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(Authored by Anil Nair) The Maharashtra Legislative Assembly recently passed the Maharashtra Housing (Regulation and Development) Bill. This is the first such Bill to be passed by any state, which sets up a housing regulator to regulate property transactions. The Bill seeks to set up a Housing Regulatory Authority to provide for relief to flat purchasers against sundry abuses, malpractices and difficulties related to the construction, sale, management and transfer of flats. According to news reports, the government felt that existing laws were not effective in protecting the interests of the flat purchasers and allowed the promoters to avoid statutory obligations imposed on them. The Maharashtra Ownership Flats (Regulation of the promotion of construction, sale, management and transfer) Act, 1963 did not provide for an effective implementing arm for its various statutory provisions, as the buyers could only approach consumer forum or civil court for acts of omission or commission regarding its provisions. The current Bill passed by the Maharashtra Assembly proposes to repeal the 1963 Act. As per the Statement of Objects and Reasons of the Bill, the Regulatory Authority will strive to encourage growth and promotion of a healthy, transparent, efficient and competitive real estate market. The Bill specifies several conditions to be fulfilled by the developer to further transparency and fairness. All projects proposing to develop more than four flats or of land area exceeding 250 square meters have to submit and update details of the project on the website of the Housing Regulatory Authority. Developers would be required to disclose detailed information regarding the project including:
Failure to give possession of the flat on the agreed date would require repayment of the full amount paid by the buyer with interest. The Authority would also be empowered to penalise the developer up to an amount of one crore rupees for non-compliance with provisions in the Bill. Among other initiatives to assist the real estate industry, the Housing Regulatory Authority would promote rating of projects and of promoters, by the association of promoters, to improve the confidence level of investors and consumers through self-regulation. The full text of the Bill is available on the Government of Maharashtra website.
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: