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EU bans imports of Alphonso mangoes: Is India’s biosecurity mechanism rigorous enough?

April 29th, 2014 2 comments

Recent news reports indicate that the European Union (EU) has banned imports of Alphonso mangoes and four vegetables from India due to the presence of harmful pests and a lack of certification before export.  The ban will be effective between May 1, 2014 and December 2015.  It has been suggested that the ban could impact the export of nearly 16 million mangoes from India, the market for which is worth nearly £6 million a year in a country like the United Kingdom. In this context, it may be useful to examine the regulation of agricultural biosecurity in India, particularly with respect to imports and exports of such agricultural produce.

Currently, two laws, the Destructive Insects and Pests Act, 1914 and the Livestock Importation Act, 1898, regulate the import and export of plants and animals with a view to control pests and diseases.  Under the laws, the authorities ensure that infectious diseases and pests do not cause widespread damage to the environment, crops, agricultural produce and human beings, i.e. the agricultural biosecurity of a country.  Common examples of pests and diseases have been the Banana bunchy top virus which stunts banana plants and stops production of fruit while another is the Avian Influenza, which caused extensive death of poultry and led to human deaths as well.

Under the existing Acts, different government departments and government-approved bodies are responsible for regulating imports and certifying exports to ensure that there are no threats to agricultural biosecurity.  The Department of Agriculture keeps a check on pests and diseases arising from plants and related produce, such as mangoes and vegetables, while the Department of Animal Husbandry monitors diseases relating to animals and meat products.  The Agricultural and Processed Food Products Export Development Authority (APEDA) certifies exports of different commodities related to plants and animals.  Various government committees have highlighted the ineffectiveness of the existing system due to its piecemeal approach and have recommended an integrated system to handle biosecurity issues.  It has also been suggested that the existing laws have not kept up with developments in agriculture and are inadequate to deal with the emergence of trans-boundary diseases that pose threats to human, animal and plant safety.

The Agricultural Biosecurity Bill, 2013, pending in Parliament seeks to replace these laws and establish a national authority, the Agricultural Biosecurity Authority of India (ABAI), to regulate biosecurity issues related to plants and animals.  ABAI shall be responsible for: (i) regulating the import and export of plants, animals and related products, (ii) implementing quarantine measures in case of the existence of pests, (iii) regulating the inter-state spread of pests and diseases relating to plants and animals, and (iv) undertaking regular surveillance of pests and diseases.  Under the Bill, exports of plants, animals and related products will only be allowed once ABAI has issued a sanitary or phytosanitary certificate in accordance with the destination country’s requirements. The penalty for exporting goods without adequate certification from ABAI is imprisonment upto two years and and a fine of Rs 2 lakh. The proposed ABAI will also meet India’s obligations to promote research and prevent pests and diseases under the International Plant Protection Convention and the Office International des Epizooties. A PRS analysis of various aspects of the Bill can be found here.

The Bill will lapse with the dissolution of the 15th Lok Sabha.  It remains to be seen how the incoming government in the 16th Lok Sabha will approach biosecurity issues to prevent incidents like the EU ban on imports of Indian fruits and vegetables in the future.

More food for thought – the Food Security Bill

May 9th, 2013 3 comments

The 15th Lok Sabha is close to the end of its tenure. A key legislation that proposes major reforms in food security was listed for discussion in Parliament. The National Food Security Bill, 2011 has been scrutinised by a Standing Committee. In January, we compared the Standing Committee’s recommendations with the provisions of the Bill. Since then, amendments to the Bill have been introduced in Parliament. Debates on the Bill have revolved around the method of delivering food security, the identification of beneficiaries and the financial implications of the Bill.

