Tag Archives: Marketing

Ensuring affordability, accessibility and safety of medicines through urgent action

Health Action

Health Action

Health Action (HA) has published articles relating to essential medicines, generic medicines, drug price control and other drug related issues in its September 2009 issue. Some of the relevant articles have been uploaded here (with permission from HA).

Dubious Rather Than Spurious Drugs – India’s Real Drug Problem
Dr Anurag Bhargava M D

Access to medicines implies access to medicines of proven efficacy, safety and acceptable quality, prescribed in a rational manner. Governments have a responsibility of ensuring availability and affordability of such medicines. Yet the situation in India with all these issues related to medicines is marked by paradoxes. In spite of having one of the largest pharmaceutical industries supplying low-cost essential medicines globally, India has the largest number of people in the world without access to essential medicines, …………

People’s Initiative for Generic Medicines
Dr. Anant Phadke

In India, medicines are unnecessarily exorbitantly costly. Prices of medicines can be brought down to one half, even to one-fourth immediately, if the government takes appropriate measures to stop reckless profiteering and waste that are prevalent in the manufacture and sale of medicines. Since the early eighties, the All India Drug Action Network (AIDAN) has been advocating these measures, but in vain. While it may take many more years to change the govt…….

Essential Medicines: Economic constraints in access in India
Dr. Purnabrata Gun & Sushanta Roy

Essential medicines are among the most costeffective elements in modern health care and their potential health impact is remarkable. This year alone, there will be over 40 million deaths in developing countries, one-third among children under age five. Ten million deaths will be due to acute respiratory infections, diarrheal diseases, tuberculosis, and malaria. Safe, inexpensive, essential drugs can be life-saving in all these disease conditions……..

Good to be True, but True! Retail Sale of Generic Drugs at Low Prices by the Government in Chittorgarh Dt
S.Srinivasan

We all know that one of the solutions for making medicines affordable to people is to make available only essential generic drugs at lower prices, that is if your doctor prescribes them in the first instance. Procurement prices of generic drugs by Governments like that of Tamil Nadu and Delhi have revealed that prices of generics are 1.5 % to 10 % of the maximum retail price (MRP) of branded equivalents at the retail level. However, to get a retail pharmacist to stock these low-priced generics is easier said than done…..

Drug Price-Control: Problems, Principles and Prospects
Dr Chandra M Gulhati

One way or the other, prices of many sensitive goods and services are subject to some sort of price regulation either through state’s intervention or other mechanisms including competition, negotiated prices by bulk buyers, reimbursement by insurance companies just to mention a few…………

To download the entire issue of Health Action, September 2009 issue, click here

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MAKING MEDICINES AFFORDABLE – Reaching the Unreached

MAKING MEDICINES AFFORDABLE - Reaching the Unreached

MAKING MEDICINES AFFORDABLE - Reaching the Unreached

LOW COST MEDICINES INITIATIVE – CHITTORGARH
DISTRICT LEVEL INTERVENTIONS – THE MODEL

“We knew that the actual cost of most of the drugs is very low. But, these were not available to patients at low rates because of three obstacles:…………….. So, the district administration adopted the following strategy to provide low cost medicines to the patients.”

These are some excerpts from the booklet “MAKING MEDICINES AFFORDABLE – Reaching the Unreached” – documented by Dr. Samit Sharma, Collector and District Magistrate, Chittorgarh. To know about the strategy or to download or read the booklet, click here

To know more about the low cost medicines initiative in Chittorgarh, click here

To see the comparisons between printed M.R.P. of medicines and prices at CHITTORGARH SAHAKARI UPBHOKTA THOK BHANDAR LTD., CHITTORGARH, click here

Open letter to WHO on Pneumococcal Vaccine

February 16, 2009

To,
Dr. Margaret Chan,
Director-General of WHO,
Geneva

Dear Dr. Chan,

Greetings from All India Drug Action Network – AIDAN !

All India Drug Action Network is an all India network of organization and concerned individuals who have been advocating for more than twenty five years on issues related to the access, prices, safety , quality and rationality of medicines in India and their appropriate use by both health professionals and consumers.  Our activities have included publications, campaigns, media briefings, meetings, and even public interest litigations. It is due to the efforts of AIDAN, that many unsafe and irrational medicines have been removed from the Indian market.

