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 Medical Council of India (MCI) has seen a few major controversies over the past decade. In the latest incident, MCI President, Dr. Ketan Desai was arrested by the CBI on charges of accepting a bribe for granting recognition to Gyan Sagar Medical College in Punjab. Following this incident, the central government promulgated an ordinance dissolving the MCI and replacing it with a centrally nominated seven member board. The ordinance requires MCI to be re-constituted within one year of its dissolution in accordance with the provisions of the original Act. Background The Medical Council of India was first established in 1934 under the Indian Medical Council Act, 1933. This Act was repealed and replaced with a new Act in 1956. Under the 1956 Act, the objectives of MCI include:
Over the years, several committees, the most recent being the National Knowledge Commission (NKC) and the Yashpal Committee, have commented on the need for reforms in medical regulation in the country. The Ministry of Health and Family Welfare (MoH&FW) has recently released a draft of the National Council for Human Resources in Health (NCHRH) Bill for public feedback. (See http://mohfw.nic.in/nchrc-health.htm) Key issues in Medical Regulation Oversight Currently, separate regulatory bodies oversee the different healthcare disciplines. These include the Medical Council of India, the Indian Nursing Council, the Dental Council of India, the Rehabilitation Council of India and the Pharmacy Council of India. Each Council regulates both education and professional practice within its domain. The draft NCHRH Bill proposes to create an overarching body to subsume these councils into a single structure. This new body, christened the National Council for Human Resources in Health (NCHRH) is expected to encourage cross connectivity across these different health-care disciplines. Role of Councils Both the NKC and the Yashpal Committee make a case for separating regulation of medical education from that of profession. It is recommended that the current councils be divested of their education responsibilities and that these work solely towards regulation of professionals – prescribing a code of ethics, ensuring compliance, and facilitating continued medical education. In addition, it has been recommended that a national exit level examination be conducted. This exit examination should then serve the purpose of ‘occupational licensing’, unlike the prevalent registration system that automatically grants practice rights to graduating professionals. In effect, it is envisaged that the system be reconfigured on the lines of the Institute of Chartered Accountants, wherein the council restricts itself to regulating the profession, but has an indirect say in education through its requirements on the exit examination. A common national examination is also expected to ensure uniformity in quality across the country. Both committees also recommend enlisting independent accrediting agencies for periodically evaluating medical colleges on pre-defined criteria and making this information available to the public (including students). This is expected to bring more transparency into the system. Supervision of education – HRD vs. H&FW The Ministry of Human Resources and Development (MHRD) is proposing a National Council for Higher Education and Research (NCHER) to regulate all university education. However, MoH&FW is of the opinion that Medical Education is a specialized field and needs focused attention, and hence should be regulated separately. However, it is worth noting that both the NKC and the Yashpal Committee recommend transferring education overseeing responsibilities to the NCHER. Internationally, different models exist across countries. In the US, the Higher Education Act, 1965 had transferred all education responsibilities to the Department of Education. In the UK, both medical education and profession continue to be regulated by the General Medical Council (the MCI counterpart), which is different from the regulator for Higher Education. Composition of Councils In 2007-08, MCI, when fully constituted, was a 129 member body. The Ministry in its draft NCHRH Bill makes a case for reducing this size. The argument advanced is that such a large size makes the council unwieldy in character and hence constrains reform. In 2007-08, 71% of the members in the committee were elected. These represented universities and doctors registered across the country. However, the Standing Committee on H&FW report (2006) points out that delays in conducting elections usually leads to several vacancies in this category, thereby reducing the actual percentage of elected members. MCI’s 2007-08 annual report mentions that at the time of publishing the report, 29 seats (32% of elected category) were vacant due to ‘various reasons like expiry of term, non-election of a member, non-existence of medical faculty of certain Universities’. In November 2001, the Delhi High Court set aside the election of Dr. Ketan Desai as President of the MCI, stating that he had been elected under a ‘flawed constitution’. The central government had failed to ensure timely conduct of elections to the MCI. As a result, a number of seats were lying vacant. The Court ordered that the MCI be reconstituted at the earliest and appointed an administrator to oversee the functioning of the MCI until this was done. Several countries like the UK are amending their laws to make council membership more broad-based by including ‘lay-members’/ non-doctors. The General Medical Council in the UK was recently reconstituted and it now comprises of 24 members - 12 ‘lay’ and 12 medical members. (See http://www.gmc-uk.org/about/council.asp) Way ahead According to latest news reports, the MoH&FW is currently revising the draft Bill. Let's wait and see how the actual legislation shapes up. Watch this space for further updates!
