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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:
Yesterday, the Election Commission announced the dates for the 2019 Lok Sabha elections. The voting will take place in seven phases between April 11, 2019 to May 19, 2019. With this announcement, the Model Code of Conduct (MCC) has comes into force. In this blog, we outline the key features of the MCC.
What is the Model Code of Conduct and who does it apply to?
The MCC is a set of guidelines issued by the Election Commission to regulate political parties and candidates prior to elections, to ensure free and fair elections. This is in keeping with Article 324 of the Constitution, which gives the Election Commission the power to supervise elections to the Parliament and state legislatures. The MCC is operational from the date that the election schedule is announced till the date that results are announced. Thus, for the general elections this year, the MCC came into force on March 10, 2019, when the election schedule was announced, and will operate till May 23, 2019, when the final results will be announced.
How has the Model Code of Conduct evolved over time?
According to a Press Information Bureau release, a form of the MCC was first introduced in the state assembly elections in Kerala in 1960. It was a set of instructions to political parties regarding election meetings, speeches, slogans, etc. In the 1962 general elections to the Lok Sabha, the MCC was circulated to recognised parties, and state governments sought feedback from the parties. The MCC was largely followed by all parties in the 1962 elections and continued to be followed in subsequent general elections. In 1979, the Election Commission added a section to regulate the ‘party in power’ and prevent it from gaining an unfair advantage at the time of elections. In 2013, the Supreme Court directed the Election Commission to include guidelines regarding election manifestos, which it had included in the MCC for the 2014 general elections.
What are the key provisions of the Model Code of Conduct?
The MCC contains eight provisions dealing with general conduct, meetings, processions, polling day, polling booths, observers, party in power, and election manifestos. Major provisions of the MCC are outlined below.
What changes have been recommended in relation to the MCC since the last general elections?
In 2015, the Law Commission in its report on Electoral Reforms, noted that the MCC prohibits the issue of advertisement at the cost of public exchequer in newspapers/media during the election period. However, it observed that since the MCC comes into operation only from the date on which the Commission announces elections, the government can release advertisements prior to the announcement of elections. It noted that this gives an advantage to the ruling party to issue government sponsored advertisements that highlights its achievements, which gives it an undue advantage over other parties and candidates. Therefore, the Commission recommended that a restriction should be imposed on government-sponsored advertisements for up to six months prior to the date of expiry of the House/Assembly. However, it stated that an exception may be carved out for advertisements highlighting the government's poverty alleviation programmes or any health related schemes.
Is the Model Code of Conduct legally binding?
The MCC is not enforceable by law. However, certain provisions of the MCC may be enforced through invoking corresponding provisions in other statutes such as the Indian Penal Code, 1860, Code of Criminal Procedure, 1973, and Representation of the People Act, 1951. The Election Commission has argued against making the MCC legally binding; stating that elections must be completed within a relatively short time (close to 45 days), and judicial proceedings typically take longer, therefore it is not feasible to make it enforceable by law. On the other hand, in 2013, the Standing Committee on Personnel, Public Grievances, Law and Justice, recommended making the MCC legally binding. In a report on electoral reforms, the Standing Committee observed that most provisions of the MCC are already enforceable through corresponding provisions in other statutes, mentioned above. It recommended that the MCC be made a part of the Representation of the People Act, 1951.
Note that this is an updated version of a previous blog published in 201