We were delighted to read your comments in the ‘The Lancet’ dated 15th January 2009, titled “Primary health care as a route to health security”. We quote here a statements you have made about Primary health care in the Lancet “This approach to health is people-centred, with prevention considered as important as cure. As part of this preventive approach, primary health care tackles the root causes of ill health, including in non-health sectors, and offers an upstream attack on threats to health. As the report1 noted, better use of existing interventions could prevent 70% of the global disease burden.”

But unfortunately this perspective is not reflected in some of your actions. For example you have not responded positively to the request one of our AIDAN members sent you in the case of pneumococcal vaccine, based on the Primary Health Care perspective. The Drug Action Forum – Karnataka (DAF-K) which is a constituent organization of AIDAN had communicated to you the concern in a letter dated 2nd September 2008, regarding the “revelation that for every four children in whom pneumonia is prevented, two children develop asthma because of the vaccine”. This is because the pneumococcal vaccine in question is the one that is being promoted by WHO globally and in India. A copy of the letter sent by DAF-K is attached with this letter for your reference.

Your personal assistant Alison Porri, has acknowledged having received DAF-K’s letter on 4th September 2008, with a promise to “to acknowledge receipt of this e-mail”. And that “Your letter will be carefully reviewed and a response will be forthcoming”. But unfortunately DAF-K has not heard from your office. The issue was discussed at the 14th November 2008 of AIDAN and members expressed grave concern over the issue. Your eerie silence is creating a doubt in the mind of the health conscious members of AIDAN whether you mean what you wrote in The Lancet article mentioned above. (AIDAN is the larger national body, whereas DAF-K is a state level organisation and member of AIDAN along with several other nation wide constituents).

We the under signed express grave concerns about this whole issue.  If by 27th February 2009 we do not hear from you then many of us will walk into the WHO office at Delhi and demand for the same information.

Hoping to hear from you soon,

Yours truly
Dr Gopal Dabade, (drdabade@gmail.com)
Dr Mira Shiva, (mirashiva@gmail.com)
Mr. Srinivasan S, LOCOST (sahajbrc@youtele.com)
Dr Anurag Bhargava (anuragb17@gmail.com)
Dr C Sathyamala (csathyamala@gmail.com)
Dr Jacob Puliyel (puliyel@gmail.com)
Dr. Anant Phadke (anant.phadke@gmail.com)

Marketing of drugs

“This branch of medicine had commonly been reckoned one of the most lucrative; for the subjects of it are generally found among the affluent: they are seldom without some complaint that requires assistance; and they measure their comforts too often by the quantity of medicine that is served up.”  -Trotter T.A. View of the Nervous Temperament being a practical enquiry into the Increasing Prevalence, Prevention and Treatment of those diseases commonly called Nervous, Biliary, Stomach and Liver complaints; Indigestion; Low spirits, Gout etc. 2nd ed. London; Longman, Hurst, Rees and Orme, 1807; 231

India has a vast Pharma market, and is rightly celebrated in international circles for making medicines very affordable and low priced. As of 2003, the Indian industry was supplying 20 percent of the world’s drugs (by volume) and is currently one of the largest pharma industries in the world (by volume). At least 60 manufacturing plants in India have US Federal Drug Administration (FDA) approval, second only to the United States. Currently a dozen top Indian Companies are major suppliers to the US and European markets as well as China.

In 2005, India’s drug pieces were among the lowest in the world (dollar terms and even in purchasing power parity terms) with China as the possible exception for even lower prices.

India’s homegrown drug companies have outstripped Western MNCs in India (see Table 1 and 2 and3). But in comparison to worldwide pharma majors, the sales of entire Indian drug industry was US $10 Billion (about 40,000 Cr) in 2005 whereas the sales of the top 15 companies in the world in 2004 was more than US $400 Billion. In 2004, US drug companies spent more than US $33 Billion in research whereas Western drug companies spent only US $33 Million in India on R and D. Indian drug companies all put together spent US $0.3 Billion on R and D. Just to give an idea of the disparity, merely world pharmaceutical packaging demand will reach US $22.20 Billion in 2007. The US will remain the largest consumer of drug packaging while China generates the fastest gains.

Nevertheless, the booming Indian pharma market coming to the rescue of generics world over, especially by making low priced antiretrovirals, is a good part of the story. The not so good part is that the Indian pharma scenario, as far as the ordinary poor consumer is concerned, is a failure of the market.

