india pharma summit speech dt 30.11.09

8/14/2019 India Pharma Summit Speech DT 30.11.09

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TEXT OF SPEECH

By

Lalit K. Jain,

Vice-Chairman, SME Pharma Industries Confederation (SPIC) atINDIA PHARMA SUMMIT

Held at

Mumbai, India

On Nov 30, 2009

India Pharma Status and Opportunities for Production, Investment & Trade

Respected Secretary of Department of Pharmaceuticals, Ladies and Gentlemen:

SME Pharma industries confederations is a apex body of small and medium scale

formulators and bulk drug manufacturers of medicines. We have over 2,346 active

members besides 3,000 associate members, which when coupled with other small scale

SME associations add to a total of over 7,000 members out of total 10,563 licensed

manufacturers in India. We account for 87% production by volume and 40% share by

value in the market.

The founder of our nation Sh. Mahatma Gandhi not only give us freedom of speech,

democracy but also give us freedom from economic dependence from foreign goods ofthe British. In a short Span of 62 years Indian Pharmaceutical Industry has grown many

fold and produce medicines of highest quality and affordability not for India alone but for

the whole human mankind whether in developed countries all in developing countries.

We are in a way self sufficient in our requirements of medicines.

Prices of medicines in India are one of the lowest priced and still this is because we have

one of the lowest per capitals income in the world.

Not only a large number of people cannot afford medicines but often have to pay

comparatively significant amounts of their wages or money taken on loan or purchase

medicines that they can ill afford. Also the majorities of medicines used are not

accessible through public health outlets and so have to be out of pocket expense.

In markets where perfect competition works, the most bought is the cheapest brand.

Competition brings down prices. Sellers and buyers are equally well-informed about the


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product before making a purchase. However, in pharmaceutical trade the purchase

decision is not of the consumer.

Therefore, the most popular brand of a drug is also often the highest priced. (In terms of

cars, this would mean a majority buys Mercedes and not Suzuki 800.)

The purchase decision here rests entirely with the doctor which the SME sector funds

difficult to tap.

Pharma is the only sector in India (and probably in the world) where government tender

procurement prices are 1-3% of the retail market prices! This if anything indicates the

level of overpricing by MNC & large firms. An example: for the Tamil Nadu

Government, a drug company bids to supply Albendazole 400 mg tablets, a medicine for

worms, at a mere 1 cent per tablet, while brands of this drug sell for 40 cents in the

market.

Today the choice of reliability, quality and affordability of medicines are the need of

human mankind all over the world. Often it is thought that medicines at lower prices can

not be of highest quality and it is often said that how is it possible that India with in a

span of 62 years against pharmaceuticals companies in the west which have been in

existence for more than 200 years, could give the human mankind quality medicines at a

fraction of the prices. The apprehensions are raised in media reports prompted by

multinational and large firms as their competitiveness is threatened by reasonable pricing

of SME units in India.

I will now take up the quality issue:

1) No manufacturing unit in India is licensed to manufacture drugs and medicines

without being GMP complied.

2) The Indian GMP standards are more stringent than some of the so called

standards laid down by the developed countries in infrastructure requirement,

validatiory procedures and Good Laboratory Practices etc.

3) Large scale media reports had tried to project India as a destination of nearly

40% spurious medicines in the world. These reports are base less and without

any evidence and proof. The Indian drug regulatory authority picks up around

40,000 to 50,000 samples of medicines every year and only 0.03% of the

samples have found to be of doubtful quality SEARO, WHO report also put the

figures of doubtful medicines at 0.29%. Due to media onslaught the Indian drug


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control authorities picked in 2009 up over 24,000 samples of medicines as per

independent scientific plan of the Indian Stastical institute, Hyderabad and only

11 samples were found to be of doubtful quality which is 0.004%. In every

country there are dandestine manufacturers of fake products like watches,

electronic goods etc., however in India, if there are a few such persons the total

percentage of doubtful medicines is till 0.004%.

4) USA based companies in India are meeting 89% of their requirements from

SME sectors. The top US based companies in India like Pfizer, Wyeth,

Sehering Plough, Novartis, Sanofi Aventis are getting manufactured their

medicines from the SME sectors in India and are likely to increase their share

of procurement from SME sector Pharma companies further for export to USA

and Europe to counter the medicines exported by Indian large companies to

their home countries?

