ORGANISATION OF PHARMACEUTICAL PRODUCERS OF INDIA

Peninsula Corporate Park, Peninsula Chambers, Ground Floor, Ganpatrao Kadam Marg, Lower Parel, Mumbai 400 013, INDIA.
y Tel.: 91 +22 + 2491 8123, 91 + 22 + 2491 2486, 91 + 22 + 6662 7007 y Fax: 91 + 22 + 2491 5168
y email: [email protected] y Website: www.indiaoppi.com

INDIA

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Area: ....................................................................................................................................................... 2 973 190 km
Inhabitants (2009): ...................................................................................................................................... 1 1207 497
Population density (2009): ...................................................................................................... 406 inhabitants per km2
Gross Domestic Product (2009) (e): .......................................................... INR 56 764.66 billion = euro 842.69 billion
General government expenditure on health as a % of total expenditure on health (2006) ............................... 63.2%
General government expenditure on health as a % of total government expenditure (2006): .......................... 10.8%
Public healthcare expenditure (2006): ................................................................................................................ 1.01%
Private healthcare expenditure (2006): .............................................................................................................. 5.09%
Total healthcare expenditure as a % of GDP (2006): ........................................................................................ 6.10%

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Sources: Eurostat, 2010. Economic Survey 2008-09 . General government health expenditure: WHO 2010.

1. CLASSIFICATION
In India, the import, manufacture, distribution and sale of drugs and cosmetics are regulated by the
Drugs and Cosmetics Act, 1940 (DCA), the Drugs and Cosmetics Rules, 1945 (DCR)2

OTC Drugs
‘OTC Drugs’ means drugs legally allowed to be sold ‘Over The Counter’ by pharmacists, i.e.
without the prescription of a Registered Medical Practitioner. Although the phrase ‘OTC’ has no
legal recognition in India, all the drugs not included in the list of ‘prescription-only drugs’ are
considered to be non-prescription drugs (or OTC drugs).

Prescription-only drugs are those medicines that are listed in Schedules H and X of the Drug and
Cosmetics Rules. Drugs listed in Schedule G (mostly antihistamines) do not need prescription to
purchase but require the following mandatory text on the label: “Caution: It is dangerous to take this
preparation except under medical supervision”. Drugs falling in these three schedules are currently
not advertised directly to the public under a voluntary commitment by the pharmaceutical industry.

Currently, non drug-licensed stores (e.g. non-pharmacists) can sell a few medicines classified as
‘Household Remedies’ listed in Schedule K of the D&C Rules in villages whose population is
below 1 000 subject to certain other conditions.

Ayurvedic Medicines
OTC drugs registered as ‘Ayurvedic Medicines’ (i.e. traditional Indian system of medicines
containing natural / herbal ingredients) are also regulated by the DCA and DCR. Ayurvedic drugs
are manufactured under a manufacturing licence issued by the Ayurvedic State Licensing
Authorities. However, they do not require a drug sale licence and can be sold freely by non-
chemists. Some of the largest OTC brands in India are registered as ‘Ayurvedic Medicines’
because of their plant-based natural active ingredients (e.g. Vicks VapoRub, Amrutanjan Pain
Balm, Zandu Pain Balm, Iodex Pain Balm, Moov Pain Cream, Itch Guard Cream, Eno Fruit Salt
antacid, Vicks Cough Drops, Halls Lozenges, Dabur’s Pudina Hara etc.).

Considering the above framework, key categories with OTC potential in India would be: vitamins
and minerals; health tonics, cough and cold; gastrointestinals; analgesics; dermatologicals; herbal /
ayurvedic medicines which do not contain any substance listed in Schedules G, H or X.

