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.
Graphic: Rahul Awasthi / Mint
“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.