Recently, there have been reports of price crashes and distress sales in case of farm produce, such as tomatoesmangoes, and garlic.  In some cases, farmers have dumped their produce on roads.  Produce such as fruits and vegetables are perishable and therefore have a short shelf life.  Further, due to inadequate storage facilities and poor food processing infrastructure farmers have limited options but to sell the produce at prevailing market prices.  This can lead to distress sales or roadside discards (in some cases to avoid additional cost of transportation).

Food processing allows raw food to be stored, marketed, or preserved for consumption later.  For instance, raw agricultural produce such as fruits may be processed into juices, jams, and pickles.  Activities such as waxing (for preservation), packaging, labelling, or ripening of produce also form part of the food processing industry.

Between 2001-02 and 2016-17, production of food grains grew annually at 1.7% on average.  Production of horticulture crops surpassed food grains with an average growth rate of 4.8%.  While production has been increasing over the years, surplus produce tends to go waste at various stages such as procurement, storage, and processing due to lack of infrastructure such as cold storages and food processing units.

Source: Horticulture Statistics at a Glance 2017, Union Budget 2018-19; PRS.

Source: Horticulture Statistics at a Glance 2017, Union Budget 2018-19; PRS.

Losses high among perishables such as fruits and vegetables

Crop losses ranged between 7-16% among fruits and around 5% among cereals in 2015.  The highest losses were witnessed in case of guava, followed by mango, which are perishable fruits.  Perishables such as fruits and vegetables are more prone to losses as compared to cereals.  Such crop losses can occur during operations such as harvesting, thrashing, grading, drying, packaging, transportation, and storage depending upon the commodity.

It was estimated that the annual value of harvest and post-harvest losses of major agricultural products at the national level was Rs 92,651 crore in 2015.  The Standing Committee on Agriculture (2017) stated that such wastage can be reduced with adequate food processing facilities.

Sources: Annual Report 2016-17, Ministry of Food Processing Industries; PRS.

Sources: Annual Report 2016-17, Ministry of Food Processing Industries; PRS.

Inadequate food processing infrastructure

As previously discussed, perishables such as fruits and vegetables are more prone to damages as compared to cereals.  Due to inadequate processing facilities in close proximity, farmers may be unable to hold their produce for a long time.  Hence, they may be forced to sell their produce soon after harvest, irrespective of the prevailing market situations.  Expert committees have recommended that agri-logistics such as cold chain infrastructure and market linkages should be strengthened.

Cold chain infrastructure: Cold chain infrastructure includes processing units, cold storages, and refrigerated vans.  As of 2014, out of a required cold storage capacity of 35 million metric tonnes (MT), almost 90% (31.8 million MT) of the capacity was available (see Table 1).  However, cold storage needs to be coupled with logistical support to facilitate smooth transfer of harvested value from farms to distant locations.  This includes: (i) pack-houses for packaging and preparing fresh produce for long distance transport, (ii) refrigerated transport such as reefer vehicles, and (iii) ripening chambers to ripen raw produce before marketing.  For instance, bananas which are harvested raw may be ripened in these chambers before being marketed.

While there are sufficient cold storages, there are wide gaps in the availability of other associated infrastructure.  This implies that even though almost 90% (32 million tonnes) of cold storage capacity is available, only 15% of the required refrigerated transport exists.  Further, the shortfall in the availability of infrastructure necessary for safe handling of farm produce, like pack-houses and ripening chambers, is over 90%.

Table 1:  Gaps in cold chain infrastructure (2014)

Facility Required Available Gap % gap
Cold storage
(in million MT)

35.1

31.8 3.2

9.3%

Pack-houses

70,080

249 69,831

99.6%

Reefer vehicles

61,826

9,000 52,826

85.4%

Ripening chambers

9,131

812 8,319

91.1%

Source: Standing Committee on Agriculture 2018; PRS.

To minimise post-harvest losses, the Standing Committee (2017) recommended that a country-wide integrated cold chain infrastructure network at block and district levels should be created.  It further recommended that a Cold Chain Coordination and Monitoring Committee should be constituted at the district-level.  The Standing Committee also recommended that farmers need to be trained in value addition activities such as sorting, grading, and pre-cooling harvested produce through facilities such as freezers and ripening chambers.

Between 2008 and 2017, 238 cold chain projects were sanctioned under the Scheme for Integrated Cold Chain and Value Addition Infrastructure.  Grants worth Rs 1,775 crore were approved for these projects.  Of this amount, Rs 964 crore (54%) has been released as of January 2018.  Consequently, out of the total projects sanctioned, 114 (48%) are completed.  The remaining 124 projects are currently under implementation.

Transport Facilities:  Currently, majority of food grains and certain quantities of tea, potato, and onion are transported through railways.  The Committee on Doubling Farmers Income had recommended that railways needs to upgrade its logistics to facilitate the transport of fresh produce directly to export hubs.  This includes creation of adjoining facilities for loading and unloading, and distribution to road transport.

Mega Food Parks: The Mega Food Parks scheme was launched in 2008.  It seeks to facilitate setting up of food processing units.  These units are to be located at a central processing centre with infrastructure required for processing, packaging, quality control labs, and trade facilitation centres.

As of March 2018, out of the 42 projects approved, 10 were operational.  The Standing Committee on Agriculture noted certain reasons for delay in implementation of projects under the scheme.  These include: (i) difficulty in getting loans from banks for the project, (ii) delay in obtaining clearances from the state governments and agencies for roads, power, and water at the project site, (iii) lack of special incentives for setting up food processing units in Mega Food Parks, and (iv) unwillingness of the co-promoters in contributing their share of equity.

Further, the Standing Committee stated that as the scheme requires a minimum area of 50 acres, it does not to promote smaller or individual food processing and preservation units.  It recommended that smaller agro-processing clusters near production areas must be promoted.  The Committee on Doubling Farmers Income recommended establishment of processing and value addition units at strategic places.  This includes rural or production areas for pulses, millets, fruits, vegetables, dairy, fisheries, and poultry in public private-partnership mode.

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.