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The ongoing Monsoon Session of Parliament is being widely viewed as the 'make or break' session for passing legislation before the end of the 15th Lok Sabha in 2014. Hanging in balance are numerous important Bills, which will lapse if not passed before the upcoming 2014 national elections. Data indicates that the current Lok Sabha has passed the least number of Bills in comparison to other comparable Lok Sabhas. The allocated time to be spent on legislation in the Monsoon Session is also below the time recommended for discussion and passing of Bills by the Business Advisory Committee of the Lok Sabha. Eight out of a total of 16 sittings of the Monsoon Session have finished with only 15 percent of the total time spent productively. Success rate of the 15th Lok Sabha in passing legislation India’s first Lok Sabha (1952-1957) passed a total of 333 Bills in its five year tenure. Since then, every Lok Sabha which has completed over three years of its full term has passed an average of 317 Bills. Where a Lok Sabha has lasted for less than 3 years, it has passed an average of 77 Bills. This includes the 6th, 9th, 11th and 12th Lok Sabhas. The ongoing 15th Lok Sabha, which is in the fifth year of its tenure, has passed only 151 Bills (This includes the two Bills passed in the Monsoon Session as of August 18, 2013). In terms of parliamentary sessions, Lok Sabhas that have lasted over three years have had an average of fifteen sessions. The 15th Lok Sabha has finished thirteen parliamentary sessions with the fourteenth (Monsoon Session) currently underway. 
Legislative business accomplished in the 15th Lok Sabha For the 15th Lok Sabha, a comparison of the government's legislative agenda at the beginning of a parliamentary session with the actual number of Bills introduced and passed at the end of the session shows that: (i) on average, government has a success rate of getting 39 percent of Bills passed; and (ii) on average, 60 percent success rate in getting Bills introduced. 
The Monsoon Session of Parliament was scheduled to have a total of 16 sitting days between August 5-30, 2013. Of the 43 Bills listed for consideration and passage, 32 are Bills pending from previous sessions. As of August 18, 2013, the Rajya Sabha had passed a total of five Bills while the Lok Sabha had passed none. Of the 25 Bills listed for introduction, ten have been introduced so far. The Budget Session of Parliament earlier this year saw the passage of only two Bills, apart from the appropriation Bills, of the 38 listed for passing. These were the Protection of Women Against Sexual Harassment at Workplace Bill and the Criminal Law (Amendment) Bill. Time allocated for legislation in the Monsoon Session The Lok Sabha is scheduled to meet for six hours and the Rajya Sabha for five hours every day. Both houses have a question hour and a zero hour at the beginning of the day, which leaves four hours for legislative business in the Lok Sabha and three hours in the Rajya Sabha. However, both Houses can decide to meet for a longer duration. For example, Rajya Sabha has decided to meet till 6:00 PM every day in the Monsoon Session as against the normal working hours of the House until 5:00 PM. The Business Advisory Committee (BAC) of both Houses recommends the time that should be allocated for discussion on each Bill. This session's legislative agenda includes a total of 43 Bills to be passed by Parliament. So far, 30 of the Bills have been allocated time by the BAC, adding up to a total of 78 hours of discussion before passing. If the Lok Sabha was to discuss and debate the 30 Bills for roughly the same time as was recommended by the BAC, it would need a minimum of 20 working days. In addition, extra working days would need to be allocated to discuss and debate the remaining 13 Bills. With eight sitting days left and not a single Bill being passed by the Lok Sabha, it is unclear how the Lok Sabha will be able to make up the time to pass Bills with thorough debate.
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:
