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
Source: Sansad TV, Lok Sabha, July 26, 2023; PRS.
Figure 3: Number of days from introduction to discussion on no-confidence motions
Note: Number of days implies calendar days.
Source: Statistical Handbook 2021, Ministry of Parliamentary Affairs; PRS.
On average, no-confidence motions (excluding the one being discussed today) have been discussed for 13 hours over three days. Discussions have lasted longer than 20 hours on four instances, most recently in 2003. Today’s no-confidence motion was allotted 12 hours discussion time by the Business Advisory Committee.
Following the discussion, the motion is put to vote. 26 out of 27 no-confidence motions (excluding the one being discussed today) have been voted upon and rejected. This means that no government has ever had to resign following a vote of no-confidence. On one occasion, in 1979, the discussion on a no-confidence motion against the Morarji Desai government remained inconclusive. He resigned before the motion was put to vote. 50% of all no-confidence motions (14 out of 28) were discussed between 1965 and 1975. Of these, 12 were against governments headed by Indira Gandhi.
Figure 4: Duration of discussion on no-confidence motions
Note: This graph excludes the no confidence motion moved on July 26, 2023.
Source: Statistical Handbook 2021, Ministry of Parliamentary Affairs; PRS.
In comparison, confidence motions have a more varied history. The first motion, brought in 1979 to demonstrate confidence in Charan Singh’s government, was not discussed at all. The Prime Minister resigned before the discussion could take place. Since then, 11 confidence motions have been discussed in Lok Sabha, with nine occurring in the 1990s. During this period, several coalition governments were formed, and Prime Ministers sought to prove their majority through confidence motions. These motions have been discussed, on average, for 12 hours over two days.
Figure 5: Duration of discussion of confidence motions
Source: Statistical Handbook 2021, Ministry of Parliamentary Affairs; PRS.
Of the 11 confidence motions discussed in Lok Sabha, seven were accepted. On three instances, governments had to resign as they could not prove that they had the support of the majority. On one instance in 1996, the motion was not put to vote. Following an eleven-hour discussion on this confidence motion, Prime Minister Atal Bihari Vajpayee announced his intention to resign on the floor of the House. He resigned 16 days into his term.
Vajpayee became Prime Minister again in 1999, and faced another confidence motion. This time, it was put to vote. The motion was defeated by a margin of one vote. This has been the closest result on a trust vote in the history of Lok Sabha. The next closest result was when a motion of no-confidence against P V Narasimha Rao’s government was defeated by 14 votes in 1993. In most cases, results have been in favour of the government by a large margin.
