Published in: The
Boss-15 Dec 2004-14 Jan 2005
The 27th
of August 2004 will
probably be remembered as the most important day in the history of the Nepalese
pharmaceutical industry. On this day, five companies out of six that had
applied were awarded the much sought after certificates for Good Manufacturing
Practice (GMP) as per guidelines set by the World Health Organization (WHO).
The awarding of these certificates was based on stringent inspections and
comprehensive audits in October 2003, March 2004 and finally, August 2004. The
five recipients of GMP certificates this year are Birganj based Nepal
Pharmaceuticals Laboratories (NPL), National Healthcare and Quest
Pharmaceuticals as well as Kathmandu based
Deurali Janta Pharmaceutical Laboratories and Omnica Laboratories.
Good Manufacturing Practice (WHO-GMP)
The recently awarded GMP
certificates have to be renewed every year or two. In the meantime, if the
manufacturing site is no more considered to be in compliance with GMP, it can
become invalid. GMP requires companies to follow exacting
guidelines right from the establishment of infrastructure to manufacture,
packaging and distribution. Strict quality control as well as rigid
documentation is required at every stage.
According to the WHO Expert
Committee on Specifications For Pharmaceutical Formulations, "Good
Manufacturing Practices for pharmaceutical products (GMP) is that part of
quality assurance which ensures that products are consistently produced and
controlled to the quality standards appropriate to their intended use and as
required by the marketing authorization. GMP rules are directed primarily to
diminishing the risks, inherent in any pharmaceutical production, that cannot
be prevented completely through the testing of final products."
GMP requirements include clear
definition and systematic review of all manufacturing processes, validation of
critical steps of manufacturing process as well as any significant changes in
process, trained and qualified personnel, adequate premises and suitable
equipment and services. Use of correct materials, containers, and labels,
approved procedures and instructions, suitable storage and transport as well as
adequate laboratories and equipment for in-process controls also come under GMP
guidelines. In addition, GMP also requires manufacturers to have clear and
unambiguous instructions and procedures applicable to the facilities provided,
documented records during manufacture as well as of distribution, proper
storage and distribution, an available system for product recalls and
examination and investigation of any complaints.
Other companies have also applied
for certification and almost all are upgrading manufacturing facilities to GMP
levels. The year 2007 (2064 BS) has been set as the deadline for all companies
to attain GMP standards at the end of which time, those failing to comply, will
be allowed to function only as repackaging units. Of the 40 industries in
operation in the country, it is expected that but for a few whose financial
condition may not allow them to make the substantial investments necessary to
upgrade facilities as required, most will have received GMP certificates by
2007.
This is especially true for the
newer industries since their infrastructure has been built keeping recent GMP
regulations in mind. As for the older facilities, those that have acquired
significant market share and those that have better liquidity, are no doubt in
the latter stages of fulfilling GMP criteria and will soon be applying for
certification. Hukam Pharmaceuticals is reportedly undergoing the final stages
of GMP audit. The Department of Drug Administration (DDA) which has been
playing such a sterling role in providing able support and good guidance will
no doubt also lend a kind ear to those applying for more time later on in order
to reach GMP standards. "Well we have already extended the deadline by one
year," says Pharmacist Gorkha D.C. at the DDA. "Previously the cut
off year was 2006 (2063)."
Whatever the case may be, it is
heartening to see that a critical section of the country's economy is making
all round progress. Particularly reassuring is the fact that people can expect
to get medicines manufactured in their own country that is safe and no less
efficacious than those of other countries. Besides, in these troubled times,
pharmaceutical manufacturers are providing a significant number of employment
opportunities. Nepal Pharmaceutical Laboratories has 150 employees in its work
force and DJPL has 154 employees out of which 10 are pharmacists, 3 are
analysts, 22, marketing personnel, 22 are administrative staff, 60, skilled and
highly skilled workers, and 35 are unskilled.
No doubt it has been a synergy of effort between the industry and the DDA
that has resulted in such a promising scenario.
Pharmaceutical Market in Nepal
However, it has been a long hard
haul for the industry to reach this position since the time Chemidrug
Pharmaceuticals first started formulating drugs in 1971, when the DDA was not
yet founded. The setting up of DDA in 1979 followed the establishment of Royal
Drugs Laboratories (RDL) in 1975. Today there are 40 pharmaceutical companies
all over the country manufacturing various formulations and some 3496 brands.
