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Taking Innovations to the Market


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Title: Taking Innovations to the Market

Taking Innovations to the Market A Scientists
Avra Laboratories Pvt. Ltd. Hyderabad, INDIA
Golden Jubilee Celebrations of Indian
Drugs Mumbai Saturday, 8th March, 2014
The need for Self Reliance
  • After independence, to manufacture any new drug
    was not possible
  • because of prevailing system of product
  • The Indian consumer was denied the use of
    several life saving drugs which
  • were launched internationally.
  • Beecham introduced the semi-synthetic
    penicillin, Ampicillin in Europe in the
  • early 60s. They were unwilling to market
    this drug in India except on terms
  • and conditions which were not acceptable to
    Indian government.
  • Same was also the case with the Cardiac Drug,
    Propranolol, introduced by
  • ICI internationally in the mid 60s.

Indian Patent System
Indian Industry fought to amend the 1911 Patent
Act, resulting in the enactment of Indian
Patent Act 1970, passed in September 1972. All
product patents for Drugs and Agricultural
chemicals were abolished and only process patents
were allowed for a period of 7 years from the
date of filling or 5 years from the date of
acceptance, which ever is earlier It was a dawn
of a golden age of the Indigenous Pharma
Production of Diazepam
Original process of HOFFMAN-LA-ROCHE (USP.
3109843, dated 5-11-1963)
NCL Process
Commercialized by Cipla in 1973
Extraction of Natural Products Vinca Alkaloids
(Vinblastine and Vincristine)
(Anti Inflammatory, Anti Rheumatic)
BOOTS Process (GB 971 7002.2.1961)
Cheminors Approach
Vitamin B6 NCL Process
  • Initiated in 1959 prevailing price 460/kg
    aimed to bring down to 350/kg
  • Based on original Folkers Route 12 steps
    synthesis carried out on Pilot Scale.
  • Completed in 1963 - Vitamine B6 price
    dropped to 80/kg in 1960.
  • New Chemical Synthesis (Kondratyers of USSR)

Merck Process NCL approach (1965 - 73)
1960, Price 80/kg 1965, Price 55/kg 1970, Price
Project failed - RM price was higher than the
prevailing market price
Vitamin B6 NCL Process 1980-83
(Based on Roche approach)
Technology was implemented by Lupin in 1985
AIDS (Acquired Immunodeficiency Syndrome), is
caused by infection with Human Immunodeficiency
Virus (HIV). Twenty years ago, an AID Diagnosis
was equivalent to a death sentence. The
introduction of AZT, First AIDS drug in 1987
offered hope.   In 1985, Scientists at National
Cancer Institute found that AZT, a molecule first
synthesized in 1964 prevented HIV from
multiplying in cultured human cells.   US FDA
approved AZT for use against AIDS in early 1987
and Burroughs Wellcome began marketing the drug
under the trade name RITROVIR.   The initial
cost of AZT (A years supply) costs 10,000 USD
per patient.   Most of the under developed
countries cont afford.
Production of AZT
Rama Rao's approach
J. C. S. Chem. Commun., 1994, 1255 US Patent No.
5596087 (Jan 1997)
HIV/AIDS Drugs Indian Contribution
  • HIV virus has already affected over 45 million
    people world over in the last 2½ decades.
  • It is estimated by the United Nations that 80 to
    90 million Africans alone will die of AIDs by
  • In India HIV infected population may be more than
    25 million by 2020
  • Cipla marketed AZT in India in 1995 at a price of
    30 cents/tablet

HIV Drugs at Affordable Price
  • HIV was and is an Epidemic in South Africa. In
    2001, the cost of Anti-Retroviral Drugs (ARVs)
    range between 12,000 to 15,000 USD per patient
    per year.
  • In that year South Africa allowed generic
    production of ARVs for treating HIV patients,
    despite the fact they were covered by patents and
    40 MNCs bought litigation against South Africa
    for its act.
  • At that time Cipla offered to make them available
    at 300 per patient per year ( 1/40th cost)
  • After massive international protests in favour of
    public health rights, the Governments of several
    developed countries backed the South Africa and
    the case was dropped in April that year.

New Policy Challenges of U.S. Pharma Companies
  • Patients with HIV / AIDS, breast cancer and other
    diseases protested drug prices for life saving
    therapies and wanted speed in regulatory reviews.
  • They also confronted firms about their pricing
    policies. These have resulted in promolgumation
    of Orphan Drug Act of 1983 and new regulations
    that speed regulatory approval of drugs in
    1990s, especially that those of life saving
    drugs such as HIV/AIDS and Cancer.
  • In 1984 Drug Price Competition and Patent Terms
    Restorative Act (Hatch-Waxman) authorized US FDA
    to approve generics without additional
    preclinical or clinical testing.
  • This has resulted in initiating generic business
    by large firms. They also purchased generic
    firms to expand their international business.
  • Further, developing countries such as India and
    China took advantage of Hatch-Waxman act and made
    their appearance globally by offering generic
    drugs at much cheaper price compared to U.S. and
    European companies.

