Merchants of death in Indian pharma

As the sterilisation tragedy unfolded in Bilaspur, where as many as 14 women succumbed to medical misconduct, the media was all over the local administration, rightfully asking some tough questions. Barkha Dutt from NDTV interviewed Raman Singh, chief minister of Chhattisgarh and pointedly asked him about “political accountability” for the tragedy. This was the line of questioning on news channels and newspaper reports.

In the last few days, local newspapers carried news of arrests of Ramesh Mahawar of Mahawar Pharmaceuticals and Rakesh Khare of Kavita Pharmaceuticals after reports emerged that the antibiotic Ciprofloxacin allegedly manufactured by these two pharmaceutical manufacturers was laced with rat poison.

One newspaper quoted GN Singh, the Drug Controller General of India, saying “if the drugs are found to be substandard, we will suspend the license of the manufacturer”. Apparently, they had done this in 2012, when Mahawar Pharmawas stopped from manufacturing medicines after it was found to have produced “sub-standard” drugs for 90 days.

The basis on which it was allowed to resume production after the ban is not entirely clear.

An incident of this nature begs the following questions: Who is responsible for public health in India? Is the role of the national regulator is limited to handing out punishment to those who indulge in fraud retroactively? Why don’t our regulators to work proactively and protect public health?

In May 2012, the Parliamentary Standing Committee on Health and Family Welfare submitted its report to the Rajya Sabha on the functioning of the Central Drugs Standards Control Organization (CDSCO).

The following are excerpts from this report: “There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts.” “… the Committee is disillusioned with the qualifications provided in the age old Rules for the head of a crucial authority like CDSCO. The extant Indian system is nowhere in so far as sheer competence and professional qualifications are concerned when compared with countries like USA and UK.” “…is a matter of grave concern that there are serious shortcomings in Centre- State coordination in the implementation of Drugs & Cosmetics Act and Rules.”

That was over two years ago. Yes, there has been an increase in the budget and resources allocated to the CDSCO; some processes and coordination between the central and State health regulators have been streamlined.

But these perfunctory changes do not address the root cause of the problem. It is important to judge the performance of the regulator not in terms of how many inspectors it has, or what kind of budget it commands, but in terms of its core mission; how effectively does it protect public health? On this scale, what rating would you give the CDSCO? I would give it a F. Let me explain why.

When my case against Ranbaxy broke in May 2013, the CDSCO made public commitments to inspect the facilities that produced adulterated and substandard drugs for the US market. We are yet to hear the outcome of these inspections.

In the meantime, 15 other well-known, India-based pharmaceutical companies, whose medicines are used extensively in India, have been cited by the US FDA for “data integrity”. During the inspections that the FDA conducted of their manufacturing facilities, it was found that these companies were faking test results to make bad medicines look good.

Some of these facilities have been put on an import-ban list. Examples of the cited behaviour include releasing failing product, reprocessing failing product with different test parameters to make it pass, backdating test results and the list goes on.

Should we not expect the CDSCO to the samein India? If large, seemingly reputable pharmaceutical companies are cited for such behaviour, what about the hundreds of small outfits such as Mahawar Pharma and Kavita Pharma? Who is keeping an eye on them?

The standard justification used by both the industry and the CDSCO is that problems with the FDA inspection are related to documentation. They say the standards for documentation that India requires are different from those expected by the FDA.

Well, let them explain that to the families of the 14 women who were murdered in Bilaspur last week. It is not enough for the CDSCO to penalise fraud after a tragedy occurs; its mandate ought to be to protect the citizens of this country from fraudulent drug manufacturers, from their adulterated products entering the supply chain. It is in this mission that it fails spectacularly. Revoking licenses retroactively is an easy face-saving measure; one that doesn’t absolve it from its primary responsibility.

I have argued in the past that the entire regulatory system for medicines in India needs a fundamental overhaul. Change begins at the top. India needs a clean, internationally experienced, medical doctor to head its public health mission whose integrity is beyond reproach.

If Raghuram Rajan can run the RBI, why can’t a trained medical doctor of Indian origin run the CDSCO? Only such a person can overhaul the rot that exists within the CDSCO.

The law governing public health dates back to 1940. Yes, it has been amended, but has not caught up with times. The interests of individual States that derive licensing revenue from pharmaceutical manufacturing facilities need to be reconciled with the overarching need for public health.

The position of the head of CDSCO needs to be at the Ministerial level so that Cabinet meetings on drug policy are not dominated by the commerce department, which routinely ignores quality concerns and promotes Indian business regardless of publicly acknowledged quality-related issues.

Only an effective leader can oversee such a fundamental overhaul of this ineffective regulator.

One had high hopes from Harsh Vardhan, who recently left the health ministry because he seemed to understand the challenge we face. He rightfully called the CDSCO “a snake pit of vested interests”.

Sadly, he did precious little to fix this mess despite my offer to help. Let’s hope that the tragedy in Bilaspur serves as a wake-up call for the current government. If it doesn’t take up this cause, it will be an opportunity lost for generations to come.

The writer is the executive chairman of Medassure Global Compliance Corp and was the whistleblower against Ranbaxy Laboratories

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