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.

Early this week, the Comptroller and Auditor General (CAG) of India tabled a report on the finances of Uttar Pradesh for the financial year 2020-21.  A few days prior to that, on May 26, the budget for Uttar Pradesh for 2022-23 was presented, along with which the final audited expenditure and receipt figures for the year 2020-21 were released.  The year 2020-21 presented a two-fold challenge for states – loss in revenue due to impact of COVID-19 pandemic and lockdown, and the need for increased expenditure to support affected persons and economic recovery.  CAG noted that Uttar Pradesh’s GSDP grew by 1.05% in 2020-21 as compared to a growth of 6.5% in 2019-20.  The state reported a revenue deficit of Rs 2,367 crore in 2020-21 after reporting revenue surplus for 14 successive years since 2006-07.  Revenue deficit is the excess of revenue expenditure over revenue receipts.  This blog looks at the key trends in the finances of Uttar Pradesh in 2020-21 and certain observations by CAG on fiscal management by the state.

Spending and Deficits in 2020-21

Underspending:  In 2020-21, total spending by the state was 26% less than the budget estimate presented in February 2020.  In sectors such as water supply and sanitation, the actual expenditure was 60% less than the amount budgeted, while in agriculture and allied activities only 53% of the budgeted amount was spent.  CAG observed that in 251 schemes across 57 departments, the state government did not incur any expenditure in 2020-21.  These schemes had a budget provision of at least one crore rupees, and had cumulative allocation of Rs 50,617 crore.  These included schemes such as Pipe Drinking Water Scheme in Bundelkhand/Vindhya and apportionment of pension liabilities.  Moreover, the overall savings due to non-utilisation of funds in 2020-21 was 27.28% of total budget provisions.  CAG observed that the budgetary provisions increased between 2016 and 2021.  However, the utilisation of budget provisions reduced between 2018-19 and 2020-21.

Pattern of spending: CAG observed that in case of 12 departments, more than 50% of the expenditure was incurred in March 2021, the last month of the financial year.  In the civil aviation department, 89% of the total expenditure was incurred in March while this figure was 62% for the social welfare department (welfare of handicapped and backward classes).  CAG noted that maintaining a steady pace of expenditure is a sound practice under public financial management.  However, the Uttar Pradesh Budget Manual has no specific instructions for preventing such bunching of expenditure.  The CAG recommended that the state government can consider issuing guidelines to control the rush of expenditure towards the closing months of the financial year.

Management of deficit and debt: As a measure to mitigate the impact of COVID-19, an Ordinance was promulgated in June 2020 to raise the fiscal deficit limit from 3% of GSDP to 5% of GSDP for the year 2020-21.   Fiscal deficit represents the gap between expenditure and receipts in a year, and this gap is filled with borrowings.   The Uttar Pradesh Fiscal Responsibility and Budget Management Act, 2004 (FRBM Act) passed by Uttar Pradesh Assembly specifies the upper limit for debt and deficits.  The Ordinance thus permitted the state government to borrow more to sustain its budget expenditure.  The fiscal deficit of the state in 2020-21 was 3.20% of GSDP, well below the revised limit. At the same time, the state’s outstanding debt to GSDP in 2020-21 was 32.77% of GSDP, above the target of 32% of GSDP set under the FRBM Act.  Outstanding debt represents accumulation of debt over the years.  

Table 1: Spending by Uttar Pradesh in 2020-21 as compared to Budget Estimates (in Rs crore)

Particular

2020-21 BE

2020-21 Actuals

% change from BE to Actuals

Net Receipts (1+2)

4,24,767

2,97,311

-30%

1. Revenue Receipts (a+b+c+d)

4,22,567

2,96,176

-30%

a. Own Tax Revenue

1,58,413

1,19,897

-24%

b. Own Non-Tax Revenue

31,179

11,846

-62%

c. Share in central taxes

1,52,863

1,06,687

-30%

d. Grants-in-aid from the Centre

80,112

57,746

-28%

Of which GST compensation grants

7,608

9,381

23%

2. Non-Debt Capital Receipts

2,200

1,135

-48%

3. Borrowings

75,791

86,859

15%

Of which GST compensation loan

-

6,007

-

Net Expenditure (4+5+6)

4,77,963

3,51,933

-26%

4. Revenue Expenditure

3,95,117

2,98,543

-24%

5. Capital Outlay

81,209

52,237

-36%

6. Loans and Advances

1,637

1,153

-30%

7. Debt Repayment

34,897

26,777

-23%

Revenue Balance

27,451

-2,367

-109%

Revenue Balance (as % of GSDP)

1.53%

-0.14%

 

Fiscal Deficit

53,195

54,622

3%

Fiscal Deficit (as % of GSDP)

2.97%

3.20%

 

Note: A negative revenue balance indicates a deficit.  The actual fiscal deficit reported by Uttar Pradesh for 2020-21 in 2022-23 budget was 2.8% of GSDP.  This difference was due to higher GSDP figure reported by the state.  
Sources: Uttar Pradesh Budget Documents of various years; CAG; PRS.

