulate the medical education and practice in India. Under the Bill, states will establish their respective State Medical Councils within three years. These Councils will have a role similar to the NMC, at the state level.
Functions of the NMC include: (i) laying down policies for regulating medical institutions and medical professionals, (ii) assessing the requirements of human resources and infrastructure in healthcare, (iii) ensuring compliance by the State Medical Councils with the regulations made under the Bill, and (iv) framing guidelines for determination of fee for up to 40% of the seats in the private medical institutions and deemed universities which are governed by the Bill.
Who will be a part of the NMC?
The NMC will consist of 25 members, appointed by the central government. It will include representatives from Indian Council of Medical Research, and Directorate General of Health Services. A search committee will recommend names to the central government for the post of Chairperson, and the part-time members. These posts will have a maximum term of four years, and will not be eligible for extension or reappointment.
What are the regulatory bodies being set up under the NMC?
The Bill sets up four autonomous boards under the supervision of the NMC, as recommended by various experts. Each autonomous board will consist of a President and two members, appointed by the central government (on the recommendation of the search committee). These bodies are:
What does the Bill say regarding the conduct of medical entrance examinations?
There will be a uniform National Eligibility-cum-Entrance Test (NEET) for admission to under-graduate medical education in all medical institutions governed by the Bill. The NMC will specify the manner of conducting common counselling for admission in all such medical institutions.
Further, there will be a National Licentiate Examination for the students graduating from medical institutions to obtain the license for practice. This Examination will also serve as the basis for admission into post-graduate courses at medical institutions.
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[1] The National Medical Commission Bill, 2017, http://www.prsindia.org/uploads/media/medical%20commission/National%20Medical%20Commission%20Bill,%202017.pdf.
[2] Indian Medical Council Act, 1933.
[3] A Preliminary Report of the Committee on the Reform of the Indian Medical Council Act, 1956, NITI Aayog, August 7, 2016, http://niti.gov.in/writereaddata/files/document_publication/MCI%20Report%20.pdf.
[4] “Report no. 92: Functioning of the Medical Council of India”, Standing Committee on Health and Family Welfare, March 8, 2016, http://164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20Health%20and%20Family%20Welfare/92.pdf
[5] “Report of the Committee to Advise on Renovation and Rejuvenation of Higher Education”, Ministry of Human Resource Development, 2009, http://mhrd.gov.in/sites/upload_files/mhrd/files/document-reports/YPC-Report.pdf.
