[Ip-health] LiveMint- Indian drug makers worried by East Africa's legal proposals

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Indian drug makers worried by East Africa's legal proposals

Countries such as Uganda and Tanzania are taking their cue from a Kenyan
law against fakes

Posted: Tue, Feb 16 2010. 1:15 AM IST C.H. Unnikrishnan

Mumbai: With at least half a dozen East African nations considering
legislation against counterfeit products that could potentially be used
to block generic drugs, Indian drug makers are working on a
multi-pronged strategy to battle the impact of such laws.

Countries such as Uganda, Tanzania, Rwanda and Burundi are taking their
cue from an anti-counterfeit law in Kenya. East African markets
accounting for up to 20% of India's annual drug exports of Rs39,500
crore.

Kenya's Anti-counterfeit Act of 2008, which came into effect in July
2009, seeking to prevent fake products, is unclear about the distinction
between generic, substandard and counterfeit drugs. Uganda has already
prepared a draft Anti-counterfeit Goods Bill that is similar to the
Kenyan law.

Domestic drug makers fear that due to a lack of clarity, the new laws
could label legitimate generic drugs as counterfeit or even spurious.

"The new legislation is mainly aimed at stopping cheap generic drugs
coming from India, which has by now gained the reputation of a key
supplier of low-cost quality drugs to the world market," said P.V.
Appaji, executive director of Pharmaceutical Export Promotion Council,
or Pharmexcil, a government body under the commerce ministry.

In the past, some consignments by Indian drug makers-among them Cipla
Ltd, Dr Reddy's Laboratories Ltd, Ranbaxy Laboratories Ltd and Lupin
Ltd-en route to African and Latin American countries were stopped at
European ports on the grounds that they either violated patents of
multinational companies or by being labelled spurious.

To avoid such incidents, besides government-level efforts to mitigate
misconceptions that generic drugs from India are counterfeit and/or
spurious, domestic pharma lobby groups the Indian Pharmaceutical
Alliance (IPA) and Indian Drug Manufacturers Association, as well as
individual companies, are launching programmes to educate patients and
non-governmental organizations (NGOs) in those countries about the
effect of such laws on access to affordable essential medicines.

India needs to take a long-term view and do a lot more on an ongoing
basis by involving all stakeholders, said D.G. Shah, IPA secretary
general. "A plan of action for an awareness campaign among users of
generic drugs in African countries is also in progress."

Another key strategy would be to help set up local manufacturing
capacities to make the nations self-sufficient in cheap and quality
drugs.

Since these markets are short of raw materials, Indian companies would
benefit from exporting active pharma ingredients.

Cipla, India's largest generics manufacturer by sales, helped commission
a plant under the local management of Quality Chemicals Industries Ltd
(QCIL) in Uganda last year. The project is a joint venture between QCIL
and the Ugandan government, with technology inputs from Cipla.

Cipla's joint managing director Amar Lulla said the firm has made
similar offers to other East African nations.

Last year, IPA had suggested a seven-point action plan to the Indian
government to discourage East African governments from adopting policies
that could hit drug exports from the nation. Among them were
capacity-building programmes for African countries, providing impact
analysis of new policy initiatives and resolutions in various
multilateral forums.

IPA also asked the Union government to provide financial aid as an
incentive to Indian firms to invest in Africa, and to undertake
bilateral initiatives.

Appaji said Pharmexcil had initiated dialogue between Indian industry
and ambassadors from East African countries. "We are now planning to
invite NGOs and drug regulatory authorities from these countries to
Indian drug manufacturing facilities to convince them about our quality
standards," he said. There are plans for publicity campaigns in the East
African nations, he said.

http://www.livemint.com/2010/02/15221607/Indian-drug-makers-worried-by.h
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