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.

The Finance Minister, Ms. Nirmala Sitharaman, presented the Union Budget for the financial year 2019-20 in Parliament on July 5, 2019.  In the 2019-20 budget, the government presented the estimates of its expenditure and receipts for the year 2019-20.  The budget also gave an account of how much money the government raised or spent in 2017-18.  In addition, the budget also presented the revised estimates made by the government for the year 2018-19 in comparison to the estimates it had given to Parliament in the previous year’s budget.

What are revised estimates?

Some of the estimates made by the government might change during the course of the year.  For instance, once the year gets underway, some ministries may need more funds than what was actually allocated to them in the budget, or the receipts expected from certain sources might change.  Such deviations from the budget estimates get reflected in the figures released by the government at later stages as part of the subsequent budgets.  Once the year ends, the actual numbers are audited by the Comptroller and Auditor General of India (CAG), post which they are presented to Parliament with the upcoming budget, i.e. two years after the estimates are made.

For instance, estimates for the year 2018-19 were presented as part of the 2018-19 budget in February 2018.  In the 2019-20 interim budget presented in February 2019 (10 months after the financial year 2018-19 got underway), the government revised these estimates based on the actual receipts and expenditure accounted so far during the year and incorporated estimates for the remaining two months.

The actual receipts and expenditure accounts of the central government are maintained by the Controller General of Accounts (CGA), Ministry of Finance on a monthly basis.  In addition to the monthly accounts, the CGA also publishes the provisional unaudited figures for the financial year by the end of the month of May.  Once these provisional figures are audited by the CAG, they are presented as actuals in next year’s budget.  The CGA reported the figures for 2018-19 on May 31, 2019.[1]  The Economic Survey 2018-19 presented on July 4, 2019 uses these figures.[2] 

The budget presented on July 5 replicates the revised estimates reported as part of the interim budget (February 1, 2019).  Thus, it did not take into account the updated figures for the year 2018-19 from the CGA.

Table 1 gives a comparison of the 2018-19 revised estimates presented by the central government in the budget with the provisional unaudited figures maintained by the CGA for the year 2018-19.[3]

Table 1:  Budget at a Glance: Comparison of 2018-19 revised estimates with CGA figures (unaudited) (Rs crore)

 

Actuals
2017-18

Budgeted
2018-19

Revised
2018-19

Provisional
2018-19

Difference
(RE 2018-19 to Provisional 2018-19)

Revenue Expenditure

18,78,833

 21,41,772

 21,40,612

20,08,463

-1,32,149

Capital Expenditure

2,63,140

 3,00,441

 3,16,623

3,02,959

-13,664

Total Expenditure

21,41,973

 24,42,213

 24,57,235

23,11,422

 -1,45,813

Revenue Receipts

14,35,233

 17,25,738

 17,29,682

15,63,170

-1,66,512

Capital Receipts

 1,15,678

 92,199

 93,155

1,02,885

9,730

of which:

 

 

 

 

 

Recoveries of Loans

 15,633

 12,199

 13,155

17,840

4,685

Other receipts (including disinvestments)

 1,00,045

 80,000

 80,000

85,045

5,045

Total Receipts (without borrowings)

15,50,911

 18,17,937

 18,22,837

16,66,055

-1,56,782

Revenue Deficit

 4,43,600

 4,16,034

 4,10,930

4,45,293

34,363

% of GDP

2.6

2.2

2.2

2.4

 

Fiscal Deficit

 5,91,062

 6,24,276

 6,34,398

6,45,367

10,969

% of GDP

3.5

3.3

3.4

3.4

 

Primary Deficit

 62,110

 48,481

 46,828

62,692

15,864

% of GDP

0.4

0.3

0.2

0.3

 

Sources:  Budget at a Glance, Union Budget 2019-20; Controller General of Accounts, Ministry of Finance; PRS.

The 2018-19 provisional figures for revenue receipts is Rs 15,63,170 crore, which is Rs 1,66,512 crore less than the revised estimates.  This is largely due to Rs 1,67,455 crore shortfall in centre’s net tax revenue between the revised estimates and the provisional estimates (Table 2).

