The implementation of the Food Safety and Standards Act, 2006 has run into rough weather.  The Act consolidates eight laws[1] governing the food sector and establishes the Food Safety and Standards Authority (FSSA) as the regulator.  It requires all food business operators (including small businesses and street vendors) to obtain a licence or registration.  The Regulations under FSSA related to procedure for obtaining a licence or registration was notified on August 1, 2011.  According to the Regulations, all food business operators had to get a licence or registration within one year of the notification.  Due to opposition from several food business operators (see here and here), the FSSA has now extended the deadline for getting a licence or registration by another six months (till February 2013).  However, some of the key concerns regarding the law have not yet been addressed.

Key issues related to the Bill raised by PRS (for more details see Legislative Brief)

  • The organised as well as the unorganised food sectors are required to follow the same food law.  The unorganised sector, such as street vendors, might have difficulty in adhering to the law, for example, with regard to specifications on ingredients, traceability and recall procedures.
  • The Bill does not require any specific standards for potable water (which is usually provided by local authorities).  It is the responsibility of the person preparing or manufacturing food to ensure that he uses water of requisite quality even when tap water does not meet the required safety standards.
  • The Bill excludes plants prior to harvesting and animal feed from its purview.  Thus, it does not control the entry of pesticides and antibiotics into the food at its source.
  • The power to suspend the license of any food operator is given to a local level officer.  This offers scope for harassment and corruption.

Other issues referred to in the media

  • The Act requires a food business operator to get different licenses if articles of food are manufactured or sold at different premises.  Newspapers reported that this provision was challenged in the Madras High Court but a stay order on the Act and its Rules was refused.
  • According to media reports, two hotel associations in Karnataka had challenged certain sections of the Act and Rules in the Karnataka High Court related to requirement of technical person for supervision of production process and requirement of a laboratory on the premises of food operators.  The court stayed these provisions for three months (till October 2012).
  • News papers reported that the Supreme Court is examining the question whether liquor is a food.

[1].  (a) The Prevention of Food Adulteration Act, 1954.  (b) The Fruit Products Order, 1955.  (c) The Meat Food Products Order, 1973. (d)  The Vegetable Oil Products (Control) Order, 1947.  (e) The Edible Oils Packaging (Regulation) Order, 1998. (f) The Solvent Extracted Oil, De oiled Meal, and Edible Flour (Control) Order, 1967. (g) The Milk and Milk Products Order, 1992. (h) Any other order issued under the Essential Commodities Act, 1955, relating to food.

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:

  • Maintenance of standards in medical education through curriculum guidelines, inspections and permissions to start colleges, courses or increasing number of seats
  • Recognition of medical qualifications
  • Registration of doctors and maintenance of the All India Medical Register
  • Regulation of the medical profession by prescribing a code of conduct and taking action against erring doctors

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!