Why did India remove cap on number of #clinicaltrials per investigator?

5 Aug

The central government, through the office of the Indian drugs regulator, has done away with the cap on the number of clinical trials per investigator. This is after it was pointed out by clinical research stakeholders such as sponsors and investigators, that this could lead to under-utilisation of clinical trials infrastructure, and investigator expertise.

The decision is now left to the Ethics Committe (EC) of the institution where the trial is to be conducted as was recommended by the Expert Committee set up by the government under the late Ranjit Roy Chaudhury. This is clearly a great relief to those involved in the conduct of clinical trials.

But at the risk of sounding like a wet blanket, I have to say – this sounds suspiciously like one of those on-again, off-again decisions that pretty much leave you where you started off with, wondering what really was achieved. Continue reading

Why do chemists hate e-pharmacies so much?

23 Jun

Last June, I wrote about the burgeoning online pharmacy business on this blog.

Taking off on a column that I had authored for the Indian Express, I pointed out that while India’s regulation of brick-and-mortar pharmacies (or chemist shops) has been slack, online pharmacies would be held to higher standards. That in the absence of a clear-cut legal pathway for online pharmacies to follow, friction with regulators could not be ruled out. And that these uncertainties would adversely impact e-pharmacies’ ability to raise funds from investors.

At a recent event organised by the Indian Internet Pharmacy Association (IIPA), it became clear that all this and more had come to fruition.

What intrigued me is that the e-pharmacy’s enemy number one appears to be India’s foremost chemist association AIOCD. IIPA members allege that they have had to endure regulatory harassment triggered by complaints from AIOCD members. These complaints have led to police investigations, regulatory raids, and the cancellation of licences of chemist shops supplying Internet pharmacies culminating in the IIPA openly accusing AIOCD members of instigating the administration to launch unnecessary probes against them. And of pressuring those chemists who do supply e-pharmacies to back off. Continue reading

Guest column : What’s up with Practo?

15 Jun

As a doctor , I was very hopeful when digital health start-ups entered India a few years ago. I am a big believer in Information Therapy, and I felt that these start-ups would use technology to help connect patients directly with doctors. They would remove the middleman and reduce information asymmetry, thus making it easier for patients to find a doctor who’s right for them.

This is one of the reasons I’ve been an angel investor in health start-ups, and have followed Practo closely, since it is the poster boy of a successful digital health start-up in India. I was optimistic that once they had raised so much money, they would be able to make a dramatic difference to the way medicine is practised in India. Unfortunately, it’s been a long time and I’m extremely unimpressed by what they accomplished so far. Continue reading

#Clinicaltrials : Are India’s Ethics Committees weak links in the chain?

7 Jun

Clinical trials, that hot-button subject hogging headlines up until a year ago, appears to have quietly slipped into the realm of business-as-usual. However, there are still some knotty issues to be resolved. Chief among them is the oversight of Ethics Committees (ECs) as was evident at a recent event I attended.

ECs – which are a mix of experts and lay persons – are the gatekeepers of ethics within their institutions. Just as a strong EC can blow the whistle on unethical behaviour, a weak or careless one might inadvertently abet it. Continue reading

Guest column : How to leverage a global policy revival in traditional medicine

19 May

Ashwin NaikOn Friday, May 13, India committed close to a million dollars to help create a benchmark document for training and practice of Ayurveda, Yoga, Unani, Siddha and Homeopathic medicine. It is indeed a significant commitment and the reinforcement of ongoing efforts by the World Health Organisation (WHO) to promote traditional health systems strengthening around the world.

What started with the Delhi declaration in 2012-13, with a consortium of South-East Asian countries is now slowly growing into an international collaboration. The Indian government used a country-by-country approach to sign bilateral agreements, starting with information centres in Mexico, Nepal, Malaysia, Russia among others. Continue reading

The ban on fixed dose combinations : Quick take #FDCban

16 Mar

I’ve been quite vocal in my views about the ban on fixed dose combinations on Twitter. So here’s a selection of my key tweets (and some retweets) on the subject. Good way to get a quick summary of the subject while I hem and haw over a longer article (if it ever gets written).  Latest tweets on top. Continue reading

Why the government wants to cap trade margins on drugs and why it shouldn’t

11 Mar

The abnormally high margin that trade channels are believed to earn on a relatively small portion of the Indian pharmaceutical market has become the latest painpoint for the central government. The  margins in question even cross 1000 per cent in some cases, according to a new report by a committee set up by the Department of Pharmaceuticals (DoP) in the Union Ministry of Chemicals and Fertilizers to investigate the matter.

The committee has now recommended capping trade margins on not just such meds which go by the moniker of ‘trade generics,’ but all drugs.

A cap on trade margins is not only difficult to implement but will do precious little to lower the price that the consumer pays. It might even lead to disputes and litigation between companies, trade, and the government. Besides, trade generics constitute not more than 15 per cent of the overall pharmaceutical market – and that is an outside estimate. Yet, this is being done in the name of the consumer. Continue reading

Hospital infection big problem in India: NABH #indiahealth #nosocomialinfections

26 Oct

Last week, the Indian Express published my column on the urgent need for hospitals – big and small – to follow infection control norms. Click here to read.

While researching the column, I spoke to officials at the National Board for Accreditation of Hospitals and Healthcare Providers (NABH) to understand how the issue might be addressed. While hospital-acquired/associated infections (HAIs) have been a concern for some years now, the spectre of drug resistance makes addressing their occurrence that much more of an imperative. For that, hospitals need to take infection control seriously.

NABH, as its name suggests, sets up and operates accreditation programmes around quality-of-care at Indian hospitals. One of the things that piqued my interest was Safe-I, a handholding programme for hospitals, that is focused on infection control. Since 2012, NABH runs this in partnership with the healthcare company Becton Dickinson. Safe-I hopes to eventually become a robust source of HAI data through a network of participating hospitals. Excerpts from an e-mail interaction with NABH CEO Dr K K Kalra. Continue reading

Tinderbox : How a meningitis vaccine tender singed GSK, Sanofi in India #UHC

23 Jun

The Competition Commission of India (CCI) recently slapped a Rs 63.5 crore fine collectively on GlaxoSmithKline Pharmaceuticals (GSK) and Sanofi Pasteur for attempting to collude to share a Union Ministry of Health tender for a meningitis vaccine and inflate prices. Indian health authorities have been immunising Indians performing Hajj, or the annual pilgrimage to Mecca, against meningitis since 2002. The case, which dates back to 2011, appears to be a great lesson in how not to tender.

What should’ve been a straightforward process for a single product with the same three suppliers year after year, took on the appearance of a farce with the tender being floated thrice over, more than one lawsuit, a disgruntled local producer and two vilified multinationals protesting their innocence. And to top it all, the guilt or lack of it of the Union Ministry of Health appears still open to question. Continue reading

My take on online drug retail for Indian Express

9 Jun

A couple of weeks ago, I met senior executives from Bengaluru start-up PM Health & Life Care. The company is getting ready to fire off an online marketplace for prescription drugs that connects chemists to consumers. I was surprised with the timing; that they would choose to reach out when just a little before, the Maharashtra Food & Drugs Administration cracked down on Snapdeal for allowing vendors to sell drugs online. More on why they felt emboldened, later.

Intermediaries for online drug retail will have to shoulder a far greater responsibility for what passes through their channels than they would say, for clothes or shoes. Read why in this column that I wrote for Indian Express published today. And yet, given the far from well-governed nature of drug retail in the country – where drugs are routinely sold without prescription and laws flouted – the intermediary can only be as good as its partner on the ground. Continue reading

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