Another half a dozen companies will probably come into existence in the coming
year.
As far as the total market of the
country is concerned there are differences in estimates among different
sources. This obviously is due to the fact that many companies, for a variety
of reasons, are reluctant to disclose their true sale figures. According to DDA
authorities, the present market for drugs is estimated to be roughly Rs.800
crores of which about Rs.540 crores is in imports from other countries, mostly India , and
sales of local companies amount to around Rs. 240 crores, i.e. about 30% of the
total market.
According to Radharaman Prasad
Saha, Senior Administrator at DDA, sales recorded in 1999/2000 was Rs.590.7
crores with growth of 18.8%. According to DDA records, 237 Indian companies
operate in the country with 5197 registered brands besides the 3496 brands
registered by 40 Nepalese companies. This potentially favorable ratio implying
a promising gap in the market yet to be substituted by local brands is the
reason why there has been such an increase in the number of players. It is
obvious that drugs manufactured in the country have gained wide acceptance from
the primary customers: doctors and chemists, as well as from end users, that
is, the patients. Certainly, the recently awarded GMP certificates will further
enhance consumer confidence and, naturally, increase turnover.
No doubt it has taken some time
to reach this point and for this, pioneering companies like Chemidrug, RDL,
NPL, Lomus and others have to be thanked. At the same time one mustn't forget
that around the 1980's, production of bottled saline water had started to take
off in a big way with full-fledged production in four such industries. But with
the advent of later regulations aimed at improving quality, bottled saline
production fell drastically and two industries closed down soon after. Factors
like newer packaging (PVC containers as opposed to glass bottles) resulted in
the need for different bottling techniques making investment in new machinery
mandatory. This, coupled with price reductions in bottled saline imports
probably contributed to some manufacturers deciding to call it quits. At
present only RDL and Vijaydeep Pharmaceuticals are producing bottled saline.
A similar situation exists at the
moment with the new regulations that has made GMP mandatory by 2007. It is
quite possible that some industries with low turnover/ poor cash reserves but
high investment requirements to attain GMP standards may opt to close down in
the future. Simca Laboratories, which is in the final stages of up-gradation of
infrastructure, says they have had to make additional investments of at least
Rs. One crore. That is why concerned authorities, especially DDA, must take a
pragmatic overall view in order to ensure the continued progress of all
manufacturers. It goes without saying that the DDA is equally, if not more so,
responsible to the populace to see to it that the drugs produced in Nepal and for
whose quality they are ultimately answerable, are of the best quality possible.
Pharmacist Gorkha D.C. has an interesting observation to make,
"Now our work will become easier since, with the new regulations,
companies themselves have started to become more conscious thereby sharing the
responsibility to maintain quality standards. After all, enhanced reputations
after receiving GMP certification will be at stake." Mukendra Singh,
National Sales Manager at DJPL agrees, "Definitely, our responsibilities
have increased a lot."
Marketing Methods
Among the pioneers it should be
noted that Nepal Pharmaceutical Laboratories (NPL), established in 1987, is
generally credited with promoting locally made drugs in a more professional
manner. That is, by promoting their products to doctors and chemists in a more
aggressive way as well as by devising more modern methods in marketing. Before
that, companies like Royal Drug Laboratories (RDL) and Chemidrug while they
produced essential and OTC (over the counter) drugs, were less proficient in
their marketing efforts. In fact during earlier years, RDL had not felt the
need to actively promote its products as it had been receiving preferential
treatment in the supply of government tenders for pharmaceuticals. As a result,
RDL's turnover reportedly had soared to a high of almost Rs. 12 crores a decade
ago. However, with more open market systems coming into play RDL lost it's
preferential treatment in government business and this, added to bad management
practices and poor marketing, has resulted in the company showing losses for
many years now and the company's turnover has reportedly nose-dived
drastically.
