Recent news reports indicate that the European Union (EU) has banned imports of Alphonso mangoes and four vegetables from India due to the presence of harmful pests and a lack of certification before export.  The ban will be effective between May 1, 2014 and December 2015.  It has been suggested that the ban could impact the export of nearly 16 million mangoes from India, the market for which is worth nearly £6 million a year in a country like the United Kingdom. In this context, it may be useful to examine the regulation of agricultural biosecurity in India, particularly with respect to imports and exports of such agricultural produce. Currently, two laws, the Destructive Insects and Pests Act, 1914 and the Livestock Importation Act, 1898, regulate the import and export of plants and animals with a view to control pests and diseases.  Under the laws, the authorities ensure that infectious diseases and pests do not cause widespread damage to the environment, crops, agricultural produce and human beings, i.e. the agricultural biosecurity of a country.  Common examples of pests and diseases have been the Banana bunchy top virus which stunts banana plants and stops production of fruit while another is the Avian Influenza, which caused extensive death of poultry and led to human deaths as well. Under the existing Acts, different government departments and government-approved bodies are responsible for regulating imports and certifying exports to ensure that there are no threats to agricultural biosecurity.  The Department of Agriculture keeps a check on pests and diseases arising from plants and related produce, such as mangoes and vegetables, while the Department of Animal Husbandry monitors diseases relating to animals and meat products.  The Agricultural and Processed Food Products Export Development Authority (APEDA) certifies exports of different commodities related to plants and animals.  Various government committees have highlighted the ineffectiveness of the existing system due to its piecemeal approach and have recommended an integrated system to handle biosecurity issues.  It has also been suggested that the existing laws have not kept up with developments in agriculture and are inadequate to deal with the emergence of trans-boundary diseases that pose threats to human, animal and plant safety. The Agricultural Biosecurity Bill, 2013, pending in Parliament seeks to replace these laws and establish a national authority, the Agricultural Biosecurity Authority of India (ABAI), to regulate biosecurity issues related to plants and animals.  ABAI shall be responsible for: (i) regulating the import and export of plants, animals and related products, (ii) implementing quarantine measures in case of the existence of pests, (iii) regulating the inter-state spread of pests and diseases relating to plants and animals, and (iv) undertaking regular surveillance of pests and diseases.  Under the Bill, exports of plants, animals and related products will only be allowed once ABAI has issued a sanitary or phytosanitary certificate in accordance with the destination country’s requirements. The penalty for exporting goods without adequate certification from ABAI is imprisonment upto two years and and a fine of Rs 2 lakh. The proposed ABAI will also meet India’s obligations to promote research and prevent pests and diseases under the International Plant Protection Convention and the Office International des Epizooties. A PRS analysis of various aspects of the Bill can be found here. The Bill will lapse with the dissolution of the 15th Lok Sabha.  It remains to be seen how the incoming government in the 16th Lok Sabha will approach biosecurity issues to prevent incidents like the EU ban on imports of Indian fruits and vegetables in the future.

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!