Method of delivery

The Bill aims to make the right to food a statutory right. It proposes to use the existing Public Distribution System (PDS) to deliver foodgrain to 75% of the rural and 50% of the urban population. However, the Bill also allows for cash transfers and food coupons in lieu of grains as mechanisms to deliver food security. While the PDS is known to suffer from leakages as high as 40%, cash transfers and food coupons are known to expose recipients to volatility and price inflation. Each method of delivery would have its own implications, financial and otherwise.  The table below compares these methods of delivery.[i]

Advantages and disadvantages of PDS and other delivery mechanisms

MechanismAdvantagesDisadvantages
PDS
Insulates beneficiaries from inflation and price volatilityPoor identification and targeting of beneficiaries
Ensures entitlement is used for foodgrains onlyLow offtake of foodgrain from each household
Well-developed network of FPS ensures access to foodgrain even in remote areasLarge leakages and diversions of subsidised foodgrain
Adulteration of foodgrain
Lack of viability of FPSs due to low margins
Cash transfersCash in the hands of poor expands their choices Vulnerable to targeting errors
Cash may relieve financial constraints faced by the poor, make it possible to form thrift societies and access creditCash can be used to buy non- food items
Administrative costs of cash transfer programmes may be much less than that of centrally sponsored schemesMay expose recipients to price volatility and inflation
Potential for fully electronic transferThere is poor access to banks and post offices in some areas
Food couponsHousehold is given the freedom to choose where it buys food Vulnerable to targeting errors
Increases incentive for competitive prices and assured quality of foodgrain among PDS storesFood coupons are not indexed for inflation; may expose recipients to inflation
PDS stores get full price for foodgrains from the poor; no incentive to turn the poor awayDifficult to administer; known to have delays in issuing food coupons and reimbursing shops

Identification

The Bill does not universalise food entitlements. It classifies the population into two categories of beneficiaries, who shall be identified by the centre and states. Mechanisms that aim to target benefits to certain sections of the population have been prone to large inclusion and exclusion errors. A 2009 expert group study headed by N.C. Saxena that evaluated PDS, estimated that about 61% of the eligible population was excluded from the BPL list while 25% of APL households were included in the BPL list. Beneficiaries under the Food Security Bill will be identified through a similar process. It is unclear how these errors in identification of beneficiaries under the PDS will be addressed by the Bill.

Financial implications – cost sharing between the centre and states

A Bill that aims to deliver food security to a large section of the country would have significant financial implications. Costs shall be shared between the centre and states. Costs imposed on states (partial or full) include: nutritional support to pregnant women and lactating mothers, mid-day meals, anganwadi infrastructure, meals for children suffering from malnutrition, transport and delivery of foodgrains, creating and maintaining storage facilities, and costs associated with District Grievance Redressal Officers and State Food Commissions.  Although the centre shall provide some assistance, states will have to bear a significant financial burden on account of implementation.

It is unclear whether Parliament can require states to allocate funds without encroaching on the powers of state legislative assemblies. If a state chooses not to allocate the necessary funds or does not possess the funds to do so, implementation of the Bill could be seriously affected. The Standing Committee examining the Bill had recommended that an independent body, such as the Finance Commission, should be consulted regarding additional funds to be borne by states. The Right to Education Act with similar centre-state sharing of funds provides for such a consultation with the Finance Commission.

Cost of implementation of the Bill

Another contentious issue is the cost of implementing the Bill. The Bill estimates the cost at Rs 95,000 crore. However, experts have made varying estimates on the costs ranging from Rs 2 lakh crore to Rs 3.5 lakh crore. Ashok Gulati, Chairman of the Commission for Agricultural Costs and Prices, estimated the cost at 2 lakh crore per year whereas the Minister of Food, K.V. Thomas was reported to have estimated the cost at Rs 3.5 lakh crore.

The passage of the food security Bill in Parliament will depend on the ability of the government to build consensus on these issues. It remains to be seen how the Bill is debated next Parliament session.

 


[i] Kapur D., Mukhopadhyay P., and A.  Subramanian.  “The Case for Direct Cash Transfers to the Poor.” Economic and Political Weekly. Vol 43, No 15 (Apr 12-18, 2008). Khera, R. “Revival of the Public Distribution System: Evidence and Explanations.” Economic and Political Weekly. Vol XLVI, Nos 44 & 45 (Nov 5, 2011). Shah, M. “Direct Cash Transfers: No Magic Bullet.” Economic and Political Weekly. Vol 43, No 34, pp. 77-79 (Aug 23-29, 2008).