As a result of this extreme failure and failure of regulation in the absence of well-functioning markets, the drug (medicines) availability situation in India is one of poverty amidst adequacy there is inadequate access and supply of even essential drugs to the poor despite adequate drug production. Adding to this misery is the poorly functioning public health system. While the sales of Indian pharma companies are increasing steadily (approximately Rs.40,000 Cr during 2005, including exports), the total government expenditure by both Central and State Governments would be of the order of a mere Rs.3000 Cr, with the Southern States spending 15% on health of the total budget while Assam, Bihar, Up and Orissa would spend only 5 percent! Share of drugs to total treatment costs vary from 50 to80 percent depending on rural/urban locations and inpatient /out patient treatment. All-India figures per capita annual drugs and other medical expenditure (rural) is Rs.294  out of Rs.380 for health as a whole.

Table.1 Earnings by top 25 Indian Pharma Companies

Rs (Crore)

Net Sales

Exports (FOB)

Imports (CIF)

Exports as % of sales

2004-05

2003-04

2004-05

2003-04

2004-05

2003-04

2004-05

2003-04

Ranbaxy Laboratories

3497.2

3398.27

2335.02

2346.07

716.64

531.03

66.8

69.0

CIPLA

2181.26

1842.24

1053.21

812.28

447.74

284.23

48.3

44.1

Dr. Reddy’s Laboratories

1557.69

1666.63

913.90

981.55

228.29

218.67

58.7

58.9

Aurubindo Pharma

1085.02

1259.89

554.62

642.04

530.69

539.58

51.1

51.0

Lupin

1161.13

1119.28

553.27

568.78

272.94

274.66

47.6

50.8

Orchid Chemicals & Pharma

638.40

680.81

520.04

531.54

283.94

258.56

81.5

78.1

Ipca Laboratories

671.17

602.53

390.97

340.16

86.52

84.99

58.3

56.5

Biocon

646.51

502.51

376.15

299.98

281.63

211.17

58.2

59.7

Matrix Laboratories

636.76

529.48

336.60

297.59

160.05

98.37

52.9

56.2

Wockhardt

846.74

729.48

308.10

280.47

107.75

87.79

36.4

38.4

Divi’s Laboratories

347.38

302.83

301.59

258.72

67.93

57.85

86.8

85.4

995.62

839.36

275.10

204.11

108.01

91.67

27.6

24.3

Strides Arcolab

305.31

274.39

266.64

248.28

68.18

54.73

87.3

90.5

Panacea Biotec

325.54

261.62

227.74

161.55

148.06

112.84

70.0

61.7

J B Chemicals & Pharma

35775

303.54

197.85

154.85

16.72

20.93

55.3

51.0

Cadila Healthcare

1063.40

1034.90

138.00

177.30

128.50

107.20

13.0

17.1

Glenmark Pharmaceuticals

463.20

320.02

130.13

48.95

43.70

29.67

28.1

15.3

Nicholas Piramal India

1232.25

1269.05

126.32

97.15

150.79

128.39

10.3

7.7

Alembic

524.46

56.46

105.91

124.29

80.68

71.09

20.2

22.3

Dishman Pharmaceuticals

157.22

123.25

105.88

83.42

40.63

26.05

67.3

67.7

Natco Pharma

154.40

129.61

91.85

61.67

11.12

9.64

59.5

47.6

Torrent Pharma

497.59

443.08

80.88

44.94

120.54

93.70

16.3

10.1

FDC

321.50

279.07

80.08

44.11

14.57

17.56

24.9

15.8

Unichem Laboratories

390.64

353.45

59.12

41.13

8.84

6.41

15.1

11.6

Medicamen Biotech

48.11

48.78

37.80

34.44

7.53

2.98

78.6

70.6

Total of 25 companies

20106.67

18870.53

9566.77

8885.37

4131.99

3419.76

47.6

47.1

Table 2: Highlights for Top 50 Indian Pharma Companies

(Rs Crore)

FY ‘ 05

FY ‘ 04

% Change

Net Sales

29402.88

27380.32

7.4

Other Income

1078.40

1047.28

3.0

Raw materials cost

14009.80

13190.92

6.2

Staff cost

2612.64

2216.37

17.9

Other expenditure

8069.18

7055.27

14.4

PBDIT Interest

6438.54

6309.47

2.0

Depreciation

478.29

594.44

-19.5

Profit before tax

1005.66

880.94

14.2

Taxation

4963.53

4836.38

2.6

Net profit after Tax & exceptional items

1028.48

804.68

27.8

Equity capital

4068.17

3878.22

4.9

Note: Totals may not add due to rounding off

1593.18

1434.62

11.1

Table 3: World’s Top15 Pharma Companies Register 28% Growth in Net Profit, 10.6% Rise in Sales in 2004

