ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

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Cleaning Up the Pharma Industry

For over 30 years pharmaceutical companies have been selling fixed-dose combination drugs with scant need to justify their efficacy, safety or rationality for use. The Government of India has finally banned 344 such drugs, though pharma companies have been able to obtain interim judicial stay orders. It is hoped that the courts take into account the serious public health implications of the sale of certain drugs and allow regulatory intervention banning uncertified combination drugs, including codeine-based cough syrups and various cold and flu drugs.

Clinical Trial-Related Injury

This article provides a detailed critique of the formulae to provide compensation to subjects of clinical trials who may suffer serious adverse effects during their participation. The present formulae used by the Central Drugs Standard Control Organization display a lack of medical ethics and disregard the accepted norms.

Intellectual Property

[An open letter to Prime Minister Narendra Modi.] We, the undersigned, wish to share with you some of our concerns on India’s position on intellectual property (IP), particularly in the context of bilateral relations between the United States (US) and India. We gather from the US-India joint...

Pharma Price Control Policy

Despite the government's and pharmaceutical lobby's claims and counterclaims, the Drugs (Prices Control) Order, 2013, which covers only 18% of the total domestic market of Rs 71,246 crore, has had very little positive effect as a price control policy. This article points out that the Order leaves out much that should have been included, while including much that should have been left out. Its provisions have made the playing field more uneven, with multiple ceiling prices, which is very unfair to consumers already dealing with an irrationally priced market.

Drug Price Control Order 2013

The hope that prices of medicines will reduce and super-profits will be curtailed has been belied by the government's drug control measures. As warned earlier, there are many loopholes which will keep most medicines out of price control, while manufacturers are likely to move away from controlled medicines to the production of unregulated ones. There is not even a proper mechanism to record and respond to consumer grievances.

Pharma Policy 2012 and Its Discontents

The National Pharmaceuticals Pricing Policy 2012 has a new method for determining the price ceiling, called a market-based pricing mechanism. This is problematic, to say the least. It can create the illusion of regulating prices without actually doing so, and will have no impact on other members of the same therapeutic class outside the National List of Essential Medicines or on existing fixed dose combinations, rational and irrational. It will reduce the prices of certain top brands, but not close potential escape routes for good. It will also leave a lot of useful life-saving drugs used in tertiary care outside the price control basket.

A Stinging Indictment of India's Drug Regulation Authority

The Central Drugs Standard Control Organisation is expected to protect the citizen from the marketing of harmful pharmaceuticals. The fi ndings of the 59th report of the Parliamentary Standing Committee on Health and Family Welfare are an expose of the shockingly lax standards followed by this so-called standards organisation, the casual approach taken in certifying drugs for sale, and the unethical and illegal steps taken by some pharmaceutical companies and medical practitioners in pushing for the introduction of certain drugs in the market. Can and will the government act?

The Compulsory Licence for Nexavar

The compulsory licence issued to Natco for manufacture of the anti-cancer drug Nexavar is a landmark decision on many grounds - the fi rst one in India since the 2005 amendment to the 1970 Patents Act and the fi rst in the world issued to a private party. There are some ambiguities in the order, but the door is now open for issue of CLs for a number of patented drugs that are not being worked.

Medicines for All

The recommendations on access to medicines, vaccines and technology made in the report of the Planning Commission's High Level Expert Group on Universal Health Coverage for India are welcome and should go a long way towards rectifying many existing problems. Yet, it would have been reassuring if a few more details had been spelled out. Given the array of vested interests that stand to lose out if they are implemented, it also remains to be seen if they will be accepted in full.

A Reply

I am most grateful to JMA Bruno Mascrenhas for pointing out the errors of transcription on my part – but errors all the same. The Cost of Drugs for Primary Health Centres (budget estimate 2011-12) is Rs 28.14 crore ( http://www.tn.gov.in/ tnbudget/demands/d1904.pdf, page 14). I have taken budget...

'Medicines for All', the Pharma Industry and the Indian State

When we consider that expenditure on medicines in India accounts for 50% to 80% of treatment costs, India's pharmaceutical success has clearly not translated into availability or affordability of medicines for all. As part of Universal Access to Healthcare, good quality healthcare should be accessible, affordable, and available to all in need. Providing quality medicines to all - free at the point of service - in all our public facilities is an achievable task. This article estimates the cost of providing free and quality medicines at all levels of public healthcare and offers suggestions on how this can be done.

Undeniable Violations and Unidentifiable Violators

The Human Papillomavirus vaccine "demonstration projects" conducted by a United States non-governmental organisation in collaboration with the Indian Council of Medical Research were suspended by the central government in 2010, following the deaths of seven tribal girls and pressure from civil society groups. An enquiry committee constituted to look into the "alleged irregularities" in the conduct of these projects has given its final report. Despite evidence of clear violations, however, the committee has absolved all involved in the project of responsibility.

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