Reviewing regulations in the sugar sector

February 6th, 2013 2 comments

There have been some recent developments in the sugar sector, which pertain to the pricing of sugarcane and deregulation of the sector.  On January 31, the Cabinet approved the fair and remunerative price (FRP) of sugarcane for the 2013-14 season at Rs 210 per quintal, a 23.5% increase from last year’s FRP of Rs 170 per quintal.  The FRP of sugarcane is the minimum price set by the centre and is payable by mills to sugarcane farmers throughout the country.  However, states can also set a State Advised Price (SAP) that mills would have to pay farmers instead of the FRP.

In addition, a recent news report mentioned that the food ministry has decided to seek Cabinet approval to lift controls on sugar, particularly relating to levy sugar and the regulated release of non-levy sugar.

The Rangarajan Committee report, published in October 2012, highlighted challenges in the pricing policy for sugarcane.  The Committee recommended deregulating the sugar sector with respect to pricing and levy sugar.

In this blog, we discuss the current regulations related to the sugar sector and key recommendations for deregulation suggested by the Rangarajan Committee.

Current regulations in the sugar sector

A major step to liberate the sugar sector from controls was taken in 1998 when the licensing requirement for new sugar mills was abolished.  Delicensing caused the sugar sector to grow at almost 7% annually during 1998-99 and 2011-12 compared to 3.3% annually during 1990-91 and 1997-98.

Although delicensing removed some regulations in the sector, others still persist.  For instance, every designated mill is obligated to purchase sugarcane from farmers within a specified cane reservation area, and conversely, farmers are bound to sell to the mill.  Also, the central government has prescribed a minimum radial distance of 15 km between any two sugar mills.

However, the Committee found that existing regulations were stunting the growth of the industry and recommended that the sector be deregulated.  It was of the opinion that deregulation would enable the industry to leverage the expanding opportunities created by the rising demand of sugar and sugarcane as a source of renewable energy.

Rangarajan Committee’s recommendations on deregulation of the sugar sector

Price of sugarcane: The central government fixes a minimum price, the FRP that is paid by mills to farmers.  States can also intervene in sugarcane pricing with an SAP to strengthen farmer’s interests.  States such as Uttar Pradesh and Tamil Nadu have set SAPs for the past few years, which have been higher than FRPs.

The Committee recommended that states should not declare an SAP because it imposes an additional cost on mills.  Farmers should be paid a uniform FRP.  It suggested determining cane prices according to scientifically sound and economically fair principles.  The Committee also felt that high SAPs, combined with other controls in the sector, would deter private investment in the sugar industry.

Levy sugar: Every sugar mill mandatorily surrenders 10% of its production to the central government at a price lower than the market price – this is known as levy sugar.  This enables the central government to get access to low cost sugar stocks for distribution through the Public Distribution System (PDS).  At present prices, the centre saves about Rs 3,000 crore on account of this policy, the burden of which is borne by the sugar sector.

The Committee recommended doing away with levy sugar.  States wanting to provide sugar under PDS would have to procure it directly from the market.

Regulated release of non-levy sugar: The central government allows the release of non-levy sugar into the market on a periodic basis.  Currently, release orders are given on a quarterly basis.  Thus, sugar produced over the four-to-six month sugar season is sold throughout the year by distributing the release of stock evenly across the year.  The regulated release of sugar imposes costs directly on mills (and hence indirectly on farmers).  Mills can neither take advantage of high prices to sell the maximum possible stock, nor dispose of their stock to raise cash for meeting various obligations.  This adversely impacts the ability of mills to pay sugarcane farmers in time.

The Committee recommended removing the regulations on release of non-levy sugar to address these problems.

