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.

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 fi xed dose combinations, rational and irrational. It will reduce the prices of certain top brands, but not close potential escape routes for good.

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 issued to Natco for manufacture of the anti-cancer drug Nexavar is a landmark decision on many grounds – the first 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.

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.