On March 10, Lok Sabha passed a Bill to amend the Right to Fair Compensation and Transparency in Land Acquisition, Rehabilitation and Resettlement Act, 2013.  The Bill is now pending in Rajya Sabha.  This blog briefly outlines the context and the major legislative changes to the land acquisition law. I. Context Land acquisition, unlike the purchase of land, is the forcible take-over of privately owned land by the government.  Land is acquired for projects which serve a ‘public purpose’.  These include government projects, public-private partnership projects, and private projects.  Currently, what qualifies as ‘public purpose’ has been defined to include defence projects, infrastructure projects, and projects related to housing for the poor, among others. Till 2014, the Land Acquisition Act, 1894 regulated the process of land acquisition.  While the 1894 Act provided compensation to land owners, it did not provide for rehabilitation and resettlement (R&R) to displaced families.  These were some of the reasons provided by the government to justify the need for a new legislation to regulate the process of land acquisition.  Additionally, the Supreme Court had also pointed out issues with determination of fair compensation, and what constitutes public purpose, etc., in the 1894 Act.  To this end, the Right to Fair Compensation and Transparency in Land Acquisition, Rehabilitation and Resettlement Act, 2013 was passed by Parliament, in 2013. II. Current legislative framework for land acquisition The 2013 Act brought in several changes to the process of land acquisition in the country.   Firstly, it increased the compensation provided to land owners, from 1.3 times the price of land to 2 times the price of land in urban areas, and 2-4 times the price of land in rural areas.  Secondly, unlike the earlier Act which did not provide rehabilitation and resettlement, the 2013 Act provided R&R to land owners as well as those families which did not own land, but were dependent on the land for their livelihood.  The Act permits states to provide higher compensation and R&R. Thirdly, unlike the previous Act, it mandated that a Social Impact Assessment be conducted for all projects, except those for which land was required urgently.  An SIA assesses certain aspects of the acquisition such as whether the project serves a public purpose, whether the minimum area that is required is being acquired, and the social impact of the acquisition.  Fourthly, it also mandated that the consent of 80% of land owners be obtained for private projects, and the consent of 70% of land owners be obtained for public-private partnership projects.  However, consent of land owners is not required for government projects.   The 2013 Act also made certain other changes to the process of land acquisition, including prohibiting the acquisition of irrigated multi-cropped land, except in certain cases where the limit may be specified by the government. III. Promulgation of an Ordinance to amend the 2013 Act In addition to the 2013 Act, there are certain other laws which govern land acquisition in particular sectors, such as the National Highways Act, 1956 and the Railways Act, 1989.  The 2013 Act required that the compensation and R&R provisions of 13 such laws be brought in consonance with it, within a year of its enactment, (that is, by January 1, 2015) through a notification.  Since this was not done by the required date, the government issued an Ordinance (as Parliament was not in session) to extend the compensation and R&R provisions of the 2013 Act to these 13 laws.  However, the Ordinance also made other changes to the 2013 Act. The Ordinance was promulgated on December 31, 2014 and will lapse on April 5, 2015 if not passed as a law by Parliament.  Thus, the Right to Fair Compensation and Transparency in Land Acquisition, Rehabilitation and Resettlement (Amendment) Bill, 2015 has been introduced in Parliament to replace the Ordinance.  The Bill has been passed by Lok Sabha, with certain changes, and is pending in Rajya Sabha.  The next section outlines the major changes the Bill (as passed by Lok Sabha) proposes to make to 2013 Act. IV. Changes proposed by the 2015 Bill to the 2013 Act Some of the major changes proposed by the 2015 Bill (as passed by Lok Sabha) relate to provisions such as obtaining the consent of land owners; conducting an SIA; return of unutilised land; inclusion of private entities; and commission of offences by the government. Certain exemptions for five categories of projects: As mentioned above, the 2013 Act requires that the consent of 80% of land owners is obtained when land is acquired for private projects, and the consent of 70% of land owners is obtained when land is acquired for public-private partnership projects.  The Bill exempts five categories of projects from this provision of the 2013 Act.  These five categories are: (i) defence, (ii) rural infrastructure, (iii) affordable housing, (iv) industrial corridors (set up by the government/government undertakings, up to 1 km on either side of the road/railway), and (v) infrastructure projects. The Bill also allows the government to exempt these five categories of projects from: (i) the requirement of a Social Impact Assessment, and (ii) the limits that apply for acquisition of irrigated multi-cropped land, through issuing a notification.  Before issuing this notification, the government must ensure that the extent of land being acquired is in keeping with the minimum land required for such a project. The government has stated that these exemptions are being made in order to expedite the process of land acquisition in these specific areas.  However, the opponents of the Bill have pointed out that these five exempted categories could cover a majority of projects for which land can be acquired, and consent and SIA will not apply for these projects. Return of unutilised land: Secondly, the Bill changes the time period after which unutilised, acquired land must be returned.  The 2013 Act states that if land acquired under it remains unutilised for five years, it must be returned to the original owners or the land bank.  The Bill changes this to state that the period after which unutilised land will need to be returned will be the later of: (i) five years, or (ii) any period specified at the time of setting up the project. Acquisition of land for private entities: Under the 2013 Act, as mentioned above, land can be acquired for the government, a public-private partnership, or a private company, if the acquisition serves a public purpose.  The third major change the Bill seeks to make is that it changes the term ‘private company’ to ‘private entity’.  This implies that land may now be acquired for a proprietorship, partnership, corporation, non-profit organisation, or other entity, in addition to a private company, if the project serves a public purpose. Offences by the government: Fourthly, under the 2013 Act, if an offence is committed by a government department, the head of the department will be held guilty unless he can show that he had exercised due diligence to prevent the commission of the offence.  The Bill removes this section.  It adds a provision to state that if an offence is committed by a government employee, he can be prosecuted only with the prior sanction of the government. Acquisition of land for private hospitals and educational institutions: While the 2013 Act excluded acquisition of land for private hospitals and private educational institutions, the Bill sought to include these two within its scope.  However, the Lok Sabha removed this provision of the Bill.  Thus, in its present form, the Bill does not include the acquisition of land for private hospitals and private educational institutions. Other changes proposed in Lok Sabha: In addition to removing social infrastructure from one of the five exempted categories of projects, clarifying the definition of industrial corridors, and removing the provision related to acquisition for private hospitals and private educational institutions, the Lok Sabha made a few other changes to the Bill, prior to passing it.  These include: (i) employment must be provided to ‘one member of an affected family of farm labour’ as a part of the R&R award, in addition to the current provision which specifies that one member of an affected family must be provided employment as a part of R&R; (ii) hearings of the Land Acquisition, Rehabilitation and Resettlement Authority to address grievances related to compensation be held in the district where land is being acquired; and (iii) a survey of wasteland must be conducted and records of these land must be maintained. For more details on the 2015 Bill, see the PRS Bill page, here. A version of this blog appeared on rediff.com on February 27, 2015. 

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.