Of course RDL's case like so many
other government run industries, corporations and businesses is not reflective
of similar businesses run privately. Turnover figures of leading Nepalese companies
show a healthy growth. For instance, latest figures by ORG (an international
market survey group) indicate growths of 38%, 18% and 29% respectively for
Lomus, NPL and DJPL in 2003/2004. Lomus Pharmaceuticals, although not yet a
recipient of the GMP certificate, nevertheless has a big share of the market
due to its effective marketing techniques and large range of products. Other
companies are also being relatively successful in making their presence felt in
the market. Relative in the sense that, even with the erratic political and
economic situation prevalent for so long now, pharmaceutical companies are
still managing to grow positively unlike most other industries in the
country.
Companies have become more
aggressive in the market with increasing numbers of Medical Representatives in
their sales force, ensuring wider coverage, and with newer marketing strategies
including better presentation methods and tools besides well planned visiting
schedules. Medical Representatives are
also being given better in house and field training and their efforts are being
awarded with lucrative incentive schemes. Rapid increase and diversification in
product range is also a key marketing strategy being adopted by most companies.
Besides this, companies are fine tuning
and making efforts to have more closer rapport with concerned professional like
doctors, chemists and medical students by sponsoring medical student
scholarships, doctor and intern meets and medical symposiums as well as by
participating in functions involving those concerned with the trade. DJPL's
Mukendra Singh says, "We have had a scholarship scheme for medical
students for quite some time now. We provide scholarships to five students at
graduate level studies and one scholarship at postgraduate level. These are
based on recommendations from Nepal Medical Students' Society and Nepal Medical
Association respectively. We are also willing to fund medical research in the
future."
Companies like NPL and DJPL have
also established their own in-house market support divisions with qualified
pharmacists in the ranks. Pharmacist Jyoti Adhikari heads the Market
Development Division at NPL and says, “Our job is to provide the sales force
with the newest scientific data and information concerned with recent developments
in pharmaceuticals. They in turn disseminate such information to doctors. We
also conduct periodic trainings and prepare promotional material in line with
the needs of the market.” Besides, many
companies have now sub divided their companies into a number of divisions, each
division responsible for the marketing of a specific number of products. Strong
distribution networks all over the country are also playing a significant part
in local companies' success. NPL has 63 distributors all over the country.
Competition
Local companies' success has to
be all the more appreciated because they are operating under difficult
circumstances where marketing efforts have been perforce curtailed in many
parts of the country due to the ongoing violence. Also, not only do they have
to compete among themselves, but also with the 237 Indian and Multinational
Companies (MNCs) who have had full fledged marketing operations as well as
established brands in Nepal for a long time. Although a small country, Nepal 's market
is said to have a high brand per capita ratio with a total of about 8693 brands
which is said to be higher than neighboring countries like Sri Lanka and Bangladesh . The
situation is such that one type of medication, for example, the antibiotic
Amoxycillin, may be available in as many as a dozen brands in the market.
Similar is the case for many other antibiotics and OTC drugs like vitamins,
painkillers and gastro-intestinals.
An excessive number of similar
brands often leads to problems of substitution, i.e. chemists substituting a
prescribed brand in preference of another that might be more profitable to
them. This has obviously resulted in cutthroat tactics by companies, leading to
unhealthy and unethical competition such as under-pricing, tempting bonus
offers and substantial gifts to not only retailers but also to doctors.
However, according to Pharmacist Gorkha D.C. of Department of Drug
Administration (DDA), "There is now a decline in number of imported brands
because of tougher regulations, and conversely, an increase in domestic
brands". Attempts are also being made to control manufacture and imports
of brands that are already available in excessive numbers in the country. At
the same time some, like Umesh Lal Shrestha of Quest, have a different view,
"Having a large number of brands is not a major problem. We are capable
enough to compete in any scenario. Besides, controlling the number of brands
does not confirm with the spirit of liberalization."
