INDIAN PHARMAStatus and Opportunities for Production, Investment & Trade in SME Pharma sector in India

Lalit Kumar Jain Sr. Vice Chairman SME Pharma Industries Confederation (SPIC) India

SME Pharma Industries Apex body of Small and Medium scale

formulators and bulk drug manufacturers Over 2,300 active members besides 3,000

associate members Over 7,000 in SME sector out of about

10,000 licensed drug manufacturers in India

SME share is 87% in production by volume and 40% share by value in the market

Situation India has one of the lowest per capita income in

the world Though prices are low but still most drugs are

unaffordable, or take the bulk of the income Majority of medicines are inaccessible through

public health outlets Perfect competition not happening in

pharmaceutical trade in India, due to distorted information and perception of the market.

Doctors prescribe expensive branded drugs for personal gain; but price paid by poor patients.

Situation ( contd.) Most expensive is the most popular

brand of a drug Myth: medicines of lower prices cannot

be of good quality Distorted Media reports are planted by

multinational and large firms SMEs remain neglected, even after

providing quality medicines at competitive prices as market is controlled by branded drugs

Quality Issue No unit is licensed to manufacture drugs

and medicines without being GMP compliant

Indian GMP standards are more stringent than most developed countries

No facts in Media reports that India source of 40% spurious medicines in the world

SME manufacturing 89% of USA based companies’ drugs in India

No difference in branded, unbranded generics, pharmacopoeial generics drugs, except prices; since all are manufactured according to the official pharmacopoeias

Access to Quality Analytical Tools Dedicated centre known as SMPIC centre at NIPER, Mohali (Punjab); more than three hundred PhD thesis, about 18,000 articles in scientific journals, SciFinder (STN) facilities. • 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

Quality yet Affordable SME, HOW? Good education and vast talented human

resource pool 350 based API medicines, identified as essential

medicines to meet 90% requirement of a patient SMEs practice spot management rather than

remote control management Well established excipient industry Only sector in India where government tender

procurement prices are 1/3 of the retail market prices

Opportunities For venture capital investments For companies abroad to cut their costs

by procuring from SME sector For Joint ventures For upcoming markets to source

technology requirements

THANKING YOULalit Kumar Jain