Yesterday, Cabinet approved amendments to the Real Estate (Regulation and Development) Bill, 2013, which is currently pending in Parliament. In this context, the blog post outlines key features and issues related to the Bill, and certain changes which were approved by Cabinet. What is the current status of the Bill? The Bill was introduced in Rajya Sabha in August 2013. It was then referred to the Parliamentary Standing Committee on Urban Development, which submitted its report in February 2014. The Bill has not been discussed in Parliament as yet, and is currently pending in Rajya Sabha. As mentioned above, Cabinet approved certain changes to the Bill yesterday. However, a comprehensive list of these changes is not available in the public domain yet. What are the key features of the Bill? The Bill regulates transactions between buyers and promoters (sellers) of residential real estate projects. It establishes state level regulatory authorities called Real Estate Regulatory Authorities (RERAs) in order to do so. Residential real estate projects, with some exceptions, need to be registered with RERAs, and their details must be uploaded on the website of the RERA. This implies that promoters cannot book or offer these projects for sale without registering them with RERAs. Real estate agents dealing in these projects also need to register with RERAs. The Bill also establishes state level appellate tribunals called Real Estate Appellate Tribunals. Decisions of RERAs can be challenged before these tribunals. The Bill outlines the duties of promoters, buyers, and real estate agents. For example, the Bill requires that promoters keep 70% of the amount collected from buyers for a project, in a separate bank account. This amount must only be used for construction of that project. The state government can alter this amount to less than 70%. The Bill also provides for penalties for the breach of certain provisions of the Bill. What are some of the issues to consider? A few key issues to consider in the Bill are related to the following: (i) certain states have already enacted laws to regulate real estate; (ii) commercial real estate has not been included within the ambit of the Bill; (iii) certain smaller sized projects have not been covered under the Bill; and (iv) 70% of the amount collected from buyers must be kept in an escrow account. Firstly, at present, certain states, such as West Bengal and Maharashtra, have already enacted laws to regulate real estate. So, any central law on real estate that is subsequently enacted will override provisions of state laws if they are inconsistent with the central law. For example, while this Bill (introduced at the centre) requires that 70% of the amount collected from buyers be kept in a separate account and be used only for construction of that project, the Maharashtra law requires that the entire amount collected from buyers be used only for purposes collected. Secondly, while the Bill seeks to regulate residential real estate, commercial real estate has been excluded from its ambit. The Standing Committee has also pointed out that commercial and industrial real estate should be regulated by the Bill. Thirdly, registration with RERAs is not required for projects that: (i) are less than 1000 square metres, or (ii) entail the construction of less than 12 apartments, or (iii) entail renovation/repair/re-development without re-allotment or marketing of the project. The Standing Committee has pointed out that the exclusion of projects, smaller than 1,000 square meters or 12 apartments, from the purview of RERAs could lead to the exclusion of a number of small housing projects. Instead, it has suggested that only projects that are smaller than 100 square meters or three apartments need not register with the RERA. Finally, the Bill mandates that 70% of the amount collected from buyers of a project be used only for construction of that project. Typically, the project cost of a real estate project includes the cost of land and the cost of construction. In certain cases, the cost of construction could be less than 70% and the cost of land more than 30% of the total amount collected. This implies that part of the funds collected could remain unutilised, necessitating some financing from other sources. Consequently, this could raise the project cost. The Standing Committee made certain other recommendations in relation to the Bill. It suggested that all real estate agents be registered with RERAs; and that a new provision be inserted to allow RERAs to give directions to state governments to establish a single window system for providing clearances for projects. Additionally, a time limit should be specified for state and local authorities to issue completion certificates for projects. What were the changes to the Bill approved by Cabinet yesterday? A comprehensive list of amendments is not in the public domain yet. However, a press release of the government, published by the Press Information Bureau, indicates the following changes have been made: firstly, the application of the Bill has been extended to cover commercial real estate, in addition to residential real estate; and secondly, the amount to be kept in an escrow account has been reduced from 70% of the amount collected from buyers to 50%. For more information, please see the PRS Legislative Brief on the Bill, available here. You can also watch a PRS video on the Bill here.
A recent news report stated that the Planning Commission has advocated putting in place a “proper regulatory mechanism” before permitting the use of genetic modification in Indian crops. A recent Standing Committee report on genetically modified (GM) crops found shortcomings in the regulatory framework for such crops. The current framework is regulated primarily by two bodies: the Genetic Engineering Appraisal Committee (GEAC) and the Review Committee on Genetic Manipulation (RCGM). Given the inadequacy of the regulatory framework, the Standing Committee recommended that all research and development activities on transgenic crops be carried out only in containment (in laboratories) and that ongoing field trials in all states be discontinued. The blog provides a brief background on GM crops, their regulation in India and the key recommendations of the Standing Committee. What is GM technology? GM crops are usually developed through the insertion or deletion of genes from plant cells. Bt technology is a type of genetic modification in crops. It was introduced in India with Bt cotton. The debate around GM crops has revolved around issues of economic efficacy, human health, consumer choice and farmers’ rights. Some advantages of Bt technology are that it increases crop yield, decreases the use of pesticides, and improves quality of crops. However, the technology has also been known to cause crop loss due to resistance developed by pests and destruction of local crop varieties, impacting biodiversity. Approval process for commercial release of GM crops
- Initially, the company developing the GM crop undertakes several biosafety assessments including, environmental, food, and feed safety assessments in containment.