5) All medicines, whether branded, branded generics or pharmacopoeial generics

are manufactured as per strict standards laid down in pharmacopeias of USA,

EU, India or Japan. The myth that branded medicines offer one a superior

medicine is floated to support unethical high promotional and administrative

expenses, when all medicines are manufactured as per pharmacopeias, it is

wrong to say branded generics or pharmacopoeial generics are inferior in any

way. I would openly throw a challenge to prove that pharmacopoeial standard

medicines have proved to be fatal to the patient or inferior to branded medicine.

6) Indian SME Pharma sector has dedicated centre known as SMPIC centre at

NIPER, Mohali and have access to sophisticated analytical instruments like 400

MHz FT NMR (Bruker), MALDI TOF-TOF (Ultra Flex, Bruker), Linear Ion

trap LC-MS/MS (Thermo LTQ-XL), Ion trap LC MS/MS (Finnigan Mat)

GC-MS with Auto Sampler (Shimadzu), GC MS/MS with Auto Sampler

(Thermo), GC with Head Space (Shimadzu), Powder XRD (Bruker), Capillary

Electrophoresis (Beckman), FT-IR with ATR (Nicolet), FT-IR with

microscope, ATR, Hot plate, SMS system (Perkin Elmer), UV-VIS

Spectrophotometer etc. The 333 PhD Thesis, 17,848 bound scientific journals

SciFinder (STN) facilities and services of 109 PhD students and 275 MSstudents are also available to SME sector in India in their quest to improve in

house specifications over and above the pharmacopoeial specifications along

with research for new molecules.

Now I would like to enlighten this August gathering has to how the quality medicines are

affordable:


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1) India has over 300 recognized colleges and 250 unrecognized colleges which

churns out nearly 30,000 to 40,000 B. Pharma students every year besides 3,000

M. Pharm / MS students, chemical engineers, biologist, Biotechnologist and

thousands of MBA students for the pharmaceuticals industry in India. These

professionals are available at 10% of the cost of a similar professional in USA.

The part of these professionals every year even migrate to the pharmaceutical

industry of USA and the majority of the same talented professionals prefer to

stay in the country.

2) Around 354 based API medicines in India have been identified to be essential

medicines, which meet over 90% of the medicine requirement of a patient.

India capability to produce this medicines is exhorting and we have still spare

capacity to meet further requirements at reasonable prices, much cheaper then it

would cost in USA, EU and the developing countries.

3) The SME Pharma sector in India has a talented pool of pharmacist,

entrepreneurs who practice spot management rather than remote control

management as in the multinationals and large Pharma firms and therefore keep

their costs down benefit of which is transferred to the patient.

4) We have a well established excipients industry, Empty Gelatin capsule units,

packaging industry which even caters to units abroad.

We in the SME Pharma sector in India feel that providing quality medicines at affordable

prices is our social commitment to our people rather than using the suffering of human

mankind to fill the offers on way of high promotional and administrative expenses in by

resorting to the Maximum Retail Prices of medicines by illusionary and unethical

practices. We offer to the world quality and affordable medicines with made in India

label at fractional cost at which it is available in their country.

Non tariff barriers like free trade agreements, regulatory measures and campaigns like

counterfeit and falsified medicines are being advocated to crush the competitiveness of

Indian Pharma industry.

Opportunities

1) Opportunities exist for investment in these small and medium scale enterprises.

Due to their scale of operation smaller investments can result in faster success

rates.


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2) Opportunities exist for companies abroad to procure and source their

requirements from the SME sector which shall not only result in bringing down

their cost but also ample availability and lower patient to expenditure in their

country while ensuring quality.

3) Joint venture

4) Upcoming markets can source their technology requirements from the SME

sector in India.

Challenges

At the same time the sector poses to be a challenge because the industry requires

tremendous capacity building in terms of awareness building, guidance, projectpreparation, implementation, technological intervention and monitoring.

I request the August audience from the government to accord SME Sector in

pharmaceutical industry a thrust status.

india pharma summit speech dt 30.11.09

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