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

Articles By S Srinivasan

FDC Ban and Endless Rounds of Litigation

Despite the recommendation of two expert committees to ban fixed dose combinations, the issue remains unresolved. Manufacturers of banned FDCs have approached Delhi High Court and sought to question the rationale of the ban on tendentious grounds. This also raises questions over the extent of judicial involvement in deciding upon the content of scientific matters.

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.

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.

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.