Therapeutic Groups
Since antibiotics (or anti-infectives),
respiratory (including cough medicines), vitamins/minerals (including
multivitamins, iron and mineral supplements), gastro-intestinals (including
anti-diarrheals, digestive enzymes, antacids) and painkillers (including
analgesics, anti-inflammatories, anti-pyretics) constitute more than 50% of the
total market, it is not a surprise that many companies have them in their
product range. As it is, many of the older companies, particularly Indian
companies and MNCs, were founded on such products that were once their research
products and only later on because of huge popularity, became over the counter
(OTC) drugs. Even now, a substantial part of their turnover is dependent on
such drugs. For example, when the popular analgesic, Novalgin and the equally
popular anti-spasmodic, Baralgan of Hoechst Pharmaceuticals (now Aventis) was
banned some years ago due to reports of adverse side effects, the company's
sales in Nepal was affected to a significant extent. According to industry
sources, DDA is seriously thinking of banning sales and manufacture of general
cough preparations (said to be of doubtful use), as well as curtailing sales
and manufacture of vitamins (which doctors say is being inappropriately over
used).
Local companies who have made it
good also have to thank their volume builders like, in Nepal Pharmaceutical
Laboratories' (NPL's) case, the anti-inflammatory/analgesic Brucet and the
vitamin, Vital, and in DJPL's case, iron preparations like Ferofolic and the
vitamin, Fortiplex. Lomus's D-Cold and Lomoplex are some of their major volume
builders. National’s major sales volumes come from its Amoxycillin range,
Nemox, as well as from its Paracetamol, Niko. Not too long ago, many companies'
main bread and butter were such OTC formulations. With high growth and healthy
cash flows, these and other leading companies have diversified their range
significantly. And even though their popular OTC brands still continue to be
major volume builders, a company like NPL that once depended to a large extent
on a few such formulations for its up keep, has now almost 150 brands covering
10 therapeutic groups. In fact today its beta-blocker Amlod is among the
leaders in cardiac therapy medication and is widely prescribed by doctors all
over the country. National Healthcare has 115 brands according to Marketing
Director Radheshyam Mahato and has recently launched Amimide, a potassium
sparing diuretic.
Similarly, DJPL has carved out a
leadership position in anti asthmatic medication with its Beta-2 range, and has
77 other brands covering 8 therapeutic groups. DJPL was also among the first to
introduce an antioxidant, called Careage. Many of the local companies are
manufacturing newer anitibiotics like third generation Cephalosporins as well
as the latest Macrolides and Fluoroquinolones besides of course older
antibacterials like Ampicillin, Amoxycillin and Tetracyclines. It should be
noted here that antibiotics command higher per unit prices and therefore
contribute substantial volume to company turnovers. According to Radheshyam
Mahato, Markeing Director of National Healthcare, a major part of the company’s
turnover comes from its sales of its Amoxycillin range, Nemox, and Paracetamol,
Niko.
It is also worth noting that some
companies like Asian and the two-year-old Quest have, right from their
inception, decided to walk a different path and manufacture mostly specialty
drugs like cardio-vasculars, anti-diabetics and psychotropics. Quest, with 40
brands in 9 therapeutic groups, manufactures cardiovasculars like Mylod,
anti-diabetics like Metfor and cholesterol lowering drugs like Bezafibrate.
According to Umesh lal Shrestha, CEO of Quest, "We have plans to further
introduce a range of drugs that are not me-too products." No doubt it is a
good strategy to carve out one's niche in the market, but at the same time,
constraints like small market, lack of qualified prescribers in rural areas and
poor economy does stifle such companies' ambitions and they too have realized
that a few OTCs are needed in their stables.
According to CEO Mahesh Pradhan
of Omnica Laboratories, market size has never been that important to them,
"We do not have many brands but most are prescription drugs. We would like
to stress on quality and not quantity." In fact, according to him,
"Even when GMP requirements were not spelt out we had already installed an
AHU (Air Handling System), one of the major infrastructure requirements for
GMP." Shrestha is proud of the fact that it was due to ethical marketing
that he could show profits right from the third year of operations. Perhaps
high margins that are inherent in sales through prescriptions drugs allow him
to be complacent about market size.
Market Data
As far as market data is
concerned, in the absence of any competent reporting organization in the
country, one has to rely on professional data collecting agencies from outside Nepal such as
ORG/ims which is a leading market research group in India . Data from such
organizations, even if they are capable and well trusted in India , cannot
be said to be foolproof in Nepal 's
context, keeping in mind the difficulties of the task demanded. As Umesh Lal
Shrestha of Quest says, " ORG reports are very misleading and do not
reflect the true picture at all." Of course, it is better to have
something rather than nothing at all. At the same time, if ORG figures are
anything close to the truth then it belies all claims by concerned authorities
about the total market size being what it is, and should be an eye opener for
all concerned, indicating the need for more active measures and wariness in
collection of data.
