Taking Innovations to the Market – A Scientist’s Journey. A V RAMA RAO. Avra Laboratories Pvt. Ltd. Hyderabad, INDIA. Golden Jubilee Celebrations of “Indian Drugs” Mumbai Saturday, 8 th March, 2014. The need for Self Reliance.
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A Scientist’s Journey
A V RAMA RAO
Avra Laboratories Pvt. Ltd.
Golden Jubilee Celebrations of “Indian Drugs”
Saturday, 8th March, 2014
because of prevailing system of product patents.
were launched internationally.
early 60’s. They were unwilling to market this drug in India except on terms
and conditions which were not acceptable to Indian government.
ICI internationally in the mid 60s.
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 Industry.
Original process of HOFFMAN-LA-ROCHE:
(USP. 3109843, dated 5-11-1963)
Commercialized by Cipla in 1973
(Vinblastine and Vincristine)
(Anti Inflammatory, Anti Rheumatic)
BOOTS Process (GB 971 700:2.2.1961):
Merck Process: NCL approach (1965 - 73)
1960, Price $80/kg
1965, Price $55/kg
1970, Price $30/kg
Project failed - RM price was higher than the prevailing market price
(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 con’t afford.
Production of AZT
Rama Rao's approach:
J. C. S. Chem. Commun., 1994, 1255
US Patent No. 5596087 (Jan 1997)
A case study for eliminating toxic substances
(Anti Thrombiotic Agents)
US Patent: 5484946 (1996)
Filed June 1995
(Avra's first project: initiated in 1996)
R&D Centre, Nacharam, Hyderabad
For medical abortion (Avra’s First Commercial Product)
Fine Chemical Block
(Trade name: Camptosar)
properties of CPT - (I)
CPT - (I)
yield 20% from CPT-(I)
SAWADA.et.al., Chem. Pharm: Bull. 1991, 1446.
Unit-3 (2010), Visakhapatnam
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 countries.
2. Compulsory licensing for Anti-Cancer Drugs:
India issued its first compulsory licensing in March 2012, when NatcoPharma won
the right to manufacture Bayer AG’s Anti-Cancer Drug, “NEXAVAR”.
Recently Inida’s health ministry recommended for compulsory licensing of three anti-
Trastuzumab (Breast cancer), Ixabepilone and Dasatinib (Leukamia). If this is
accepted, these products will be available at a fraction of original price.
Ex:Polypill: New concept development by DRL, Hyderabad.
by value (1.5%). This is because drug prices are lower in India to the extent of
25-50% compared to developed countries
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
(ANDS) filled with US FDA for marketing generic products
during the last 5 years) to meet the world’s need for high quality products at
1971 – Socialist India
2011 – A Flourishing market economy
New life style aliments such as Heart diseases, Hypertension, Cancers and Diabetes.
These are major cause of all deaths by 2030 (75%)
“Surely, Science is not merely an individual’s 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”
At WHO, Geneva, 1981
Acknowledgement for truth. It is something infinitely more than that……. It must have a social objective before it.”
Council of Scientific and Industrial Research
All the three DG’s of CSIR (1985 – 95)
And three directors of NCL (1960 – 85)
All My Ph.D. Students and Colleagues
From NCL & IICT
National Chemical Laboratory
E J Corey
Professor of Chemistry
Harvard University, USA
1990 Nobel Prize for Chemistry
Dr. Y. K. Hamied
Chairman, Cipla Limited