the PRS Blog

The right to food and food security have been widely discussed in the media.  The National Food Security Bill, 2011, which makes the right to food a legal right, is currently pending in Parliament.  The Bill seeks to deliver food security by providing specific entitlements to certain groups of individuals through the Targeted Public Distribution System, a large-scale subsidised foodgrain distribution system.  The Standing Committee on Food, Consumer Affairs and Public Distribution presented its report on the Food Security Bill on January 17, 2013.  It made recommendations on key issues such as the categorisation of beneficiaries, cash transfers and cost sharing between the centre and states.

A comparison of the Bill and Committee’s recommendations are given below.

To access the Bill, a detailed comparison of the Standing Committee recommendations and the Bill, and other relevant reports relevant, see here.

A recent news report has discussed the methods by which states such as Chattisgarh have attempted to reform the Public Distribution System (PDS).  Chattisgarh has computerised its PDS supply chain and introduced smart cards as part of a slew of measures to plug pilferage and weed out corruption in the system.  In an effort to create a national computerised database for PDS, the Ministry of Consumer Affairs has launched an online National Transparency Portal for the Public Distribution System.  The portal aims to provide end-to-end computerisation of PDS; it is a single platform in the public domain for all PDS related information.

The PDS is a centrally sponsored scheme that entitles beneficiaries to subsidised foodgrains every month.  Currently, beneficiaries are divided into the following groups: Below Poverty Line (BPL), Above Poverty Line and Antodaya Anna Yojana.  As such, several challenges have been identified in the implementation of PDS.  Some of them are as follows:

1. Targeting errors: Separating beneficiaries of the PDS into three categories requires their classification and identification.  Targeting mechanisms, however, have been prone to large inclusion and exclusion errors.  In 2009, an expert group estimated that about 61% of the eligible population was excluded from the BPL list while 25% of non-poor households were included in the BPL list.
2. Large leakages and diversion of subsidized foodgrain:  Foodgrain is procured by the centre and transported from the central to state godowns.  Last mile delivery from state godowns to the Fair Price Shop (FPS) where beneficiaries can purchase grain with ration cards, is the responsibility of the state government.  Large quantities of foodgrain are leaked and diverted into the open market during this supply chain.

The creation of the e-portal could help track these issues more effectively and increase transparency in the system. The portal contains information relating to FPS and ration cards attached to the FPS.  It is likely that this will help weed out bogus ration cards and improve targeting of subsidies.  The portal also has information on capacity utilization of Food Corporation of India, state storage godowns, and data on central pool stocks.  This helps track storage supplies of grains at each level and aims to prevent leakage of grain.

With respect to data on PDS in states, the portal hosts information such as the central orders on monthly allocation of foodgrain to states, state-specific commodity sale prices, lifting position of states, etc. for public view.  All states and union territories will be required to maintain and update the data on the portal.

The reforms come at a time when the National Food Security Bill, 2011 is pending in Parliament.  The Bill aims to deliver foodgrain entitlements through Targeted PDS to 75% of the rural and 50% of the urban population.  The Bill is currently under examination by the Standing Committee of Food, Consumer Affairs and Public Distribution.  It proposes reforms to the TPDS, which include the application of information and communication technology, including end-to-end computerisation.  These reforms seek to ensure full transparency of records in the PDS and prevent diversion of foodgrains.  The creation of the e-portal might be a step towards reforming the PDS.

For an analysis of the National Food Security Bill, see 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.

There are indications that the Lok Pal Bill, 2011 is likely to be taken up for consideration and passing during the current Winter session of Parliament.  The Bill was introduced on Aug 4, 2011 in the Lok Sabha after a prolonged agitation led by Anna Hazare (see PRS analysis of the Bill).  It was referred to the Parliamentary Standing Committee on Personnel, Public Grievances, Law and Justice (see PRS note on Committee Systems).  The Committee submitted its report on December 9, 2011.  The report includes 10 dissent notes from 17 MPs.

(a)    Kirti Azad, Bal Apte, D.B. Chandre Gowda, Harin Pathak, Arjun Ram Meghwal, and Madhusudan Yadav.

(b)   Ram Jethmalani

(c)    Ram Vilas Paswan

(d)   Shailendra Kumar

(e)    Prasanta Kumar Majumdar

(f)     Pinaki Misra

(g)    A. Sampath

(h)    S. Semmalai

(i)      Meenakshi Natrajan, P.T. Thomas, and Deepa Dasmunshi

(j)     Vijay Bahadur Singh

Presently, the government and the Opposition are in the process of formulating their stands on various key issues such as inclusion of the Prime Minister, the lower bureaucracy and the role of the Central Investigation Bureau.  We provide a broad overview of the views of the members of the Committee on various key issues.

