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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:
The nominations for all phases of the General Election have been submitted. We examine highlights from data on candidates who are participating in the ongoing elections. There are 8,039 candidates contesting for 542 Parliamentary constituency seats.
On average, 14.8 candidates are contesting per constituency across the country. Among all the states, Telangana has the highest average number of candidates contesting. This is primarily due to 185 contestants from Nizamabad. Excluding Nizamabad, the state’s average number of contestants would be 16.1. |
The Election Commission of India recognises parties as either national or state parties based on their performance in previous elections. Delhi and Haryana have a high number of candidates contesting from parties that have not been recognised as either national or state parties. After Telangana, Tamil Nadu has the highest average of independent candidates contesting in this election. On average, of the candidates in each constituency in Tamil Nadu, two-thirds are contesting as independent candidates. |
After Nizamabad, the second highest number of candidate representation is seen in Belgaum, Karnataka. The five constituencies that have the highest candidate representation are from the southern states of Telangana, Karnataka, and Tamil Nadu. |
The Bharatiya Janata Party and Congress are contesting 435 and 420 seats respectively. In 373 seats they are in competition with each other. BSP has the third highest number of candidates contesting in this election. |
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The seven national parties together fielded 2.69 candidates per constituency. Among the largest five states, West Bengal has the highest representation of candidates from national parties, at 4.6. In that state, candidates from five national parties are contesting. Recognised state parties, together, fielded 1.53 candidates per constituency. Bihar (6 state parties) and Tamil Nadu (8 state parties) see a high representation of candidates from state parties, at 1.2 and 1.3 respectively. Largest states are ones with more than 30 Parliamentary constituency seats: Uttar Pradesh (80), Maharashtra (48), West Bengal (42), Bihar (40), and Tamil Nadu (39). These states together have 249 seats i.e., 46% of Lok Sabha. |
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For these five states, the number of seats being contested by national and state parties is shown in the figures below. |
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This analysis is based on the candidate list available on the Election Commission website (eci.gov.in) on May 8, 2019.