On 30 April, Mint wrote a page one story about the proliferation of fake drugs in the heart of the nation’s capital. Meanwhile, legislation, in the form of an amendment to the Drugs & Cosmetics Act, proposed back in 2005, is gathering dust in Parliament even after some of the original proposals—such as death penalty for counterfeited drugs—has been watered down. Some of the recommendations stemmed from an even earlier report from a committee headed by R.A. Mashelkar, the former director general of Council of Scientific and Industrial Research.
While Union health minister A. Ramadoss as well as other ministry officials declined to talk about the delayed legislation, the department of chemicals and petrochemicals said the amendment may be taken up by Parliament in “the coming sessions.”
But enough is enough, some are saying. Harinder S. Sikka , a director at drug maker Nicholas Piramal India Ltd, has filed a public interest litigation (PIL) in the Delhi high court, asking the government to explain what has been happening with the Mashelkar report. Sikka, who has filed the litigation in his individual capacity, says that dealing in spurious drugs violates Article 21 of the Indian Constitution, which guarantees the fundamental right to life.
In a wide-ranging conversation with Mint’ s reporter, Sikka explains his motives in trying to force the issue and also offers some solutions. Edited excerpts:
What made you file a PIL on the issue of counterfeit and spurious drugs?
I have been concerned about the menace of counterfeit and spurious drugs for long. Many years ago, while writing for a newspaper (the Pioneer), I went to cover the Kargil war. It was then that I ran into the stark reality of spurious drugs. The seriously injured jawans were being administered drugs that no one had heard of. Most of the drugs being supplied there were substandard or spurious.
I have spent 13 years in the drugs industry and I have sufficient knowledge about spurious and substandard drugs. While I was in the Navy, I had the privilege of availing a Local Purchase Order (where senior officers can procure drugs from the marketplace). Why was this LPO freely given to senior officers? It was only because the government doesn’t think too highly of their own procurement system.
What is amiss in the current regulatory environment and government set-up?
It is widely known that the drugs supplied through the government tender system, focuses on L1, or the lowest-priced drugs. The focus here is not on the quality or the reputation of the company. Neither is much attention paid to the question whether the firm has the infrastructure, or is following Schedule M (good quality manufacturing norms).
On paper, some of these quality checks are done but, I can assure you, some of these drug companies are operating out of their garages. But, they have the wherewithal and the paperwork in place to procure these government contracts.
The entire Indore belt is filled with operators operating out of one bedroom. While the Indore belt is what we have personally seen, you can go to the Kanpur and the Agra dawa mandis, (local drug markets), the small-town shops close to Delhi with their linkages to famous markets in the capital, (such as Bhagirath Palace) and you’ll find numerous such operations going on.
All you need to spend on is high-quality packaging, that’s all. God knows what is put inside and how you are going to find out if the drug is spurious or not. That is the question the government has to answer, when they have just seven testing laboratories that were adequately equipped.
Two children died after Vitamin A inoculation in Lucknow more than three months ago, according to media reports. We kept telling the government that Vitamin A inoculation, administered by the Unicef and provided by Nicholas Piramal India Ltd, cannot kill anybody. There were reports that the drug was kept along with pesticides and there was a mix-up. The UN-affiliated body had a laboratory in Mumbai and got the report within two days. UN sent the drug for testing to Australia and the entire process took a week. At the government laboratory in Kolkata, it took four months for the drug to be tested.
For four months, the sword of Damocles hung over us and it took us that long to be cleared of blame. In the mean time, all the crooks and culprits got away. The children had died; the drug was contaminated.
If the government doesn’t implement Schedule M in toto, then we don’t need a war as our jawans will suffer at our own hands. The government, on the other hand, is only harping on the Drug Price Control Order and focusing on controls on drug prices.
The issue of counterfeit drugs has been there for a while but nothing has happened on the ground. What are you looking to do through this litigation?
I have discussed the issue with even the Prime Minister more than once and he said that there was a Bill that the government was very seriously looking at. Starting with the President and the Prime Minister, there are well-meaning people at the helm of affairs, but if the fake drug lords are having a field day, the establishment must take the blame and stand up to the challenge. This Bill has an agreement from all stakeholders and parties across the board. We have spoken to everybody and the net
result is zilch.
Harinder S. Sikka
The PIL seeks to do two things: It tells the government that Mashelkar’s report has been with you for four years. Please discuss it, rapidly implement it and bring a law to enforce it.
Secondly, the government’s drug procurement norms are archaic. No reputed drug company even participates in these tenders, as we cannot afford to supply the drug at rock-bottom prices. The government must understand this. Also, at those prices, someone has to be paying out of his pockets to be in the system.
Bodies, such as the All India Institute of Medical Sciences and the Municipal Corporation of Delhi, procure drugs worth crores and only a part is consumed. The remaining stock that has expired, is supposed to be destroyed. Who guarantees that these drugs actually get destroyed and don’t find their way back into the market? Media reports have suggested that these drugs are sold in the open market after their batch numbers and expiry dates are tampered with and restamped. All one needs is a nail polish remover. In those cases, even a genuine drug can become dangerous.
