India & drug pricing : Now, list of essential meds questioned

In continuation of the challenges arising from the roll-out of India's new drug pricing policy, a question has now been raised on the current National List of Essential Medicines (NLEM) that specifies the universe of drugs under price control. "Some may argue that the NLEM is not appropriately designed," said Dilsher Singh Kalha, Secretary, Department … Continue reading India & drug pricing : Now, list of essential meds questioned

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Can Indian regulator “fix” drug combos?

Come September 30, a new deadline that the Indian drugs regulator, Drugs Controller General of India, has set for state food and drug administrations to produce safety and efficacy data on scores of marketed fixed dose combinations - two or more molecules combined in specific ratios - from manufacturers, will lapse. This is the latest effort by the DCGI to weed out … Continue reading Can Indian regulator “fix” drug combos?

Mitigating regulatory risk at Indian Pharma

Earlier this month, Mumbai-based brokerage Ambit Capital published an Expert White Paper on pharmaceuticals in which it observed that the US Food & Drug Administration's decision to conduct surprise inspections at Indian manufacturing sites (as opposed to inspections with prior notice) has "raised regulatory risks" at Indian companies. The US FDA has been under pressure … Continue reading Mitigating regulatory risk at Indian Pharma

Guest column : Indian Pharma and collaborating beyond the obvious

Last month, Pfizer Asia Pacific, Glaxo Wellcome Manufacturing and Siemens signed on as founding members of a consortium that will offer a platform to pharma companies to address challenges such as costs, regulatory compliance, and responsiveness in production and processes to take drugs from trials to market. As also, leverage new manufacturing technologies to drive … Continue reading Guest column : Indian Pharma and collaborating beyond the obvious

Guest column : In defence of India’s pioglitazone ban

There is some debate on whether the Indian regulatory agency ought to have banned anti-diabetes drug pioglitazone given the large diabetic population in India. The decision to ban is a correct and proactive step considering the harm that it may cause in patients who have been taking the drug for over two years. Since hardly … Continue reading Guest column : In defence of India’s pioglitazone ban

Guest column : Can Indian generics move from blockbusters to biologics?

For generic dug manufacturers in India and elsewhere the number of blockbuster drugs that have recently come off patent has been a bonanza. But the product mix coming off patent over the next three years is dramatically different to the small molecule blockbuster drugs that dominated patent expirations in 2012. This presents a problem for … Continue reading Guest column : Can Indian generics move from blockbusters to biologics?

Guest column : Ponzi schemes in Indian pharma sales a real problem

Last week, a PharmaAsia News story reported sales malpractices at Mumbai-based drug maker Novartis India. The article, which told of how representatives for Novartis’ market-leading diabetes treatment Galvus had fudged distributor receipts and bought back stock using their cash incentives to meet sales targets, may have shocked some. But when MedicinMan posted this article on … Continue reading Guest column : Ponzi schemes in Indian pharma sales a real problem

Guest column : Is Indian Pharma’s spectacular growth Bonanza or Bubble?

Indian pharmaceutical companies’ profits have grown hugely in recent years. Contrary to claims that India’s robust generics industry is driven by being ‘the drug store for the developing world’, overwhelmingly the growth of the industry is from sales to established country markets in the US and Europe. But predictions for continued growth may prove to be … Continue reading Guest column : Is Indian Pharma’s spectacular growth Bonanza or Bubble?

The Ranbaxy effect : My op-ed in The Indian Express

This morning's Indian Express op-ed page carries my views on the impact of the Ranbaxy revelations on Indian generics. To read click here.  Just to clarify, I had attributed numbers on US imports of bulk drugs and finished medicines that I have cited in the column to Fortune magazine. The attribution appears to have fallen … Continue reading The Ranbaxy effect : My op-ed in The Indian Express

Guest column : Indian patent rulings and pharma strategies

The Indian government made several critical patent decisions over the past year.  Their impact on the Indian intellectual property (IP) landscape is still evolving, with important implications for IP rights, the global pharmaceutical industry, Indian consumers, and emerging economies. The stakes are high and reflecting on the ways in which these decisions will shape the … Continue reading Guest column : Indian patent rulings and pharma strategies