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http://exim.indiamart.com/
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http://cdsco.nic.in/html/Drugs&CosmeticAct.pdf
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2. MARKETING AUTHORISATION
The major legislation for pharmaceutical regulation is the Drugs and Cosmetics Act, 1940 (DCA)
and its subordinate legislation, the Drugs and Cosmetics Rules,1945 (DCR)1. Drug (Prices Control)
Order, 1995, Drugs (Magic Remedies) Objectionable Advertisement Act, 1954 and Pharmacy Act,
1948 are other regulations which have a bearing on the pharmaceutical business in India.

The legislations apply to the whole of India and to all categories of medicines (e.g., allopathic,
ayurvedic, siddha, unani and homeopathy.), whether imported or manufactured in India. The
legislation is regulated by the Central Government (Ministry of Health & Family Welfare2) in New
Delhi, which is responsible for its overall supervision and enforced by State Government through its
Food and Drug Administration (FDA).

The office of the Drugs Controller General of India (DCGI) has the primary responsibility for
approving new drugs, molecules and standards, Vaccines & Sera, new usage and claims, new
method of administration, clinical research and trials, introductions of a new unique formulation
and granting import and export licences. It oversees the activities of the Central Drugs Standard
Control Organization (CDSCO)3. The DCGI also exercises control over medical devices imported
or manufactured in India.

However, power to provide manufacturing and selling licences - which are the two main stages
required to manufacture and sell a drug - belongs to each individual State Government through its
Food and Drug Administration (FDA). These Food and Drug Administrations (FDAs) also carry
out enforcement of the DCA and the DCR.

The DCGI office is established in modern premises in Delhi:

Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India
FDA Bhavan, ITO, Kotla Road, New Delhi - 110002
Phone: +91-11-23 23 69 68
Fax: +91-11-23 23 69 73

3. PATIENT INFORMATION
Rule 96 of the DCR (‘Manner of Labelling’) mandates the minimum information which needs to be
put on the label of all medicines other than ISM medicines (ayurveda, siddha, unani). This
includes:
a) proper (generic) and trade (brand) name
b) net contents and content of active ingredients,
c) name and address of manufacturer including manufacturing licence number,
d) distinctive batch number, manufacturing and expiry date etc.
e) Maximum Retail Price (inclusive of all taxes)

Rule 97 requires on-label caution statements for the different drug schedules. For example, drugs
falling under Schedule G require “Caution: it is dangerous to take this preparation except under
medical supervision”. Schedule H drugs need the symbol ‘Rx’ as well as “Schedule H – Warning:
To be sold by retail on the prescription of a Registered Medical Practitioner only”.

1
http://cdsco.nic.in/html/Drugs&CosmeticAct.pdf
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http://mohfw.nic.in/
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http://cdsco.nic.in/index.html
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There are no separate labelling requirements for ‘OTC drugs’. Under The Standards of Weights &
Measures (Packaged Commodities) Rules, most packaged consumer products including ISM drugs
are required to have the Maximum Retail Price (MRP) printed on the label. The maximum retail
sale price of scheduled and non-scheduled drugs are as per the provisions of
DPCO 1995. The trade margins (wholesale and retail) are also restricted under DPCO. The selling
of any product at a price higher than the MRP is not permitted.

The labelling provisions of ISM medicines are covered by Rule 161.

4. ADVERTISING TO THE GENERAL PUBLIC

The Drug & Magic Remedies (Objectionable Advertisement) Act & Rules mentions a list of
ailments for which no advertising is permitted. It also prohibits false or misleading advertisements
which, directly or indirectly, give false impressions regarding the true character of the drug, make
false claims, or are otherwise false or misleading in any particular respect. The DCGI’s office -in
collaboration with the Organisation of Pharmaceutical Producers of India (OPPI) - has released a
Voluntary Code on OTC Advertising which is being followed by all OPPI member companies.
There is also an OPPI Code of Pharmaceutical Marketing Practices, January 20071, based on the
IFPMA code. Based on the DCGI code, the Advertising Standards Council of India (ASCI) has
brought out a code of advertising for pharmaceutical products.