(US $ Million)

Sales

Cost of Mfg,

Selling, R&D

EBDIT

Net earnings

Company Name 2004

2004

2003

2004

2003

2004

2003

2004

2003

Abbott Laboratories

19680

17280

15782

14306

3898

2974

3236

2753

Amgen

9977

7868

6273

4836

4277

3520

3148

2539

AstraZeneca PLC

21426

18849

16971

14938

4455

3911

3813

3036

Bayer

40602

35872

39232

38731

1370

-2247

823

-1709

Bristol-Myers Squibb

19380

18653

14979

13720

4401

4933

2388

3106

Eli Lilly & Co

13858

12583

10591

9080

3267

3503

1810

2561

GlaxoSmithKline

39224

38133

27376

26557

11849

11576

8288

7964

Johnson & Johnson

47348

41862

34503

31909

12845

9953

8509

7197

Merck & Co

22939

22486

16316

14112

6623

8374

5813

6831

Novartis

28247

28864

21708

18975

6539

5889

5767

5016

Pfizer

52516

44736

38509

41490

14007

3246

11361

3910

Roche

27641

25143

22765

21170

4876

3973

5870

2472

Sanofi-Aventis

34680

30509

23543

21400

11138

9109

7159

5589

Schering-Plough

8272

8334

8488

7776

– 216

558

-981

-92

Wyeth

17358

15851

13208

12152

4150

3699

1234

2051

Total for 15 companies

403148

363023

310244

291152

93479

72971

68238

53224

Exchange Rate – As on 31/12/04; $ 1 Euro = 1.365 1Chf =0.885

As on 31/12/ 03; $ 1 Euro = 1.265 1Chf =0.815

More players in an uncontrolled market have meant only a wide range of prices for the same drugs. On the other hand, you have the same drug being sold by different companies (and sometimes by same company) at vastly different prices. There is not even a direct relation between top-selling drugs and real need as per the disease and illness conditions prevalent. These severe distortions are compounded by poor regulation, nexus between medical profession and Pharma companies and their aggressive and often unethical marketing.

2. Marketing of Top 300 Drugs in India: A brief Analysis

We now present an analysis of the top-selling 300 drugs of India accounting for Rs.19000 crores sales in India. This analysis of the Indian market is based on the October 2003 data of ORG- Nielsen. This data is collected from a sample of around 280 outlets in India and is based on data from wholesale dealer’s sales to retailers. It is not based on retail sales. It is indicative, of market trends in general. And in view of the sample taken and the exclusion of Institutional sales, it is likely to be an underestimate of the total volume of sales.

This analysis of the top-selling brands, along with the analysis of the variation in drug prices already discussed gives some insights into the nature of the Indian drug market.

The sales from 300 brands alone are huge and put the government estimates of the sales of the pharmaceutical sector into question. The government quotes lower figures. The total Moving Annual Total of from the retail sales of 300 brands alone (there are more than 20,000 formulations in the market) is a whopping Rs.18,000 Crores. This figure of Rs.18,000 Crores would only be a part of the total sales. The final figure of the total sales does not take into account institutional and governmental purchases, which would also be of very considerable magnitude. Some industry estimates put the figure to Rs.40,000 crores (for instance see (www.pharmabiz.com) editorial, June 20, 2001; “A Rs.40,000 crores industry”0. This has to be seen in the context of sales of top-selling drugs in the world (Table 4). But it is interesting to note top 300 brands sell 50 percent of drugs by sales value (of Rs.18,000 Cr) in India.

Global pharmaceutical sales tallied in at $500 Billion. Of that revenue, $230 Billion was in North America. That’s more than double the dollar sales booked in the European Union. But cost differences become even more striking when one looks at the nine top-selling medicines in the world. Comparing the global sales figures last month reveals that all but one of these medicines won most of its dollar sales in the United States. The reason is not likely merely that people in the US use more medicine, but also that they are more expensive.

