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 2010 Commonwealth Games may have ended on October 14th, but the controversy surrounding the organising of the games is far from over. In Parliament, the Opposition has called for a Joint-Parliamentary Committee (JPC) to be formed to investigate suspected financial irregularities in the organising of the Games[1]. In a statement in Parliament on Tuesday, Minister for Youth Affairs & Sports M.S. Gill commented that “All irregularities will be examined and the guilty will not be spared”[2]. In July 2010, the Central Vigilance Commission (CVC) found irregularities in 14 Games related construction projects[3]. It has been reported that officials from the CVC now believe total misappropriation of Games Funds could be between Rs 5000 crore and Rs 8000 crore [4]. So what is being done about it? Currently, six different government organisations are conducting independent inquiries into financial irregularities, corruption, and mismanagement of the Games: the High Level (Shunglu) Commission, CVC, CAG, CBI, Income Tax Department, and Enforcement Directorate (ED). With so many government organisations involved, it can be difficult to decipher the big picture. Here is a breakdown of what each organisation is doing: High Level Commission (Shunglu Commission): The Commission was appointed by the Prime Minister on October 15th[5]. It is chaired by V.K. Shunglu, former Comptroller and Auditor General of India, who has been given the status equivalent to a Supreme Court Judge[6]. The Commission has a broad mandate to investigate all matters regarding the Games, specifically:[7]
A report from the Commission detailing its findings is expected by mid January. Central Vigilance Commission (CVC): The CVC first found financial irregularities in 14 Games projects in July 2010. Subsequently, it asked the CBI to register a corruption case against MCD officials in connection with a tender issued for a Games project[8]. In total, the CVC has found irregularities in 38 games related projects, under the following departments and agencies:[9]
The CVC has directed the above agencies to respond to queries regarding the irregularities and has directed the CBI to begin a Preliminary Inquiry into them [10]. The CVC will report its findings to the Shunglu Commission. Income Tax Department: The I-T Department is investigating tenders and awards of contracts for Games related works, as well as tax evasion [11]. It has conducted raids in offices of over 30 business firms and individuals [12]. Enforcement Directorate (ED): The ED is proceeding against Organising Committee officials for violations of the Foreign Exchange Management Act (FEMA) for projects involving venue development and overlays contracts awarded by the Organising Committee. Central Bureau of Investigation (CBI): It has been reported that the CBI had received over 300 complaints of corruption in Games projects by August 2010[13]. It is verifying these claims and investigating matters highlighted by the CVC. Comptroller and Auditor General (CAG): In August 2009, the CAG published a report entitled Preparedness for the XIX Commonwealth Games highlighting the lack of preparedness for the Games and its escalating cost. The CAG is conducting a detailed audit of the Games that is expected to be published in March 2011[14]. Given that CAG reports are tabled in Parliament, the March 2011 report will be critical to the Parliamentary debate on the Games. Two members of the Organising Committee, the Joint Director and the Deputy Director General, were arrested by the CBI this past Monday. However, Given that the report of the Shunglu Commssion is due in January 2011, the CAG audit will follow two months later, and the current Opposition demand for a JPC remains unresolved, it may be some time before significant details are made public.
[1] http://economictimes.indiatimes.com/news/politics/nation/BJP-to-press-for-JPC-probe-into-spectrum-Adarsh-CWG-scams/articleshow/6934697.cms [2] http://www.thehindu.com/news/article890174.ece [3] ttp://economictimes.indiatimes.com/news/news-by-industry/et-cetera/CVC-finds-irregularities-in-several-CWG-projects/articleshow/6229429.cms [4] http://www.deccanherald.com/content/105830/cwg-fraud-may-touch-rs.html [5] http://www.business-standard.com/india/news/games-over-pm-orders-probe-into-pre-event-mess/411739/ [6] http://economictimes.indiatimes.com/news/politics/nation/CWG-probe-Shunglu-given-status-of-SC-judge/articleshow/6818404.cms [7] http://pib.nic.in/newsite/PrintRelease.aspx?relid=66561 [8] http://timesofindia.indiatimes.com/city/delhi/CWG-construction-CVC-asks-CBI-to-register-corruption-case/articleshow/6237714.cms [9] http://www.hindustantimes.com/specials/sports/cwg-2010/22-more-CWG-works-under-CVC-scanner/CWG2010-TopStories/SP-Article10-614446.aspx [10] http://www.indianexpress.com/news/Claiming-fraud---favour-in-Games-rentals--CVC-to-CBI--begin-probe/700998/ [11]http://www.indianexpress.com/news/it-dept-collects-cwg-works-related-documents/698683/ [12] http://www.thehindu.com/news/national/article837892.ece [13] http://www.indianexpress.com/news/cbi-has-over-300-complaints-regarding-games-works/655692/ [14] http://economictimes.indiatimes.com/news/politics/nation/CAG-starts-Commonwealth-Games-audit-report-by-March-2011/articleshow/6252852.cms