Currently, there is no specific law which prohibits the advertising of prescription drugs although
industry practice is not to advertise prescription-only drugs. The DCGI’s office is considering
coming out with a notification prohibiting the advertising of any drug which legally requires a
doctor’s prescription for its supply.

The following OTC medicines advertising can be seen on TV in India:

• digestives
• antacids
• antiflatulents
• cold rubs and analgesic balms/creams
• vitamins/tonics/health supplements (especially herbals and Ayurvedic-registered)
• medicated skin treatment
• analgesic /cold tablets
• antiseptic creams/liquids
• glucose powders
• cough liquids
• throat lozenges
• medicated dressings (band-aids)
• baby gripe water
• ayurvedic medicines and preparations.

5. TRADE NAMES
Trade names are regulated by the Trade and Merchandise Marks Act (TMMA). The TMMA
provides for registration of trademarks for a period of seven years at a time, renewable after each
period. For any item, trademarks should not be objectionable from a religious or social point of
view. They should not contravene the Emblems and Names (Prevention of Improper Use) Act,
1950. They should also not yet be registered or applied to be registered in India. The trademark
can be registered even if the item is not produced or sold in India at present.

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A foreign trademark can be used without any restriction. Foreign companies can license their trade
mark to their local subsidiaries or joint ventures. The Indian Copyright Act, 19571 also provides
protection for unique logos and designs on packaging.

“Infringement” and/or “Pass-off” or look-alike copies, counterfeits and spurious products of popular
OTC drugs are a major issue because the licence to manufacture and sell drugs is issued by state-
level FDAs who do not independently verify whether they issue a manufacturing and selling licence
to a pass-off drug. However, the Indian courts are known to provide quick and corrective action
against such violators, although the burden of searching and taking the pass-off manufacturer to
court falls on the individual affected company.

6. DISTRIBUTION
India is geographically a very large country, with the population spread over urban (33%) and rural
(67%) areas. There is at present no system of national chains of supermarkets or drugstores /
pharmacies, and retailing is dominated by small independent shops. However, a few chains such as
Apollo Pharmacy, Medicine Shoppe, Good Health etc., are entering the market and are expected to
make inroads all over India in the near future.

Typically however, less than 5% of sales of FMCG manufacturers in 2006 went through organised
retailers. A manufacturer or importer has to make his proper arrangements for distribution to the
retail level.

Due to interstate Central Sales Tax (CST), operating a warehouse or stockist in each state and
distributing within the state from there is a common practice. Further, there are very few national
distribution agencies that distribute third-party products throughout the country.

The method of distribution is therefore from the manufacturer’s location to a company’s own state
depots for stocking before making a sale. This avoids the 2% Central Sales Tax. These depots are
either run by the company or outsourced to Clearing and Forwarding agents (C&F) who operate the
depots on the company’s behalf but employ their own staff and premises.

Each warehouse is required to take out a drug-selling licence. The C&F is under the supervision of
the company’s regional office (usually located at the four metropolitan areas of Mumbai, New
Delhi, Kolkata and Chennai, representing the West, North, East and South regions). Each regional
office looks after sales in five or six states.

The dispatch of goods takes place from the manufacturer’s location to the C&F locations, but
without invoicing at that stage as it is only a transfer of goods and not a sale. The C&F invoices
goods to stockists or distributors who have town or area-wide stocking points. The responsibility of
stockists is to resell and distribute goods to wholesalers and retailers in their defined area of
operations. In some cases stockists provide sales personnel to cover retail stores as well. The
company’s sales / medical representatives co-ordinate with the C&F agent as well as the stockists to
support retail sales and avoid shortages.

Buying and selling of allopathic drugs is regulated through a licensing system either by the central
authority and/or by state drug control authorities. It is an offence to manufacture, store, sell or
distribute drugs without a valid drug licence.

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7. DISTANCE SELLING
Distance selling and teleshopping of non-prescription medicines is not permitted in India as the sale
of drug products can only take place through licensed stores.

