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DRUGS DEVELOPED In INDIA.

Posted on August 29, 2016 By Dr Rakesh Sonawane

29 Aug 2016

Centchroman (Non-steroidal oral contraceptive)

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The ever increasing population burden has devoured all the benets that India gained due to rapid Industrial and
agricultural development after the independence. The population growth has been the prime concern of the

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planners. It is no surprising that the concern for having smaller families has been equally, if not more, widespread
among the scientic community as well as the decision makers of the nation. Even though the educated and

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otherwise population of the nation has been convinced of the need of having smaller children, there were hardly
safer and acceptable method to restrict population growth. Safer antifertility drugs were the main motto of all
research on antifertility projects.

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CDRI, being one of the leading research labs of the country had obviously put enough attention and intellectual
resources to develop safer and acceptable antifertility drugs. One of the main focus was to have an alternative to
steroidal pills available in the market which were not free from side effects.

Drugs Approved by FDA in 2015

FDA approves biosimilar to
etanercept for inammatory
diseases.

The need for a safer alternative to Progestogen Estrogen combination pills has been felt ever since the sixties.

DRUGS DEVELOPED In INDIA.

Clearer understanding of the role of estrogen-progesterone balance in the development of fertilized ovum and the
priming of the uterus for implantation served as the basis for developing an agent that would prevent pregnancy by

LIST OF NEW DRUG APPROVED BY

CDSCO in 2016

interfering with implantation but without disturbing the hypothalamus-pituitary-ovarian axis. Researchers the world

New Drug Approved for Diabetes.

over have been designing and synthesising non-steroidal estrogen antagonists that would act by disturbing the
delicate balance between estrogen and progesterone at the uterine level without interfering with their synthesis or
blood levels. This task was sucessfully completed by CDRI when the rst non-steroidal once a week pil, centchroman
was devloped by CDRI taht reached the general public by the end of the 1980s.
Centchroman is a novel non-steroidal agent unrelated to any conventionally used contraceptive. This is the only antiimplantation agent approved for clinical use in the world. It offers a unique combination of weak estrogenic and
potent antiestrogenic properties. Due to this subtle mix of estrogenic and antiestorgenic action it inhibits the
fertilized ovum from nidation and thus prevents pregnancy, but at the same time it does not appear to disturb the
other estrogen effects.
Use of Centchroman as a contraceptive has been extensively evaluated in more than 2000 women of the reproductive
age groups who wanted to space their children. Intensive monitoring by clinical examination, haematology and
biochemical tests as well as laparascopy and ultrasonographic examinations of ovaries and uterus have shown the
drug to be quite safe. Centchroman does not cause nausea, vomiting, dizziness and break through bleeding and has
no adverse effect on lipid prole and platelet function as is seen with steroidal contraceptives. Babies born to use
failure cases have shown normal milestones. The contraceptive effect is readily reversible and subsequent pregnancy

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and its outcome is normal. It scores over steroidal contraceptive pills because it does not disturb the endocrine
system and the normal ovulatory cycle is maintained.

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Dr.RakeshSonawane

SAROGLITAZAR

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Discovered and developed by Zydus, Saroglitazar is a rst-in-class molecule to be approved by the Drug Controller
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General of India to treat diabetic dyslipidemia or hypertriglyceridemia in type-2 diabetes not controlled by statins

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alone. Researched & developed over a span of 12 years, LipaglynTM is the rst New Chemical Entity (NCE) from India
to successfully complete the journey from the lab to the market.

30Aug

CENTBUCRIDINE
Surgeons all over the country had been experiencing the need of a more effective and safer low dose local
anesthetics. The currently available local anesthetic agents were not very quick in action and the duration of

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anesthetic effect was also not very long.