Indian Drug Industry Post 1972 Patent Era
  • In 1972, multinational companies controlled 70
    of the domestic pharmaceutical market.
  • Of the leading 50 pharma companies, 33 were
  • Now, the national sector occupies the leading
    position with 38 Indian companies in the top 50
    and controlling 80 of the market.
  • From Rs.10 crores in 1947 and Rs.360 crores in
    1972, it has crossed 100,000 crores (1.2 of the
    world pharma market)
  • Pharma exports crossed Rs.60,000 crores as
    against Rs.200 crores in 1972.
  • All this was possible due to the efforts of the
    indigenous pharma companies
  • Indian companies built up an enviable reputation
    for producing good quality drugs at affordable

Active Pharmaceutical Ingredients (APIs)
  • The present API market in the world 113
  • It is very competitive as there are more than
    2000 firms and they have 5000 manufacturing
  • Cipla is one of the first companies to fully
    develop and manufacture APIs and laid foundation
    for the pharmaceutical industry. In India they
    manufacture 200 generic API and reaching more
    than 170 countries world wide.
  • Dr. Reddys is another leading API manufacturer
    (60 APIs).
  • Ranbaxy produces 100 APIs and present in 65
  • Aurobindo manufacture 200 APIs and exporting to
    200 countries.
  • Sun Pharma manufacture 200 APIs at nine different
    places located in Hungary, Israel and the U.S.

Avra Laboratories Pvt. Ltd., Founded on 15th
August, 1995.Mainly devoted to RD Projects,
Custom Synthesis Manufacture
G.D. Searle Project
A case study for eliminating toxic substances
UREA DERIVATIVES (Anti Thrombiotic Agents) US
Patent 5484946 (1996) Filed June 1995
(Avra's first project initiated in 1996)
Avra Laboratories Pvt. Ltd.,
Pilot plant
Unit-1 (2000)
RD Centre, Nacharam, Hyderabad
RU 486 (Mifepristone)
For medical abortion (Avras First Commercial
Sune Bergström
  • RU 486 is a synthetic steroid used as an
    abortifacient in the first two months of
    pregnancy and in small doses as an emergency
  • The drug was initially made available in France
    and other countries followed often amid
  • RU 486 was discovered as a progesterone receptor
  • US FDA approved in 28th September, 2000.
  • Avra commercialised RU 486 in 2003 and
    exclusively supplied to Zydus Cadila for
    formulating and marketing in India.

Avra Laboratories Pvt. Ltd.,
Unit-2 (2005) Nacharam, Hyderabad
Fine Chemical Block
Camptothecin and its Analogs
Irinotecan CPT-(II) (Trade name Camptosar)
  • Irinotecan is one of a number of analoges
    developed to circumvent the undesired
  • properties of CPT - (I)
  • Irinotecan functions as the soluble prodrug for
    the active metabolite SN - 38.

Synthesis of Irinotecan from Camptothecin
Camptothecin CPT - (I)
7-Ethyl Camptothecin
IRINOTECAN yield 20 from CPT-(I)
SAWADA.et.al., Chem. Pharm Bull. 1991, 1446.
Avras Final Synthesis of Irinotecan and its
Key Intermediates
Avra Laboratories Pvt. Ltd.,
Unit-3 (2010), Visakhapatnam
Indian Patent Act 2005
  • India joined WTO and accepted TRIPS Mandate
  • Indian Patent Act 2005 was passed through an
    ordinance effective from 1st January 2005
  • Product Patents allowed for all sectors
  • Patentability of Inventions
  • Licenses of Right Deleted
  • Micro organisms to be made patentable
  • Compulsory licenses for domestic use as well for
    export against third party licenses
  • Pre and Post-Grant opposition provisions included

Post 2005 I.P. Issues
  • Drugs with Incremental changes not worthy of
    exclusive rights.
  • Ex Indian supreme court did not permit
    the validity of patent of Novatis Anti-Cancer
  • drug, GLIVEC (Imatinib) as it has
    improved version and not a new invention.
  • However this drug received patents in 38
  • 2. Compulsory licensing for Anti-Cancer Drugs
  • India issued its first compulsory
    licensing in March 2012, when Natco Pharma won
  • the right to manufacture Bayer AGs
    Anti-Cancer Drug, NEXAVAR.
  • Recently Inidas health ministry
    recommended for compulsory licensing of three
  • cancer drugs.
  • Trastuzumab (Breast cancer), Ixabepilone
    and Dasatinib (Leukamia). If this is
  • accepted, these products will be available
    at a fraction of original price.

Health Benefit for All
  • Japans Eisai Pharma is expected to launch in
    India, its novel anti-cancer drug Eribulin, sold
    under the brand name of Halaven. It is used in
    the treatment of third line metastatic Breast
  • The company has divided patients in to three
  • The lower income group will get the drug free.
  • The middle income patients will be eligible for
    discount on the full price.
  • The rich patients will be asked to pay full
  • Indias Oncology market is estimated to be close
    to Rs.700 crores and growing at 20. It is
    estimated to touch Rs.3000 crores by 2017.