According to ORG reports, Lomus,
NPL and DJPL hold the first three positions in the Nepalese market with sales
of Rs.11.1, Rs.10.0 and Rs.9.4 crores respectively. National Healthcare with
sales of Rs. 7.2 crores is in 6th place, up from 8th
place a year ago. It must be mentioned here that National Healthcare, a
comparatively recent entrant in the market, has been reportedly showing very
fast growth that is exceptionally good by any yardstick. Their outstanding
success is attributed to a large product range coupled with an innovative
marketing strategy. Others in the top twelve are Indian and Multinational
Companies (MNCs) like Aristo (Rs.8.9cr), Dabur (Rs.8.4cr), Knoll. (Rs.6.8cr), Ranbaxy
(Rs.6.4cr), Nicholas (Rs.5.7cr), Alkem (Rs.5.6cr), Aventis (5.1cr) and
Cipla (4.8cr).
Top Twelve Companies in 2003/2004
(Source: ORG/ims Report--March Mat 2004)
Company Country Rs. (Crores) Growth % Mkt Share %
1.
Lomus Nepal 11.1 38 4.6
2.
NPL Nepal 10.0 18 4.2
3.
DJPL Nepal 9.4 32 3.9
4.
Aristo India 8.9 15 3.7
5.
Dabur India 8.4 20 3.5
6.
National Nepal 7.2 13 3.0
7.
Knoll MNC 6.8 4 2.8
8.
Ranbaxy India 6.4 28 2.7
9.
Nicholas India 5.7 5 2.4
10. Alkem India 5.6 1 2.3
11. Aventis MNC 5.1 -18 2.1
12. Cipla India 4.8 49 2.0
As far as ranking of purely
Nepalese companies is concerned, again one has to rely on ORG figures which as
mentioned before, should be taken with due caution.
Top Twelve Nepalese Companies in 2003
Source: Nepal Pharmaceutical Index, 2003, ORG/ims
Company Rs.
(Crores) Mkt Share %
1.
Nepal Pharmaceutical Laboratories 8.9 3.9
2.
Lomus Pharmaceuticals 8.0 3.5
3.
Deurali Janta Pharmaceutical Laboratories 7.1 3.1
4.
National Healthcare 5.8 2.5
5.
GD Pharmaceuticals 2.8 1.2
6.
Royal Drug Laboratories 2.5 1.1
7.
Apex Pharmaceuticals 2.1 0.9
8.
Asian Pharmaceuticals 2.0 0.9
9.
CTL Pharmaceuticals 2.0 0.9
10. Simca
Laboratories 1.9 0.8
11. Siddartha
Laboratories 1.2 0.5
12. Time
Pharmaceuticals 1.2 0.5
Many in the industry are
skeptical of the above figures because, as Mahesh Gorkhali, Marketing Director
of NPL, says, "It is difficult to get the correct picture since companies
do not want to reveal their true sales figures for a variety of reasons." Seemingly, those with high turnover are wary
of tax authorities and those with low turnovers would like to display inflated
sales to enhance their reputations. He adds, "The top five Nepalese
companies each probably will have from Rs.15 crore to Rs.21 crore in sales this
year." Radheshyam Mahato of National agrees, “Yes the top two Nepalese
companies have sales exceeding Rs. 20 crores each while the other three in the
top five should have about Rs.14-Rs.15 crores each.” According to Umesh Lal
Shrestha,of Quest, "Our turnover should be around Rs.5 crores this
year." Mahesh Lal Pradhan of Omnica is also predicting sales of about Rs.5
crores in 2004.
According to Naresh Shrestha,
Marketing Manager in the Nepal Pharmaceutical Laboratories, "The top five
Nepali companies are NPL, Lomus, DJPL, National and GD Pharmaceuticals, and
their combined sales should be around Rs.90 crores." His statement perhaps
corroborates with the figure expounded by DDA authorities stating that the
Nepal pharmaceutical market is worth at least Rs.800 crores and that Nepalese
companies account for 30% of that.