Trade policy: The government has set controls on both export and import of sugar that fluctuate depending on the domestic availability, demand and price of sugarcane.  As a result, India’s trade in the world trade of sugar is small.  Even though India contributes 17% to global sugar production (second largest producer in the world), its share in exports is only 4%.  This has been at the cost of considerable instability for the sugar cane industry and its production.

The committee recommended removing existing restrictions on trade in sugar and converting them into tariffs.

For more details on the committee’s recommendations on deregulating the sugar sector, see here.

Food security: some food for thought

January 23rd, 2013 2 comments

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.

Issue

Food Security Bill

Standing Committee’s Recommendations

Who will get food security?  75% of the rural and 50% of the urban population (to be divided into priority and general categories). Of these, at least 46% of the rural and 28% of urban populations will be priority (the rest will be general). Uniform category: Priority, general and other categories shall be collapsed into ‘included’ and ‘excluded’ categories.Included category shall extend to 75% of the rural and 50% of the urban population.
How will they be identified? The centre shall prescribe guidelines for identifying households; states shall identify the specific households. The centre should clearly define criteria for exclusion and consult with states to create inclusion criteria.
What will they get?  Priority:7 kg foodgrains/person/month (at Rs 3/kg for wheat, Rs 2/kg for rice, Rs 1/kg for coarse grains).General: 3 kg foodgrains/person/ month (at 50% of MSP). Included: 5 kg foodgrains/person/month (at subsidised prices).  Pulses, sugar, etc., should be provided in addition to foodgrains.
Reforms to TPDS Doorstep delivery of foodgrains to ration shops, use of information technology, etc. Implement specific IT reforms, for e.g. CCTV cameras in godowns, use of internet, and GPS tracking of vehicles carrying foodgrains.  Evaluate implementation of TPDS every 5 yrs.
Cost-sharing between centre and states Costs will be shared between centre and states. Mechanism for cost-sharing will be determined by the centre. Finance Commission and states should be consulted regarding additional expenditure to be borne by states to implement the Bill.
Cash Transfers Schemes such as cash transfer and food coupons shall be introduced in lieu of foodgrains. Cash transfers should not be introduced at this time. Adequate banking infrastructure needs to be set up before introduction.
Time limit for implementation The Act shall come into force on a date specified by the centre. States to be provided reasonable time limit i.e., 1 year, after which Act will come into force.

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

Ministry of Consumer Affairs launches National Transparency Portal on PDS

November 2nd, 2012 2 comments

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.

Are genetically modified crops safe enough?

October 15th, 2012 5 comments

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

  1. Initially, the company developing the GM crop undertakes several biosafety assessments including, environmental, food, and feed safety assessments in containment.
  2. This is followed by Bio-safety Research Trials which require prior approval of the regulators, the GEAC and the RCGM.
  3. Approval for environmental release is accorded by the GEAC after considering the findings of bio-safety studies.
  4. 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.

Supreme Court stays Calcutta High Court judgement on Singur Act

September 17th, 2012 1 comment

According to news reports, the Supreme Court stayed a Calcutta High Court judgement on the Singur Land Rehabilitation and Development Act, 2011 [Singur Act] on August 24, 2012. The apex court also issued a notice to Tata Motors seeking its response within four weeks, on the West Bengal government’s petition challenging the High Court order.

In 2008, the Left Front government acquired land in Singur under the Land Acquisition Act, 1894, for Tata Motors to build a Nano car factory.  In its first year of coming to power in West Bengal, the Trinamool Congress (TMC) led government notified the Singur Act through which it sought to reclaim this land to return a portion of it to farmers.

On June 22, 2012, a Division bench of the Calcutta High Court struck down the Singur Act terming it unconstitutional and void.  In its judgment, the Court found some sections of the Singur Act to be in conflict with the central Land Acquisition Act, 1894.  As land acquisition is a Concurrent List subject under the Constitution, both Parliament and state legislatures have the power to make laws on it.  However, if provisions in the state law conflict with provisions in the central law, then the state law cannot prevail unless it receives Presidential assent.  The Calcutta High Court held the Singur Act to be unconstitutional because: (a) it was in conflict with the central Land Acquisition Act, 1894, and (b) Presidential assent was not obtained for the Act to prevail in West Bengal.