CDRI drug research programme has addressed to this need of the country and has come up Centbucridine. This
compound is not only safer and more effective than the currently available local anesthetic, lignocaine but also has
features that give it better acceptability. This drug is a totally new chemical moiety and has no relation whatsoever
with lignocaine.
Centbucridine is superior to lignocaine in many aspects. Centbucridine has been found to possess several desirable
properties. As compared to lignocaine, it is 4 to 5 times more potent, its onset of action is much quicker, and the

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duration of action is longer. Due to its vasoconstrictor activity, it does not require simultaneous administration of
adrenaline. It does not effect the cardiovascular parameters due to its moderate antihistaminic activity and is not
likely to show skin sensitivity. Moreover, it can be used in patients showing hypersensitivity to lignocaine.
It had earlier been licensed to Themis Chemicals Ltd., Mumbai which marketed it under the brand name Centoblok.

Archives
August 2016(4)
July 2016(2)

ARTEETHER
Arteether is a semi synthetic derivative of artemisinine, the active constituent of the plant, Artemisia annua. CDRI
conducted extensive preclinical, toxicological and other regulatory studies in which the drug was not only found to be
very safe but also proved to be a fast acting, blood schizontocidal agent which attacks at the erythrocytic stage of
malaria in blood. Extensive clinical trials were conducted at 7 centres in malaria prone areas of India. Over 500
patients showed excellent response and the recrudescent rate was very low. Arteether has been developed by CDRI
and is being prescribed to the patients as second line of treatment for chloroquine-resistant P. falciparim malaria
including cerebral malaria.

June 2016(9)
May 2016(10)
April 2016(15)
March 2016(10)
February 2016(5)
January 2016(3)
December 2015(10)
November 2015(8)
October 2015(5)

Though choloroquine has been and still remain one of the most extensively used rst line drug for malaria,

September 2015(9)

resistance against this drug is quite frequent. Search for a drug which could be more effective than chloroquine and

August 2015(7)

which could minimize the chance of resistance development has been going on the world over. CDRI has always been

May 2015(5)

quite in the forefront in searching for natural or synthetic drug that could be used as a weapon to ght malaria since

April 2015(6)

it is causing so much of devastation in tropical countries, especially India. Many plants used by traditional systems of
medicine have been tried and many of the leads are being pursued.
CDRI got a major success when it developed Arteether from the plant Artemisia annua while working in collaboration
with, Central Institute of Medicinal and Aromatic plants (CIMAP), the other CSIR laboratory based at Lucknow.
The Drugs Controller General (India) has allowed the drug exclusively for use in hospitals and nursing homes.
Being a new drug, it is indicated for use only in severe P. falciparum malaria including cerebral malaria as a second

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line treatment for chloroquine resistant cases. It is not recommended to be used as a rst line treatment for malaria
to avoid its overuse which may lead to the emergence of resistance against this drug once again.
CDRI has licensed the drug to Themis Chemicals Ltd., Mumbai which is marketing it under the trade name E-Mal as an
injectable formulation.
Post marketing surveillance data on 400 patients received from clinicians from 6 states has validated the efcacy and
safety of Arteether in uncomplicated/complicated cases of P.falciparum malaria. No drug related side effects have

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been observed so far.

EBULAQUIN (Aablaquine)

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The Central Drug Research Institute has developed an antimalarial Drug given in house number Compound 80/53

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and allotted International Nonproprietary Name (INN) as Bulaquin which is a primaquine derivative.
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Primaquine is the only drug available for use as anti-relapse, antimalarial for prophylactic in P.vivax malaria.

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However, this drug causes many side effects and the most commonly cited effect is methaemoglobinaemia in patients
with G6PD deciency. Higher doses of primaquine cause methaemoglobinaemia in most subjects and leukopenia in