Among the therapeutic groups,
again according to ORG reports, anti-infectives (Rs.67.4cr), respiratory
(Rs.26.6cr), vitamins/minerals (Rs.25.4cr), gastro-intestinals (Rs.25.4cr) and
painkillers (Rs.18.7cr) constitute a major part of total turnover. Others like
cardiacs, dermatologicals, gynecologicals, anti-allergics, anti-diabetics and
psychotropics, etc… make up the rest.
Top Five Therapeutic
Groups by Sales--2003/2004
Source: ORG/ims--March
Mat 2004
Therapeutic Group Brands Rs. (Crores) Mkt Share % Growth %
1. Anti-Infectives 628 67.4 28 7
2. Respiratory 337 26.6 11 -2
3. Vitamins/Minerals 238 25.4 10.5 1
4. Gastrointestinals 402 25.4 10.5 1
5. Painkillers/Analgesics 325 18.7 7.8 -7
Market Size Comparisons
According to industry sources
most pharmaceutical manufacturing units in the country are operating at less
than 40% of their capacity. In 2003, DJPL's utilized capacity was 40%. The
small size of the market does place a strain on economics of scale. To get a
better perspective on this issue it should be noted that the market in India
for many Multinationals is generally 1 % of their worldwide turnover and the
market for the same Multinationals operating in Nepal is 1 % of their sales in
India. For example, Aventis's all India sales was Rs.536.7 crores last year
compared to Rs. 5.1 crores in Nepal. With Indian companies too, the same
yardstick applies. Ranbaxy had sales of Rs. 920.7 crores in India compared to
Nepal sales of Rs. 6.4 crores in the same year and Nicholas had only Rs. 5.7
crores sales in Nepal compared to Rs. 865.3 crores in India.
Looking at the large size of
India's population it does seem surprising that MNC 's Indian sales account for
only 1% of their worldwide turnover, but one must also consider that due to
government control on essential drug prices, Indian drugs are among the
cheapest in the world. Nepal's population of almost 2.5 crores also cannot
exactly be called small if we are to compare this with many countries in
Europe. However, poor economy, poverty, less than ideal health services and
relative isolation of many regions within the country forces one to conclude
that the full potential of the market is yet to be tapped.
.
Export Potential
With the domestic industry
becoming increasingly competitive viz a viz imports and recent technological
progress as evidenced by the awarding of GMP certifications, there is
widespread belief that Nepalese companies will now be able to market drugs
abroad. At the present moment however, this optimism should be taken as just
that because one must remember that the worldwide pharmaceutical market is
among the most competitive amongst all industries. And protected to a good degree if we are to
take the stringent rules of different countries regarding drug manufacturing
and marketing to be a form of protection. For example, even in Nepal, DDA does
not allow outside companies into Nepal if they do not have WHO-GMP
certification, a law that was not there until a few years ago. One must keep in
mind that in some countries it is not mandatory that manufacturers have
WHO-GMP, instead opting for other kinds of GMP such as ASEAN-GMP in Malaysia.
As far as exports are concerned,
according to Pharmacist Gorkha D.C. at the DDA, "No Company has as yet
applied for CCP (Certificate of Pharmaceutical Product moving in International
Market) which is a necessary requisite for exporting medicines". Some
years ago, Nepal Pharmaceutical Laboratories (NPL) did make attempts to
penetrate the Indian market by exporting 5 brands worth about Rs.1 crore to
India. The long delays in having their products analyzed by concerned Indian
authorities (sometimes even as long as 9 months), led to many of their
products' shelf life being reduced to near expiry period levels. Here one must
understand that drugs on an average have an expiry period of three years and
some like antibiotics and vitamins, only 1.5 to 2 years. And then there is the
added fact that retailers are free to return drugs when the expiry period left
is less than 6 months. Such problems probably resulted in NPL discontinuing
their pioneering efforts.
