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:
According to a press release, the Ministry of Civil Aviation is considering abolishing the development fee being levied at the Delhi and Mumbai airports. The Ministry has already asked the Kolkata and Chennai airports not to levy a development fee. According to the Ministry, this is being done to make air travel more affordable. Currently, development fee charged at the Delhi Airport ranges from Rs 200 to Rs 1300. At the Mumbai airport, the fee ranges from Rs 100 to Rs 600. It is pertinent to note that though, the Ministry has proposed abolishing the development fee, the airport operators may still levy a user development fee. In this blog we discuss some of the aspects of development fee and user development fee. What is a development fee and a user development fee? Development Fee (DF) is primarily intended to fund the establishment or upgradation of an airport. It is intended to bridge the gap between the cost of the project and the finance available with the airport operator. Currently only the Mumbai and Delhi Airports levy a DF. However, there are other types of tariffs, such as a user development fee (UDF), which may be levied by the airports. UDF is generally regarded as a revenue enhancing measure. It is levied by the airport operators to meet operational expenditure Section 22 A of the Airports Authority Act, 1994 (amended in 2003) gives the Airport Authority of India (AAI) the power to levy and collect a development fee on embarking passengers. The Act provides that the development fee can be utilised only for: (a) funding or financing the upgradation of the airport; (b) establishing a new airport in lieu of the airport at which is levied; and (c) investing in shares of a private airport in lieu of an existing airport . Unlike DF, UDF is not levied and collected under the Airport Authority of India Act but under Rule 89 of the Aircraft Rules, 1937. Under the Aircraft Rules, UDF may be levied and collected by either the AAI or the private operator. According to the Airport Economic Regulatory Authority, UDF is levied to ensure that the airport operators can get a fair return on their investments. What is the role of the Airport Economic Regulatory Authority? In 2008, the Airport Economic Regulatory Authority (AERA) was established to regulate aeronautical tariffs. Among others, AERA’s functions include determining the amount of DF and UDF for major airports. In case of non-major airports, the UDF shall be determined by the central government. What has been the role of the Supreme Court? In 2009, the central government permitted the Mumbai and Delhi Airports to levy a DF. The rate of was prescribed by the central government and not by AERA. In 2011, the Supreme Court held that this levy of DF was illegal. The Court based its decision on two grounds. Firstly, the court held that the rate of DF has to be determined by the AERA and not the central government. Secondly, the Court held that the power to levy the fee lies with the Airport Authority as the development fee can only be utilised for the performance of the purpose specified in the Act. The court held that while the Airport Authority can utilise the development fee for any of the functions prescribed in the Act, it can assign the power to levy a development fee to a private operator only for funding or financing the upgradation or expansion of the airport. Can private operators collect a development fee and a user development fee? In 2003, the government amended the Airport Authority of India Act to allow the AAI with the prior permission of the central government to: (i) to lease the premises of airports to private entities to undertake some of the functions of the AAI; (ii) levy and collect a development fee on the embarking passengers at a rate that may be prescribed. Till 2011, the power to collect the development fee lay only with the Airport Authority. However with the notification of the Airports Authority of India (Major Airports) Development Fees Rules, 2011, private operators have also been permitted to collect the development fee.
