From: Secretary (Pharmaceuticals)
Dear Readers
The Indian pharma industry has made significant
progress in creation of required infrastructure, meeting global needs for
supply of quality medicines and Active Pharmaceuticals Ingredients (APIs), as also entering into the
highly opportune area of Contract Research and Manufacturing (CRAM) and
Clinical Trials.
The Department
of Pharmaceuticals (DoP) endeavours to formulate and implement policies and
programmes for achieving growth and development of the domestic Pharmaceutical
sector in the Country along with ensuring adequate availability of medicines at
reasonable prices to the consumers. DoP
is also now engaged in some of the newer areas of work assigned to this
Department, such as R&D for pharma industry; environment and disaster
management; education and capacity building in pharmaceuticals etc. in the country.
I would like to keep you abreast of the
developments and initiatives taken by us and present a synoptic view of the
sector through such round-ups from time to time based on information and data
collected and collated by this Department, both from within the Department as
well as outside agencies and sources.
2. Investment
·
Domestic investment
in the Pharmaceuticals sector is
estimated at Rs. 31.43 thousand crores[1] which is equivalent to US $ 7.14 billions (Source: Ministry of Commerce & Industry).
·
The Pharmaceuticals sector has been able to
attract FDI amounting to US $
1401.60 million in the sector during 2000-01 to 2008-09 (upto
September), of which, there has been
an inflow of US $ 125.30 million during
the first half of 2008-09 (Source: Ministry
of Commerce & Industry).
·
There has been an
upward trend in FDI inflows in the sector. In 2007-08, the FDI inflow at US $
334.09 million (Rs. 13264.28 million) has been the highest (Source: Ministry of Commerce & Industry).
·
In so far as domestic industrial proposals between August 1991-March 2008
are concerned, total IEMs[2]
filed including LOI[3] & DIL[4]
add upto Rs. 31257 crores in Drugs & Pharmaceutical Sector (Source: Ministry
of Commerce & Industry).
·
The Pharmaceutical
sector is estimated to have created 2.20
lakh employment opportunities (Source: Ministry
of Commerce & Industry).
·
The aggregate sectoral income grew by 18.9% during the quarter ending
June 2008 while the growth in net profits during 2007-08 was 8.2% (Source: CMIE).
·
Several new investments have materialized including Hindustan Latex
Limited’s integrated vaccine complex at Chengalpattu (near Chennai, T.N.),
Rubicon Research Clinical trial drug manufacturing facility at Ambernath
(Maharashtra) and Ban Labs’ manufacturing facility at Ponta Sahib (H.P.), Eisai
India in Pharma Pack at Vizag. Pharma CPSUs are also actively engaged in
setting up new facilities like Cephalesporin plant (with WHO GMP) by HAL,
Pimpri at an approx. cost of Rs. 20.00 crores, expansion by KAPL, Bangalore at
a cost of Rs. 22.00 crores, expansion by RDPL, Jaipur at a cost of Rs. 8.00
crores. BCPL, Kolkata has also started
setting up new plant facilities for tablets, liquids & home products at an
estimated cost of about Rs. 145 crores provided by DoP as part of its rehabilitation
package.
3. Pharma Growth
·
The domestic pharma
industry has shown resilience, recording a growth of 6.8% in November 2008,
after a drop of 1.2% in October. During the 12 month period from December 2007–
November 2008, the domestic retail market grew by 10.3%, according to ORG-IMS
as quoted by the “Times of India” (TOI)(December 25, 2008).
·
Growth in November
2008 could have been higher if anti-infectives and respiratory segments had
recorded a better growth, according to experts as quoted by the TOI (December
25, 2008).
·
Clinical trials in
India can cost less than 50% of those conducted in western countries.
Therefore, clinical research in India
attract outsourcing work from western countries and the market for the
purpose is projected to expand two-fold
from US$ 176 billion in 2008 to 356 billion in 2012 as exhibited in
Graph-1(Source: IMS Health, McKinsey, ABLE, as quoted by the “Financial
Express” dated 29.12.08).
·
The size of Indian
pharmaceuticals industry is poised to grow from Rs.30,200 crores in 2007 to
Rs.33,500 crores in 2008 and further to Rs.140,000 crores in 2020 as exhibited
in Chart-2 (Source: IMS Health, McKinsey, ABLE, as quoted by the Financial
Express 29.12.08).