Finances of State Public Sector Undertakings

Public sector undertakings (PSUs) are set up by the government to discharge commercial activities in various sectors.  As on March 31, 2021, there were 115 PSUs in Uttar Pradesh.  CAG analysed the performance of 38 PSUs.   Out of these 38 PSUs, 22 companies earned a profit of Rs 700 crore, while 16 companies posted a loss of Rs 7,411 crore in 2020-21.  Note that both the number of PSUs incurring losses and the quantum of losses has decreased since 2018-19.  In 2018-19, 20 PSUs had reported losses worth Rs 15,219 crore.  

Figure 1: Cumulative losses incurred by Uttar Pradesh PSUs (Rs crore)
 
 image
 Sources: CAG; PRS.

Losses of power sector PSUs: Three power sector PSUs—Uttar Pradesh Power Corporation Limited, Purvanchal Vidyut Vitran Nigam Limited, and Paschimanchal Vidyut Vitran Nigam Limited—were the top loss incurring PSUs.  These three PSUs accounted for 73% of the total losses of Rs 7,411 crore mentioned above.   Note that as of June 2022, for each unit of power supplied, the revenue realised by UP power distribution companies (discoms) is 27 paise less than cost of supply.  This is better than the gap of 34 paise per unit at the national level.   However, the aggregate technical and commercial losses (AT&C) of the Uttar Pradesh discoms was 27.85%, considerably higher than the national average of 17.19%.  AT&C losses refer to the proportion of power supplied by a discom for which it does not receive any payment.

Off-budget borrowings: CAG also observed that the Uttar Pradesh government resorted to off-budget borrowing through state owned PSUs/authorities.  Off budget borrowings are not accounted in the debt of the state government and are on books of the respective PSUs/authorities, although, debt is serviced by the state government.  As a result, the outstanding debt reported in the budget does not represent the actual debt position of the state.  CAG identified off-budget borrowing worth Rs 1,637 crore.  The CAG recommended that the state government should avoid extra-budget borrowings.  It should also credit all the loans taken by PSUs/authorities on behalf of and serviced by the state government to state government accounts.

Management of Reserve Funds

The Reserve Bank of India manages two reserve funds on the behalf of state governments.   These funds are created to meet the liabilities of state governments.  These funds are: (i) Consolidated Sinking Fund (CSF), and (ii) Guarantee Redemption Fund (GRF).  They are funded by the contributions made by the state governments.  CSF is an amortisation fund which is utilised to meet the repayment obligations of the government.  Amortisation refers to payment of debt through regular instalments.  The interest accumulated in the fund is used for repayment of outstanding liabilities (which is the accumulation of total borrowings at the end of a financial year, including any liabilities on the public account).  

In line with the recommendation of the 12th Finance Commission, Uttar Pradesh created its CSF in March 2020.  The state government may transfer at least 0.5% of its outstanding liabilities at the end of the previous year to the CSF.  CAG observed that in 2020-21, Uttar Pradesh appropriated only Rs 1,000 crore to the CSF against the requirement of Rs 2,454 crore.  CAG recommended that the state government should ensure at least 0.5% of the outstanding liabilities are contributed towards the CSF every year.

GRF is constituted by states to meet obligations related to guarantees.  The state government may extend guarantee on loans taken by its PSUs.  Guarantees are contingent liabilities of the state government, as in case of default by the company, repayment burden will fall on the state government.  GRF can be used to settle guarantees extended by the government with respect to borrowings of state PSUs and other bodies.  The 12th Finance Commission had recommended that states should constitute GRF.  It was to be funded through guarantees fees to meet any sudden discharge of obligated guarantees extended by the states.  CAG noted that Uttar Pradesh government has not constituted GRF.  Moreover, the state has also not fixed any limits for extending guarantees.  

For an analysis of Uttar Pradesh’s 2022-23 budget, please see here.