The story of fake drugs

It was at Kargil during the war that I realised the far-reaching consequences of counterfeiting and fake drugs.

Our wounded soldiers, injured while engaging the invaders, were now suffering due to the enemy within by consuming substandard drugs manufactured by the fly-by-night operators.

Since then, many campaigns have been run to sensitise the government on the burning issue as also bring about the changes in the existing laws.

That the problem has gained international proportions and magnitude can be viewed from the recently aired BBC sting operation where an established Indian pharma company was shown as willing to counterfeit and export any drug to make a quick buck.

Even under the existing laws, the health ministry is often caught off-guard in implementing strict measures against the offenders. Pyrazinamide tablets, meant to control tuberculosis from spreading, were found to be substandard in 2001 by various government laboratories.

The health ministry, however, instead of blacklisting the company, merely de-registered the drug despite being aware of the fact that such an action would have no effect on the ground. There is no foolproof system of recall of drugs in India.

Therefore, once a medicine is released into the market, the distribution network is so widespread that it becomes nearly impossible to recall the defective drug.

Ironically, the same company was caught again in 2003 for supplying sub-standard anti-TB drugs.

The company survived yet again and continues to do so till date, thanks to the inadequate laws and unwilling government machinery even as the spurious drug was consumed by gullible patients despite the official recall.

Unlike candies and chocolates, medicines play the role of a lifesaver. It, thus, needs to be manufactured under strictest quality control guidelines.

As a right step in the direction, Drugs Controller General (India) implemented Schedule "M" effective June this year. However, without a change in the government procurement policy that buys life saving drugs on the basis of lowest quotations (L1) and not necessarily high qualitative standards, scores of government-run dispensaries and hospitals are flooded with medicines that are manufactured by shady outfits.

The rates quoted by these so-called pharma companies are sometimes much lower than even the basic raw material cost.

It is, therefore, not surprising that established pharma companies find it difficult to compete. Most of them have even stopped bidding for government procurement orders.

The state of affairs in rural India, occupied by nearly 70 per cent of our population, is even worse due to lack of adequate checks and balances. As Dr Mashelkar's report states, with only seven laboratories functioning out of the total 27, counterfeiters are here to stay.

First, the Bharatiya Janata Party and now, the Congress coalition has promised suitable amendments to the anti-spurious drugs Bill. But five years since the campaign began against spurious drugs after the Kargil war, our country is still struggling with the right definition of the Bill.

Meanwhile, the entire pharma industry is facing the flak from the importers overseas.  The US, in fact continues to maintain India under the 301 watch list for this very reason. It is unfathomable for the common man to appreciate the delay in the said Bill, especially when there is consensus amongst political parties across the board.