Some real action for fake drugs?

HARINDER S. SIKKA 

All those raking profit from fake drugs businesses are knowingly killing patients and deserve to be sent to dungeons... I am going to push for a bill in the Parliament’s Monsoon Session that would seek death penalty for the merchants of death.” This was Health Minister Sushma Swaraj speaking last week to a delegation from the Confederation of the Indian Industry, which had met her to plead for stricter laws to control the menace of spurious drugs. Her resolve to tackle the menace head-on gave a clear direction to the attending bureaucrats. Many in the CII delegation felt that here, at last, was someone who had displayed the courage to think the unthinkable.

Fake drugs are estimated to constitute a Rs 4000-crore business in India — nearly one-fourth of the total pharma industry’s turnover. What’s more, it impacts on our exports. Many African and Latin American countries have complained about our fakes reaching their shores. This has also resulted in the United States putting India under the ‘Special 301’ watch list.

There are basically two types of “businessmen” dealing with spurious drugs. One lot produces drugs without licences or trades in expired drugs removed clandestinely from government stores. The second manufactures fake drugs after obtaining licences from the drug controller. This category is even more dangerous for it produces drugs with inadequate potency which could play havoc with the human body’s immune system. Small manufacturers work for majors and churn out genuine drugs under loan licences. Many, however, switch sides during night shifts and produce counterfeits using authentic batch numbers, packaging and infrastructure. These fakes are then mixed with the genuine drugs at the distribution level and sold through established channels, making it impossible for the consumer to differentiate between the genuine and the fake. The lack of testing laboratories only helps them.

For example, an antibiotic that otherwise costs Rs 50 per strip is produced for less than Re 1 and sold to the distributor for Rs 10. Between the manufacturer and the retailer, there lies the 5,000 per cent profit margin which provides adequate security against legal wrangles. So widespread is the cancer that over eight out of ten drugs supplied by the government tested randomly proved to be spurious.

Since faking is not a cognisable offence, those few who do get arrested are able to seek bail and resume business in no time. The limited resources available to regulate over 20,000 manufacturers has worked to the advantage of the spurious players. Spurious businesses could not have thrived without the active involvement of the regulators. According to Transparency International (India), bribes worth over Rs 7,500 crore are paid in the health sector making it a win- win situation for all — except the patient.

CNBC recently reported on a patient who suffered serious brain damage from a drug that subsequently failed quality tests. Even as the patient was rendered a mere vegetable, the company’s licence was not cancelled. The case is still in the courts. Similarly, another established company faked claims for its newly-launched anti-cancer drug. It would have continued to dupe the patients but for a front-page expose in this newspaper. The drug controller sent the matter for examination to a committee which, after two long years, is yet to submit its report. The company hopes to get away without any punishment. Abroad, a much smaller crime would have put the manufacturer behind bars. The health minister’s move towards zero-level tolerance would do wonders in restoring India’s image across the globe. One also hopes that the impending report of the Mashelkar Committee on spurious drugs will not be allowed to gather dust. Simultaneously, the government should plan to set up a statutory body, like the FDA in the US. We need to clean up this vital sector fast.