NCL’s association with pharma industry dates back to mid-1960s when
products such as berberine hydrochloride, hexylresorcinol,
4-hydroxycoumarin, phenoxyacetic acid, acetanilide, diethylstilbestrol,
vitamin C, sorbitol, acriflavine, calcium hypophosphite, emetine,
l-menthol, opium alkaloids, sodium cyclamate were manufactured by mostly
private industries, besides public sector units like Hindustan
Antibiotics Ltd., Pune and Govt. Opium Factory at Neemach and Gazipur
based on NCL’s know-how.
Allowing senior scientists to guide as
many research students as possible in its formative years resulted NCL
becoming a centre of excellence in all fields of chemistry and chemical
engineering. The research groups in natural products chemistry under Dr.
Sukh Dev and Dr. S.C. Bhattacharya brought international recognition to
NCL and formed a backbone for qualified manpower for pharma sector.
In
1970 much of the country's pharmaceutical consumption was met by
imports and the bulk of domestic production of formulations was
dominated by MNC subsidiaries. The process to discover a new drug was
expensive and ranged from five to 10 years. The liberalised Indian
Patent Law of 1970 helped both the national laboratories and the Indian
pharmaceutical industry to develop alternative innovative processes for
several drugs which were either insufficiently available or totally
imported.
Realising the vital role that organic chemistry can
play in the synthesis of drugs, emphasis was laid at NCL mainly on
development of technologies for various drugs and drug intermediates
under the leadership of Dr. A.V. Rama Rao, Dr. N.R. Ayyangar, Dr. T.
Ravindranathan, Dr. S. Rajappa, and Dr M.K. Gurjar. The main aim was to
find new and innovative synthetic routes which will ultimately lead to
up-to-date and economic technologies. To achieve this objective, NCL
encouraged drug industry to sponsor specific time-targeted and
well-identified projects to develop processes for established drugs
which were either exclusively imported or insufficiently made in the
country. The response from drug industry in this respect was highly
encouraging and a number of such projects covering a wide range of
products were developed at NCL and successfully transferred to drug
industry. NCL’s research programme was aimed at developing efficient
chemistries for producing cost -effective drugs for Indian consumers.
Over
the years, NCL has built an unprecedented reputation in chiral
synthesis. A chiral drug offers distinctive benefits, particularly in
the form of reduced dosage for the same efficiency as the conventional
drug. Chiral form of a drug diminishes the side effects due to the
removal of unwanted enantiomer. NCL also provided the processes for the
chirally active part of the drugs.
NCL's research programme
covered a wide product spectrum including anti-infective agents,
antimalarials, analgesics, anti-inflammatory drugs, antiasthamatics,
beta-blockers, calcium antagonists, other drugs for cardiovascular
diseases, antidepressants, beta-Lactam antibiotics, anticancer drugs and
some important drug intermediates.
While synthesizing a known
drug by a new route NCL evolved novel approaches that offered economic
benefits such as minimising number of reaction steps, avoided handling
of hazardous chemicals, ready availability of raw materials etc. Indian
companies also successfully faced challenges from innovator companies in
Africa for introducing HIV/ AIDS drugs at a fraction of global cost.
NCL
guided the Indian pharmaceutical industry in various ways in their
formative years. NCL provided institutional consultancy to the Indian
pharma industry, besides NCL scientists were on the board of directors
of a few pharma industries. NCL scientists are involved in identifying,
funding research proposals for the Govt. funding agencies such as
Department of Biotechnology (DBT), Department of Science and Technology
(DST) etc. NCL scientists also act as members of Govt. committees on
regulating import duties, drug price control for pharma sector,
recognising in-house R&D units established by corporate industry
etc.
NCL’s contribution to Indian pharma sector was recognised by
conferring prestigious ICMA /ICC Acharya PC Ray Award for development
of indigenous technology and Vasvik award besides other innumerable
awards on multiple occasions.
NCL’s contribution to the Indian
pharma Industry can be summed up by the comments of Dr. Y.K. Hamied,
Chairman, CIPLA Ltd in his speech at IICT, Hyderabad on April 2, 2005,
“This was the start of a very useful and productive partnership between
NCL and the pharmaceutical industry. Our collective effort in the post
Indian Patents Act 1970 era laid the foundation on which was built the
API manufacturing industry as it exists today”.
Acknowledgements:
I thank Dr. S. Sivaram and Dr. Ganesh Pandey for helpful suggestions
and Dr. R.A. Joshi for his help while writing this article.
The author is head of Publication and Science
Communication Unit, National Chemical Laboratory , Pune