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some. However, there is a small fraction of black population with G6PD deciency who develop anaemia due to
intravascular haemolysis at daily dose levels of 15 mg (base) and above.
It is being increasingly felt that the eroding efcacy of commonly used antimalarials has contributed substantially to
the resurgence of malaria during last three decades. Although new antimalarials have appeared in the market during
this time, none has yet supplemented chloroquine. There are no drugs in the market or in advanced stages of
development that appear to be as well tolerated as chloroquine.
Combinations of existing antimalarials especially those now available in rural clinics and market hold great potential
for effective, self-administered therapies for uncomplicated malaria, particularly where relapses are frequently
encountered. Applying combined therapies to the problem should demand a high standard of proof of safety and
efcacy in randomised double blind, placebo controlled trials.
Bulaquin is without any side effects that have been observed with primaquine. A comparative data analysis on initial
(0 day pre-drug) and nal (+7 day post-drug) values of haemoglobin, methaemoglobin, prothrombin time, partial
thromboplastin time and brinogen in healthy human subjects treated with primaquine (15 mg OD x7 days) and
Bulaquin (25 mg OD x7 days) have been carried out. The study has shown that one week primaquine treatment leads
to rise in methaemoglobin levels from 3.97% to 16.32%, which is highly signicant in comparison to the 2.29% and
3.02% levels of methaemoglobin before and after 7 days treatment with Bulaquin respectively. Thus, it is evident that
primaquine treatment produces rise in methaemoglobin contrary to Bulaquine does not produce rise in
methaemoglobin levels. This result manifests a clear superiority of Bulaquin over Primaquine.
Bulaquin has been licenced to Nicholas Piramal India Ltd., Mumbai for marketing. Nicholas Piramal has introduced
Bulaquin alongwith chloroquine into the market as a combination pack under the trade name Aablaquine. The
objective of the combined therapy is to control P.vivax malaria more effectively by providing initial cure and
thereafter preventing relapses by use of this combination pack. It is hoped that the introduction of this combination
pack of Bulaquin should contribute substantially to the ongoing National Malaria action programme advocated by
Government of India.

GUGULIPID (Hypolipidaemic)

CDRI has developed gugulipid, a cholesterol lowering drug taking the lead from ancient Indian system of medicine,
Ayurveda. The Drug has been developed from the plant, Commiphora mukul.
Ayurvedic Practitioners have been utilizing the gum of the tree of Commiphora mukul commonly known as Gugglu.
Ayurvedic literature also mentions the gugglu as a drug for the treatment of goutt, arthritis, rheumatism and lipid
disorders.
The establishment of promising hypolipidaemic activity in a non-toxic fraction of guggulu led to the identication of
the active constituents, gugulsterones. However, as the fraction was equally active as the individual active entities,
this fraction designated Gugulipid has been developed as a drug. Gugulipid passed through all the three phases of
clinical trials successfully and was found to possess hypolipidaemic activity comparable to the present drug of
choice, Clobrate.
Clinical trials conducted on a large number of patients have clearly indicated the supremacy of gugulipid over other
drugs due to absence of any signicant side effect. The cholesterol lowering effect is also quite remarkable

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The use of Gugulipid led to the average reduction in serum cholesterol and triglycerides by 24% and 22% respectively
and there were 80% responders in a group of 330 hyperlipidemic patients. As clobrate is on the verge of being
phased out on account of toxic manifestations, there is a scope for introduction of Gugulipid at international level.
The future of this material as a drug will, however, depend on the availability of the plant material.
Drug controller General of India, after the three phases of clinical trials approved the drug for marketing in 1986.
Guggulipid is being manuactured and marketed by Cipla Ltd, Mumbai under the brand name Guglip.

MEMORY ENHANCER (Standardised Brahmi)

Since the time of Vedas, Brahmi, a perennial creeping plant (Bacopa monnieri) has been in use as a nerve tonic for
rejuvenating mental health and for enhancing memory. This plant, found extensively in wet, marshy and damp areas,
has been mentioned by ancient sages, medical men in almost all social, medical and religious treatises. Ayurveda, the
ancient science of life has more than one reference of the plant for the enhancement of memory and mental agility
of mankind. The famous Charaka Samhita written in the 1st century refers this plant for curing mental retardation
leading to psychosis. Pharmacological properties of this plant have been clearly mentioned as having properties of
cognitive enhancement and anxiolytic effect. The other treatise Sushruta Samhita makes this more explicit and
describes Brahmi to be effective in memory loss.
Initially, CDRIs interests in Brahmi were prompted by its effect on learning and memory described in ancient
Ayurvedic treatises. The early systematic studies carried out at the institute were very encouraging and therefore, it
was taken up for detailed investigation of active plant component and pharmacological and other studies.
Subsequently, it was decided to develop the plant as a herbal remedy. As a result, a quality herbal preparation has
been developed from B. monnieri which has been standardised in terms of its bacosides contents.
During efcacy and safety studies in rodent and non-rodent models, the Brahmi extract was found safe and
efcacious. Preclinical neuropharmacological studies demonstrate that both the standardised extract and bacosides
improve short-term and intermediate memories, thus , improving the long-term memory. The bacosides also
signicantly enhance protein synthesis in those regions of the brain which are implicated in the memory formation, a
possible explanation for its memory improving effect.
Double blind cross over clinical studies have been carried out in children, elderly persons and normal healthy
volunteers. Studies carried out in normal healthy volunteers, elderly subjects with age associated memory
impairment and children with attention decit hyperactivity disorder (ADHD) have shown that the drug is safe, well
tolerated, efcacious and devoid of any side effects. Study on children with ADHD has shown that the preparation ,
after 12 weeks of its use, signicantly improves sentence repetition, logical memory and paired associate learning.
This standardised preparation has been licensed to M/s Lumen Marketing Company, Chennai, for commercialisation.
They have launched the preparation in the market under the brand name Memory Sure .