Unanimity on issues

On some issues, there was unanimity among the Committee members:

• Constitutional status for Lokpal.
• Immunity from prosecution for the MPs for any vote and speech in the House
• Exclusion of judiciary from the ambit of the Lokpal.
• Qualification of chairperson and Lok Pal members.
• Selection process of Lok Pal members.
• Lokpal should not have the powers to tap phones.

Dissent on issues

Certain members of the Committee dissented on specific issues.  In Table 1, we list the issues and the reason for the dissent.

Table 1: Recommendation of Standing Committee and dissent by individual MPs

In the aftermath of the 2G scam, there has been a great deal of discussion on how Parliamentary Committees can be used for scrutinising the functioning of the government.  Committee Reports are generally put in the public domain, but how transparent are the internal workings of the Committees themselves?

As one measure of transparency, minutes of Parliamentary Committee meetings are included in Committee reports. The meetings themselves, however, are held behind closed doors.

A number of other democracies allow in-person public viewing of some (if not all) Committee meetings.  Several of these offer live webcasts of meetings as well. See options in Canada, New Zealand, Scotland, and the United Kingdom.

In recent public discourse over lobbying, two issues that have underscored the debate are:

1. Greater transparency in the policymaking process, and
2. Equality of access for all stakeholders in engaging with the process.

There is a need to build linkages between citizens and the policy making process, especially by strengthening scrutiny before a Bill is introduced in Parliament. Currently, there is no process established to ensure pre-legislative scrutiny by the citizenry.

Other democracies incorporate several measures to enhance public engagement in the pre-legislative process. These include:

• Making all Bills available in the public domain for a stipulated period before introducing them in the legislature. This includes, publishing these Bills in forms (language, medium etc) that are accessible to the general public.
• Making a report or Green paper on the legislative priorities addressed by the Bill available for citizens.
• Forming adhoc committees to scrutinise the Bill before it is piloted in the House.
• Having Standing Committees examine the Bill before introducing it in the House.
• Providing a financial memorandum for each Bill, which specifies the budgetary allocation for the process/bodies created by the Bill.
• Creating online fora for discussion. For the sections of the stakeholders who have limited access to the internet, efforts are made to proactively consult them through other media.
• Expanding the purview of citizens’ right to petition their representatives with legislative proposals.

There are several instances, in the last few years itself, wherein civil society groups have played an active role in the development of pre-legislative scrutiny in India.

• Public consultation with cross-section of stakeholders when drafting a Bill: The Right to Information Act is seen as a landmark legislation when highlighting the role of civil society actors in the drafting of a Bill.  It also serves as a prime example for how it the movement mobilised widespread public opinion for the Bill, bringing together different sections of the citizenry.
• Public feedback on draft Bills: In several cases, after a Bill has been drafted the concerned ministry or public body publishes the Bill, inviting public comments. The Right to Education Bill, the National Identification Authority Bill and the Draft Direct Taxes Code Bill 2009 are recent cases in point. These announcements are made through advertisements published in newspapers and other media. For instance, the government has recently proposed to amend the rules of the RTI and has invited public feedback on the rules by December 27.
• Engaging with legislators: It is important to expand engagement with lawmakers after the Bill has been introduced in Parliament, as they will determine what the law will finally contain.  This is done by approaching individual legislators or members of the committee which is likely to examine the legislation. Standing Committees invite feedback on the Bill through newspaper advertisements.  For instance, the Standing Committee examining the Civil Nuclear Liability Bill heard testimonies from journalists, civil society groups, thinktanks, public bodies and government departments.

The role of the media and channelising the potential of the internet are other key approaches that need to be explored. Other examples and channels of engagement with the legislative process are illustrated in the PRS Primer on Engaging with Policymakers

One of the most politically contentious issues in recent times has been the government’s right to acquire land for ‘public purpose’.  Increasingly, farmers are refusing to part with their land without adequate compensation, the most recent example being the agitation in Uttar Pradesh over the acquisition of land for the Yamuna Express Highway.

Presently, land acquisition in India is governed by the Land Acquisition Act, an archaic law passed more than a century ago in 1894.  According to the Act, the government has the right to acquire private land without the consent of the land owners if the land is acquired for a “public purpose” project (such as development of towns and village sites, building of schools, hospitals and housing and state run corporations).  The land owners get only the current price value of the land as compensation.  The key provision that has triggered most of the discontent is the one that allows the government to acquire land for private companies if it is for a “public purpose” project.  This has led to conflict over issues of compensation, rehabilitation of displaced people and the type of land that is being acquired.

