Indian pharmaceutical companies export over Rs 600 crore worth of affordable high quality medicines to Africa and the African market is the fourth largest global pharmaceutical export market for Indian players. The reason these medicines are affordable is that they are knock- offs (copies) of medicines that have lost patent protection.
However, certain African countries are not so accessible to Indian generic manufacturers anymore. Recently, governments of African countries like Nigeria and Uganda adopted legislation that would block imports of cheaper anti-HIV drugs from Indian manufacturers. Despite efforts on the part of commerce ministry and Pharmaceuticals Export Promotion Council (Pharmexcil) to assure representatives of these countries that these products pose no health risks, are efficacious and do not violate intellectual property laws, a third African country, Libya, has followed suit by seizing some consignments and holding back consignments at ports, citing a notification dated June 9, banning the imports of drugs from non-EU and non-North American countries. Sources in Pharmaexcil say they have requested and are awaiting a copy of the notification to study the same, so that they can effectively address the issues raised.
This was preceded by Kenya?s move to pass anti-counterfeit legislation that allows generics having patent protection anywhere in the world to be considered counterfeit in case of an intellectual property dispute with the patent holder. This law has been branded anti-patient as the African continent is a beneficiary of affordable drugs from India, the largest supplier of generic anti-retrovirals to low- and middle-income countries.
Indian pharma industry players unfortunately seem to be under a pincer attack, considering that drug regulators in developed countries continue to make inspections of manufacturing facilities more stringent. Jubilant Organosys?s Belgium subsidiary is the latest example of this trend, which started with Ranbaxy-Daichii, and also has Sun Pharma?s Caraco facility in its grip. Industry experts say it cannot be proved that India is being singled out for more stringent inspections but this is cold comfort for industry players.
What Pharmexcil members object to is the fact that they were not given adequate prior intimation of the Libyan Government?s notification. Many exporters have sizeable order lists, and have taken bank loans to process and meet these commitments. Their substantial investments will go to naught if their consignments are held up in ports and there is no doubt that the new stand by Libya and other African players will be a blow to these players.
Indian generic exports to the Libyan market are relatively small (Rs 20 crore in 2007-08 as per Pharmexcil estimates). It?s not the amount but the trend that is giving pharma exporters sleepless nights. The logic that Indian generic drugs can meet a substantial portion of the healthcare needs of these countries, which bear a huge disease burden (prime among these being HIV infection, malaria and TB) seems a no-brainer, but if these governments have legitimate concerns about safety, these fears need to be assuaged. Pharmexcil says it will lead a delegation to Johannesburg beginning July 23 to assure these countries of the quality of India?s generic medicines and answer any queries. At the same time, the association has advised its members to proactively take steps towards self-regulation and to share their learning with other members as well.
There has always been a debate on definitions of the term ?counterfiet?. The actual quantum of counterfiet drugs orginating from India is also a controversial topic, with guestimates ranging from 30-0.5%. But the fact of the matter is that for patients, a spurious drug can kill 100%. Also, while Indian drug regulatory authorities may claim that only 0.5% of the samples they tested are spurious, observers hint that the sample quantity is statistically too small. It is a well-known fact that if a country of India?s size has only 26 government drug testing laboratories, each with a backlog of 6-9 months, counterfeiters can rest assured that their business model will thrive undetected. The counterfeit drug problem does not merely concern consumer health and safety, it has also started eating into the market shares and business margins of drug producers who invest a lot in infrastructure and toe the line as far as good manufacturing practices are concerned. This also creates a negative image of Indian drug manufacturers as well as the country as a whole. There is now a perception that this industry is wary of international regulation, when in fact the Drug and Cosmetics Act already has provisions for dealing with such a problem. Industry players should therefore actively address these concerns. One way of doing that is to proactively protect their products and brands by incorporating anti-counterfeit technologies.
This is really the need of the hour, especially with some Chinese manufacturers blatantly passing off their spurious drugs with a ?Made in India? label. It may seem foolhardy to add to the cost of manufacturing by incorporating these technologies, but the savings are almost immediate as most brands that have incorporated these technologies report a spurt in sales. Also, some of these technologies actually create a database of location-wise sales of individual brands, which can easily become market intelligence and sales tracking tools.
Access to affordable medicine should be topmost on the agenda of every government, not just the US. Right now, certain African countries? recent measures suggest that the citizens will have to wait longer for this basic right.
The author is editor, Express Pharma