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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:
There has been much discussion about bringing the GDP growth on track and the need for expediting infrastructure projects in this regard. At the Planning Commission Meeting to approve the Twelfth Five Year Plan, last month, there were concerns about the implementation of such projects because of the delay in the grant of environment and forest clearances. In this context, there has been talk of setting up a singular body that will grant approvals for large infrastructure projects. News reports suggest that the government is considering forming a National Investment Approval Board (NIAB). The NIAB will be responsible for expediting the clearances for mega project proposals above a certain financial threshold. The Board would be headed by the Prime Minister and will have the authority to provide the ‘final decision’ on investment projects. According to news reports, the NIAB will be the final decision making body. The Ministry of Environment & Forests (MoEF) has raised concerns that this would create ambiguity in the current process of granting clearance for projects. While the formation of the NIAB is still being deliberated and discussed, it would be relevant to understand the process that the MoEF follows before granting clearance to a project and look at data on number of clearances granted and pending. The MoEF has developed certain processes to examine the potential environmental impact of new projects or expansion of existing projects. These are contained in the Environment Impact Assessment Notification, 2006. This notification empowers the Expert Appraisal Committees (EAC) to review the environmental impact of projects. The EAC carries out a combination of these steps depending on the classification of the project:
The MoEF considers the grant of environmental clearance to development projects in terms of the provisions of EIA Notification, 2006. From July 13, 2011 to July 12, 2012 the MoEF has given environmental clearances to 209 development projects. For a sector wise break up see Table 1. Table 1: Number of Environment Clearances Accorded
Sector | No. of projects accorded EC |
Industry (Steel & Cement) |
88 |
Thermal Power |
29 |
River Valley and Hydro-electric |
6 |
Coal Mining |
29 |
Non-Coal Mining |
25 |
National Highways |
32 |
Total |
209 |
Source: “Environmental Clearance accorded from 13.07.2011 to 12.07.2012”, MoEF A total of 593 proposals are pending for environmental clearance as on August 13, 2012.[i] It remains to be seen how the process of granting clearances as established by the MoEF will be reconciled with the expedited process of the NIAB.
[i] MoEF, Lok Sabha, Unstarred Question no. 637, August 13, 2012,