Tuesday, March 31, 2009

India:Urgent Steps Are Needed To Ensure Quality Medicines

The WHO is trying to fight the huge international trade in counterfeits but faces opposition from India and others, driven by a strange coalition ranging from the far Left to business organisations: this author blows away some of the straw men these people have built up. Barun Mitra says robust trademark protection will give Indian companies a stake in quality and give Indian, and worldwide, patients the guarantees that they need.

My article titled India: Urgent steps are needed to ensure quality medicines was published in The Pioneer on March 31, 2009

Indian pharmaceutical companies are supplying sub-standard drugs in Maharashtra. While the home-grown nature of the problem at least means that a solution lies in our own hands, the Government is sending a worrying signal by blocking the World Health Organisation's efforts to improve drug quality around the world.

Maharashtra's Medical, Education and Drugs Secretary Bhushan Gagrani said that 547 samples of Indian-produced sub-standard drugs were seized there during 2007 and 'we have initiated proceedings against 13 companies in Maharashtra and 97 firms outside the State'. The authorities are having to accept evidence contradicting the Centre's 2003 claims that only half a per cent of drugs in India were counterfeit and less than 10 per cent substandard ó especially as these figures were based on unverified data and small sample sizes, and some States provided no data at all.

Recent figures are far less optimistic. Last year a survey by the Associated Chambers of Commerce and Industry estimated that counterfeit drugs account for between 20 and 25 per cent of the market in the National Capital Region. In 2004, the Delhi Medical Association sampled drugs from the medicines bazaar at Bhagirath Palace and found 92.5 per cent were fakes. News reporters found exporters who sell the fakes to Sub-Saharan Africa.

It is of course difficult to trace the true origin of drugs in fake packages but the Organisation for Economic Co-operation and Development has estimated that 75 per cent of the world's counterfeit drugs originate in India.

It seems clear that substandard and counterfeit drugs are a huge problem, within India and beyond. India, however, has been opposing the work of the WHO's International Medical Products Anti-Counterfeiting Taskforce.

IMPACT needs to define the problem in order to fight it. Yet the group's new definition of the term 'counterfeit' is opposed by an unholy coalition ranging from anti-market activists to business associations and officials, claiming it would impose stricter patent protection and block the export of cheap Indian generic drugs to Africa. IMPACT is a front for Western ëBig Pharma', they cry.

But IMPACT is mainly run by national drug-regulatory authorities. Moreover, its proposed new definition states that 'patents must not be confused with counterfeiting'. The European Generic-medicines Association supports the definition precisely because it 'puts an end to any confusion with alleged patent infringement products which have nothing to do with counterfeiting'. The International Generic Pharmaceutical Alliance, of which the Indian Pharmaceutical Alliance is a member, was a founder of IMPACT. Where, then, is the ëBig Pharma' patent-enforcing conspiracy?

Whatever happens to IMPACT, however, it will not solve India's problem alone ó IMPACT's remit is primarily to guide countries on how they might protect their citizens from counterfeit drugs. It is a collaborative advice centre. The real action is down to us.

The plan for an India-wide Federal Drugs Authority seems permanently stalled but in any case we should question the instinctive assumption that greater regulation results in better products. There are some 20,000 pharmaceutical manufacturers in India, producing literally millions of drugs ó can a regulator really check every item, or even a reasonable sample?

The US has some of the highest standards of drugs in the world, in spite of vast numbers of packages continually crossing its borders and being traded by thousands of wholesalers. Meanwhile China's authorities continually announce clampdowns, introducing layer upon layer of regulation ó yet China continues to suffer from fakes and from lethally substandard foods and medicines.

An observable difference between the two countries is the existence in the US of trademark laws, upheld by independent courts. Manufacturers and patients can take legal action against the makers of substandard or counterfeit products. Sadly, the Confederation of Indian Industry describes the inadequacy of civil jurisprudence' in India as a reason why counterfeiting is so rife.

Brands are even more important to generics than to patented medicines. Free trade and fierce competition are the most effective measures for increasing quality ó and this relies on trademarks and copyrights being protected, so that authentic generic manufacturers are not undercut by spurious imitations.

New technologies are helping brands guard against counterfeiters. Soon Indian patients will be able to send an SMS text to check if their medicine is genuine. Meanwhile, the Indian unit of an MNC drug-manufacturer is introducing a new tracking system for its products.
These technologies offer great hope but the fundamental problem remains.

Counterfeit and substandard drugs harm the reputation of India's pharmaceutical industry, threatening people's health and even their lives. Competent and honest manufacturers must help cut through the unfounded conspiracy theories in order to defend themselves, the public and the rest of the world.