Sunil Jain: India's bigger drug problem

RATIONAL EXPECTATIONS

With every fifth medicine sold by the Rs 19,000 crore pharmaceuticals industry in the country a fake, according to a petition filed by Nicholas Piramal's Harinder Sikka (in his personal capacity), it is obvious the problem of counterfeiting is very serious. For, though the Drug Controller General of India says the problem of counterfeiting is not unique to just the pharmaceuticals industry, it's unlikely that using a pirated Windows will kill you; but if there's tap water in the adrenaline ampoule that's used to revive you after a cardiac arrest, it is certain this is precisely what will happen.

A BBC documentary on spurious drugs that documents one such case of fake adrenaline causing death has the Nigerian anti-counterfeiting head naming India as one of the big suppliers of fake drugs imported into that country (more on the video later). And a "significant contributing factor" for India staying on the US special watch list of countries with poor intellectual property rights compliance, according to the report released a few days ago, is "the unauthorised use of bulk active pharmaceutical ingredients (APIs) to manufacture counterfeit pharmaceuticals". "Countries must ... enforce against the unauthorised use of APIs domestically and to ensure that they are not exported for unauthorised use abroad," the report says.

Most, including Sikka, who won a global anti-counterfeiting award, presented by none other than Justice KG Balakrishnan (now the Chief Justice of India), have focused on the lack of drug inspectors in the country and the handful of government laboratories"�we have just 900 inspectors to take care of around 20,000 registered and unregistered producers and 400,000 chemist shops across the country. But this is missing the wood for the trees. It is obviously good to have more drug inspectors and more government laboratories, but what is required is a more intelligent approach, assuming of course, and that's a big assumption, that the government is keen to do anything.

Though it is true spurious drugs are sold in small towns and distant villages (that's where having more inspectors can be useful), large enough sales take place under the very nose of the authorities, and that is where concentrated action can help. Most of those in the pharma industry will tell you, for instance, that large proportions of medicines that are procured in bulk by the armed forces, the CGHS, and so on are fake"�indeed, the government's system of awarding the tender to the lowest bidder often results in cases where the bids are lower than the cost of the active ingredient itself; that the medicine sold will be spurious, with less or no active ingredient, is obvious.

One solution then is to make it mandatory that all bulk buying of drugs by the armed forces, the CGHS, big hospitals and so on will have to be tested, randomly, not by government laboratories but by roping in private ones as well. Just look at the impact one Centre for Science and Environment (CSE) has had on the standards for soft drinks and water as compared to stodgy government laboratories! "�and ensuring that these results are well publicised. Imagine the impact if a sign outside a big hospital says its medicines are spurious. A good example to emulate would be that of the public sector oil firm BPCL. At a time when oil sales were growing quite slowly, sales in select BPCL pumps rose by several times. This, when the company began its Pure-for-Sure campaign, promising unadulterated fuel to customers. Apart from tamper-proof locks on its tankers, the company hired a certifying agency (in this case, TUV) whose job it was to conduct random checks on various pumps without even BPCL's management knowing when and where the check would take place. To make the system even more strong, make the head of the organisation caught with fake drugs legally culpable.

This, of course, would also require a big step on the part of the government, which, till date, continues to prescribe nominal punishment for counterfeits/spurious drugs"�imprisonment of up to three years and a fine more than Rs 5,000 are clearly not a deterrent, especially when the crime is non-cognisable and bailable. A new more stringent law was proposed by the NDA government in December 2003 but never got passed in the din of the elections, and nothing has been heard of the UPA's bill after the standing committee to which it was referred gave its recommendations in December 2005. Call it government apathy or call it the power of the big counterfeiting industry, the result is the same"�counterfeiters rule.

In the BBC documentary, the journalist posed as a Chechenyan looking to buy low-priced fake drugs and secretly filmed the head of one such firm who openly bragged that he was paying off politicians, including gifting a Bentley to a former chief minister. He spoke of how, deliberately, one or two letters in the name of the drug were changed as this provided protection under the law! The firm, by the way, continues to do business even today. In another case, reported by this newspaper, a firm was blacklisted for providing poor-quality (read spurious) medicine by the government but, within a short while, it was back to winning government tenders. So the next time your fever doesn't respond to medicines, don't go back to your doctor, visit your chemist first and have the medicine analysed at a laboratory. You have to fight for your rights, the government won't.