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:
Recently, the President repromulgated the Securities Laws (Amendment) Ordinance, 2014, which expands the Securities and Exchange Board Act’s (SEBI) powers related to search and seizure and permits SEBI to enter into consent settlements. The President also promulgated the Scheduled Castes and the Scheduled Tribes (Prevention of Atrocities) Amendment Ordinance, 2014, which establishes special courts for the trial of offences against members of Scheduled Castes and Scheduled Tribes. With the promulgation of these two Ordinances, a total of 25 Ordinances have been promulgated during the term of the 15th Lok Sabha so far. Ordinances are temporary laws which can be issued by the President when Parliament is not in session. Ordinances are issued by the President based on the advice of the Union Cabinet. The purpose of Ordinances is to allow governments to take immediate legislative action if circumstances make it necessary to do so at a time when Parliament is not in session. Often though Ordinances are used by governments to pass legislation which is currently pending in Parliament, as was the case with the Food Security Ordinance last year. Governments also take the Ordinance route to address matters of public concern as was the case with the Criminal Law (Amendment) Ordinance, 2013, which was issued in response to the protests surrounding the Delhi gang rape incident. Since the beginning of the first Lok Sabha in 1952, 637 Ordinances have been promulgated. The graph below gives a breakdown of the number of Bills passed by each Lok Sabha since 1952, as well as the number of Ordinances promulgated during each Lok Sabha. 
Ordinance Making Power of the President The President has been empowered to promulgate Ordinances based on the advice of the central government under Article 123 of the Constitution. This legislative power is available to the President only when either of the two Houses of Parliament is not in session to enact laws. Additionally, the President cannot promulgate an Ordinance unless he ‘is satisfied’ that there are circumstances that require taking ‘immediate action’. Ordinances must be approved by Parliament within six weeks of reassembling or they shall cease to operate. They also cease to operate in case resolutions disapproving the Ordinance are passed by both Houses. History of Ordinances Ordinances were incorporated into the Constitution from Section 42 and 43 of the Government of India Act, 1935, which authorised the then Governor General to promulgate Ordinances ‘if circumstances exist which render it necessary for him to take immediate action’. Interestingly, most democracies including Britain, the United States of America, Australia and Canada do not have provisions similar to that of Ordinances in the Indian Constitution. The reason for an absence of such a provision is because legislatures in these countries meet year long. Ordinances became part of the Indian Constitution after much debate and discussion. Some Members of the Constituent Assembly emphasised that the Ordinance making power of the President was extraordinary and issuing of Ordinances could be interpreted as against constitutional morality. Some Members felt that Ordinances were a hindrance to personal freedom and a relic of foreign rule. Others argued that Ordinances should be left as a provision to be used only in the case of emergencies, for example, in the breakdown of State machinery. As a safeguard, Members argued that the provision that a session of Parliament must be held within 6 months of passing an Ordinance be added. Repromulgation of Ordinances Ordinances are only temporary laws as they must be approved by Parliament within six weeks of reassembling or they shall cease to operate. However, governments have promulgated some ordinances multiple times. For example, The Securities Laws (Amendment) Ordinance, 2014 was recently repromulgated for the third time during the term of the 15th Lok Sabha. Repromulgation of Ordinances raises questions about the legislative authority of the Parliament as the highest law making body. In the 1986 Supreme Court judgment of D.C. Wadhwa vs. State of Bihar, where the court was examining a case where a state government (under the authority of the Governor) continued to re-promulgate Ordinances, the Constitution Bench headed by Chief Justice P.N. Bhagwati observed: “The power to promulgate an Ordinance is essentially a power to be used to meet an extraordinary situation and it cannot be allowed to be "perverted to serve political ends". It is contrary to all democratic norms that the Executive should have the power to make a law, but in order to meet an emergent situation, this power is conferred on the Governor and an Ordinance issued by the Governor in exercise of this power must, therefore, of necessity be limited in point of time.” 
Thanks to Vinayak Rajesekhar for helping with research on this blog post.
