The Indian active pharmaceutical ingredients (APIs) manufacturers are
gearing up to improve the export market prospects. The companies are
chalking out roadmaps to increase opportunities in the regulated regions
as well as in the emerging markets. They are looking to provide
competitive prices and engage in the production of niche APIs to remain
aggressive in the market, said Anjan K Roy, president, Karnataka Drugs
& Pharmaceutical Manufacturers Association (KDPMA) and Managing
Director, RL Fine Chem.
From the regulated markets we are
looking to tap the contract manufacture business. The country has over
140 USFDA approved facilities, in addition to approvals from UK
MHRA(Medicines And Healthcare Products. Regulatory Agency), TGA
(Therapeutic Goods Administration), Australia; MCC (Medicines Control
Council), South Africa and three certified by EDQM (European Directorate
for the Quality of Medicines and Healthcare) which gives confidence to
international companies to outsource API production to India, he added.
The
key strengths of India in the space are inherent expertise in
chemistry. In the last three to four years, the sector has been
recognized for its research and development capabilities. Over the
years, there has been an increased focus on augmenting the research
quality and manufacturing practice, in addition to intellectual property
security. Indian companies are also known to have a high number of Drug
Master Filings (DMFs), said industry sources.
The Bulk Drugs
Manufacturers Association estimates the APIs industry to be around Rs
32,000 crore to Rs 35,000 crore ($6.61 billion to $7.23 billion) out of
the total Rs 78000 crore ($16.12 billion) Indian pharma industry. Out of
the total API business, almost Rs 15,000 crore to Rs 18,000 crore ($3.1
billion to $3.7 billion) is from exports.
The industry has
maintained almost 10 to 15 per cent growth both in API and its exports
business. The country has around 600 API manufacturing companies. The
country has world's second largest API manufacturing industry after
China. The leading API companies are Dr. Reddy's ,Ranbaxy Laboratories
Ltd, Aurobindo Pharma, Cadila Pharmaceuticals Ltd, Sun Pharmaceuticals
Industries Ltd, Cipla Ltd, Dishman Pharmaceuticals & Chemicals Ltd,
Divi's Laboratories Ltd, Hikal Ltd, Orchid Chemicals &
Pharmaceuticals Ltd, Torrent Pharmaceuticals Ltd., Biocon, Micro Labs,
Bal Pharma, Strides Arcolabs, Nandu Chemicals, Shilpa Medicare, Bayir
Chemicals part of Bayir Group and Orchid Chemicals among others.
Challenges of the API sector
The
lack of government support is one of the key issues to be addressed.
The pricing strategy of China is another major issue. Indian API and
excipients manufacturers are seriously affected by imports from that
country. Although the main threat is for certain segments like
analgesic-antipyretic drug (paracetamol), antibiotics (penicillin), anti
fungal (Metronidazole) and vitamins, China has captured a substantial
part of the Indian market, industry sources stated.
Other issues
are the pollution control board allegations for non compliance of
environmental laws, high cost and power shortage . The poor
infrastructure like roads and connectivity are also impeding the growth
of the industry. Added to these is labour problems which are affecting
the deadlines for contract manufacture.
KDPMA is of the view
that a dedicated pharma park for APIs industry could ease a lot of
hassles. The industry has been facing infrastructural problems in the
state for some time now. The need of the hour is a special chemical zone
to tackle pollution control and effluent treatment issues, adds Roy.
Threat from developed nations
In
the meanwhile according to some reports,the western world, especially
the leading players like America, supported by the multinationals, who
had been targeting the fast growing Indian generic in the recent years,
is training guns against the active pharmaceutical ingredients sector
too, as India is gradually emerging as a world leader in the global
market.
If the last `Special 301' report, the annual review of
the global state of IPR protection and enforcement by the Office of the
United States Trade Representative (USTR) is any indication, the US is
likely to forge ways to wither the Indian API industry.
The
report said the US had concerns on the proliferation of the manufacture,
sale, and distribution of counterfeit pharmaceuticals in countries such
as Brazil, China, India, Indonesia, and Russia. In many cases, bulk
active pharmaceutical ingredients that are used to manufacture
pharmaceuticals that bear counterfeit trademarks are not made according
to good manufacturing practices, it claimed.
Placing India yet
again in the `priority watch list in 2010', the US wanted India to
``provide protection against unfair commercial use, as well as
unauthorised disclosure, of undisclosed test or other data generated to
obtain marketing approval for pharmaceutical and agricultural chemical
products.''
"Concerns remain over India's inadequate legal
framework and ineffective enforcement. Piracy and counterfeiting,
including the counterfeiting of medicines, remains widespread and
India's enforcement regime remains ineffective at addressing this
problem.
The United States continues to urge India to improve
its IPR regime by providing stronger protection for patents. One concern
in this regard is a provision in India's Patent Law that prohibits
patents on certain chemical forms absent at showing of increased
efficacy. While the full import of this provision remains unclear, it
appears to limit the patentability of potentially beneficial
innovations, such as temperature-stable forms of a drug or new means of
drug delivery. The United States also encourages India to provide
protection against unfair commercial use, as well as unauthorised
disclosure of undisclosed test or other data generated to obtain
marketing approval for pharmaceutical and agricultural chemical
products,'' according to the report.
Pharmaceutical Research and
Manufacturers of America (PhRMA) has supported the report and backed up
the call for IP protection. ``PhRMA and our members place a high
priority on addressing the harm caused by inadequate IP protection and
by the market access barriers put in place by some trading partners. The
value of IP protection should not be undermined by discriminatory
market access barriers. We welcome USTR's recognition of market access
barriers faced by US pharmaceutical companies,'' its president
Christopher Singer said.
The formulation sector, especially the
generic industry, has already seen lots of trouble from the
multinationals. The European customs authorities had seized nearly 20
consignments of generic medicines from India en route to different
destinations in the developing and underdeveloped countries over the
last two years.
The authorities have cited patent violation for
the seizure of the drugs, prompting sharp reactions from Indian
authorities and public interest groups worldwide. The issue has also
reached the WTO dispute forum.