- This is followed by Bio-safety Research Trials which require prior approval of the regulators, the GEAC and the RCGM.
- Approval for environmental release is accorded by the GEAC after considering the findings of bio-safety studies.
- Finally, commercial release is permitted only for those GM crops found to be safe for humans and the environment.
Committee’s recommendations for strengthening the regulatory process The Standing Committee report found several shortcomings in the regulatory framework, some of which are as follows:
- State governments are not mandatorily consulted for conducting open field trials on GM crops. Several states such as Kerala and Bihar have opposed field trials for GM crops. The Committee recommended that mandatory consultation with state governments be built into the regulatory process.
- The key regulators, the GEAC and the RCGM, suffer from poor organisational set-up and infrastructure. The Committee recommended that the regulatory framework be given statutory backing so that there is no scope for ambiguity or complacency on the part of the authorities responsible for the oversight of GM organisms. It urged the government to introduce the Biotechnology Regulatory Authority Bill.
- There is evidence that the GEAC has not complied with international treaties. These include the Cartagena Protocol on Biosafety and the Rio Declaration on Environment and Development. It recommended that legislation relating to liability and redress for damage arising from living modified organisms be enacted.
- Some international scientists have raised doubts about the safety of Bt Brinjal and the way tests were conducted. To remedy this situation, the Committee recognised the need for an overarching legislation on biosafety to ensure that biotechnology is introduced without compromising the safety of biodiversity, human and livestock health, and environmental protection.
Note that over the last few sessions of Parliament, the government has listed the Biotechnology Regulatory Authority Bill for introduction; however the Bill has not been introduced yet. The Bill sets up an independent authority for the regulation of GM crops. For a PRS summary of the report and access to the full report, see here and here.
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:
- drugs that have not been used in the country before,
- drugs that have been approved by a Licensing Authority but are now being marketed for different purposes, and
- fixed dose combinations of two or more drugs that have been individually approved before but are proposed to be combined in a fixed ratio that has not been approved.
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:
- Under the Rules, the Drugs Controller General (India) (DCGI), the head of CDSCO, can clear sites of clinical trials after ensuring that major ethnic groups are enrolled in these trials to have a truly representative sample. This rule was violated by the DCGI when sites for clinical trials were approved without ensuring diversity. The Committee recommended that the DCGI approve sites for trials only if they cover patients from major ethnic backgrounds.
- The Report found that certain actions by experts were in violation of the Code of Ethics of the Medical Council of India. A review of expert opinions revealed that several medical expert recommendations had been given as personal opinions rather than on the basis of scientific data. Additionally, many expert opinions were written by what the Report calls ‘the invisible hands’ of drug manufacturers. The Committee recommended that CDSCO formulate a clear set of written guidelines on the selection process of experts with emphasis on expertise in the area of drugs.
- The Rules ban the import and marketing of any drug whose use is prohibited in the country of origin. CDSCO violated this rule by approving certain Fixed Dose Combination drugs for clinical trials without considering the drugs’ regulatory status in their respective country of origin. Drugs such as Deanxit and Buclizine, which have been prohibited for sale and use in their countries of origin, Denmark and Belgium, respectively, were approved for clinical trials. The Committee recommended an inquiry into the unlawful approval of these drugs.
- The Rules require animal studies to be conducted for approval of a drug for use by women of reproductive age. CDSCO violated this rule in approving Letrozole for treating female infertility. Globally the drug has only been used as an anti-cancer drug for use among post-menopausal women. The drug has not been permitted for use among women of reproductive age because of side effects. The Committee recommended that responsibility be fixed for unlawfully approving Letrozole.
- Rules require Post-marketing Safety Update Reports (PSURs) on drugs to be submitted to CDSCO. PSURs are used to collect information on adverse effects of drugs on Indian patients as a result of ethnic differences. When asked by the Committee to furnish PSURs on 42 randomly selected new drugs, the Ministry was able to submit PSURs for only 8 drugs. The Report contended that this action reflected a poor follow-up of side effects on Indian patients. The Committee recommended that manufacturers of new drugs be warned about suspension of marketing approval unless they comply with mandatory rules on PSURs.