An overdose of intention

When Sushma Swaraj, the telegenic and articulate Union health minister, announced in a room packed with TV cameramen a month back that she would seek the death penalty for those peddling fake drugs, it seemed a perfect climax for a theatre of the absurd.

The televised soap opera perhaps prompted the minister to borrow a dialogue from her predecessor, Shatrughan Sinha, who had called those who raked in profits from spurious drugs "merchants of death."

No doubt, the phrase is apt for people responsible for killing so many innocent lives with fake drugs, but will the minister's crusading enthusiasm be backed by some action on the ground? The answer would be in the negative if the track record of the health ministry since independence is any indication.

To be fair, while demanding the death penalty for fake drug manufacturers -- pharmaceutical companies estimate the size of the spurious drug industry to be about Rs 4,000 crore (Rs 40 billion) -- Swaraj was only repeating what a committee headed by R A Mashelkar, director-general of the Council for Scientific and Industrial Research, had suggested in its recently released interim report.

But listen to the pharmaceutical industry, which is supposed to benefit the most from the recommendations. Despite their public posturing, the industry's leading lights are not enthused.

Says one of them: "If wishes were horses, such right noises would have been put into action long back. Manufacture of spurious medicines is not even a cognisable offence now and the move to straightaway make it an offence which leads to the death penalty is just wishful thinking."

He may be right. At a time when 97 countries have abolished the death penalty (only Vietnam believes in execution of fake drugs manufacturers) and a raging debate is going on even in India against capital punishment, Swaraj must be extremely naïve to honestly expect that she would be able push through such a Bill in Parliament.

Take the other crucial recommendation of the Mashelkar committee that Swaraj wants to implement on a war footing. The committee has recommended elevating the Central Drugs Standard Control Organisation to a strong, well equipped and professionally managed Central Drug Administration.

Laudable plan indeed, but the point is that Swaraj did not need the Mashelkar committee to suggest this and should have just looked at the ministry's past files to see how countless similar recommendations made in the past to strengthen the regulatory structure for the drug industry have been gathering dust -- some of them for over 20 years now.

The Mashelkar committee itself has pointed this out. Says the committee: "The health ministry had made several proposals earlier for expansion and upgradation of the CDSCO. In 1992, several posts to strengthen port offices, zonal offices and testing laboratories were created. These posts, however, could not be filled due to administrative complexities and have since lapsed."

Some efforts were made to revive these posts but there have been no final approvals till date.

Result: 11 years after the proposal, there are only 26 drug-testing laboratories in India of which only seven are functioning. The rest 19 simply do not have the wherewithal to carry out such sophisticated tests, making it easier for fake drugs to be sold over the counter after licences are obtained from drug controllers.

In 1999, the Pharmaceutical Research & Development Committee (this was also headed by Mashelkar) had recommended comprehensive strengthening of the CDSCO to enable it to carry out the multifarious activities the department was expected to perform.

Four years have lapsed since the acceptance of the PRDC report by the government, and the CDSCO has seen no infrastructural improvement till date.

The idea of setting up a National Drug Authority starting with the Hathi committee report (1975) was reiterated by the drug policies (1986 and 1994). However, it was not implemented.

The Mashelkar committee further observed that right from the time of the Hathi committee report, states have been repeatedly requested to set up intelligence-cum-legal cells to curb the spurious drug menace, but so far only 10 states are reported to have set up such cells. It is just not known as to how many of these are really functioning.

Yet another recommendation of the Mashelkar committee that Swaraj wants to implement with a missionary zeal pertains to manpower increase in the drug regulatory agencies. But look at the track record. In 1982, a task force appointed by the Centre had recommended a sharp increase in the number of drug inspectors.

The report, which was promptly accepted by the then health minister with a lot of fanfare, suggested that the number of drug inspectors should be on the basis of one drug inspector for 25 manufacturing units and one for 100 sales premises. It's a pity that Swaraj needed another committee to tell her the same thing 20 years later.

What's the actual situation on the ground? According to Harinder Sikka, senior president, Nicholas Piramal, there are only 600 inspectors for 20,000 registered drug producers in the country.