Is there a system for our modern hospitals to insure that expired drugs are actually destroyed? If not, who is accountable?
You are putting the onus completely on the government. What can pharma companies do?
I’m afraid the pharmaceutical companies can do nothing. It is a very hard reality if one looks at the prices at which drug companies are forced to supply drugs. If we were to add the tamper-proof packaging, radio (identification) chips, it would all cost more bringing d profitability down.
The National Pharmaceutical Pricing Authority (India’s drug price regulator) has no provision for hi-tech packaging (in its drug-price ceiling formula) at all. How do you expect firms to provide drugs in remote parts of the country, provide hi-tech packing systems and then sustain the onslaught of price controls?
Can the companies themselves be more vigilant, conduct more in-house intelligence, track this?
One of Nicholas Piramal’s drugs was in the net in Karnataka. It has been months and we have put all our might, including one-on-one contact with the state drug controller. I’m told the distributor (in the racket) has been caught. But there is no sign of the manufacturer. You mean to tell me that if the law wants, the manufacturer can’t be found and the distributor does not know who he bought it from? The slackness is in the system, for various reasons, and the law provides that anyone who is caught can get bail within 24 hours. It is a bailable offence. And look at the massive shortage of drug inspectors. Even if a drug inspector works for 24 hours and every day of the year, he cannot cover the entire ground.
Are drug firms in a state of denial? They address the issue through forums but brush the issue under the carpet for their own brands...
Of course, they are. They have to be. Company A knows that if one of their drugs is fake and the word gets out, an impression could gain ground that (their) other drugs could also be fake. This would hit them hard. The fact is that the companies, the government and the world at large are all aware of this problem.
We do gather a lot of information through our field-force and pass them on to the regulatory side. Even after that, either the police is not available or there are problems in testing the drug. Even if the drug lands up in the laboratory, it doesn’t always test as a spurious drug as money has changed hands in the meantime. The long time-window facilitates wrong-doing.
If there were to be a tight regulatory regime, with an army of activist drug inspectors, won’t the pharmaceutical industry be the first to cry foul?
The regulator has to be stronger. For this, he has to have infrastructure. In India, the Drug Controller General works in isolation. Here, infrastructure is under the ministry of health and family welfare, while drug pricing is under the ministry of chemicals and fertilizers. The two may not see eye-to-eye or the matter may get lost between the files.
A pharma firm today depends on the following ministries to make a drug: ministry of commerce, finance, chemicals and fertilizers, health and family welfare, environment, law, science and technology. Then it has to undertake research, supply drugs at cheapest possible prices, see if the drugs are substandard or not and then fight court battles.
The government is only interested in bringing the prices of drugs down with the result that most firms are now focused on overseas markets or contract manufacturing and research. Policing is not our job. It is not the companies’ purview.
Who is providing the financial backing to your PIL?
The PIL has been filed by me, in my personal capacity and I can take care of all the expenses involved. It is not from Nicholas Piramal’s side. My lawyer, Amit Sibal, has been gracious enough not to charge for this case.
How does one tackle the problem?
The solutions are simple. If the government announces monetary incentives to a whistle-blower against this racket, you can solve half the problem.
Secondly, the number of drug-testing laboratories and the people doing it has to be increased. For this, there can be a public private partnership. For a country like India, seven labs are not enough. We need 170 such labs. The results (of tests) must come out immediately.
The drugs procured by the government should undergo random sampling tests. If they are being undertaken (now), they are only on paper.
Does anyone go and inspect these agencies that supply the drugs to see if they are Schedule M compliant or not? It is not candies and chocolates they are supplying, but life-saving drugs.
The public agencies can procure drugs from manufacturers directly. We have offered a formula to the chemicals ministry wherein, we will provide the essential drugs at 50% of list price. Thereafter, leave us alone from price controls, to research newer drugs. We don’t know why it has not been accepted.
Also, there is no ‘recall’ mechanism in India. Recently, anti-tuberculosis drugs were supplied to the Jharkhand government. These were found to be substandard, but, by the time, it was discovered, they had already been disbursed to various government agencies. There was no system to call back these drugs. You need a stronger grip over the distribution chain.
You need to create the fear of God in offenders. That can happen through legislation and the infrastructure around it. Then have the whistle-blowing policy with incentives. Otherwise, you and I are sitting targets. The problem in our country is that there is a sab chalta hai attitude. When the patient dies, it is deemed God’s will. Now how many die because of God’s will and how many owing to man’s will, needs to be brought out. That is what this PIL is all about.
Ashish Sharma contributed to this interview.
Mint also invites readers to comment and suggest their own remedies to a problem that potentially affects everyone who needs to buy and use drugs, by writing to us at firstname.lastname@example.org.