Major taxes which see a shortfall between the gross tax revenue presented in the revised estimates vis-à-vis the provisional figures are income tax (Rs 67,346 crore) and GST (Rs 59,930 crore).  Non-tax revenue and disinvestment receipts as per the provisional figures are higher than the revised estimates.

Table 2:  Break up of central government receipts: Comparison of 2018-19 RE with CGA figures (unaudited) (Rs crore)

 

Actuals
2017-18

Budgeted
2018-19

Revised
2018-19

Provisional
2018-19

Difference
(RE 2018-19 to Provisional 2018-19)

Gross Tax Revenue

19,19,009

22,71,242

22,48,175

20,80,203

-1,67,972

of which:

 

 

 

 

 

Corporation Tax

5,71,202

6,21,000

6,71,000

6,63,572

-7,428

Taxes on Income

4,30,772

5,29,000

5,29,000

4,61,654

-67,346

Goods and Services Tax

4,42,562

7,43,900

6,43,900

5,83,970

-59,930

Customs

1,29,030

1,12,500

1,30,038

1,17,930

-12,108

Union Excise Duties

2,59,431

2,59,600

2,59,612

2,30,998

-28,614

A. Centre's Net Tax Revenue

12,42,488

14,80,649

14,84,406

13,16,951

-1,67,455

B. Non Tax Revenue

1,92,745

2,45,089

2,45,276

2,46,219

943

of which:

 

 

 

 

 

Interest Receipts

13,574

15,162

12,047

12,815

768

Dividend and Profits

91,361

1,07,312

1,19,264

1,13,424

-5,840

Other Non-Tax Revenue

87,810

1,22,615

1,13,965

1,19,980

6,015

C. Capital Receipts (without borrowings)

1,15,678

92,199

93,155

1,02,885

9,730

of which:

 

 

 

 

 

Disinvestment

1,00,045

80,000

80,000

85,045

5,045

Receipts (without borrowings) (A+B+C)

15,50,911

18,17,937

18,22,837

16,66,055

-1,56,782

Borrowings

5,91,062

6,24,276

6,34,398

6,45,367

10,969

Total Receipts (including borrowings)

21,41,973

24,42,213

24,57,235

23,11,422

-1,45,813

Note:  Centre’s net tax revenue is gross tax revenue less share of states in central taxes.  Figures for GST include receipts from the GST compensation cess.  Note that GST was levied for a nine-month period during the year 2017-18, starting July 2017.

Sources:  Receipts Budget, Union Budget 2019-20; Controller General of Accounts, Ministry of Finance; PRS.

While the provisional figures show a considerable decrease in receipts (Rs 1,56,782 crore) as compared to the revised estimates, fiscal deficit has not shown a comparable increase.  Fiscal deficit is estimated to be Rs 10,969 crore higher than the revised estimates as per the provisional accounts.

On the expenditure side, the total expenditure as per the provisional figures show a decrease of Rs 1,45,813 crore as compared to the revised estimates.  Certain Ministries and expenditure items have seen a decrease in expenditure as compared to the revised estimates made by the government.  As per the provisional accounts, the expenditure of the Ministry of Agriculture and Farmers’ Welfare and the Ministry of Consumer Affairs, Food and Public Distribution are Rs 22,133 crore and Rs 70,712 crore lower than the revised estimates, respectively.  The decrease in the Ministries’ expenditure as a percentage of the revised estimates are 29% and 39%, respectively.  The food subsidy according to CGA was Rs 1,01,904 crore, which was Rs 69,394 crore lower than the revised estimates for the year 2018-19 given in the budget documents.

 

[1] “Accounts of the Union Government of India (Provisional/Unaudited) for the Financial Year 2018-19”, Press Information Bureau, Ministry of Finance, May 31, 2019.

[2] Fiscal Developments, Economic Survey 2018-19, https://www.indiabudget.gov.in/economicsurvey/doc/vol2chapter/echap02_vol2.pdf.

[3] Controller General of Accounts, Ministry of Finance, March 2018-19, http://www.cga.nic.in/MonthlyReport/Published/3/2018-2019.aspx.