·
The world contract research market is expected to grow
monotonously from 19% in 2005 to 29% in 2008 and further to 47% in 2011 as
depicted in the Graph-3 (Source: IMS
Health, McKinsey, ABLE, as quoted by the Financial Express 29.12.08).
4. Important Initiatives
Jan Aushadhi:
·
The DoP strives to
promote quality generic medicines at affordable prices. As part of the Generic
Drug Campaign of this Department, the first
Generic Drug Store ‘Jan Aushadhi’ 24x7 generic drug store has been
launched on 25th November 2008 at Amritsar with the full support and
assistance of the Govt. of Punjab. It has been decided to gradually set up more
such generic drug stores in Punjab.
Four ‘Jan Aushadhi’ stores at Mohali,
Bhatinda, Jalandhar and Ludhiana would be set up in the next phase by March
2009. Besides, one store in New Delhi would
be opened by the end of this month through
the network of Kendriya
Bhandar. Some more locations are being
planned for such stores in Delhi and New Delhi. DoP is also exploring to set up
Generic Drug Stores in premier hospitals of the country. If you have any
suggestions, please enrich us on this so that we may consider them for our expansion plan.
·
The Jan Aushadhi
store is for providing quality unbranded generic medicines at very reasonable
prices. This can be seen below in the comparative prices in the illustrative list
of some of the medicines in table-1, which are on sale at the Jan Aushadhi
store at Amritsar.
Table-1 : Illustrative Prices of Branded Medicines vis-à-vis
Generic Prices at Jan Aushadhi Generic Store
Prices of pack size 10 (Rs.)
|
Medicines |
Market Prices of Branded Medicines |
Price of
Generic Medicines at Jan Aushadhi Generic Store, Amritsar
|
Average Higher Prices of Branded
Medicines (%) |
|
Tab. Ciprofloxacin 500 mg |
97.00 |
20.10 |
383 |
|
Tab. Diclofenac 100 mg |
36.70 |
3.10 |
1084 |
|
Tab. Cetirazine 10 mg |
27.00 |
2.50 |
980 |
|
Tab. Nimesulide 100 mg |
32.00 |
2.50 |
1180 |
|
Cap. Cephalexin 500 mg |
155.00 |
29.40 |
427 |
·
The Generic Drug store at Amritsar has been opened through the Pharma
CPSUs and space etc. has been provided in the Civil Hospital, Amritsar for this
purpose by the Govt. of Punjab. We are
planning to have NGOs, charitable institutions, hospitals, cooperatives, Govt.
and other bodies to set up such stores across the country. Also, the range of unbranded generic
products in these outlets is proposed to be enlarged by involving private
sector players. For this purpose,
“Expressions of Interest” have been invited on 5th & 8th
December, 2008 in national newspapers.
·
A brochure on Jan Aushadhi and Generic Drug Campaign is available on
this website which could provide further information.
5. Environment
& Disaster Management
·
Like the chemical industry, Pharma industry also has various
environmental issues especially in manufacture of APIs. We have recently crated
an Environmental Cell in the Department to accord high importance to
Environmental issues as well as on Disaster Management. The Cell would collect, disseminate
information and data on this aspect, identify issues and create awareness on
these issues, coordinate with other organizations and agencies to synergize
efforts as well as resolve issues. We
look forward to information, data and issues on this subject.
·
We are contemplating
to hold a seminar on Environment issues in Pharmaceuticals on 30th January,
2009 and another Symposium on “Environment & Disaster management for Pharma
Industry” towards the end of March 2009.
6. Pharma Education & Research
·
Six new NIPERS have
been established at Ahmedabad, Guwahati, Hajipur, Hyderabad, Kolkata and
Raebareili, in addition to the one at Mohali.
Academic courses have been started in Raebareili also on 17th
Nov, 2008. Thus, all six new NIPERs have become functional in the country.
·
We are planning to
start at least three courses on Clinical Research and one on “Advanced
Instrumental Methods in Pharmaceutical Analysis” through NIPERs during 2008-09.
Similarly, a short-term course on Pharmaceutical Export management is also
planned in NIPER, Hyderabad jointly with Pharmexcil this year (2008-09) itself.
·
This Department also
proposes setting up of Incubator facilities in some of the NIPERs to assist the
industry and entrepreneurs.
·
The revival package
for HAL, Pimpri and BCPL, Kolkata are under implementation and the work is
progressing well.
