Elder Pharma to sell Indian brands in European market

Elder Pharmaceuticals Ltd will soon roll out its leading Indian brands in the European market through
its subsidiaries in Britain and Bulgaria , to step up its exports in the region, the company said Tuesday.
It plan to launch five products in Europe during this fiscal (2011-12) through Bugarian subsidiary Elder
Biomedia, which has secured approvals to market them in the region.

Of the five products to be exported, Shelcal, a calcium supplement for women, is one of the largest
selling pharma brands in the country, contributing Rs.200 crore to the company's sales turnover of
Rs.800 crore in fiscal 2010-11. The Rs.800-crore Delhi-based Elder plans to double its export revenue
to 20 percent over the next two years from 10 percent last fiscal by foraying into the European market
in a big way.

The company has seven manufacturing plants in located in Maharashtra, Uttarakhand and Himachal
Pradesh. Its research and development centre at Navi Mumbai is recognised by the department of
scientific and industrial research under the ministry of science and technology.

Dr. Reddy’s Identifies Partner to Sell Medicines in Japan

Dr. Reddy’s Laboratories Ltd.,India’s second-biggest drugmaker by revenue, has identified a partner to
market its medicines in Japan and bolster its presence in the estimated $96 billion market.
Negotiations are still in progress to establish a structure for the venture, Chief Financial Officer Umang
Vohra said in an interview at the company’s new headquarters in Hyderabad. It eventually hopes to
supply products which will then be marketed by the Japanese partner, Vohra said. Dr. Reddy’s makes
both drug ingredients and finished drugs. He declined to name the likely partner.

Japan, the world’s second-biggest drug market, is attractive for companies such as Dr. Reddy’s
because the island nation has set a target of increasing the share of generic medicines to 30 percent
by 2012.

The Hyderabad, India-based Dr. Reddy’s will announce details of the venture by next quarter,
Vohra said. Dr. Reddy’s hasn’t tapped Japan, because “we were more excited about the U.S. and
what it could get us,” Vohra said. The drugmaker gets about a third of its revenue from the U.S. It
doesn’t report sales figures for Japan.

Chinese drug firm turns back inspectors, may lose licence

India will terminate the licence of a Chinese drug manufacturing firm for not allowing an Indian
delegation to inspect its premises and manufacturing facility. Located in China's Beibei district,
Chongiqing Daxin Pharmaceutical Company is a bulk drug (BD) exporter to India. A three-member
delegation from the Central Drugs Standard Control Organization (CDSCO), led by assistant drugs
controller of India Arvind Kukrety, visited the manufacturing sites in China from May 9 to 21. This was
CDSCO team's maiden international trip. Altogether, they inspected manufacturing facilities of five
major Chinese BD exporters.

India is the largest importer of Chinese bulk drugs. More than 45% of BD exporters registered in India
are from China. The number of registered Chinese BD manufacturers in India is 272, and altogether
417 different drugs from the Asian giant are registered. In comparison, Italy, the second biggest
supplier after China, has 55 registered BD and overall 97 drugs registered, respectively. In 2009-10,
the value of drugs imported from China stood at Rs 3094.4 crore against a total import value of Rs
4953.87 crore.
The decision to audit Chinese drug manufacturing units was taken after several import licences of local
agents of such overseas units were cancelled due to poor drug quality and their failure to comply with
good manufacturing practices (GMP). The office of the Drug Controller General of India (DCGI) had
shortlisted 11 Chinese drug manufacturing units for inspection. A second team of Indian drug
inspectors will leave for China soon that will visit three diagnostic tool manufacturers in Zhejiang,
Fujian and Guangho districts.

Emami sets up 10-member advisory board for succession plan

Consumer products firm Emami, maker of Boroplus antiseptic cream and pain-reliever Zandu balm , is
setting up a 10-member advisory body to guide the promoters in its succession planning as its two
founders, chairman RS Agarwal and director RS Goenka, plan to pass on the baton to the younger
generation over the next 12-18 months.

This advisory body will work closely with Ernst & Young (E&Y) to identify the next chairman, groom the
younger generation to professionalise the business in the long run and evolve the future business
model. Advisory board would suggest possible candidates for the chairman post, heads of various
group businesses such as the flagship FMCG, paper, retail, realty and healthcare, and would devise the
means and methodology of working for the next generation. While two seniors still call the ultimate
shots, it is the second generation Agarwals and Goenkas who already steer the day-today course at
Emami.

The FMCG business alone has crossed sales of Rs 1,100 crore in 2010-11. The firm is targeting Rs
3,000-crore sales from its FMCG business in the next two years and evaluating targets for acquisitions
including the personal care business of Paras Pharma which Reckitt Benckiser acquired last year and is
looking to sell. It says it can spend up to Rs 1,000 crore to Rs 1,500 crore acquisitions.

Herbal drug makers to swallow bitter European pills

UK health regulatory authority enforces strict norms for export, in wake of EU directive.

Indian ayurvedic medicines manufacturers are set to face a tough time as far as exports to European
countries are concerned. Domestic majors, such as Himalaya and Baidyanath, are in a dilemma after
the UK Medicines and Healthcare products Regulatory Agency (MHRA) made traditional herbal
registration mandatory for herbal medicines. The health regulatory authority introduced the new
norms with effect from May 1.

According to European Traditional Herbal Medicinal Products directive issued in 2004, all over-the-
counter manufactured herbal medicinal products placed in the UK and European markets will need
either a traditional herbal registration (THR) or product licence. The European Commission announced
earlier this year that all member-countries would have to implement this from May.

Although the companies are busy filing new registrations, the cost of registering products and
indefinite delay for the process remain a major concern. If not registered, products based on traditional
Indian herbs such as ashvagandha, brahmi, karela, neem, shatavari, guggulu, triphala, tulsi will be
banned from exporting to European countries. However, products based on a few herbs like
ashvagandha, triphala, ginger, turmeric and amla, which are already registered in European
Pharmacopeia, can be distributed.The cost of registration, which would be approximately Rs 15-20
lakh per product and varies from country to country, may not be affordable for all exporters.

The criteria for approving a herbal drug is based on its presence in the European Union countries for
15 years and in the country of origin for a minimum of 30 years.
In 2004, a study released by the Journal of the American Medical Association had alleged that 14
products, made by firms like Dabur, Zandu, Baidyanath and Himalaya, contained harmful levels of
lead, mercury and arsenic. Following the study, UK MHRA, Health Canada and Singapore's regulator
HSA had issued warnings.In 2005, UK MHRA directed people to stop consuming certain Indian
ayurvedic drugs — Karela (Himalaya Drug Co), Safi (Hamdard-WAKF-India), Maha Sudarshan Churna
Powder (Zandu Pharmaceuticals). UK MHRA had also advised caution against Yograj guggul tablets
(Zandu Pharmaceutcals), Sudarshan tablets (Zandu Pharmaceuticals) and Shilajit capsules (Dabur
India Ltd.)The incident also led India's ministry of health to make heavy metal tests mandatory for
herbal, ayurvedic, siddha and unani medicine exports from January 1, 2006.