Indian #pharma policy : Missing the wood for the trees

The latest round of price interventions imposed on the drug industry by India’s National Pharmaceutical Pricing Authority (NPPA) has the industry fulminating. Just when it was recovering from being all but snubbed in the Union Budget, it finds that the NPPA has quietly pulled the rug from under its feet leaving it sprawled on the floor.

After the initial shock, industry captains have probably dusted themselves off and regrouped to figure out if they can sue the NPPA to oblivion. In their position, I would. Continue reading

India and clinical trials/drug safety : Progress. And questions

India’s drugs regulatory office, the Central Drugs Standard Control Organisation (CDSCO), recently issued a raft of notices on the subject of clinical trials and drug safety.

While the sheer number of them – 14 ‘orders’ dated July 3 – does raise an eyebrow or two, the communiques are noteworthy as they address issues that have turned clinical trials and drug safety in India into a lightning rod for controversy. The orders are based on a report of an Expert Committee headed by Dr Ranjit Roy Chaudhury and set up by the Health Ministry “to formulate policy and guidelines to approve new drugs, clinical trials and the banning of drugs.” Here’s my view on some of these orders. Continue reading

Think deeper about drugs affordability : my column in the Indian Express

My latest column in The Indian Express addresses the question of drug affordability. In this column, I have argued that the new Drug Price Control Order (DPCO), soon to complete a year in existence, while a major preoccupation with mandarins and managers alike in the last few months, is not a panacea for affordability.  I have used the Campaign for Affordable Trastuzumab to illustrate my point.  For the article click here.

 

 

 

 

Stop tinkering with FDI norms : my column in the Indian Express

Today’s edition of the Indian Express has an edit piece that I have authored on why the government should stop repeatedly tinkering with India’s foreign direct investment (FDI) policy for pharmaceuticals.

In this piece I have argued that there is no connection between the availability of essential medicines and the FDI policy and that this repeated hullabaloo around foreign investment is taking away the focus from those factors that do, in fact, have an impact on essential medicines. Not to mention the blatant double standards that it displays towards foreign-owned companies. You can read the column hereContinue reading

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 of Pharmaceuticals (DoP) which administers the policy, addressing CEOs and senior executives at the annual general meeting of industry body OPPI three weeks ago. Continue reading

Guest column : Analysing India’s proposed ‘new and improved’ drugs legislation

The Drugs and Cosmetics (Amendment) Bill, 2013, which was introduced in the Rajya Sabha on August 29, is finally open to comments from the public on wide-ranging legislation that covers the regulation of drugs, cosmetics and medical equipment. This Bill is overdue given the shambles in which the current system finds itself.  Continue reading

Guest column : India’s new regulatory environment hostile to clinical trials

Since January 2013, Indian regulatory authorities have announced a spate of laws and guidelines that will make a huge impact on the clinical trial sector in India.

These changes are the need of hour. If made in a pro-active manner over a period of several years, various stakeholders such as the industry, investigators and ethics committees that these rules impact, will have had adequate time to adapt to them. Instead, these changes have been reactive – in point, a reaction to the Supreme Court’s orders.

Besides, the manner in which they have been made will only serve to make clinical trials in India slow and expensive, compelling sponsors to look at alternatives.

Continue reading

Sanofi’s not a “colonial company,” says CEO Chris Viehbacher

Chris Viehbacher, Chief Executive Officer (CEO) of Sanofi, signalled his company’s continued interest in India as an investment destination and healthcare market in spite of challenges facing foreign-owned pharmaceutical companies in the country such as foreign direct investment (FDI) restrictions and drug price controls. He also drew attention to his company’s local manufacturing investments to counter the perception that foreign acquisitions of domestic firms were creating little value for the country. Continue reading

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 a number of drug combos that, at best, have no scientific reason to exist and at worst, can cause harm.  Will it work? Continue reading

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 at home to increase its inspections and audits of overseas facilities which are nowhere near as frequent as audits of factories located in the US, even as US imports of pharmaceuticals have grown rapidly.

But do more inspections mean more Indian companies will go the Ranbaxy and Wockhardt way?

The paper attempts to tackle such tricky questions by asking a panel of three former CEOs and drug industry veterans, each armed with over three decades of experience in the Indian drug industry, to try and answer them. Continue reading