Press Note
1. There have been extensive media
reporting in the print as well as electronic about on the quality of drugs
(pharmaceutical products like APIs and formulations) manufactured in India for
exports. Some isolated reports have also been received about export of spurious
/ counterfeit drugs attributed to some source in India
2. The Pharmaceutical sector is a highly
regulated one and the exports are heavily guided by various regulatory regimes
of the importing countries and there is also a requirement for continuous
monitoring of quality related aspects including complaints of sub-standard /
falsified drugs from various countries.
All the concerned organizations in the government are constantly
interacting to ensure that India’s image as a safe exporter is protected from
all angles. Government and the industry is already
working on a ‘trace and track’ mechanism which would enable monitoring of the
supply chain possible at all the three levels viz. Tertiary, Secondary &
Primary.
3. Indian Pharmaceutical industry is a
highly knowledge based industry which is growing steadily and playing a major
role in the Indian economy. India has a large vendor base for supplying
quality generics/API/ contract manufacturing with state of the art facilities. Indian pharmaceutical companies have huge
manufacturing built in capacities hence able to meet time schedules. India has
proven international quality standard capabilities as measured by number of
ANDA approvals, DMF filings, USFDA/UK MHRA approved manufacturing facilities/
bio equivalence centers, which are considered as key indicators for assessing
the capabilities of any national pharma sector. This fact is further firmly demonstrated by
the trends in the number of product approvals received from various major
regulatory authorities of the world.
4. The following statistics reported by
Pharmexcil indicates the strong presence of Indian industry in the US and the reports
of US FDA penalizing Indian companies are only a small aberration:
·
India had as on
30th December 2012 over 3000 Drug master filings (DMF’s) with USA amounting to a almost 40% of the total DMF’s filed With USFDA. These are
filed by over 233 different companies from India.
·
During the year
2012 USFDA has granted 476 ANDAS and India has 178 market authorizations of
them i.e. amounting to 37.4% of the total.
·
As on 30th Dec
2012over 2275 ANDA’s (Abbreviated new drug application)(Generics)
are approved by USFDA covering over 31 different companies.
·
There are over
550 manufacturing sites registered with USFDA out of Which 323 sites are
approved by USFDA as on 31st March 2013.
·
130 companies
have over 902 CEP’s approved by EDQM, which is more than 25% of the total CEP’s
approved by EDQM globally.
·
27% of the
formulations are exported to USA and India has a share of 15% of US generics by
way of volume.
5. There are more than 350 manufacturing
sites endorsed by EU for their GMP in India as on 30th April 2013. All the facts quoted above speak about
India’s ability to harness large talent pool to produce quality pharmaceuticals
- second to none in quality and that too at the most
competitive prices. There are
reasons to believe that vested interests are raking up isolated issues reported
regarding technical deficiencies on manufacturing and GMP. India is enjoying a
unique position of low cost manufacturing and highest quality medicine, best of
both the worlds. Government has strong
reason to believe that some of the spurious drugs detected in the international
markets, alleged to be exported from India, are desperate attempts by other
countries getting affected by the strength of Indian pharma
industry.
·
Salient
features of export trends:
o
4th
in the world in terms of production volumes
o
13th
in domestic consumption
o
12th
in terms of export value of bulk actives and dosage forms
o
Over
55% exports of India are to highly regulated markets.
o
USA
the largest exports destination followed by UK.
o
Largest
exporter of formulations in terms of volume with 14% market share.
o
The
increase in exports over the last few years indicates the growing strength of pharma industry:
|
Year
|
Total
Exports (value in USD million - rounded off)
|
% growth
over previous year
|
|
2008-09
|
8789
|
14.86
|
|
2009-10
|
8971
|
2.08
|
|
2010-11
|
10722
|
19.51
|
|
2011-12
|
13165
|
22.78
|
|
2012-13
|
14,590
|
10.55
|
Indian regulatory system
6. Drugs Controller
General of India (DCGI) is responsible for approval of licenses of
specified categories of drugs such as blood and blood products, IV fluids,
vaccines and sera in India. The State
Drug administration offices regulate issue the manufacturing licenses and
quality control monitoring etc. The DCGI
regularly holds meeting the State authorities and also interacts with drug
regulators across the globe to ensure that the international practices of
manufacture and supply of drugs are followed in India. India’s compliance with TRIPS and consequent
implementation of Patents Act is appreciated all over the world.
7. Companies/importers
from all over the globe are encouraged to visit the manufacturing facility in
India to satisfy themselves of the quality of production of drugs.
Recent Actions taken by GoI to ensure export of quality drugs
·
The
trace and track technology mandate at tertiary and secondary level stands
implemented. Date of primary level packaging is postponed to 1.7.2014. Steps being taken to ensure the
authentication process for trace and track under way. DoC in talk with
Health& FW in the matter seeking common approach for both exports and
domestic tracking.
·
The Government of India has demonstrated its keenness to meet
international requirements for exports of pharmaceutical products yet again by
taking timely action for complying with the new procedural requirements of the
European Union (EU) for import of Active Pharmaceutical Ingredients (APIs) into
the EU. This landmark achievement underlines the seriousness the
Government of India towards pharma exports.
·
In
due course of time, online application filing and tracking system would be
evolved to bring in sufficient expediency and transparency in the entire supply
chain.
……………..
Department
of Commerce, Ministry of Commerce & Industry
DS/RK