The central Act mentions that for the government to acquire land, it has to demonstrate: (1) that land is being acquired for a public purpose,[i] and (2) that the government will provide compensation to persons from whom land is being acquired.  Provisions in the Singur Act that relate to public purpose and compensation were found to be in conflict with the corresponding provisions in the central Act.  The Court was of the opinion that transfer of land to the farmers does not constitute ‘public purpose’ as defined in the central Act.  As argued by the Tata Motors’ counsel, return of land to unwilling owners is a ‘private purpose’ or in ‘particular interest of individuals’ rather than in the ‘general interest of the community’.  Second, clauses pertaining to compensation to Tata Motors for their investment in the Nano project were found to be vague.  The Singur Act only provides for the refund of the amount paid by Tata Motors and the vendors to the state government for leasing the land.  It does not provide for the payment of any other amount of money for acquiring the Tata Motors’ land nor the principles for the determination of such an amount.  The High Court ordered that these provisions tantamount to ‘no compensation’ and struck down the related provisions.

The matter will come up for consideration in the Supreme Court next on October 15, 2012.


[i] According to Section 3 of the Land Acquisition Act, 1894, acquisition of land for ‘public purpose’ includes, among others: provision or planned development of village sites; provision of land for town or rural planning; the provision of land for planned development of land from public funds in pursuance of a scheme or policy of the Government; and the provision of land for a corporation owned or controlled by the State.

 

Alternate proposal to the National Food Security Bill

July 31st, 2012 1 comment

According to news reports, the Prime Minister recently chaired a meeting with ministers to discuss an alternative plan (“Plan B”) for the National Food Security Bill, 2011 (hereinafter “Bill”).  The Bill is currently pending with the Standing Committee of Food, Consumer Affairs and Public Distribution.  It seeks to deliver food and nutritional security by providing specific entitlements to certain groups.  The alternative proposal aims to give greater flexibility to states and may bind the centre to a higher food subsidy burden than estimates provided in the Bill.  It suggests changes to the classification of beneficiaries and the percentage of the national population to be covered by the Bill, among others.

Classification of beneficiaries

The Bill classifies the population into three groups: priority, general and excluded.  Individuals in the priority and general groups would receive 7 kg and 3 kg of foodgrain per person per month respectively at subsidized prices.

Plan B suggests doing away with the priority-general distinction.  It classifies the population on the basis of 2 categories: included and excluded.  Those entitled to benefits under the included category will receive a uniform entitlement of 5 kg per person per month.

Coverage of population

Experts have suggested that the Bill will extend entitlements to roughly 64% of the total population.  Under the Bill, the central government is responsible for determining the percentage of people in each state who will be entitled to benefits under priority and general groups.

Plan B suggests extending benefits to 67% of the total population (33% excluded), up from 64% in the Bill.  The Ministry has outlined two options to figure out the number of people in each state that should be included within this 67%.  The first option envisages a uniform exclusion of 33% in each state irrespective of their poverty level.  The second option envisages exclusion of 33% of the national population, which would imply a different proportion excluded in each state depending on their level of prosperity.

The Ministry has worked out a criterion to determine the proportion of the population to be included in each state.  The criterion is pegged to a monthly per capita expenditure of Rs 1,215 in rural areas and Rs 1,502 in urban areas based on the 2009-10 NSSO survey. Thus, persons spending less than Rs 40 in rural areas and Rs 50 in urban areas per day will be entitled to foodgrains under the alternative being considered now.

Financial estimates

Newspaper reports have indicated that the revised proposal will add Rs 7,000 to Rs 10,000 crore per year to the current food subsidy estimate of Rs 1.1 lakh crore.  According to some experts, the total cost of the Bill could range anywhere between Rs 2 lakh crore to Rs 3.5 lakh crore (see here and here).

Lapses in the process of drug approval in India

May 29th, 2012 1 comment

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.