Tuberculosis (T.B.) Major Killer in India
  • WHO Global T.B. report of 2012 indicates that
    T.B. kills one person every two minutes in India
    and 750 people every day.
  • It is a very serious disease and annually
    3,30,000 Indian die due to the T.B.
  • In the world, an estimated 8.6 million people
    developed T.B. 1.3 million died.
  • Dr. Wadia (Hinduja Hospital) was the first to
    describe totally drug resistant T.B. from India,
    building up to a new sense of urgency.
  • India is the Worlds largest T.B. drugs producing
    countries and marketing. All the four major
    drugs (Etambutol, Rifampicin, INH, Pyrazinamide)
    are manufactured by Lupin (Mumbai).
  • No new T.B. drug was developed for almost four
    decades after discovery of Rifampicin.
  • Recently Johnson Johnson discovered,
    Bedaquiline (US FDA Approved) for MDR T.B. Drug.

Malaria Major Threat to Developing Countries
  • As per the World Health Organisation, 219 Million
    cases of Malaria were reported, resulting in
    about 800,000 deaths. 90 of which occurred in
    Africa. This is the main cause of death for
    children under five, claiming every 45 seconds.
  • Although Malaria is preventable and treatable,
    life saving drugs do not always reach the
  • Ranbaxy had launched the countrys first
    indigenously developed Anti-Malarial Drug Synriam
    against Plasmodium Vivax, a strain responsible
    for almost half of Malaria infections in the
  • Synriam (3 tablets Rs.130/- is a three day
    course) - It is a mixture of Arterolane Maleate
    and Piperaquine Phosphate.

Affordable and Convenient Treatment for
Patients(Cardiovascular Disease)
  • Ex Polypill New concept development by DRL,
  • Polypill contains Aspirin, Cholesterol lowering
    and Blood Pressure lowering drugs.
  • The recent study involving a 1000 patients from
    India and a 1000 from Europe (UK, Ireland and
    Netherlands) were randomly assigned either the
    Polypill or their normal combination of
  • The Polypill group had lower Blood Pressure and
    Cholesterol measurements.
  • Heart disease is a leading cause of premature
    death and disability in India and is growing at
    Epidemic proportions.
  • The Late Dr. Anji Reddy was keen to provide an
    affordable convenient treatment package to
    patients in India and elsewhere.


Indian Pharmaceutical Industry Current Status
  • It ranks 3rd in terms of volume of products
    with 10 global share and 14th largest
  • by value (1.5). This is because drug prices
    are lower in India to the extent of
  • 25-50 compared to developed countries
  • The country has more then 100 manufacturing
    facilities approved by US FDA.
  • The US FDA official figures indicate that 6300
    active Drug Master Files (DMFs)
  • with the regulatory body, of which 26 or
    1,700 are from Indian companies
  • The country has also a major share in the
    Abbreviated New Drug applications
  • (ANDS) filled with US FDA for marketing
    generic products
  • Indian API manufacturing industry moves forward
    (average growth of 19
  • during the last 5 years) to meet the worlds
    need for high quality products at
  • competitive prices.

How Indian Economy Changed
1971 Socialist India 2011 A Flourishing
market economy
  1970-1971   1990-1991   2010-2011  
GDP (Rs. Lakh Crores)   Rs.4.7   Rs.10.8   Rs.48.8
Per Capita Income (at constant prices)   Rs.8,091   Rs.11,535   Rs.41,129
  Forex Reserves   0.97 bn   5.8   274.0
  Exports   2.1 bn   18.0   254.0
  FDI   -   0.13 bn   30.3
Number of Passenger cars   36,032   0.18 mn   2.9 mn
Pay Cheques (Cabinet secretarys monthly salary)   Rs.4,000   Rs.30,000   Rs.90,000
Life Expectancy at Birth
  1950 2000 2010
India 40 years 61 65
Indian Men   60 63
Indian Women   62 66
World Wide   66 68
  • Today India has nearly 117 Million people over
    60 years
  • This is because of amazing progress in Medical
    Biological Research
  • Major challenges are
  • New life style aliments such as Heart
    diseases, Hypertension, Cancers and Diabetes.
  • These are major cause of all deaths by 2030

Surely, Science is not merely an individuals
search for truth. It is something infinitely more
than that. It must have a social objective
before it. Pandit Jawaharlal Nehru (1947)
My idea of better ordered world is one in which
medical discoveries would be free of patents and
there would no profiteering from Life or
Death Indira Gandhi At WHO, Geneva, 1981

Council of Scientific and Industrial Research
All the three DGs of CSIR (1985 95) And three
directors of NCL (1960 85) All My Ph.D.
Students and Colleagues From NCL IICT
K Venkataraman Former Director, National Chemical
E J Corey Professor of Chemistry Harvard
University, USA 1990 Nobel Prize for Chemistry
Dr. Y. K. Hamied Chairman, Cipla Limited
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