Isaptent (Cervical Dilator)

Isaptent was developed by CDRI for its use as a cervical dilator for carrying out Medical Termination of Pregnancy
(MTP) or abortion as well as for performing minor gynecological surgeries.
Before Isaptent was made available, Laminaria tents were being imported which were not only expensive but were
also not readily available. CDRI made use of the husk of the plant, Plantago ovata (Isapgol) which is an agricultural
product. Isapgol has this unique property of getting swelled in contact with water. The swelling is up to seven times of
the original volume when the seed husk gets absorbed in water. This swelling property has been utilized for dilating
the cervix for performing abortion or operation. The added natural advantage is the lubrication that the husk
provides.
Isapgol seed husk is granulated and compressed into stick of appropriate size, which are encapsulated in cloth tubes
either lined inside with a resized paper or coated with a thin lm of micro-crystalline cellulose. These tubes are then
compressed, packed in glass or polythene containers and sterilized under gamma radiation.
Isaptent is being extensively used by primary healthcare centers, family planning establishments, hospitals and
individual gynecologists for performing MTP. The Isaptent, due to its indigenous characteristics and abundantly

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available raw materials comes quite cheap and can be made easily available.
The Isptent is commercially made available by M/s Unichem Ltd, Mumbai under the brand name Dilex C.

ENTPROPAZINE (Antidepressant)
Interest in the development of antidepressants had its beginning in early sixties after the introduction of imipramine.
This was followed by introduction of several antidepressants belonging to the major groups of tricyclic
antidepressant and monoamine oxidase inhibitors. However, following their increasing use in psychiatry and
general practice, several limitations were observed such as they were not effective in 20-30% patients; the onset of
effect takes 2-3 weeks; excess consumption risk by patients having suicidal tendency; and adverse effects of
anticholinergic and cardiovascular nature.
Limitations of existing antidepressant drugs have led to persistent global efforts to develop newer drugs.
Centpropazine is a new antidepressant compound with a different pharmacological prole. The early clinical studies
showed it to be safe and well tolerated in normal human volunteers. Multicentric clinical efcacy studies were carried
out in nearly 250 patients suffering from depression. These studies reveal Centpropazine to have comparable
response rate with remarkably safer tolerability prole.

CONSAP (local contraceptive cream, spermicide)

C D R Is Contraceptive development programme has acieved anther great success in this area of national and
international importance. Its contraceptive Cream, CONSAP has now been approved bu the Drugs Controller General
of India for its marketing and use. CONSAP is a sterile contraceptive cream developed from the saponins obtained
from soap nuts (Reetha) collected from the plant, Sapindus mukorosii. The cream is recommended for all women of
reproductive age group who want to space their children. It is safe and free from systemic side effects on continuous
prolonged use.The preparation has been developed by using saponins from the soapnut or reetha (Sapindus
mukorossi). The cream went through all regulatory testing and Phase I, II and III clinical trials and proved to be an
effective contraceptive product. DCG(I) cleared the cream for use.
The CONSAP Cream has been licensed to the Hindustan Latex Limited who are going to market the product in very
near future