Table 4: World’s Top-selling Drugs, 2003

Drug

Purpose

Maker

Global

Sales ($bil)

US

Sales ($ bil)

% of sales in US

Lipitor

Lowers cholesterol

Pfizer

$10.3

$6.8

66%

Zocor

Lowers cholesterol

Merck

6.1

4.4

72

Zyprexa

Anti –psychotic

Eli Lilly

4.8

3.2

66

Norvasc

Lowers Blood pressure

Pfizer

4.5

2.2

40

Erypo (Procrit)

Treats Anemia

Johnson & Johnson

4.0

3.3

83

Ogastro/ prevacid

Treats Ulcers

Takeda & Abbott Laboratories

4.0

4.0

100

Nexium

Treats Ulcers

Astra Zeneca

3.8

3.1

82

Plavix

Blood thinner

Bristol-Myers Squibb

3.7

2.2

59

Seretide (Advair)

Treats asthama

GlaxoSmithKline

3.7

2.3

62

Zoloft

Anti-depressant

Pfizer

3.4

2.9

85

2.1 Top 300 Brands and their Relation to the National Essential Medicines List.

There are a total of 354 drugs in the National Essential Medicines List, which are adequate to take care of the majority of the health needs of the population during outpatient or in-patient care. If we examine the list of top 300 brands (as per ORG-Neilson Oct 2003, see Table 5 for a partial list), we find that only 115 brands are of drugs that are mentioned in the National Essential Medicines List (NEMI) 2003, i.e. only 38% of brands  of the top selling ones are of drugs mentioned in the NEML. The other 62% are of drugs which do not find mention in the NEML. Of course 62% brands comprise drugs that are higher priced alternatives without a clear therapeutic advantage, and many drugs that are unnecessary, irrational and even hazardous. The number represented by these 115 brands is only 68.

That means the majority of the top selling brands are drugs which are outside the National Essential Medicines List, which means that the majority of the drugs which are the most cost-effective for the treatment of property health needs of the people are not the ones which are selling the most. (See also Table 6.)

A dramatic illustration of the lack of public health relevance of these top-selling preparations is the case of preparation for iron deficiency anemia, which is one of the India’s most prevalent public health problems. (See Table 7).

There is not a single preparation in the top 300, which has the ingredients for an anemia preparation as mentioned in the National Essential Medicines List.

The top selling preparation (Dexorange) is patently irrational (See chapter 3) while others contain substances which are not required (e.g in Fefol-Z), and which can in fact impair iron absorption. (See also Table 7.)

Table 5: Top – Selling 25 Brands in India as per ORG-Neilsen Retail Audit, Oct 2003)

Sl No.

Brand Name

Uses and Remarks

Moving Annual Total in Rupees Crores

1

Corex

Cough suppressant. Abused as drug of addiction because of presence of codeine.

88.18

2

Becosules

Multivitamin unnecessary preparation

79.74

3

Taxim

Bacterial infections

77.05

4

Voveran

Pain relief

76.14

5

Althhrocin

Bacterial infections

68.46

6

Human Mixtard

Diabetes Mellitus

63.39

7

Cifran

Bacterial infections including Typoid

62.70

8

Liv-52

Ayurvedic Liver preparation

62.67

9

Asthalin

Asthma

61.76

10

Sporadex

Bacterial infections

61.71

11

Betnesol

Allergy

61.11

12

Zinetac

Dyspepsia, Ulcer disease

60.70

13

Neurobion

Irrational Multi vitamin preparation

60.27

14

Nise

Hazardous drug for pain relief

58.31

15

Digene

Antacid

57.86

16

Dexorange

Irrational preparation for anemia

57.65

17

Phexin

Antibiotic for Bacterial infection

57.03

18

Mox

Bacterial infection

56.36

19

Cardace

Hypertension, Heart failure, much cheaper alternatives exist.

55.31

20

Rabipur

Vaccines against Rabies

54.40

21

Omez

Peptic Ulcer

53.52

22

Ciplox

Bacterial infections

51.69

23

Combiflam

Analgesic combination

49.02

24

Aten

Hypertension

48.87

25

Augmentin

Costly antibiotic

48.63

Total

1532.53

The mere inclusion of a drug in the National Essential Medicines List does not translate into affordability for the patient, because most of the drugs included in the NEML, are outside price control. Even when the drug is under National Essential Medicines List because of the lack of regulation over drug prices, it is often the costlier version that sells more: For example, Ciprofloxin is sold by Ranbaxy at Rs.8.96 a tablet. Yet the cheapest brand of Ciprofloxin at RS.2.90 does not sell as much.

Table 6: Top Selling 10 Categories of Drugs in the Top 300 Brands: Where is the people’s Money going.