7. Prices
During 2008-09, NPPA has
reduced prices of 1118 scheduled
formulation packs till November 2009. Since its inception, the total
number of scheduled formulation packs
for which prices have been fixed till November 2009 are 8057 (Table-2, source:
NPPA).
Table-2 : Prices of Formulation Packs
|
Parameter |
2008-09 (upto November) |
Total (Since
inception upto(upto November) |
|
No.
of Packs Approved Of which |
1118 |
8057 |
|
i.
Prices reduced |
85 |
2845 |
|
ii.
Prices fixed for the first time |
865 |
3906 |
|
iii.
Prices increased |
127 |
1062 |
Likewise, prices of 321 bulk drugs have been
reduced since inception till November 2009 (Table-3, source: NPPA).
Table-3: Prices of Bulk Drugs
|
Parameter |
2008-09 (upto
November) |
Total (Since
inception (upto November) |
|
i. No. of bulk drugs whose
Prices reduced |
5 |
321 |
|
ii. No. of bulk drugs whose
Prices fixed for first time |
0 |
14 |
|
iii. No. of bulk drugs whose
Prices increased |
18 |
104 |
8. Inflation
Inflation under ‘Drugs and medicines’ has been low between
1.87% and 1.97% during last eight weeks (from 1st November to 20th
December 2008), signifying price stability of the drugs. This is quite
impressive within the overall scenario of prices (Source: Ministry of Commerce
& Industry).
9. Exports and Imports of Pharma Products
·
Pharmaceuticals exports
(valued in US dollar terms) registered an impressive growth rate at 30.7% terms
during April-October, 08 compared to the corresponding period of the last
year. This growth further increases to
38.5% when valued in rupees terms (Source: Quick Estimates of DGCIS).
·
Imports on account of
pharmaceutical products (valued in US dollar terms) grew by 3.4% during
April-October, 08 compared to the corresponding period of the last year. When
imports are valued in rupees terms, the growth further increases to 9.5% (Source: Quick Estimates of DGCIS).
·
Exports on account of
Pharmaceuticals have been consistently outstripping the value of corresponding
imports during 1996-97 to 2007-08. The trade
balance increased from Rs. 2157 crores in 1996-97 to Rs. 13893 crores in
2007-08. Exports of pharmaceuticals registered a growth at the rate of 16.22%
during 2007-08 (Source: Quick Estimates of DGCIS).
- The share of exports of Pharmaceuticals
products to the total national exports have been in excess of 2% during
each of last 12 years ending 2007-08. It has exhibited a long
term upward trend from 2.01% in 1996-97 to 2.55% in 2007-08 (Source:
DGCIS).
- The share of imports of Pharmaceuticals
products compared to national imports fluctuated in a band of 0.16% (in 1996-97) to
0.39% (in 2002-03). In 2007-08, imports constituted 0.28% of the
total national imports compared to 0.35% in the previous year. Lower share of imports, ceteris paribus, signifies more
self reliance and can therefore be construed as a positive sign for
the economy in general and for the
pharma sector in particular in the long run.
- While Pharmaceutical products are exported
mainly to USA, Germany, Russia, UK,
Brazil, India’s imports emanate primarily from China, Switzerland, USA
& Italy.
10. Other
Events
We have introduced a separate item, ‘Upcoming Events’ on our website
regarding some of the events being organized by this Department, NPPA, and
NIPERs.
11. Future
Outlook
Early results for September 2008 quarter indicate that aggregate sales
grew by 28.2%, aggregate sectoral PAT by 18.4% and PAT margin to 15.1%,
according to CMIE. For the year ending March 2009, net sales are expected to
grow by 19.2% compared to 19.7% in the preceding year (Source: CMIE).
Notwithstanding fears of a global recession, pharma exports are
expected to grow by 25.2% while pharma imports are likely to register a growth
rate of 31.8% in 2008-09, according to CMIE.
12. General
This is our first attempt in preparing the “Round Up of Pharmaceutical
Developments”. We have tried to collate information from various sources
including media reports for this round-up. If there are any corrections
required or more data and information available with you, please send it to us
for our future round-up. In addition, if there are any suggestions or comments,
please email to us at js-pharma@nic.in or
write to Joint Secretary (Pharma), Department of Pharmaceuticals, Ministry of
Chemicals and Fertilisers, Shastri Bhawan, New Delhi-110001, Tele :
011-23385131.
Let me also wish you all a very HAPPY NEW YEAR from this Department.
*******