8. PRICING
Price controls are exercised on certain drugs by virtue of the Drugs (Prices Control) Order 1995
(DPCO)1, in the framework of the Essential Commodities Act (ECA). The DPCO is the
responsibility of the Ministry of Chemicals and Fertilisers2 and is supervised by the National
Pharmaceutical Pricing Authority (NPPA)3. It outlines the classification of price-controlled
products and methods of price fixation and revision. The NPPA monitors drug prices by fixing and
revising them. The 347 price-controlled drugs under the Drugs (Prices Control) Order 1979 were
brought down to 143 in the Drugs (Prices Control) Order 1987. Under the DPCO-1995, there are
74 bulk drugs and their formulations under price control (known as scheduled drugs) covering
significant percentage of the total pharmaceutical market in India. Only a few OTC actives, e.g.
acetylsalicylic acid and ephedrine and its salts, fall under the current DPCO price control.

The price of scheduled drug fixed by NPPA is revised from time to time. The manufacturer is not
allowed to increase retail price of scheduled drugs without approval of NPPA. However, prices of
non-scheduled drugs are fixed by the manufacturer subject to a maximum increase of 10% on the
prevailing price over a 12-month period.

There are no price controls on ‘Ayurvedic Medicines’.

Under the National Pharmaceutical Policy 2006, the government intended to:
• Strengthen the Patent office infrastructure,
• Focus on Research & Development strategies to increase access to anti-cancer and anti-HIV
drugs,
• Rationalise the Excise Duty schemes in order to promote access to drugs for the poor,
• Set up a Drugs Price Monitoring Awareness and Accessibility Fund
• Create a Pharma Advisory Forum and
• Increase the range of price controls.

However, at the beginning of 2010 the Policy was still under review by a government-appointed
high level committee of cabinet ministers.

9. PRICE BUILD-UP
The stockist / wholesale and retail margins on OTC medicinal products are fixed by an agreement
of Industry Associations including OPPI and the All India Organisation of Chemists & Druggists
(AIOCD) whereby a 10% margin on the Maximum Retail Price (MRP exclusive of all taxes &
duties) is provided for the stockist/wholesaler and 20% for retailers for non-price-controlled drug
products. For price controlled products 16% margin for Retailers is mandated by the DPCO.
Generally, Stockists retain between 5-6% of margin while passing on the balance 3-4% margin to
sub-wholesaler or bulk retail buyer.

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http://nppaindia.nic.in/drug_price95/txt8.html
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http://chemicals.nic.in/
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http://nppaindia.nic.in/index1.html
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The consumer price or Maximum Retail Price (MRP) build-up for non-price-controlled medicines
and Ayurvedic medicines is as follows:
% %
Manufacturer’s selling or ex-factory price (MSP) 100.0 60.4
Central VAT (16% of 57.5% of the MRP) 115.2 69.7
State VAT (4% of the MRP) 121.8 73.7
Stockist / Wholesale price (margin = 10% of the MRP1) 136.6. 82.6
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Maximum Retail Price (MRP) (margin = 20% of MRP ) 165.3 100.0
1
Excluding taxes.

10. MARKET DATA

The value of the pharmaceutical market in India in 2007 was USD 10 billion (euro 7.296 billion),
representing a growth of 13.4% over 2006. India’s pharmaceutical market represents 1.8% of the
global pharmaceutical market in terms of value and 8% in terms of volume. Globally, India ranks
4th in volume and 14th in value terms. The exports of bulk drugs and formulations represented
USD 6 billion (euro 4.378 billion) in 2007.

OTC medicines
India currently ranks 11th in the global OTC market size. It is estimated that it will reach 9th
position within five years.

Currently the Indian OTC market (i.e. advertised non-prescription medicines) is estimated to
represent approximately USD 1,793 million (euro 1 310 million) with an annual growth rate of 23
%.

