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:
Elections to the 13th Legislative Assembly of Gujarat are scheduled to be held in two phases on the 13th and 17th of December. The BJP has been the dominant majority party in the Assembly since 1995. The 2002 elections saw the largest victory for the party, winning 127 seats. The Congress last held power in Gujarat in 1985. In the Assembly elections held for the the seventh Assembly, the Congress had a clear majority of 149 seats. In 1990, the Janata Dal emerged as the largest party with 70 seats. The BJP registered major gains in 1990, improving their tally of 11 seats in 1985 to 67 seats. The Congress came third with 33 seats. The electoral trends over the last 22 years may be viewed here. In the current Assembly, 117 of the 182 seats are held by the BJP. It is useful to look at the work done by the 12th Gujarat Assembly during its term from 2008 to 2012. Here we look at key metrics like the number of days the assembly was in session, members’ attendance, and legislative business. Performance of the Assembly During its five year term, the assembly sat for a total of 157 days – an average of 31 days each year. In comparison, the Lok Sabha sat for an average of 66 days each year during the period 2008 to 2011. In the same period the Kerala Assembly sat for an average of 50 days – highest among states - followed by Maharashtra (44). However, the Gujarat Assembly sat for more number of days than the Haryana Assembly which sat for an average of 13 days and Rajasthan (24). The average attendance among Gujarat MLAs stood at 83% for the whole term, with two members registering 100% attendance. 87 Bills were passed by the Assembly since the beginning of its term in 2008 till September 2011. Of these, 80 Bills i.e. over 90% of all Bills were passed on the same day as they were introduced. None of the Bills were referred to any Committee. In the Budget Session of 2011, 31 Bills were passed of which 21 were introduced and passed within three sitting days Amendments sought by the President and the Governor One of the significant laws passed by the 12th Assembly was the Gujarat Control of Terrorism and Organised Crime Bill, 2003 which was introduced and passed in July 2009. However the Bill did not receive the Presidents Assent and was sent back to the Gujarat Assembly for amendments. In December 2009, the assembly passed the Gujarat Local Authorities Laws (Amendment) Bill 2009 which sought to make voting compulsory in elections to local self-government bodies like municipal corporations and Panchayats. The Gujarat governor returned the Bill for reconsideration in 2010. It was re-introduced in the house in September 2010 without changes. Another Bill that was returned by the Governor was the Gujarat Regularisation of Unauthorised Development Bill which sought to regularise unauthorised construction on payment of an Impact Fee. The Bill was passed by the Assembly in March 2011. The Governor returned the Bill with a suggestion to include a provision to bar the regularisation of unauthorised construction beyond a specified date. The Bill was re-introduced and passed with amendments by the Assembly in September 2011.