Type of  drug Category

No. of Brands

Moving Annual total (in crores

of rupees)

Remarks

1. Anti-infectives

65

1650.02

Most frequently used & abused drugs when antibiotics are given for fever sue to viral infections.

2. Analgesics

26

705.06

Hazardous analgesics like nimesulide are one of the top sellers.

3. Endocrine disorders like Diabetes mellitus, hormones

25

694.10

4. Multivitamins and minerals

27

651.29

Contains predominantly non-essential drugs in all kinds of irrational combinations.

5. Drugs for cardiovascular disease

26

601.64

The top selling cardiovascular drug is one that has little therapeutic advantage over less costly alternatives.

6. Drugs for respiratory system, including cough preparations

21

512.59

Cough syrups sell more than drugs for asthma.

7. Drugs for gastrointestinal system

20

427.21

Their large sale is also the result of over prescription.

8. Drugs for allergy

10

326.51

9. Anticonvulsants

9

221.35

10. Hematinics

6

128.13

Contains such irrational wonders of the pharmaceutical world as Dexorange (57 Crores) which till recently contained animal blood from slaughter houses, Hepatoglobine, etc.

2.2 Top-Selling Drugs outside the NEML.

These are diverse types and include:

  • Higher priced brand of either the same drug or a higher priced alternative to a lower cost essential drug.
  • Irrational drugs and irrational combinations of antibiotics, vitamins, analgesics which include unsafe and hazardous drugs.

Examples abound in this regards:

  • Cifran brand of Ciprofloxin is the largest selling antibiotic, whereas it is the costliest among the ciprofloxins. Other brands of ciprofloxin, e.g. Zoxan which are 3 times sells 5 times.
  • Ramipril is an angiotensin converting enzyme inhibitor like enalapril. It has no therapeutic advantage over enalapril, and is costlier. enalapril is mentioned in both the National and WHO list of medicines as being representative of the class of ACE inhibitors, while ramipril has not been.; Yet sells more than enalapril.
  • Penicillins including amoxicillin, ampicillins are effective antibiotics for a variety of infections Oral.
  • Cephalosporins are to be used in certain situations only and mainly when it is not possible to administer oral penicillins because of penicillins allergy. Yet according to the sales figures brands of Cephalosporins (Phexin, sporidex) clearly outperform penicillins, which indicate inappropriate use. The indications for erythromycin are similarly limited. However the sales figure for erythromycin is also higher than of penicillins.
  • This is another area of concern in the Indian drug industry. Irrational combinations of drugs, which only add cost but no therapeutic value, are touted as effective remedies and promoted aggressively.

Table 7: Most common and important Public Health Problem of India According to the Pharmaceutical Industry: Not Anemia, but B-Complex Deficiency!

Brand

Rank in Top 300 Brands

Moving Annual Total (Rupees Crores)

Becosules

2

79.74

Revital

27

47.64

Polybion

42

40.85

Zincovit

60

32.26

Cobadex forte

88

26.10

Methycobal

116

21.87

Zincovit

118

21.65

Neogadine

119

21.52

Riconia

125

20.78

R.B. tone

129

20.21

A to Z

145

19.07

M2tone

157

18.22

Supradyn

221

1525

Becadexamin

229

14.63

Raricap

239

13.89

Becosules-Z

295

12.03

Optineuron

297

11.97

437.68

2.3 Irrational drugs of No Therapeutic Value in the Top 300

Consider the following:

  • Irrational drugs like Electral (since rationalised), or drugs which are used irrationally like Evion, Glucon-D, Deca-durabolin are top selling drugs, Protein products are irrationally prescribed and irrationally priced.
  • Irrational combinations of vitamins , minerals and other ingredients including ginseng (which has supposedly aphrodisiac properties), or even and outmoded and dangerous ingredient like animal hemoglobin from slaughterhouse blood, fresh liver extract, are passed off as tonics, haematinics, and food suppliants to a gullible population via the medium of obliging Doctors. Most of these  preparations would hard to find in any pharmacoepia in the world, but the drug regulatory authorities do not find anything wrong in approving their manufacture, Examples include Revital elixir Neogadine, hepatoglobins, etc.
  • Irrational combinations of antibiotics: the most common being ampicillin plus cloxacillin which is widely used inappropriately.