Main self-medication product groups

Category 2005 2006 2007 2008 2009 CAGR %

Sales in US$ mn-MSP
OTC sales - India 1243.4 1371.4 1491.0 1638.9 1813.4 9.9%

Analgesics 178.8 192.9 201.7 223.4 258.6 9.7%

Cough, Cold & Allergy 227.2 250.7 269.7 295.1 318.1 8.8%

Gastrointestinals 231.4 256.7 281.0 301.2 332.6 9.5%

Vitamins, Minerals &
447.1 494.3 538.6 583.0 634.5 9.1%
Supplements
Dermatologicals 144.1 160.3 181.9 212.4 236.5 13.2%
Lifestyle OTCs 14.8 16.4 18.1 23.9 33.1 22.3%

Source: Nicholas Hall & Company, India, DB6 2009 – 1US$ = INR.46.54

11. RESTRICTIONS CONCERNING IMPORTS

Imports of formulations into India are negligible given the price disadvantage arising from import
tariffs and local manufacturing cost advantages. Further, the product approval process for new
molecules can be difficult and time-consuming. Price controls are also an added negative factor.

The Ministry of Health and Family Welfare has published a Gazette Notification GSR no. 604 (E)
dated 24.08.2001 amending the various provisions of the Drugs & Cosmetics Rules, thereby
introducing a new provision for the registration of the manufacturing premises of foreign drug
manufacturers and individual drugs prior to their import into the country. The notification also
introduced a few other provisions, e.g. enhanced import licence fees, increased validity period of
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licence, deletion of exemption from requirement of import licence for bulk drugs for actual users,
requirement of minimum 60% of residual shelf life for imported drugs and provisions for import of
small quantities of new drugs by Government hospitals for the treatment of their patients, etc.

Under these provisions, foreign manufacturers have to apply for a registration certificate for their
manufacturing premises and the individual drugs they want to export to India. Authorised agents of
foreign firms in India can make the applications. The documents required for registration
certificates are clearly specified in the amendments. The validity of registration certificates is three
years from the date they are issued.

According to the modified rules, an import licence is required for all types of drugs instead of the
previous import licence requirements for Schedule C & C (1) and Schedule X drugs only.

12. SWITCH CLIMATE

Currently, aches/pains, cough, colds, hyperacidity, minor topical infections and indigestion are
major OTC categories. Emerging categories include cuts, wounds and burns, muscle pains and
sprains, diarrhoea and constipation. There are many products in the Rx sector which could be
revitalised through OTC switches. An analytical interpretation of various data places the focus on
vitamins, cough & cold, antacids, antipyretics and NSAIDs as opportunity areas for switch in India.

However, the big issue in OTC marketing is not the ‘switch’ climate as currently even drugs which
do not require a prescription are promoted via the doctor because:
a) Marketing through medical representatives is less expensive than mass media advertised
marketing. This makes that OTC medicines are higher priced than the equivalent medicines
promoted ethically.
b) Practically all Rx drugs can be purchased without a prescription.
c) Doctor influence is strong in patients’ purchase behaviour.
d) Distribution of allopathic OTC medicines is limited to drug licensed stores (mainly pharmacies).

13. PHARMACY TRAINING AND ATTITUDES

OTC drugs require no pharmacists’ consultation for selling. However, an active role and
responsibility of pharmacists in promoting self-medication is important.

14. DOCTORS TRAINING AND ATTITUDES

A survey among doctors on OTC medicines1 brought out the following interesting responses:
• 72% of doctors were willing to give an opinion on the OTC medicine
• 21% of doctors were willing to recommend / prescribe an alternative
• Only 7% of doctors found it against their medical ethics to give advice on advertised brands.