In Delhi, for example, 20 inspectors are on duty for 8,000 registered chemist shops, which means one inspector for 400 shops. "The inspectors have obviously chosen the best way out. Concentrate on a few chosen chemists and improve your lifestyle," Sikka says tongue-in-cheek.

He, though, strongly defends the death penalty suggested by the Mashelkar committee and gives the example of a Chandigarh-based company that was using contaminated tap water instead of the drugs in vials.

The problem runs very deep indeed. There are over 20,000 registered drug producers in India who have been given the CGMP (certified good manufacturing practices) certificate. As many as 19,950 of the drug producers account for just Rs 10,000 crore (Rs 100 billion) turnover of the total Rs

22,000 crore (Rs 220 billion) annual turnover of the drug industry, while the balance 50 (big corporations) have a turnover of Rs 12,000 crore (Rs 120 billion).

Sikka has a simple question: "A majority of these manufacturers operate from garages and hovels. Who is renewing their CGMP licences?"

According to a report by Transparency International, bribes worth Rs 7,500 crore (Rs 75 billion) are paid in the health sector in India making it a win-win situation for all -- except the patient.

The profit margins are phenomenal. Sikka gives an example: an antibiotic that otherwise costs Rs 50 a strip is produced for less than Re 1 and sold to the distributor for Rs 10. It's like selling a litre of milk at Rs 4 a litre when the market price is around Rs 10.

Between the manufacturer and the retailer there lies a 5,000 per cent profit margin which provides adequate security against legal wrangles.

Over eight out of 10 drugs supplied by the government tested randomly proved to be spurious.

Studies done by non-governmental agencies have, in fact, shown that reusage of expired drugs is a flourishing racket in rural areas, which account for 40 per cent of the total sales of the drug industry.

This is despite the fact that expired drugs degenerate fast and in some cases are more harmful than even spurious drugs.

A chemists' association representative openly admitted that quite a few chemists do not keep a pharmacist as required by the law, sell life-saving drugs without having a cold chain (most life-saving drugs lose efficacy if they are not kept in a freezer for even half an hour), do not have generator back-up, do free home delivery even though the law says clearly that drugs cannot be sold without prescription.

His justification is that the chemists' association is not a regulatory authority and it's the job of the police or the drug inspectors to take action.

The Mashelkar committee, which is expected to give its final report in October, has no doubt done a fine job in its interim report. But as an industry observer says, the minister already had enough sensible recommendations on her plate to act on.

"And unless she implements some of them immediately, her televised dialogues would continue to sound embarrassingly implausible."

One zero too many?

What's the size of the spurious drug industry? While the Indian Pharma Alliance (IPA) claims an annual damage of Rs 4,000 crore (Rs 40 billion) to the pharmaceutical industry due to spurious drugs, the Delhi Pharmaceutical Trust says the industry may have added an extra zero inadvertently.

The IPA representatives admitted before the Mashelkar committee that the figures extrapolated by them are a matter of general perception and may not be accurate. The DPT made a presentation to suggest a scheme to carry out a statistically validated and scientific study so that its final evidence-based analysis will stand the test of scrutiny.

The committee seems to have gone with the latter view and has asked the government to undertake such a study immediately.

Harinder Sikka, who has been battling the fake drugs mafia for the last three years on behalf of the IPA, however, says it's a non-issue. On a conservative estimate, there are over 650 unregistered medicine shops in Delhi alone which do Rs 1.5 to Rs 2 lakh (Rs 150,000 to Rs 200,000) business a day -- all in cash.

This itself adds up to Rs 2,500 crore (Rs 25 billion). The industry has estimated another Rs 1,500 business in the rest of the country. According to available data, Delhi, Haryana, UP and Rajasthan accounted for over 60 per cent of the fake drugs manufactured into the country. Sixty of the 129 cases detected in 2002-03 and 70 of the total 96 detected the previous year were from these states.

"You don't need to know rocket science to do this simple calculation. Those who are doubting our estimate should just go to Bhagirath Place, the spurious drug business hub in the capital, and see," he says.

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