PICROLIV
Picroliv is a hepatoprotective agent of plant origin. It is an iridoid glycoside mixture
containing 60% picroside I and kutoside in the ratio of 1:1.5 obtained from the plant, Picrorhiza kurrooa ( root and
rhizome ). Picroliv ( 6 and 12.5 mg/ kg ) has shown efcacy comparable to silymarin ( 10 and 20 mg/ kg ) in rodent
models of galactosamine, paracetamol, thioacetamide and CC14 induced hepatic damage. Picroliv has shown
cholerectic effect in rat and anti-cholestatic effect in rat, guinea pigs and cats treated with paracetamol and ethinyl
estradiol. It has also antiviral and immunostimulant activities. Picroliv is devoid of any signicant CNS and CVS ,
autonomic and other systemic activity.
Picroliv appears to be safe in rats and monkeys and has excellent therapeutic index. Phase I and II clinical trials have
been conducted and the drug has shown no side effect and is well tolerated.

Diagnostic Vaccine
PCR-based diagnostic probe for leishmaniasis
A probe for early detection of visceral leishmaniasis has been developed by using a pair of oligonucleotide
primers constructed from predominant sequence class of kinetoplast DNA minicircle of Leishmania donovani. Indian
patent has been led for the technology.

Direct agglutination test (DAT) for leishmaniasis

A sensitive, specic (98%) and inexpensive assay for diagnosis of visceral leishmaniasis has been developed
and validated in sera of over 3,000 human subjects from endemic and non-endemic areas and can be performed on
very small quantities of blood. This is the rst global introduction of a simple and reliable test developed for the

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early diagnosis of kala-azar. The application potential of DAT test has been increased with the preparation of freezedried antigen.

LDH-based diagnosis of malaria

This comprises an immunodot enzyme staining test, employing anti-LDH polyclonal antibodies for the
diagnosis of malaria. The test is highly specic and sensitive.

PCR based diagnostic probe for tuberculosis

A novel DNA fragment of M. tuberculosis useful in early diagnosis of tuberculosis coupled with PCR
technology has been developed. Indian patent has been led.

Lipoprotein
A potential marker of coronary heart disease and atherosclerosis Clinical signicance of serum lipoprotein
Lp(a), a cholesterol rich protein, in determining degree of risk of coronary heart disease (CHD) has been established.
Serum Lp(a) concentration of 10mg/dl or more has been demonstrated as a potential risk marker in the Indian
population. The assay will be a potential risk marker in the Indian population. The assay will be useful in the
diagnosis of human subjects at a higher risk of CHD.

Cholera Vaccine
The role of plasmid in the regulation of toxin biosynthesis, virulence factors, novel adhesive and
colonisation factors of Vibrio cholerae have been demonstrated. A new subunit vaccine based on these colonisation
antigens is being developed.
An anti-leprosy vaccine developed using Mycobacterium habana antigen could not be taken to phase II and III trials
because other two anti-leprosy vaccines developed in the country were showing equally promising protection. The

same strain of M. habana is being evaluated as anti-TB vaccine, as an alternative to BCG.

PostedBy Dr Jayesh Rajgopal.

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LIST OF NEW DRUG APPROVED BY CDSCO IN 2016

FDA APPROVES BIOSIMILAR TO ETANERCEPT FOR

INFLAMMATORY DISEASES.

5 thoughts on DRUGS DEVELOPED In INDIA.

Pingback: DRUGS DEVELOPED In INDIA Pharmacologynews

Dr Prashant Shukla says:

August 29, 2016 at 2:01 pm

Awesome compilation sir!! Very helpful indeed

REPLY

Dr Rakesh Sonawane says:

August 29, 2016 at 2:01 pm

http://pharmacologyupdate.com/2016/08/29/drugsdevelopedinindia/

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Thank You Dr Prashant..!!

REPLY

Pawan Sharma says:

August 30, 2016 at 3:58 am

Very valuable information, indeed. Thank you so much

REPLY

Dr Rakesh Sonawane says:

August 30, 2016 at 3:59 am

Thank you Pawan!!

REPLY

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