15. CONSUMER ATTITUDES/RESEARCH

Indian consumers confidently self-treat a wide range of common ailments such as cough, cold,
fever, pain and sprains, heartburn and diarrhoea. When suffering from an ailment, consumer
behaviour is as follows;

• Go to the pharmacist: 45%

• Go to the doctor: 24%
• Self-medication: 23%
• Do nothing: 9%

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Source: “OTC-the final frontier” by Nicholas Hall, Sorento Communications and IMRS, 2006.
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With a strong heritage of Ayurveda and alternative medicines, the usage of home remedies is quite
high in Indian households. In fact, more than 30% of the time Indian consumers use home
remedies. Major usage of home remedies is found in cough, cold, heartburn and indigestion
categories1.

16. OTHER NATIONAL DEVELOPMENTS

Intellectual property rights
As a founder member of the World Trade Organization (WTO), India was obliged to introduce an
Intellectual Property Rights (IPR) regime compliant with TRIPS (Trade Related Aspects of
Intellectual Property Rights) in January 2005. India ushered in a product patents regime by
introducing The Patents (Amendment) Ordinance, 2004 on 26 December 2004. After debating the
provisions of the Ordinance, Parliament later passed The Patents (Amendment) Bill, 2005. This
signalled the start of a new era for the pharmaceutical industry in India. The 2005 Act was
expected to boost R&D, help bring in Foreign Direct Investment and contribute to improved
healthcare. As of now, patents can only be granted to new chemical entities. However, a
committee has been formed to study the patentability of Novel Drug Delivery System (NDDS),
polymorphs, metabolites etc.

Local manufacture
India not only produces pharmaceutical formulations but also manufactures over 400 Active
Pharmaceutical Ingredients (APIs) from the basic stage. An ancillary industry is also fully
developed, and a full range of pharmaceutical manufacturing equipment is locally produced.

The Pharmaceutical Industry in India has quality producers, and regulatory authorities in the United
States and the United Kingdom have approved many products. Today, India has the highest
number of U.S. FDA-approved manufacturing facilities outside the United States, and Indian
companies filed the highest number of DMFs with the U.S. FDA in 2007. The country has a pool
of personnel with high managerial and technical competence as a skilled workforce. Its track
record, particularly in the area of cost-efficient chemical synthesis for various drug molecules, is
excellent.

Other data
• R&D expenditure: USD 520 million, equivalent to 6.6% of pharmaceutical sales.
• Life expectancy during the period 1951-2008 has increased from 37 to 69 years. Infant mortality
(per 1000 live births) during the same period has come down from 150 to 34. Also, the death
and birth rates (per 1000 inhabitants) have come down from 25 to 6 and from 41 to 22
respectively during the same period.

Promotion of responsible self-medication

The OTC Committee of the Organisation of Pharmaceutical Producers of India (OPPI) is working
towards the promotion of responsible self-medication with a view to grow the OTC sector. It is
aiming to get regulatory support for issues such as the accessibility of household OTC remedies and
increasing the awareness of the importance of responsible self-medication with the general public
and the Government.

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17. ELECTRONIC INFORMATION
OPPI has a website (www.indiaoppi.com) with information on its activities.

Electronic information about the Indian market can also be obtained from the following websites:
• Ministry of Health and Family Welfare: http://mohfw.nic.in/
• Drug Controller General (India): http://mohfw.nic.in/ph/tdghs.htm
• Central Drugs Standard Control Organization (CDSCO): http://cdsco.nic.in/index.html
• Medicines laws: http://cdsco.nic.in
• Department of Chemicals (Ministry of Chemical & Fertilizers): http://chemicals.nic.in/
• National Pharmaceutical Pricing Authority (NPPA): http://nppaindia.nic.in/index1.html

18. INFORMATION KINDLY COMPILED BY:

Organisation of Pharmaceutical Producers of India (OPPI)
Peninsula Chambers, Ground Floor, Ganpatrao Kadam Marg, Lower Parel
Mumbai 400 013
India
Phone: +91 22 / 2491 8123 – 2491 2486 – 6662 7007
Fax: +91 22 / 2491 5168
E-mail: [email protected]
Website: www.indiaoppi.com