The UPA government introduced the Land Acquisition (Amendment) Bill in conjunction with the Rehabilitation and Resettlement Bill on December 6, 2007 in the Lok Sabha and referred them to the Standing Committee on Rural Development for scrutiny.  The Committee submitted its report on October 21, 2008 but the Bills lapsed at the end of the 14^th Lok Sabha.  The government is planning to introduce revised versions of the Bills.  The following paragraphs discuss the lapsed Bills to give some idea of the government’s perspective on the issue while analysing the lacunae in the Bills.

The Land Acquisition (Amendment) Bill, 2007 redefined “public purpose” to allow land acquisition only for defence purposes, infrastructure projects, or any project useful to the general public where 70% of the land had already been purchased from willing sellers through the free market.  It prohibited land acquisition for companies unless they had already purchased 70% of the required land.  The Bill also made it mandatory for the government to conduct a social impact assessment if land acquisition resulted in displacement of 400 families in the plains or 200 families in the hills or tribal areas.  The compensation was to be extended to tribals and individuals with tenancy rights under state laws.  The compensation was based on many factors such as market rates, the intended use of the land, and the value of standing crop.  A Land Acquisition Compensation Disputes Settlement Authority was to be established to adjudicate disputes.

The Rehabilitation and Resettlement Bill, 2007 sought to provide for benefits and compensation to people displaced by land acquisition or any other involuntary displacements.  The Bill created project-specific authorities to formulate, implement and monitor the rehabilitation process.  It also outlined minimum benefits for displaced families such as land, house, monetary compensation, skill training and preference for jobs.  A grievance redressal system was also provided for.

Although the Bills were a step in the right direction, many issues still remained unresolved.  Since the Land Acquisition Bill barred the civil courts from entertaining any disputes related to land acquisition, it was unclear whether there was a mechanism by which a person could challenge the qualification of a project as “public purpose”.  Unlike the Special Economic Zone Act, 2005, the Bill did not specify the type of land that could be acquired (such as waste and barren lands).  The Bill made special provision for land taken in the case of ‘urgency’.  However, it did not define the term urgency, which could lead to confusion and misuse of the term.

The biggest loop-hole in the Rehabilitation and Resettlement Bill was the use of non-binding language.  Take for example Clause 25, which stated that “The Government may, by notification, declare any area…as a resettlement area.” Furthermore, Clause 36(1) stated that land for land “shall be allotted…if Government land is available.”  The government could effectively get away with not providing many of the benefits listed in the Bill.  Also, most of the safeguards and benefits were limited to families affected by large-scale displacements (400 or more families in the plains and 200 or more families in the hills and tribal areas).  The benefits for affected families in case of smaller scale displacements were not clearly spelt out.  Lastly, the Bill stated that compensation to displaced families should be borne by the requiring body (body which needs the land for its projects).  Who would bear the expenditure of rehabilitation in case of natural disasters remained ambiguous.

If India is to attain economic prosperity, the government needs to strike a balance between the need for development and protecting the rights of people whose land is being acquired.

Kaushiki Sanyal

The article was published in Sahara Time (Issue dated September 4, 2010, page 36)

Because of the interest in the Women’s Reservation Bill and the Civil Liability for Nuclear Damage Bill, we’ve received a number of queries about the process by which a bill becomes an Act.

We have a more comprehensive primer on the subject, but here’s the process in brief:

• The ministry drafts a text of the proposed law, which is called a ‘Bill’, after calling comments from other ministries, and even from the public.  The draft is revised to incorporate such inputs and is then vetted by the Law Ministry. It is then presented to the Cabinet for approval.

• After the Cabinet approves the Bill, it is introduced in Parliament. In Parliament, it goes through three Readings in both Houses.

• During the First Reading the Bill is introduced. The introduction of a Bill may be opposed and the matter may be put to a vote in the House.

• After a Bill has been introduced, the Bill may be referred to the concerned Departmentally Related Standing Committee for examination.

• The Standing Committee considers the broad objectives and the specific clauses of the Bill referred to it and may invite public comments on a Bill. It then submits its recommendations in the form of a report to Parliament.

• In the Second Reading (Consideration), the Bill is scrutinized thoroughly. Each clause of the Bill is discussed and may be accepted, amended or rejected. The government, or any MP, may introduce amendments to the Bill.  However, the government is not bound to accept the Committee’s recommendations.

• During the Third Reading (Passing), the House votes on the redrafted Bill.

• If the Bill is passed in one House, it is then sent to the other House, where it goes through the second and third readings.

• After both Houses of Parliament pass a Bill, it is presented to the President for assent.   He/She has the right to seek information and clarification about the Bill, and may return it to Parliament for reconsideration. (If both Houses pass the Bill again, the President has to assent)

• After the President gives assent, the Bill is notified as an Act.