One should of course not be
pessimistic and one mustn't underestimate the competitive ability of Nepalese
pharmaceutical industries but according to Mahesh Gorkhali "It would be
more realistic to first gain more of domestic market share by gradually
replacing imported brands with domestic ones". Of course this in itself is
a big challenge because foreign companies that are active in the Nepalese
market operate from a very strong base. This is especially true for Indian companies
who have much larger economics of scale to play with, the Nepal market being
only a small part of their overall turnover in India. Besides of course, they
do have a number of established brands. However, Gorkhali is confident about
gaining increased ground domestically and says, " NPL was the first
company in Nepal to produce cardiac, diabetic and drugs for neurological
disorders. We were also the first to export. Now with GMP, we will definitely
increase our market share dramatically."
DJPL on the other hand have set
up an export division and according to Mukendra Singh, National Sales Manager,
"We are looking at markets like Africa, CIS countries and Latin
America." He is of the opinion that the Indian market is a tough nut to
crack not only due to its strong domestic industry but also because of long
bureaucratic delays in procedures. Besides, the fact that the Indian market is
not as lucrative in terms of prices as are third countries must be on Nepalese
manufacturers' minds.
According to Quest's Umesh Lal
Shrestha, " The government's attention towards this industry is nil. There
is no initiative at all from their side towards developing and promoting an
export market for pharmaceuticals. Things like export incentives and sending
delegations abroad to explore markets just hasn't crossed the government's
mind." One must agree with him since the pharmaceutical industry is one of
the few sectors that is still alive and kicking in the country's industrial
scenario, and so should get all the support it can receive to make sure it
keeps on going.
Future Plans
Besides exploring markets abroad,
domestic industries are now feeling the need to diversify further by investing
in production of sophisticated formulations like injectables and vaccines. This
is one very important area where domestic companies can really contribute to
the self-reliancy of the country, but because the manufacture of such
formulations requires extremely high investments, it is possible that many will
not find it feasible as a business venture. Presently, one company in Dharan,
Shiv Pharmacuticals has been manufacturing injectables for some time now but it
is yet to be seen how the mandatory requirement of GMP by 2007 affects this
company. According to Mukendra Singh of Deurali Janta Pharmaceuticals,
"Up-gradation of our manufacturing facilities is going on and we also have
plans to manufacture injectables in the future." In the meanwhile, NPL and
National are well into the process of setting up injectable plants and reportedly
have already started construction of new buildings. According to Radheshyam
Mahato, Marketing Director of National, “We are constructing a 30,000 square
feet injectable plant which should be operational by next year. This is in
addition to the existing 32,000 square feet infrastructure we already have. The
new plant will cost us from Rs. 10 crores to Rs. 11 crores." "Quite
substantial investments are needed to set up such units," says Pharmacist
Gorkha D.C.
Government Policies
Presently, while on the whole, DDA's
supportive role has to be appreciated as far as policies for this industry are
concerned, the industry does have a few grouses. For instance, while the duty
levied on raw materials is only 1 %, duties on packing materials, laboratory
chemicals and equipment are reported to be much higher. "5% customs, 2%
surcharge and 10% Vat," according to Quest's Umesh Lal Shrestha. Imports
of finished products attract only 2.5% according to Mahesh Pradhan of Omnica.
As almost all of the main raw materials as well as many packaging materials
(for instance, bottles) have to be imported, the higher custom duties do have
an effect on competitiveness of local industries. At the same time the industry
should be thankful that there are no price controls like in India , but of
course, because they have to compete with their Indian counterparts, market
forces are in command while pricing.
One area of concern now and in
the future is the risk of counterfeit drugs finding their way onto chemists'
shelves. This is very real and clear danger keeping in mind the fact that
extremely large instances of counterfeiting has been unearthed in India ,
especially in adjoining states like Bihar and
Uttar Pradesh. Because the production of identical packaging is quite easy
nowadays, one cannot be but too careful in this matter and surely this is a
major area of concern to not only manufacturers and authorities, but to
patients as well. One can only pray that the DDA that is doing such a
commendable job in other departments under the able guidance of Mr. Bhupendra
Thapa and his dedicated team, continues its vigilance in this sector also to
ensure that spurious drugs do not enter the country.
Extremely well researched and very informative piece you have on written on this topic.
ReplyDeleteI am currently researching the landscape of drug companies in Nepal and I would be more than grateful if you could guide me on some of the sources I might use.
Best Regards,
Aayam