Regulation Columns

Ignoring the elephant in the room

"Only 10-15 per cent of the overall industry follows World Health Organisation (WHO) manufacturing standards." Photo: R.Ragu  

The Supreme Court recently dismissed a public interest litigation filed by a whistle-blower seeking “the creation of a framework for the recall of drugs and a commission to examine faulty drug approvals” in India. The petitioner was asked: “An overseas citizen has to come all the way to challenge a rule. What is your locus? Bring a public person affected by the rule.” This episode frames two of the most crucial public health problems facing us today. Let’s look at two seemingly unrelated issues.

Lax emission control

The first is the Volkswagen ‘Dieselgate’. An independent study found that the company apparently used software in its diesel-engine cars to trick emission tests into showing that the cars produced a low amount of pollution. As expected, the incident led to millions of cars being recalled in Europe. Most other countries where they sell their cars have launched investigations into Volkswagen’s operations, and as per reports, the company could even recall 3,23,000 vehicles, based on a government-ordered probe that found that the company’s cars fitted with EA 189 diesel engine used a ‘defeat device’ to cheat emission tests in India too.

While the government seems to have done what is required here, an almost unrelated interview in a business daily threw up a whole new perspective. On the day he was demitting office in December 2015, the outgoing Road and Transport Secretary stated in an interview that Volkswagen was just “being made a scapegoat… if you have found a problem with Volkswagen, I am sure you will find it with all others... We don’t have an in-service regime. You do it for any vehicle, you will find it. We are so much fixated with how much a new car emits… The real test is on the road. We don’t have that regime established”.

The full measure of what he was pointing out was indeed eye-opening. It seems astounding but we are essentially only following up on a company and its failures because it was identified as a part of an international investigation. However the U.S. Environmental Protection Agency’s civil suit on Volkswagen’s violations of that country’s clean air laws has not had us raising the next set of logical questions locally — namely that other vehicles sold in India could have the same problem. Will it require yet another international scandal impacting another big brand before we join the dots and ask for a strong regulatory and testing mechanism that will test on-road emissions for all vehicles and address the larger problem?

Apathy for drug safety

And that brings us to the other issue that’s been around for years — of the U.S. Food and Drug Administration’s (FDA) warnings to Indian drug manufacturers. A simple Google search for the words “FDA, warnings, drugs, India” will throw up a long list of warnings that have been issued to practically all the big names in the Indian industry. Various big players have over the years been hauled up by the FDA on aspects that range from supplying adulterated drugs to questionable data reporting, hygiene and sanitation standards, process and production quality, etc.

A few years ago when one of the largest Indian pharma companies made the cover pages of leading international magazines for allegedly supplying adulterated medicines to the U.S. and African markets, the whistle-blower from this company was quoted as saying that once he discovered the details about the safety of his company’s products he “resolved not to give his family any more (of these) drugs”.

Scared? We all should be.

And yet the local chemist I asked about the case proceeded to wave it away indicating that such niceties like product quality were not important, especially when such a ‘big company’ was involved. A follow-up discussion with a few doctors elicited almost the same response, some indicating that the industry suffered from poor standards/oversight but at least these manufacturers were better than our ‘friendly neighbourhood’ small manufacturer who followed the rules in the loosest sense of the word.

Since that incident was followed up with stiff warnings to other pharma majors, some issued as recently as a few months ago, it is puzzling that we don’t worry about the FDA standards that our drug companies seem to be failing with alarming regularity — and its possible implications for us as consumers. While I’m not sure if the same drugs are being sold in the Indian market, if nothing else the fact that a number of these companies have different plants that produce drugs for the Indian and overseas markets (and the latter presumably follow higher standards) and only 10-15 per cent of the overall industry follows World Health Organisation (WHO) manufacturing standards should make us go off our antibiotics!

As should reports that the changes proposed by the Drugs Controller General of India (DCGI) to existing pharmaceutical manufacturing laws to bring them on a par with those recommended by the WHO are nowhere in sight.

Or that the obvious next steps to taking poor quality drugs is probably hospitalisation, burgeoning hospital bills, loans, loss of working days… Do you know any public person affected by the (absence of these) rules?

(Barkha Deva, a commentator on the intersects between politics, governance and policy, is Associate Director at the Rajiv Gandhi Institute for Contemporary Studies. These are her personal views and do not represent the views of the RGICS or its trustees.)

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Printable version | Jan 23, 2021 2:06:00 PM |

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