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:
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.
