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:
Discussion on the first no-confidence motion of the 17th Lok Sabha began today. No-confidence motions and confidence motions are trust votes, used to test or demonstrate the support of Lok Sabha for the government in power. Article 75(3) of the Constitution states that the government is collectively responsible to Lok Sabha. This means that the government must always enjoy the support of a majority of the members of Lok Sabha. Trust votes are used to examine this support. The government resigns if a majority of members support a no-confidence motion, or reject a confidence motion.
So far, 28 no-confidence motions (including the one being discussed today) and 11 confidence motions have been discussed. Over the years, the number of such motions has reduced. The mid-1960s and mid-1970s saw more no-confidence motions, whereas the 1990s saw more confidence motions.
Figure 1: Trust votes in Parliament
Note: *Term shorter than 5 years; **6-year term.
Source: Statistical Handbook 2021, Ministry of Parliamentary Affairs; PRS.
The no-confidence motion being discussed today was moved on July 26, 2023. A motion of no-confidence is moved with the support of at least 50 members. The Speaker has the discretion to allot time for discussion of the motion. The Rules of Procedure state that the motion must be discussed within 10 days of being introduced. This year, the no-confidence motion was discussed 13 calendar days after introduction. Since the introduction of the no-confidence motion on July 26, 12 Bills have been introduced and 18 Bills have been passed by Lok Sabha. In the past, on four occasions, the discussion on no-confidence motions began seven days after their introduction. On these occasions, Bills and other important issues were debated before the discussion on the no-confidence motion began.
Figure 2: Members rise in support of the motion of no-confidence in Lok Sabha