2.4 Unsafe and Hazardous Drugs Among the Top 300

  • Preparations containing animal tissue without therapeutic rationale. e.g, Hepatoglobin containing fresh liver extract carry the risk of transmitting infection.
  • The high sales figures for codeine containing cough syrups are a matter for concern. Both Corex (the Number 1 brand in the country with sales of Rs.88 Crores) and Phensedyl (rank 29, sales Rs.47.30 crores). These syrups are widely used especially in the northeast as drugs of addiction because of the presence of codeine. They are also smuggled into neighbouring countries like Bangladesh and Myanmar. Does the abuse of these syrups contribute to their high their high turns over? In contrast Glycodin contains detromethorphan that is a safe constituent. It however does not sell as much (rank 259, sales Rs.13.15 crores).
  • Nimesulide, which is one of the best-selling analgesic drugs in India, is not approved in most of the developed world because its side effects on the liver.

2.5 Preponderance of Combinations Among the Top 300.

  • A significant number of the top selling formulations are combinations of drugs, rather than single ingredients. In fact there are 118 combinations in the list of 300. The Majority of the combinations are irrational. Only around 20 of these combinations are rational, the rest are combinations, which lack any therapeutic rationale for being combined.
  • The pattern of production and the pattern of sales do not adequately reflect the real health needs of the people. There is overrepresentation of costly antibiotics, irrational multivitamin preparations, cough syrups, ineffective haematinics, pain balms, rather than cost-effective drugs of real therapeutic value.
  • The sales figures reflect the fact that in India, drugs which are not considered essential sell more than rational and essential drugs, that costlier drugs most often sell more than cheaper alternatives (even those made by well known manufacturers), and downright irrational and hazardous drugs are among the Top-selling sellers. The majority of sales are coming from the sales of drugs not considered relevant by experts for inclusion into an essential medicines list, and not considered important by the government for regulation of their price.

Banning of Liver Extract

A large number of pharmaceutical products with poor rationality profiles are being manufactured and marketed by drug companies in India today. Most of them are fixed dose combinations of drugs and vitamin preparations. No control on their has been achieved despite frequent regulatory interventions. One such controversial preparation is the brands containing crude animal liver extracts with a few other ingredients for the treatment of megaloblastic anemia. These formulations have been found to be carrying infective diseases from animals to humans besides causing allergic reactions as they are containing biological products. Currently there are six leading brands of liver extracts formulations available in the market for the treatment of anemia. These are Livogen, Ibberol, Plastuules B12, RB Tone, Heptaglobine and Hep-Forte. Recent medical studies conducted in India and abroad have questioned the relevance of the continuing use of anti-anemic preparations containing multiple ingredients like Liver, iron, folic acid, vitamin B12, copper, manganese, etc. Some of these ingredients are unnecessary, wasteful and only increase the cost of therapy and risk of infection, the studies have pointed out. But none of the pharma companies had taken any steps to withdraw the liver extract from their products or reformulate them although the use of liver extract has been banned in several countries ago.

The need to ban the use of liver extracts in drug preparation was first raised by Pharmabiz.com in April 2001. The issue was subsequently taken up by Ahmedabad based Consumer Education Research Centre with DCGI. But no serious action was initiated by the drug Controller General of India in this regard. DCGI is reported to be now moving to prohibit the use of liver extracts. A circular is expected to be issued in this regard asking the pharma companies to replace liver extract with pure Vitamin B12. Merck, the leading player in this segment, meanwhile, has decided to withdraw liver extract from its brand, Livogen. Liver extract has been the key ingredient of Livogen tablet and the tonic marketed by the company. The decision of the company is in the wake of its acceptance of the fact that this ingredient has no place in the modern therapy as it is unsafe and irrational. Liver extracts used to be the only option before the development of folic acid and vitamin B12 in pure form. But the drug companies have been avoiding use of vitamin B12 in place of liver extracts despite its abundant availability. Reluctance of the drug companies is mainly on account of the cost of factor. Regulatory authorities should only know that resistance of pharma companies to recall an established product or change the composition of a well known brand do cause a lot of damage to the public. In matters like this, a faster regulatory initiate is called for.

This brief analysis of the Top-selling 300 brands suggests that the Indian doctors are prescribing drugs without adequate concern for evidence of their efficacy, safety, and cost. This is because of the poor access to unbiased information on drugs, for doctors as well as lay persons in India, compounded by the aggressive and misleading drug promotion by the drug industry. The result is increased health care costs for the patients, irrational use of drugs, and exposure of patients to the risks of unsafe drugs.